(170 days)
The PADChek™ ABI/PVR is a non-invasive device used to assist in the detection of peripheral artery disease (PAD). Pressure measurements at the ankles (dorsalis pedis and/or posterior tibialis arteries) are compared to the highest pressure in either arm (brachial arteries) and a ABI (Ankle Brachial Index) is calculated. A Pulse Volume Recording (PVR) is simultaneously performed to determine the presence of blood flow. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.
PADCHEK ABI/PVR performs an Ankle Brachial Index (ABI) test by measuring systolic BP at the brachial artery in each arm and systolic BP at the dorsalis pedis and/or posterior arteries The ABI is expressed as the ratio of ankle systolic pressure divided by the at the ankles. highest brachial systolic pressure. A result is obtained for each leg. A pulse wave pattern and pulse volume recording is recorded for each limb measurement. A sitting BP, pulse, pulse pressure at the brachial artery is also obtained. Results are stored in a database and can be printed at the time of point-of-care testing or later.
The provided text describes the PADCHEK ABI/PVR device, its intended use, and general compliance with standards, but does not contain the specific details about acceptance criteria, the study proving it meets those criteria, or the performance data requested in your prompt.
The document states "See attached data" under "Device Performance" but this attachment is not provided in the input text. Therefore, I cannot extract the specific information you are looking for regarding the device's performance against acceptance criteria, study details, ground truth, or expert involvement.
Based on the provided text, I can only provide the following information:
- 1. A table of acceptance criteria and the reported device performance: This information is "See attached data" in the original document, which is not provided.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available in the provided text.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
- 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: Not available in the provided text. This device is not described as an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. This device is not described as an algorithm-only device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in the provided text.
- 8. The sample size for the training set: Not applicable, as this device is not described as an AI/ML product requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable, as this device is not described as an AI/ML product requiring a training set.
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K093205
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510(k) summary
1. General Information
Submitter's Name: Osachi Co., LTD Address: 9-11, Osachikohagi 2 chrome, Okaya-shi, JAPAN 394-0085 Telephone: (310) 901-7536 Contact Person: James R. Greenwood Registration Number: 8043882
2. Device
| Name: | PADCHEK ABI/PVR |
|---|---|
| Trade Name: | PADCHEK ABI/PVR |
| Common Name: | Pneumatic |
| Classification Name: | Non-invasive Blood Pressure Monitors |
| Product Code: | DXN |
| Class: | II |
| Regulation Number: | 21 CFR 870.1130 |
Identification of Legally Marketed Devices 3.
| Name: | PADnet Lab |
|---|---|
| K Number: | K042616 |
| Name: | VP-1000 |
| K Number: | K013434 |
Product Overview 4.
PADCHEK ABI/PVR performs an Ankle Brachial Index (ABI) test by measuring systolic BP at the brachial artery in each arm and systolic BP at the dorsalis pedis and/or posterior arteries The ABI is expressed as the ratio of ankle systolic pressure divided by the at the ankles. highest brachial systolic pressure. A result is obtained for each leg. A pulse wave pattern and pulse volume recording is recorded for each limb measurement. A sitting BP, pulse, pulse pressure at the brachial artery is also obtained. Results are stored in a database and can be printed at the time of point-of-care testing or later.
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K093205
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ડ. Indication For Use
The PADChek™ ABI/PVR is a non-invasive device used to assist in the detection of peripheral artery disease (PAD). Pressure measurements at the ankles (dorsalis pedis and/or posterior tibialis arteries) are compared to the highest pressure in either arm (brachial arteries) and a ABI (Ankle Brachial Index) is calculated. A Pulse Volume Recording (PVR) is simultaneously performed to determine the presence of blood flow. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.
6. Device Performance
See attached data.
7. Standard compliance list
| Application Standard | |
|---|---|
| ISO13485:2003 | |
| IEC60601-1:2005 +A1+A2 | |
| IEC60601-1-2:2007 | |
| ISO10993-5:1999 | |
| ISO14971:2007 | |
| ANSI/AAMI SP10:2002+A1 + A2 |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR - 1 2010
Osachi Co., Ltd. c/o Mr. James R. Greenwood Director of Regulatory Affairs PADTest, LLC. 801 S. Grand Ave., #1907 Los Angeles, CA 90017
Re: K093205
Trade/Device Name: PADCheck TM ABI/PVR Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Monitors Regulatory Class: Class II (two) Product Code: DXN Dated: March 5, 2010 Received: March 16, 2010
Dear Mr. Greenwood:
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.
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
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Page 2 - Mr. James R. Greenwood
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
K093205 510(k) Number (if known): __
PADChek ABI/PVR Device Name:
Indications for Use:
The PADChek ABI/PVR is a non-invasive device used to assist in the detection of peripheral artery disease (PAD). Pressure measurements at the ankles (dorsalis pedis and/or posterior tibialis arteries) are compared to the highest pressure in either arm (brachial arteries) and a ABI (Ankle Brachial Index) is calculated. A Pulse Volume Recording (PVR) is simultaneously performed to determine the presence of blood flow. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or It is also not intended for use on or near non intact fetal use. skin.
X Prescription Use_ Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
DRH Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number: K07305
Page 1 of
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).