(90 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
Yes
The device is intended to improve blood circulation and reduce health risks (deep vein thrombosis, edema), which are therapeutic effects.
No
The device's intended use is to improve blood circulation and reduce risks like DVT, edema, and discomfort, which are therapeutic or preventative functions, not diagnostic. It does not mention detection, diagnosis, or monitoring of a disease state.
No
The device description "AviaFit™ Pulsating Legband" strongly suggests a hardware component (a legband that pulsates), not a software-only device.
Based on the provided information, the Aviafit™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Aviafit™ is to improve blood circulation and reduce the risk of DVT, edema, and discomfort in the lower limbs. This is a therapeutic or preventative physical function, not a diagnostic one.
- Device Description: It's described as a "Pulsating Legband," which aligns with a physical therapy or preventative device, not a device used to test samples from the body.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a disease, condition, or state of health.
- Using reagents or other materials typically associated with IVD testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Aviafit™'s function is external and physical, aimed at improving circulation.
N/A
Intended Use / Indications for Use
The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.
Product codes
JOW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at home, at the office and during mid-long haul flights.
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)
Not Found
Reference Device(s)
Not Found
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
SECTION 5 - 510(K) SUMMARY
AVIAFIT™ DEVICE 510(k) Number K_◎フ/フ 44
SEP 25 2007
Applicant's Name:
| Company name: FlowMedic Ltd. | |
|---|---|
| Address: | 15 Alon Hatavor St. |
| Industrial Area Caesarea | |
| Caesarea, 38900 | |
| ISRAEL | |
| Tel.: | +972 (4) 627-5559 |
| Fax: | +972 (4) 627-5560 |
| E-mail: | info@flowmedic.com |
Contact Person:
| Contact Name: | Ahava Stein |
|---|---|
| Company: | A. Stein - Regulatory Affairs Consulting |
| Address: | 20 Hata'as St. (P.O.B. 124) |
| Kfar Saba 44425 | |
| ISRAEL | |
| Tel.: | +972 (9) 7670002 |
| Fax: | +972 (9) 7668534 |
| E-mail: | asteinra@netvision.net.il |
Date Prepared:
Date: June 20, 2007
Name of the device:
AviaFit™ Pulsating Legband
Trade or proprietary name, if applicable:
AviaFit™ Pulsating Legband
Common or usual name:
Compressible Limb Sleeve
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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2007
FlowMedic Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consulting Ltd. Beit Hapaamon Suite 102 20 HATAAS Str. (P.O.B 124) Kfar Saba 44425 Israel
Re: K071744 AviaFit™ Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 2, 2007 Received: September 7, 2007
Dear Ms. Stein:
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 - Ms. Ahava Stein
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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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SECTION 4 - INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | Ko71744 |
|---|---|
| Comments of the comments on an experience and proportions and consideration and consideration of the comments of |
Device Name:
AviaFit™ Device
Indications for use:
The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.
Prescription Use (Per 21 C.F.R. 801 Subpart D)
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OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
сестор
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071744
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