AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
Device Facts
| Record ID | K122009 |
|---|---|
| Device Name | AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER |
| Applicant | Panasonic Healthcare Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 3, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Indications for Use
The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel application. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A also 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. This system is contraindicated for fetal use.
Device Story
Portable ultrasound system for non-invasive peripheral vessel examination. Inputs: ultrasound echoes via transducer. Processing: real-time Brightness (B), Color Doppler, and Pulse Doppler imaging; automated intima-media thickness (IMT) measurement; cardiovascular risk score calculation (Framingham, PROCAM, Reynolds, SCORE) via user-inputted risk factors. Output: anatomical visualization, IMT measurements, and comprehensive cardiovascular risk assessment reports. Used in clinical settings by healthcare providers. Benefits: aids diagnosis of vascular structures and dynamic processes; assists in cardiovascular risk stratification.
Clinical Evidence
Bench testing only. Compliance with safety and performance standards including UL 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1/5/10, and NEMA UD 2/3.
Technological Characteristics
Portable ultrasound system; B-mode, Color Doppler, Pulse Doppler, and BIMT modes. Transducer model LV13-5V1. Complies with IEC 62304 (software), ISO 10993 (biocompatibility), and NEMA UD 2/3 (acoustic output). Connectivity includes touchscreen interface for parameter input and report generation.
Indications for Use
Indicated for peripheral vessel application in patients requiring ultrasound imaging and fluid flow analysis. Includes automated intima-media thickness (IMT) measurement of peripheral vessels (e.g., common carotid) for heart rates 20-150 bpm. Contraindicated for fetal use.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
Submission Summary (Full Text)
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长122009
.
Panasonic Healthcare Co., Ltd
Chapter 4. 510(k) Summary
# 510(k) Premarket Notification AIDA V1.8 Diagnostic Ultrasound System GM-72P00A
·
| 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: | July 6, 2012 |
| Trade Name: | AIDA V1.8 Diagnostic Ultrasound System GM-72P00A |
| Model No: | GM-72P00A |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550)<br>Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560)<br>Diagnostic Ultrasound Transducer (21 CFR 892.1570) |
| Classification Number(s): | 90-IYN; 90-IYO; 90-ITX |
| Regulatory Class: | Class II |
| Predicate Device(s): | K113612 - AIDA V1.5 Diagnostic Ultrasound System GM-72P00A,<br>Panasonic Healthcare Co., Ltd<br>K093171 - Viamo SSA-640A,<br>Toshiba America Medical Systems, Inc. |
Э 2012
ОСТ
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Device Description:
The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis.
This system also provides an automated measurement of the intimamedia thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using realtime Brightness, Color Doppler and Pulse Doppler imaging modes. The touchscreen keyboard allows the user to input various 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 V1.8 Diagnostic Ultrasound System GM-72P00A is designed to comply with the following standards:
UL 60601-1: 2003;
IEC 60601-1-1: 2000;
IEC 60601-1-2: 2nd Edition (2001), Amendment 1 (2004);
IEC 60601-2-37: 2001, Amendment 1 (2004), Amendment 2 (2005); IEC 62304: Ed. 1.0 (2006);
ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; NEMA UD 2-2004 (R2009); NEMA UD 3-2004 (R2009);
Intended Use:
The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel application. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic process within the human body using ultrasound to aid diagnosis. The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A also 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. This system is contraindicated for fetal use.
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### Panasonic Healthcare Co., Ltd
Technological Comparison to Predicate Device
> The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is substantially equivalent to products that have already been cleared for USA distribution with 510(k) premarket notification numbers K113612 and K093171. 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.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 curved lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 3 2012
Panasonic Healthcare Co., Ltd. c/o Ram Bedi Puget Ultrasound, Inc. 2425 Squak Mountain Loop SW Issaquah, WA 98027
Re: K122009
Trade Name: AIDA V1.8 Diagnostic Ultrasound System GM-72P00A Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Codes: IYN, IYO, ITX Dated: July 9, 2012 Received: July 9, 2012
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 V1.8 Diagnostic Ultrasound System, as described in your premarket notification:
### Transducer Model Number
### LV13-5V1
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.
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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 (OS) 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 Lauren Hefner at (301) 796-6898.
Sincerely Yours,
Michael D O'Brien for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure(s)
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### Panasonic Healthcare Co., Ltd
510(k) Premarket Notification AIDA V1.8 Diagnostic Ultrasound System GM-72P00A
# Indications for Use Statement
| 510(k) Number: | 122009 |
|----------------|--------|
|----------------|--------|
AIDA V1.8 Diagnostic Ultrasound System GM-72P00A Device Number:
Company Name: Panasonic Healthcare Co., Ltd.
Indications for Use:
The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel application. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A also 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. This 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)
***_***.
Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation and Safety
510K 15 12 2009
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# System:
# AIDA V1.8 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>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 | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | N | | P | 1 | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Combined mode BIMT (B + IMT), BD (B + Pulse Doppler) and BCD (B + Color Doppler + Pulse Doppler)
Prescription Use Only (Per 21 CFR801.109)
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#### AIDA V1.8 Diagnostic Ultrasound System GM-72P00A System: LV13-5V1 Transducer:
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 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>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 | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | N | | P | 1 | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined mode BIMT (B + IMT), BD (B + Pulse Doppler) and BCD (B + Color Doppler + Pulse Doppler)
Prescription Use Only (Per 21 CFR801.109)
ly (Per 21 CFR801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K 122009
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