(90 days)
Not Found
No
The description focuses on a software-controlled electro-mechanical system for sequential inflation and deflation, with no mention of AI/ML terms, image processing, or data-driven training/testing.
Yes
The device is described as a "Compression Therapy Device" and its intended uses include prevention of DVT, reduction of pain and swelling, enhancement of circulation, and aiding the healing of ulcers, all of which are therapeutic indications. It also treats symptoms of venous disorders and "muscle pump" dysfunction.
No
The device is described as a "Compression Therapy Device" used for prevention and treatment of conditions like DVT, pain and swelling reduction, and circulation enhancement. Its mechanism involves physical compression rather than detection or diagnosis of medical conditions.
No
The device description explicitly states it consists of a main console containing an air compressor, electro-mechanical mechanisms, pressure sensors, solenoid valves, and compression garments. These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed (prevention of DVT, reduction of pain/swelling, enhancement of circulation, etc.) are all related to treating or preventing conditions within the body through physical means (compression). IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a mechanical device that applies external pressure to a limb using air compression. This is a physical therapy/treatment device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of a therapeutic medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Prevention of Deep Vein Thrombosis (DVT) in susceptible patients; Reduction of pain and swelling after injury and surgery; Enhancement of venous and arterial circulation; Prevention of venous stasis; Assist healing of cutaneous ulcers; Reduction of compartmental pressures.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
Mego Afek's Model 601 Compression Therapy Device utilizes a software controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus treat the symptoms of a variety of venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and solenoid valves. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. In the Model 601 device, each garment contains up to 4 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Model 601A Compression Therapy device has been subjected Test Data: to extensive safety, performance testing, and validation before release. Final testing of the Model 601A Compression Therapy device included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Mego Afek 510(k)
510(K) SUMMARY
PHLEBOPRESS DVT MODEL 601A
COMPRESSIBLE LIMB SLEEVE DEVICE
| 510(k) Number K | ||
|---|---|---|
| Applicant's Name: | Mego Afek Ltd. | |
| Kibbutz Afek | ||
| Post Afek | ||
| Phone: (972)-4-8784277 | ||
| Fax: (972)-4-8784148 | ||
| E-mail: aharon@megoafek.co.il | NOV 2 1 2007 | |
| Contact Person: | Ahava Stein/ Ofer Hornick | |
| A. Stein – Regulatory Affairs Consulting | ||
| 20 Hata'as St. | ||
| Kfar Saba 44425 | ||
| Israel | ||
| Tel. + 972-9-7670002 | ||
| Fax. +972-9-7668534 | ||
| e-mail: asteinra@netvision.net.il or oh_asra@netvision.net.il | ||
| Date Prepared: | August 2007 | |
| Trade Name: | Model 601A Compression Therapy Device | |
| Device Common or Usual Names: | Compressible Limb Sleeve | |
| Classification Name: CFR Classification section 870.5800 (Product code JOW) | ||
| Classification: | Class II medical Device | |
| Predicate Device: | The Model 601A Compression Therapy Device is substantially | |
| equivalent to a combination of the following predicate devices: |
- PhleboPress Model 701A (K060220) manufactured also by Mego
Afek, Ltd (Israel). PhleboPress Model 701A is a compressible | |
1
limb sleeve, similar to the Model 601 Compression Therapy Device.
- Flowtron Excel Model AC550 (K961166), manufactured by Huntleigh Healthcare Inc.
- Flowtron Universal Model AC600 (K010744), manufactured by Huntleigh Healthcare Inc.
- Mego Afek's Model 601 Compression Therapy Device utilizes a Device Description: software controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus treat the symptoms of a variety of venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and solenoid valves. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. In the Model 601 device, each garment contains up to 4 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.
- Intended Use / Indication for Use: Prevention of Deep Vein Thrombosis (DVT) in susceptible patients; Reduction of pain and swelling after injury and surgery; Enhancement of venous and arterial circulation; Prevention of venous stasis; Assist healing of cutaneous ulcers; Reduction of compartmental pressures.
Performance Standards:
2
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for a compressible limb sleeve device.
The Model 601A Compression Therapy device has been subjected Test Data: to extensive safety, performance testing, and validation before release. Final testing of the Model 601A Compression Therapy device included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.
Substantial Equivalence: The Model 601A Compression Therapy device is similar to currently distributed Compression Therapy devices intended for treatment of venous and lymphatic disorders, dysfunction of the "muscle pump" and prevention of deep venous thrombosis. The device uses sequential inflation and deflation of cells within compression sleeves put around a limb. Inflation/ Deflation pressures and sequences are similar to those of predicate devices. Operating modes are similar to those of predicate devices. All of the above features are similar to these features in the predicate devices.
- Conclusions: The conclusions drawn from the above Performance Testing and comparison to predicate devices is that the Model 601A compression therapy device is substantially equivalent in safety and efficacy to the predicate devices listed above.
3
Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
NOV 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEGO AFEK c/o Ms. Ahava Stein Regulatory Affairs Counseling Beit Hapa' Amon (Box 124) 20 Hata'As St. Kfar Saba. Israel 44425
Re: K072372
Phlebopress Model 601A Compression Therapy Device Regulation Number: 21 CFR 870. 5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: August 17, 2007 Received: August 23, 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.
4
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Wachner
Л Bram D. Zuckerman, M.D. - Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): ko72372
Model 601A Compression Therapy device Device Name:
Indications for Use:
Prevention of Deep Vein Thrombosis (DVT) in susceptible patients.
Reduction of pain and swelling after injury and surgery.
Enhancement of venous and arterial circulation.
Prevention of venous stasis.
Assist healing of cutaneous ulcers.
Reduction of compartmental pressures.
Prescription Use V (Per 21 C.F.R. 801 Subpart D) C)
OR
Over-The-Counter Use (Optional Format Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. hchmer
(Division Sign-Off) (Division Orgh Olyn Scular Devices
510(k) Number K072372