<1&If3 - Food and Drug Administration

1 <1&If3GE Healthcare5 10O(k) Premarket Notification Submission510(k) Summrary JAN 3 1 2014In accordance with 2 1 CFR the fbollowing summary of informiation is provided:Date: December 5, 2013 Submitter: GE H-Iealthcare9900 Innovation DrWauwatosa, WI 53226 Primary Contact Person: Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(4 14)72 1-42 141F:(4 14)918-8275 Secondary Contact Person: Jiawei 71-ANGR egulatory AffairsGE HeIalthcare1T: +86 510 8527 8259F: +86 5 10 8522 7347 Device: Trade Name: logiq F SERIESC ommon/Usual Name: logiq F&. logiq F6. logiq 1-5, logiq F'3 Classification Names: Class 11 Product Code: Ultrasonic Pulsed Doppler Imaging System. 2I1 CFR 90-I YN Ultrasonic Pulsed Echo Imaging System. 2I1CF-R ,90-IYO Diagnostic Ultrasound Transducer, 2 1 CER ,90-ITXP redicate Device(s): K 122387 GE Voluson P8K 131527 GE logiq S8K 113690 logiq eli, Vivid eDevce escipion ,Thle logiq F Series is the full featured general purposediagnostic ultrasound system which consists of a mobile console(Approximately 72 cm wide.)

2 80 cm deep and 145 cm high) thatprovides digital acquisition. processing and display user interface includes a computer keyboard, color LCDimage display and touch Healthcare5 1 0(k) Premarket Notification SubmissionMain Differences Between ModelsProduct name logiq F8 logiq F6 logiq F5 logiq F3 Imaging Color Color Color Black & WhileLCD 19'LD LC D r I LCI or I 9 LCD IT7 LCD19' logiq F SERIES is a general purposed ultrasound imagingInteded se:and analysis systems providing digital acquisition, processing anddisplay capability, clinical applications including: Abdominal,Obstetrical, Gynecological, Small parts, Vascular/PeripheralVascular, Transcranial, Pediatric, Musculoskeletal, Urological,Cardiac, TransvaginalTechnology: T he logiq F SERIES employs the same fundamental scientifictechnology as its predicate of Comparison to Predicate DevicesSubstantial Equivalence: The logiq F Series system is substantially equivalent to thepredicate devices with regard to intended use, imagingcapabilities, technological characteristics and safety andeffectiveness.

3 * The systems are all intended for diagnostic ultrasoundimaging and fluid flow analysis.* The logiq F Series and predicate systems have similarclinical intended use and similar imaging modes.* All the transducers used on logiq F Series have beencleared on Voluson P8 (K 122387) except 8C-RS and L-6-12-RS.* 8C-RS has been cleared on logiq eli, Vivid e(KI 13690).* L6-1 2-RS is a new transducer equivalent to the predicateL-l8-RS on the logiq eli. Vivid e (KI 13690).* The systems are manufactured with materials which havebeen evaluated and found to be safe for the intended useof the device.* The systems have acoustic power levels wvhich are belowthe applicable FDA limits." Elastography, Tissue Velocity Imaging (TVI)/TissueVelocity Doppler (l'VD), Auto IMT and Quantitative27GE Healthcare5 10(k) Premarket Notification SubmissionAnalysis have been previously cleared on the logiq S8(K1I3- 15 27).The logiq F Series and predicate systems have been designedin compliance with approved electrical and physical of Non-Clinical Tests:The logiq F SERIES has been evaluated for acoustic output,biocompatibility, cleaning and disinfection effectiveness as wellas thermal, electrical, electromagnetic, and mechanical safety,and have been found to conform with applicable medical devicesafety standards.

4 The logiq F SERIES complies with voluntarystandards:* AAMI/ANSI E56060 I-I, Medical Electrical Equipment-Part I1: General Requirements for Safety* 1EC60601-l-2, Medical Electrical Equipment -PartI -2:General Requirements for Safety -CollateralStandard: Electromagnetic Compatibility Requirementsand Tests* IEC6060 1-2-37, Medical Electrical Equipment -Part :Particular Requirements for the Safety of UltrasonicMedical Diagnostic and Monitoring Equipment* NEMA UD 3, Standard for Real Time Display of Thermaland Mechanical Acoustic Output Indices on DiagnosticUltrasound Equipment* IS0 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition* NEMA liD 2. Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment* 15014971, Application of risk management to medicaldevices* NEN4A, Digital Imaging and Communications inMedicine (DICOM) Set. (Radiology)28GE Healthcare5 10(k) Premarket Notification SubmissionThe following quality assurance measures were applied to thedevelopment of the system:*Risk Analysis*Requirements Reviews*Design Reviews*Testing on unit level (Module verification)*Integration testing (System verification)*Performance testing (Verification)*Safety testing (Verification)*Simulated use testing (Validation)Transducer material and other patient contact materials such asneedle guidance kits are of Clinical Tests:The subject of' this premarket submission.

