ULTRASOUND SCANNER FLEX FOCUS 1202

{0}------------------------------------------------ ## 510(k) Summary: K132677 Page 1 of 4 JAN - 7 2014 This summary is provided as part of this Premarket Notification in compliance with 21 CRF. Section 807.92. Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Gert Nielsen, Regulatory Manager Date updated: November 01, 2013 Trade name: Ultrasound Scanner Flex Focus 1202 Common name: Diagnostic Ultrasound System Classification names: (90 IYO, CFR 892.1560) Ultrasonic Pulsed Echo Imaging System Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) Diagnostic Ultrasonic Transducer (90 ITX. CFR 892.1570) Identification of predicate, legally marketed device: The predicate device(s) is(are): ZONARE Medical Systems Inc .: ZONARE ZS3 Ultrasound System (K120703) Transducer Model Number: C10-3 - . Philips Healthcare, Inc.: CX50 Diagnostic Ultrasound System (K111513) Transducer Type: C8-5 - Toshiba America Medical Systems, Inc .: . Diagnostic Ultrasound System (K121422) - o Aplio 500 TUS-A500 v2.1 - o Aplio 400 TUS-A400 v2.1 - o Aplio 300 TUS-A300 v2.1 Transducer Model Number: PVT-712BT #### Device description: Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-mode. CFM mode. Amplitude (Power) Doppler mode The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. #### Transducers Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. 1/4 {1}------------------------------------------------ The patient contact materials are biocompatible and comply with ISO10993-1. All transducers used together with Flex Focus 1202 are Track 3 transducers. ### Acoustic output The system controlling the Acoustic Output in the modified Flex Focus 1202 is the same as the System in the Flex Focus 1202. The system will assure that the acoustic output alwavs will stav below the pre-amendments upper limits i.e. Ispta ≤ 720 m W/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0 ### Clinical measurement accuracy. Clinical measurements and calculations are described and accuracies are provided with the User Guide. #### Thermal, mechanical and electrical safety. The scanner 1202 has been tested by a recognized, certified body according to IEC 60601-1. #### Acoustic Output Reporting The Acoustic Qutput Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 2008" The acoustic output is measured and calculated according to: * Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment'' (AIUM 1998). ## Intended use. See comparison below {2}------------------------------------------------ ## Technological characteristics compared to the predicate device(s). The predicate device(s) has the same major technological characteristics as the subject device, see comparison below. | Supplier | BK Medical Systems | ZONARE<br>Medical Systems | Philips | Toshiba | Comparison | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510K No. | K081154, K123254 | K120703 | K123754 | K121422 | Comparable | | Intended use | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body as follows | Diagnostic Ultrasound<br>Imaging and fluid<br>flow analysis in the<br>following applications: | Diagnostic Ultrasound<br>Imaging and fluid<br>flow analysis in the<br>following applications. | Visualization of<br>structures and dynamic<br>process with the<br>human body using<br>ultrasound and to<br>provide image<br>information for<br>diagnosis in the<br>following clinical<br>applications: | Comparable | | Indications<br>for use | Abdominal<br>Fetal (incl Obstetrics)<br>Intraoperative<br>Transurethral<br>Neurosurgery<br>Pediatrics<br>Small Parts (organs)<br>Neonatal Cephalic<br>Cardiac<br>Transrectal<br>Transvaginal<br>Peripheral vascular<br>Muskulo-skeletal<br>(conventional and<br>superficial) | Opthalmic.<br>Fetal/Obstetric.<br>Gynecological,<br>Abdominal (renal,<br>TYN/Pelvic: Intra-<br>operative (abdominal,<br>thoracic, and vascular,<br>Intra-operative<br>neurological,<br>Pedicatric,<br>Small organ (thyroid,<br>breast, testes, etc).<br>Adult Cephalic.<br>Neonatal Cephalic,<br>Trans-rectal,<br>Trans-vaginal,<br>Trans-cranial,<br>Trans-esophageal<br>(non-cardiac and<br>cardiac).<br>Musculoskeletal<br>(conventional &<br>Superficial).<br>3D/4D. Cardiac<br>Adult/Pediatrics/Fetal.<br>Echo, Intra-Cardiac.<br>Pelvic,<br>Perpheral vasuclar,<br>harmonic tissue and<br>contrast imaging and<br>tissue elasticity, Vet<br>and others | Opthalmic,<br>Intracardiac echo.<br>Intraoperative,<br>Laparoscopic.<br>Fetal, Abdominal,<br>Pediatric,<br>Small organ, Adult<br>Cephalic, Neonatal<br>Cephalic.<br>Transvaginal,<br>Musculosceletal.<br>Gynecological,<br>Cardiac Adult.<br>Cardiac Pediatric.<br>Trans-Esophogeal<br>(Cardiac),<br>Peripheral Vessel.<br>Other (Carotid) | abdominal, intra-<br>operative (abdominal).