(88 days)
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No
The summary provides no indication of AI/ML technology; it describes a reusable calf aircell for DVT prophylaxis, which is a mechanical device.
Yes
The device's intended use is for "Prophylaxis for DVT (Deep Vein Thrombosis)," which indicates it is used for preventing a medical condition. This falls under the definition of a therapeutic device as it aims to maintain health and prevent disease.
No
The device is described as a "Prophylaxis for DVT" and a "Reusable Calf Aircell," which indicates a preventative or therapeutic function rather than a diagnostic one. There is no mention of measuring, analyzing, or interpreting physiological signals or imaging for diagnosis.
No
The device description "VenaFlow Reusable Calf Aircell" clearly indicates a hardware component (an aircell) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Prophylaxis for DVT (Deep Vein Thrombosis)". This is a preventative measure for a medical condition within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "VenaFlow Reusable Calf Aircell". This sounds like a physical device applied externally to the body (the calf) to aid in blood circulation, which is consistent with DVT prophylaxis.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the VenaFlow Reusable Calf Aircell, as described, is a therapeutic or preventative medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
_Prophylaxis for DVT (Deep Vein Thrombosis)
Product codes
JOW
Device Description
VenaFlow Reusable Calf Aircell
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2003
AIRCASTS, INC. Mr. Stephen L. Kenney Director of Quality 691 Central Avenue Murray Hill, NJ 07974
Re: K023800
Trade Name: Aircast VenaFlow System Regulation Number: 21 CFR 870.5800 Regulation Name: Compression Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: October 23, 2002 Received: November 11, 2002
Dear Mr. Kenney:
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 such 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.
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Page 2 - Mr. Stephen L. Kenney
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 Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nelle Tellh
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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Page 1_of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VenaFlow Reusable Calf Aircell
Indications for Use: _Prophylaxis for DVT (Deep Vein Thrombosis)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Ogletree
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K023800
(Optional Format 3-10-98)
Prescription Use Only