5 logiq F Series, didnot require clinical studies to support Substantial : GE H-ealthcare considers the logiq F Series to be as safe, aseffective, and performance is substantially equivalent to thepredicate device(s).29 Page 3-Mr. Behn------E1 FMOVE 'IllIS PAGE WHlEN PRZINTING OR E'MAI LING TO SIPONSO)R0(k)fNuimber: K133034/S02 -GEllatcareDigital Signatute Concurrence T Alie%Reviewer Sign-Off' Shahram VaezyJanuary 30, 2014 Branch Chief Sign-Off Robert OchsJanuary 30, 2014 Division Sign-Off Sean M. Boyd -S) :52:42 -0o'ooQC: EMEba fm& 1/30/2014 Template Name: OIR Letter Generator -Letter type: SEDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service$ 4 food and drug Administration '410903 New Hampshire AvenueDocument Control Center -W066-G6D9 Silver Spring. MD 209Q3-OD02 January 3 1, 20 14GE healthcare % Mr. Bryan BehnRegulatory Affairs Manager9900 Innovation DriveWAUWATOSA WI 53226Re: K133034 Trade/Device Name: logiq F SeriesRegulation Number: 21 CFR Name: Ultrasonic pulsed doppler imaging systemRegulatory Class: 11 Product Code: IYN, IYO, ITXD ated: January 22, 2014 Received: January 23, 2014 Dear Mr.

6 Behn:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal food , Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration. listing ofdevices, good manufacturing practice. labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties.

7 We remind you, however, that device labeling must be truthful and not determination of substantial equivalence applies to the following transducers intended foruse with the logiq F Series, as described in your premarket notification:Transducer Model Number4C-RS 8C-RS3Sc-RS L6-12-RSE8C-RS RAB2-6-RSIf your device is classified (see above) into either class 11 (Special Controls) or class Ill (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Pants 800 to 898. In addition, FDA maypublish fuirther announcements concerning your device in the Federal 2-Mr. BehnPlease be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies.

8 You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CER you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet addresslitti://! [)evices/ReSOuircesfor'Yoti/ Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (2 ICFR ). For questions regarding the reporting of adverse events under the MDR regulation (2!]

9 CFR Part 803), please go /Reroortallimblem/deI' for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp)://www;%. Devices/RcsoturccstorYou/ yours,forJanine M. MorrisDirector, Division of Radiological HealthOffice of In Vitro Diagnosticsand Radiological HealthCenter for Devices and Radiological HealthEnclosureGE Healthcare510(k) Premarket Notification Submission5 10(k) Number (if known): K133034 Device Name: logiq F SeriesIndications for Use:The logiq F SERIES are general purposed ultrasound imaging and analysis systemsproviding digital acquisition, processing and display capability, clinical applicationsincluding: Abdominal. Obstetrical. Gynecological.

10 Small parts, Vascular/PeripheralVascular, Transcranial. Pediatric, Musculoskeletal. Urological. Cardiac. TransvaginalPrescription Use x AND/ORk Over-The-Counter UseNIA_(Part 21 CFR S8l Subpart D) (Part 21 CER 801 Subpart C)-(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGEIF NEEDED)Concurrence-of CDRH, Office of In Vit-ro Diagnostics -and Radiological Health (OIR)Page I of 9(Division Sign-Off)Division of Radiological HealthOffice of In Vitro Diagnostics and Radiological Health510(k) ____K133034____Diagnostic Ultrasound Indications for Use FormLOCIO F8, F6. FS Ultrasound SystemsIntended Use: Ultrasound imaging, measurement and analysis of the human body as follows:ClnialApliatonMode of Operation ___Dopple Modes ombined I larnvonic 'Region of I1niereri B M CW ClrColor modes Imaging Pulse' OtherPW CWClrM PowvcAbdominal11 N N N N N N 151 Pediatric N N N N N N N N NSmall Organ (specify)"~' N N __ N N- N N [6 Neonatal CephalicAdult CephalicCardiac1~l N N N N N N N N NPeripheral Vascular N N N N N NMusculo-skeletal Conventional N N N N N NMusculo-skeletal Superficial N N N N N NThoracic/Plural (specify) I___ I_Other (specify)Exam Type.]