(86 days)
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.
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 intima-media 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.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the AIDA V1.8 Diagnostic Ultrasound System GM-72P00A:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on regulatory clearance for an ultrasound system, not the detailed performance characteristics of its automated IMT measurement feature. Therefore, explicit "acceptance criteria" and "reported device performance" in the terms of a quantitative study (e.g., accuracy, precision) are not directly stated in this document.
However, we can infer some criteria from the context:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Primary Indication: Provide ultrasound imaging and automated IMT measurement for peripheral vessels. | The device is intended for "Peripheral Vessel application," provides "ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic process within the human body using ultrasound to aid diagnosis," and "provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation." This is a statement of functionality and intended use, implying it does perform these actions. |
| Heart Rate Range: Operate within a specified heart rate range for IMT measurement. | The automated IMT measurement operates for "heart rate range of 20-150 beats per minute." |
| Safety and Effectiveness: Substantial equivalence to predicate devices for intended use. | The FDA's substantial equivalence determination (K122009) indicates that the device is considered as safe and effective as the predicate devices (K113612 - AIDA V1.5 Diagnostic Ultrasound System GM-72P00A, and K093171 - Viamo SSA-640A). This is the primary "acceptance criterion" for regulatory clearance based on substantial equivalence. |
| Compliance with Standards: Adherence to relevant medical device and electrical safety standards. | The system is designed to comply with 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). This implicitly means passing tests related to these standards. |
| Specific Clinical Applications: Support specified clinical applications and modes of operation (e.g., Peripheral Vessel, B-mode, Pulse Doppler, Color Doppler, Combined BIMT). | The "Indications for Use Statement" and the "Intended Use" tables (Pages 6 and 7) list "Peripheral Vessel" as the application with operational modes B (P, existing), PWD (N, new), Color Doppler (P, existing), and Combined Mode Note 1 (BIMT, BD, BCD). This implies that these functionalities have been demonstrated or are considered to be equivalent to predicate devices. |
Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not include detailed performance data from clinical trials or validation studies for the device's diagnostic accuracy or specific metrics beyond what's required to prove equivalence (e.g., comparison of technical features or a limited performance comparison if there are significant changes from the predicate).
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain any information regarding a specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) for validating the IMT measurement accuracy. The 510(k) process for this type of device often relies on demonstrating substantial equivalence through technical comparisons and sometimes limited comparative performance data, but detailed clinical validation study results with specific sample sizes are rarely included in the publicly available 510(k) summaries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for a test set in the provided document. This type of information would typically be found in detailed performance studies, which are not outlined here.
4. Adjudication Method for the Test Set
Since there is no test set or ground truth establishment described, there is also no information about an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
This document describes a diagnostic ultrasound system with an automated IMT measurement feature, which is a type of image analysis tool. However, it does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Such studies are more common for AI systems that assist or augment human interpretation of medical images (e.g., CAD systems for radiology). The automated IMT measurement is presented as a standalone functional feature. Therefore, there is no information on the effect size of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device "provides an automated intima-media thickness measurement of peripheral vessels." This statement inherently implies a standalone algorithm performance for the IMT measurement. However, the document does not provide the results of such a standalone performance study (e.g., accuracy, precision relative to a gold standard). It merely states the functionality exists and is part of a system determined substantially equivalent to predicate devices.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not specify the type of ground truth used for validating the automated IMT measurement. If a performance study were detailed, ground truth for IMT is typically established through manual measurements by highly trained sonographers or experts, or occasionally compared against other established, highly accurate measurement techniques.
8. The Sample Size for the Training Set
There is no information regarding a training set sample size provided in this 510(k) summary. This document describes an ultrasound system, and while it has an "automated" IMT feature, it doesn't characterize this feature as a machine learning/AI model that would require a distinct "training set" in the modern sense. Even if it uses algorithms that were developed using data, the specifics of that development data are not disclosed here.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or described, there is no information on how its ground truth was established.
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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 Unit600 Saedo-Cho, Tsuzuki-KuYokohama, 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)Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560)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,Panasonic Healthcare Co., LtdK093171 - Viamo SSA-640A,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(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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
Page 2-3
§ 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.