(66 days)
Not Found
No
The document describes an "automated intima-media thickness measurement" and "post processing of received echoes," but it does not explicitly mention the use of AI, ML, or related terms like deep learning or neural networks in the description of the automated process. The risk score calculations are based on traditional formulas.
No
The device is described as a "Diagnostic Ultrasound System" intended for "Peripheral Vessel applications" to measure intima-media thickness and detect plaques. Its function is to provide information for risk assessment, not to treat any condition.
Yes
The intended use explicitly states "The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel applications." and "The system provides an automated intima-media thickness measurement of peripheral vessels...". Furthermore, the device description mentions it "is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels." and it "generates a comprehensive report of cardiovascular risk assessment." All these functions are characteristic of a diagnostic device.
No
The device is described as a "portable ultrasound system" and mentions transmitting ultrasonic energy and processing received echoes, indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is a non-invasive ultrasound system. It uses ultrasonic energy transmitted into the patient's body to create images and perform measurements. It does not analyze samples taken from the body.
- Intended Use: The intended use is for imaging and measuring peripheral vessels, which is a direct examination of the patient's anatomy, not an analysis of a biological sample.
Therefore, based on the provided information, the AIDA V1.5 Diagnostic Ultrasound System GM-72P00A falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A 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 V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use.
Product codes
IYN, IYO, ITX
Device Description
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. It provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using real-time Brightness and Color 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral vessels, common carotid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
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FEB 1 0 2012
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence starts with the letter 'K', followed by the number '11', then '3612'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance.
Panasonic Healthcare Co., Ltd
510(k) Premarket Notification AIDA V1.5 Diagnostic Ultrasound System GM-72P00A
Chapter 4. 510(k) Summary
| Submitter's Name: | Panasonic Healthcare Co., Ltd. |
|---|---|
| Address: | Medical Imaging Business Unit |
| 600 Saedo-Cho, Tsuzuki-Ku | |
| Yokohama, 224-8539 Japan | |
| Contact: | Keijiro Asayama, Division Director |
| Telephone: | +81 45 939 1010 |
| Date: | December 5, 2011 |
| Trade Name: | AIDA V1.5 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) |
| Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560) | |
| Diagnostic Ultrasound Transducer (21 CFR 892.1570) | |
| Classification Number(s): | 90-ΙΥΝ; 90-IYO; 90-ITX |
| Regulatory Class: | Class II |
| Predicate Device(s): | K103148 - AIDA Diagnostic Ultrasound System GM-72P00A, |
| Panasonic Healthcare Co., Ltd | |
| K093171 - Viamo SSA-640A, | |
| Toshiba America Medical Systems, Inc. | |
| Device Description: | The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is a portable |
| ultrasound system optimized to perform a non-invasive examination o | |
| the peripheral vessels. It provides an automated measurement of the | |
| intima-media thickness (IMT) of peripheral arteries such as the commo | |
| carotids and allows the user to search for arterial plaques using real- | |
| time Brightness and Color Doppler imaging modes. The touchscreen |
1
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 V1.5 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; NEMA UD 3-2004;
Intended Use:
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A 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 V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use.
Technological Comparison
to Predicate Device
The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is substantially equivalent to products that have already been cleared for USA distribution with 510(k) premarket notification numbers K103148 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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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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". Inside the circle is an emblem featuring a stylized human figure with three faces in profile, representing health and well-being. The emblem is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB 1 0 2012
Panasonic Healthcare Co., Ltd. % Mr. Ram Bedi President Puget Ultrasound, Inc. 2425 Squak Mountain Loop SW ISSAQUAH WA 98027
Re: K113612
Trade/Device Name: AIDA V1.5 Diagnostic Ultrasound System GM-72P00A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 5, 2011 Received: December 6, 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 V1.5 Diagnostic Ultrasound System GM-72P00A, 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.
3
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 Lauren Hefner at (301) 796-6881.
Sincerely Yours,
Michael D'Aun for
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
510(k) Premarket Notification AIDA V1.5 Diagnostic Ultrasound System GM-72P00A
Indications for Use Statement
| 510(k) Number: | K113612 |
|---|---|
| Device Number: | AIDA V1.5 Diagnostic Ultrasound System GM-72P00A |
| Company Name: | Panasonic Healthcare Co., Ltd. |
| Indications for Use: | The AIDA V1:5 Diagnostic Ultrasound System GM-72P00A 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 V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use. |
| Prescription Use | X | 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 Sign-Off)
Division of Radiological Dev Office of In Vitro Diagnostic Do
5
Panasonic Healthcare Co., Ltd
AIDA V1.5 Diagnostic Ultrasound System GM-72P00A System:
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Imaging | |||||||||
| & Other | Fetal | 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 | |||||||||
| Vessel | Peripheral vessel | P | N | 1 | |||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined mode BIMT (B + IMT)
Prescription Use Only (Per 21 CFR801.109)
(Division Sign-Off)
Office of In \
510K K113612
Page 2-2
6
Panasonic Healthcare Co., Ltd
.
AIDA V1.5 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 | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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 | ||||||||
| Vessel | Peripheral vessel | P | N | 1 | ||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined mode BIMT (B + IMT)
Prescription Use Only (Per 21 CFR801.109)
Divisio on and Setety
Office of In Vitro Diagnostic Device Evaluation and Safe
510k
K113612
Page 2-3