(71 days)
Not Found
No
The device description and performance studies focus on mechanical and software control of air pressure and inflation cycles, with no mention of AI or ML algorithms for decision-making or data analysis.
Yes
The device is described as a "Compression Therapy Device" and its intended use is for "Treatment of primary lymphedema, secondary lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the muscle pump." This indicates its purpose is to provide therapy for various medical conditions.
No
Explanation: The device description clearly states its purpose is "Treatment of primary lymphedema, secondary lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the muscle pump" and explains how it achieves this through compression therapy. There is no mention of the device being used for diagnosis or generating diagnostic information.
No
The device description clearly outlines hardware components including an air compression pump, main console, pressure knobs, LCD display, air distributor, hoses, and compression garments. While software validation is mentioned, it is for software contained within the hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of various conditions (lymphedema, venous insufficiency, etc.) by applying external compression. This is a therapeutic function, not a diagnostic one.
- Device Description: The device description details a mechanical system that applies pressure to a body part. It does not involve analyzing samples from the human body (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Treatment of primary lymphedema, secondary lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the muscle pump.
Product codes
JOW
Device Description
Mego Afek's Lympha Press 201MAX™ Compression Therapy Device utilizes an air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) which is placed on a body part. This helps to push excessive interstitial fluid in the treated body part, back into the venous and lymphatic systems; improve fluid circulation; and thus treat the symptoms of a variety of lymphatic and 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 a mechanical mechanism, pressure knobs and an LCD display. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. In the Model Lympha Press 201MAX™ device, each garment contains up to 12 overlapping pressure cells. The sleeve fits on the affected body part and can be easily adjusted to any size within the sleeve tolerance.
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
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 Lympha Press 201MAX™A Compression Therapy device has been subjected to extensive safety, performance testing, and validation before release. Validation of the device software was performed according to the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002) and software documentation was written according to the relevant IEEE standards. The Lympha Press 201Max™ device was tested and complies with the following standards:
- IEC/EN60601-1:1988 (am1-91, am2-95), Medical Electrical Equipment Part 1: . General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995-03 standard.
- IEC/EN 60601-1-2 (2005/ 2001): Medical Electrical Equipment-Part 1: General . requirements for safety and Part 1-2 Collateral standard: Electromagnetic Compatibility-Requirements and tests.
Performance testing of the Lympha Press 201MAX™A device included additional testing, designed to ensure that the device met all its functional specifications, including noise measurements: pressure accuracy at room temperatures (15℃ & 30℃), at extreme temperature conditions (-40°C and +70°C) and at mains voltages (127V & 103V); cycle time: pressure vs, time cvcle sequence: distributor failure testing: cyclic redundancy testing; sensor stability calibration testing; pressure gradient testing; and calibration procedure validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(K) SUMMARY
LYMPHA PRESS MODEL 201MAXTM COMPRESSIBLE LIMB SLEEVE DEVICE
510(k) Number K100677
Applicant's Name:
Mego Afek Ltd. Kibbutz Afek Post Afek Phone: (972)-77-9084361 Fax: (972)-4-8784148 E-mail: eran@megoafek.co.il
MAY 2 0 2010
Contact Person:
Ahava Stein A. Stein - Regulatory Affairs Consulting 20 Hata'as St. Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534 e-mail: ofer@asteinrac.com
Date Prepared: March 2010 Trade Name: Model Lympha Press 201MAXTMA Compression Therapy Device Device Common or Usual Names: Compressible Limb Sleeve Classification Name: CFR Classification section 870.5800 (Product code JOW) Class II medical Device Classification:
Predicate Device:
The Lympha Press 201MAX™A Compression Therapy Device is substantially equivalent to a combination of the following predicate devices:
- Lympha Press Optimal Model 1201AP (K082149) manufactured also by Mego Afek. -Ltd (Israel). Lympha Press Optimal Model 1201AP is a compressible limb sleeve, similar to the Model Lympha Press 201MAX™ Compression Therapy Device.
- -Lympha Press Plus Model 1033 (K013331) manufactured also by Mego Afek, Ltd (Israel). Lympha Press Plus Model 1033 is a compressible limb sleeve, similar to the Model Lympha Press 201MAXTM Compression Therapy Device.
Device Description:
Mego Afek's Lympha Press 201MAX™ Compression Therapy Device utilizes an air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) which is placed on a body part. This helps to push excessive interstitial fluid in the treated body part, back into the venous and lymphatic systems; improve fluid circulation; and thus treat the symptoms of a variety of lymphatic and 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 a mechanical mechanism, pressure knobs and an LCD display. The regulated compressed air is
1
transferred via an air distributor through a series of hoses to the sleeve garments. In the Model Lympha Press 201MAX™ device, each garment contains up to 12 overlapping pressure cells. The sleeve fits on the affected body part and can be easily adjusted to any size within the sleeve tolerance.
Intended Use / Indication for Use:
Treatment of primary lymphedema, secondary lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the muscle pump.
Performance Standards:
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for a compressible limb sleeve device.
Test Data:
.
The Model Lympha Press 201MAX™A Compression Therapy device has been subjected to extensive safety, performance testing, and validation before release. Validation of the device software was performed according to the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002) and software documentation was written according to the relevant IEEE standards. The Lympha Press 201Max™ device was tested and complies with the following standards:
- IEC/EN60601-1:1988 (am1-91, am2-95), Medical Electrical Equipment Part 1: . General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995-03 standard.
- IEC/EN 60601-1-2 (2005/ 2001): Medical Electrical Equipment-Part 1: General . requirements for safety and Part 1-2 Collateral standard: Electromagnetic Compatibility-Requirements and tests.
Performance testing of the Lympha Press 201MAX™A device included additional testing, designed to ensure that the device met all its functional specifications, including noise measurements: pressure accuracy at room temperatures (15℃ & 30℃), at extreme temperature conditions (-40°C and +70°C) and at mains voltages (127V & 103V); cycle time: pressure vs, time cvcle sequence: distributor failure testing: cyclic redundancy testing; sensor stability calibration testing; pressure gradient testing; and calibration procedure validation.
Substantial Equivalence:
The Model Lympha Press 201MAX™ Compression Therapy device is similar to currently distributed Compression Therapy devices intended for treatment of lymphatic disorders, venous disorders and dysfunction of the "muscle pump". The device uses sequential inflation and deflation of cells within compression sleeves put around a body part. 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 Lympha Press 201MAX™A compression therapy device is substantially equivalent in safety and efficacy to the predicate devices listed above.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The graphic element is an abstract representation of a human figure or a bird-like shape, composed of curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAY 2 0 2010
Mego Afek Ltd. c/o Ms. Ahava Stein Regulatory Consultant Beit Hapa'amon Box 124 20 Hata'as Street 44425 Kfar Saba Israel
K100677 Re:
Lympha Press 201MAX™ Compression Therapy Device Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: March 7, 2010 Received: March 10, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Ms. Ahava Stein
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 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 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/ucm115809.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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Oma R. Vachner
- 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
510(k) Number (if known):_K | 00677
Device Name:
Lympha Press Model 201Max A Compression Therapy device
Indications for Use:
Primary lymphedema
Secondary lymphedema
Venous insufficiency
Venous stasis ulcers
Dysfunction of the muscle pump
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)
Dunes R. L. Aune
(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices
510(k) Number K100677