(10 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the "Treatment of Venous disorders and Dysfunction of the 'Muscle Pump'", which directly indicates its therapeutic purpose.
No
The device is described as a "Compression Therapy Device" for "Treatment of Venous disorders and Dysfunction of the 'Muscle Pump'," indicating a therapeutic rather than diagnostic function.
No
The device is described as a "Compression Therapy Device" and is given a model number, suggesting it is a physical device, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Treatment of Venous disorders and Dysfunction of the 'Muscle Pump'". This describes a therapeutic treatment applied to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "Compression Therapy Device". Compression therapy is a physical treatment method, not a diagnostic method.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is to apply physical compression for therapeutic purposes.
N/A
Intended Use / Indications for Use
Treatment of Venous disorders and Dysfunction of the "Muscle Pump"
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
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 6 - SUMMARY OF SAFETY AND EFFECTIVENESS
Kobo2ZO
(Premarket Notification [510(k)] Number)
1. Applicant
Mego Afek Ltd. Kibbutz Afek Post Afek ISRAEL 30042 Tel: +972-4-8784277 Fax: +972-4-8784188
Corresponding Official:
Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534
| 2. Device Name: | PBS Compression Therapy Device |
|---|---|
| Device trade/proprietary name: | PBS (Petit Basic System) Model 701 A |
| Compression Therapy Device | |
| Common Name: | Compression Therapy Device |
| Classification Name: | Compressible Limb Sleeve (product code JOW, |
| Class II, 870.5800 |
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB 9
Mego Afek c/o Mr. Ahava M. Stein Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as Street 44425 Kfar Saba ISRAEL
Re: K060220
PBS Model 701A Compression Therapy Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 18, 2006 Received: January 30, 2006
Dear Mr. Stein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becased on and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the energly, 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). and Cosmetier for , 10 / ket 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.
2
Page 2 - Mr. Ahava M. 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 Bart 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Duna R. Lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): _____ ڪ ڪ 26 PBS (Petit Basic System) Compression Therapy device Device Name: Indications for use: Treatment of Venous disorders and Dysfunction of the "Muscle Pump"
Prescription Use _ V (Per 21 C.F.R. 801.109)
ાર
Over-The-Counter Use (Optional Format 1-2-96)
——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Viihnes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko6220__________________________________________________________________________________________________________________________________________________________