(169 days)
Not Found
No
The device description details a sequential pneumatic compression system with a pressure control unit, hoses, and a garment with air cells. The operation is described as a simple compress-and-release cycle based on regulated pressure and a fixed sequence. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML. The performance studies focus on standard electrical and safety testing, not AI/ML performance metrics.
Yes
The device is described as a "sequential pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the 'muscle pump'." The system aims to stimulate lymphatic vessels and reduce venous edema through a compress-and-release massage action, which are therapeutic actions.
No
The device description indicates that the Petite Basic System™ is a treatment system (sequential pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, etc.), and it describes how it applies a compressive massage to stimulate lymphatic vessels and reduce edema. There is no mention of it being used to detect, monitor, or diagnose a condition.
No
The device description explicitly lists hardware components: a pressure control unit, hoses, and a compression garment. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Petite Basic System™ is a therapeutic device. It applies external pressure to the body to treat conditions like lymphedema and venous insufficiency. It does not analyze any biological samples.
- Intended Use: The intended uses listed are all related to treating physical conditions, not diagnosing them through laboratory analysis.
- Device Description: The description details a mechanical system for applying pressure, not a system for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, using reagents, or any other activities typically associated with IVD devices.
Therefore, based on the provided information, the Petite Basic System™ is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- . Primary lymphedema
- . Secondary lymphedema
- t Venous insufficiency
- . Venous stasis ulcers
- Dysfunction of the "muscle pump" ●
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Petite Basic System™ is a sequential pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump". The Petite Basic System™ consists of:
- The pressure control unit (sometimes called "compressor" or . "pump"), supplies air at regulated pressure to a compression garment that is worn over the area to be treated.
- Hoses that transfer the air from the pressure control unit to each of the . cells in the compression garment.
- The compression garment (sometimes called a "sleeve"), fastened 0 around the area to be treated. Each garment contains 4 overlapping air cells. These air cells are filled with air from the pressure control unit in sequence, applying a compressive massage. Once the entire area has been compressed, the Petite Basic System™ pressure control unit releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.
The compress-and-release massage action of Petite Basic System™ stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.
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)
Non-clinical: As required by the risk analysis, verification, validation and testing activities were conducted to establish that the changes made to the device perform as designed. The following standards were included as part of the testing: IEC60601-1, IEC60601-2 and IEC TR-60721-2. The device passed all of the tests based on pre-determined Pass/Fail criteria.
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
Exhibit 1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5|0(k) number is: K131420
- Submitter's Identification: 1. MEGO AFEK LTD. Kibbutz Afek 30042 ISRAEL Phone: 972-77-9084276 Fax: 972-4-877-3523
NOV 0 1 2013
Date Summary Prepared: May 13, 2013
2. Name of the Device:
Proprietary name: Petite Basic System 701 ELT
Common Name: Compressible Limb Sleeve
3. Common or Usual Name/Classification:
Common name: Compressible Limb Sleeve Classification name: Compressible Limb Sleeve Regulation: 21 CFR 870.5800 Product Code: JOW
4. Predicate Device Information:
Lympha Press 201Max Previously cleared 510(k) number: K100677
5. Description:
The Petite Basic System™ is a sequential pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump". The Petite Basic System™ consists of:
- The pressure control unit (sometimes called "compressor" or . "pump"), supplies air at regulated pressure to a compression garment that is worn over the area to be treated.
1
- Hoses that transfer the air from the pressure control unit to each of the . cells in the compression garment.
- The compression garment (sometimes called a "sleeve"), fastened 0 around the area to be treated. Each garment contains 4 overlapping air cells. These air cells are filled with air from the pressure control unit in sequence, applying a compressive massage. Once the entire area has been compressed, the Petite Basic System™ pressure control unit releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.
The compress-and-release massage action of Petite Basic System™ stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.
6. Intended Use:
- . Primary lymphedema
- Secondary lymphedema .
- Venous insufficiency .
- Venous stasis ulcers .
- Dysfunction of the "muscle pump" .
7. Technological Characteristics
The technological characteristics of the Petite Basic System 701ELT are substantially equivalent to the predicate device. Both systems have the same specifications -
2
Comparison to Predicate Device
| ltem | Lympha-Press
201 Max | Petite Basic System
701ELT | Comments |
|----------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Air Distribution
method | rotating disc which
distributes air in a
predefined sequence | diaphragm which
distributes air in a
predefined sequence | Both devices provide
the same output.
No impact on safety &
effectiveness as
demonstrated by
verification/validation
testing performed |
| Accessories | 4 - 12 cell garments | 4 cell garments | Treated body areas
are equivalent.
Output is equivalent. |
| Cycle time | 30 seconds full cycle,
of which:
24 sec Inflation (2
sec per cell)
2 sec Hold
4 sec Deflation | Minimum Cycle Time:
20 seconds.
Determined by
pressure and pause
settings, depending
on garment size | The 701ELT allows
the physician to
predefine the
pressure level &
pause time.
201Max allows the
physician to predefine
the pressure level. |
| Display | LCD | Dial Selector | Both display pressure
values. |
| Software/firmware | Proprietary | Proprietary | Changes were made
to remove the digital
display feature, add
overpressure timeout. |
8. Performance Data:
Non-clinical: As required by the risk analysis, verification, validation and testing activities were conducted to establish that the changes made to the device perform as designed. The following standards were included as part of the testing: IEC60601-1, IEC60601-2 and IEC TR-60721-2. The device passed all of the tests based on pre-determined Pass/Fail criteria.
9. Conclusions:
The data from consensus standard testing and comparison to the predicate device show that the Petite Basic System 701ELT is as safe and effective as the legally marketed predicate device.
Therefore Mego Afek, Ltd. conclude that the Petite Basic System 701ELT is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1. 2013
MEGO AFEK LTD. Ms. Maria F. Griffin mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K131420
Trade/Device Name: Petite Basic System 701 ELT Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 12, 2013 Received: June 14, 2013
Dear Ms. Griffin:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Maria F. Griffin
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit 3
Indications for Use
Page 11
510(k) Number (if known): _ K131420
Device Name Petite Basic System 701ELT
Indications For Use:
- . Primary lymphedema
- . Secondary lymphedema
- t Venous insufficiency
- . Venous stasis ulcers
- Dysfunction of the "muscle pump" ●
Prescription Use × Over-The Counter Use (Per 21 CFR 801 Subpart D) OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)