AIDA DIAGNOSTIC ULTRASOUND SYSTEM

{0}------------------------------------------------ K103/48 ### Panasonic Healthcare Co., Ltd 510(k) Premarket Notification AIDA Diagnostic Ultrasound System GM-72P00A MAR 1 1 2011 ## Chapter 4. 510(k) Summary | Submitter's Name: | Panasonic Healthcare Co., Ltd. | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Medical Imaging Business Unit<br>600 Saedo Cho, Tsuzuki Ku<br>Yokohama, 224-8539 Japan | | Contact: | Keijiro Asayama, Division Director | | Telephone: | +81 45 939 1010 | | Date: | October 18, 2010 | | Trade Name: | AIDA Diagnostic Ultrasound System GM-72P00A | | Model No: | GM-72P00A | | Common Name: | Ultrasound Imaging System | | Classification Name(s): | Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560)<br>Diagnostic Ultrasound Transducer (21 CFR 892.1570) | | Classification Number(s): | 90-IYO; 90-ITX | | Regulatory Class: | Class II | | Predicate Device(s): | K093171 - 7 Viamo SSA-640A, Toshiba America Medical<br>Systems, Inc.<br>K081794 - 7340 Ultrasound System, Esaote, S.p.A.<br>K022567 - Sequoia Diagnostic Ultrasound System, Acuson Corp. | | Device Description: | The AIDA diagnostic ultrasound system is a portable ultrasound system<br>optimized to perform a non-invasive examination of the peripheral<br>vessels. It provides an automated measurement of the itima-media<br>thickness (IMT) of peripheral arteries such as the common carotids and | allows the user to search for arterial plaques using real-time B-mode imaging. The touchscreen keyboard allows the user to input various {1}------------------------------------------------ parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment. The AIDA diagnostic ultrasound system is designed to comply with the following standards: UL 60601-1 :2003 IEC 60601-1-1:2000 IEC 60601-2-37 2001, Amendment 1 (2004), Amendment 2 (2005) IEC 60601-1-2, (Second Edition, 2001), Amendment 1 (2004) IEC 62304 Ed. 1.0 ISO 10993-1:2003, ISO 10993-5:1999, ISO 10993-10:2002 NEMA UD 2-2004, NEMA UD 3-2004 Intended Use: The AIDA diagnostic ultrasound system is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT mode of operation for heart rate range of 20-150 beats per minute. The AIDA ultrasound system is contraindicated for fetal use. Technological Comparison to Predicate Device > The AIDA diagnostic ultrasound system is substantially equivalent to products that have already been cleared for USA distribution with 510(k) premarket notification numbers K093171, K081794 and K022567. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures. All systems permit specialized measurement of anatomic structures. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, rendered in a flowing, abstract manner. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper portion of the circle. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Panasonic Healthcare Co., LTD. % Mr. Ram Bedi President Puget Ultrasound 2425 Squak Mountain Loop SW ISSAQUAH WA 98027 MAR 1 1 -201 Re: K103148 Trade/Device Name: AIDA Diagnostic Ultrasound System GM-72P00A Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: February 20, 2011 Received: February 23, 2011 Dear Mr. Bedi: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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. This determination of substantial equivalence applies to the following transducers intended for use with the AIDA Diagnostic Ultrasound System GM-72P00A, as described in your premarket notification: Transducer Model Number #### L13-5V1 {3}------------------------------------------------ If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 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); 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. This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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. If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242. Sincerely Yours. Mary S Patel Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure(s) {4}------------------------------------------------ ## Chapter 2. Statement of Indications for Use K103148 510(k) Number: AIDA Diagnostic Ultrasound System GM-72P00A Device Number: Company Name: Panasonic Healthcare Co., Ltd. Indications for Use: The AIDA diagnostic ultrasound system is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT mode of operation for heart rate range of 20-150 beats per minute. The AIDA ultrasound system is contraindicated for fetal use. Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Per 21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Mary S. Padilla (Division Sign Off) 510K K103/48 {5}------------------------------------------------ # System: AIDA Diagnostic Ultrasound System GM-72P00A Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |--------------------------|------------------------------------|---|---|-----|-----|------------------|-----------------------|---------------------| | General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | (Track 1 only) | (Tracks 3) | | | | | | | | | Opthalmic | Ophthalmic | | | | | | | | | | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | Fetal Imaging<br>& other | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal<br>(Conventional) | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | N | | | | | 1 | | | | Other (Specify) | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined mode B + IMT Prescription Use Only (Per 21 CFR801.109) Mung S. Patel (Division Sign-Off) 510K Division of Radiological Device on and Safety Office of In Vitro Diagnostic I {6}------------------------------------------------ # . System: AIDA Diagnostic Ultrasound System GM-72P00A Transducer: L13-5V1 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General<br>(Track 1 only) | Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | Opthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal<br>(Conventional) | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | N | | | | | 1 | | | | Other (Specify) | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined mode B + IMT Prescription Use Only (Per 21 CFR801.109) May S. Patel (Division Sign-Off) Division of Radiological D Office of In Vitro Diagnostic Dev 510K :