<br>Pediatric,<br>Small organs,<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-vaginal,<br>Trans-rectal<br>Musculoskeletal<br>(conventional and<br>superficial)<br>Cardiac Pediatric<br>Cardiac Adult<br>Peripheral Vascular<br>Transesophageal | Comparable | | Transducer<br>specific | | | | | | | 510K No. | K043524 | K120703 | K123754 | K121422 | Comparable | | Indication<br>for use | Neonatal Cephalic | Neonatal Cephalic | Neonatal Cephalic | Neonatal Cephalic | Comparable | | Frequency | 10-3.8 MHz | 10-3 MHz | 8-5 MHz | 10-3 MHz | Comparable | ## Comparison with the predicate devices mentioned above from: ## Summary of Clinical Tests: This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound system with these characteristics are well accepted for both predicate and subject devices. {3}------------------------------------------------ K132677 Page 4 of 4 4/4 Conclusion: The device Flex Focus 1202 and the probe N13C5 type 8862 in this application has similar intended uses, and in particular the subject for the submission, the addition of the new application Neonatal Cephalic, is the same. B-K Medical ApS therefore considers, that 1202 is substantially equivalent to the predicate devices. {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. To the left of the eagle is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 7, 2014 B-K Medical ApS % Mr. Gert Nielsen Regulatory Affairs Manager Mileparken 34 Herlev DK-2730 DENMARK Re: K132677 Trade/Device Name: Ultrasound Scanner Flex Focus 1202 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: December 5, 2013 Received: December 19, 2013 Dear Mr. Nielsen: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. This determination of substantial equivalence applies to the following transducers intended for use with the Ultrasound Scanner Flex Focus 1202, as described in your premarket notification: Transducer Model Number ## N13C5 Type 8862 If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act {5}------------------------------------------------ Page 2-Mr. Nielsen or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from 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 address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Sincerely yours,  for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use ## 510(k) Number (if known): K132677 Device Name: Ultrasound Scanner Flex Focus 1202 Ultrasound Transducer N13C5, Type 8862 Indications for Use: Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Clinical applications: Ultrasound Scanner Flex Focus 1202: Fetal. Obstetrics. Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Cardiac, Transvaginal, Transvaginal, Transurethral, Peripheral Vascular, Musculoskeletal. Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic. Details on specific Indication for Use forms Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) fmh.p) Page 1 of 1 (Division Sign-Off) Division of Radiological Health/OIR 510(k) K132677 Page 001 of 003 {7}------------------------------------------------ ### Diagnostic Ultrasound Indications for Use Form #### System: 1202 #### Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |------------------------------------------------------------------------|-------------------|---|---|-----|--------------------------------|------------------|----------------------|------------------------------|-------------------------|----------| | Clinical Application | A | B | M | PWD | Tissue-<br>harmonic<br>imaging | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify 1) | Other 3) | | Ophthalmic | | | | | | | | | | | | Fetal 2) (K081154) | P | P | P | P | P | P | P | | P | | | Abdominal (K081154) | P | P | P | P | P | P | P | | P | | | Intraoperative (specify)<br>(K081154) | P | P | P | P | P | P | P | | P | | | Intraoperative Neurological<br>(K081154) | P | P | P | P | P | P | P | | P | | | Pediatric (K081154) | P | P | P | P | P | P | P | | P | | | Small Organ (specify)<br>(K081154) | P | P | P | P | P | P | P | | P | | | Neonatal Cephatic | N | N | N | N | N | N | N | | N | | | Adult Cephalic | | | | | | | | | | | | Cardiac (K081154) | P | P | P | P | P | P | P | | P | | | Transesophageal | | | | | | | | | | | | Transrectal (K081154) | P | P | P | P | P | P | P | | P | | | Transvaginal (K081154) | P | P | P | P | P | P | P | | P | | | Transurethral (K081154) | P | P | P | P | P | P | P | | P | | | Intravascular | | | | | | | | | | | | Peripheral Vascular<br>((K081154 except other 3))<br>(K123254 other 3) | P | P | P | P | P | P | P | | P | P | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional (K081154) | P | P | P | P | P | P | P | | P | | | Musculo-skeletal Superficial<br>(K081154) | P | P | P | P | P | P | P | | P | | | Other (specify) | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:_ 1) B+M. B+D. B+C. B+D+C. D is PWD, C is Color Doppler, 2) Fetal is often called Obstetrics 3) Vector Flow Imaging (PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON 4NOTHER PAGE IF NEEDED) Concurrence of CDRH: Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109) . {8}------------------------------------------------ ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM | System: | 1202_ | |-------------|-------| | Transducer: | 8862_ | 1202 cer: 8862 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation | | | | | | |---------------------------|------------------------------------------|---|-------------------|-----|-----|------------------|-------------------------|----------------------| | General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify 1) | Amplitude<br>Doppler | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify 2)<br>(K081154) | E | E | E | | E | E | E | | | Intra-operative (Neuro)<br>(K081154) | E | E | E | | E | E | E | | | Laparoscopic | | | | | | | | | Fetal Imaging<br>& Other | Pediatric<br>(K081154) | E | E | E | | E | E | E | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | N | N | N | | N | N | N | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel.<br>(Conventional) | | | | | | | | | | Musculo-skel. (Superficial) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging 1) Mode combinations: B+M, B+D, B+C, B+D+C. (D is PWD, C is Color Flow Additional Comments:_ mapping Doppler including Amplitude(power)Doppler)_ 2)Intraoperative: Gall bladder_ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)