(89 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 "Intended Use / Indications for Use" section explicitly states that the device is intended for "treating many conditions" such as various types of edema, venous insufficiency, and ulcers, which are therapeutic applications.
No
The "Intended Use / Indications for Use" section clearly states that the device is for "treating many conditions" and for "management of Lipoedema," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly names a model number ("Lympha Press Optimal Plus Model 912"), which strongly suggests a physical hardware device, not software alone. The intended use also describes treating conditions, which is typically done with a physical therapy device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for treating various medical conditions like lymphedema, venous insufficiency, and edema. These are all conditions related to the circulatory and lymphatic systems, and the treatment involves physical intervention (likely some form of compression therapy based on the name "Lympha Press").
- Lack of Diagnostic Function: The description does not mention any diagnostic purpose. It doesn't describe analyzing samples (like blood, urine, or tissue) to provide information about a patient's health status or disease.
- Device Description: The name "Lympha Press Optimal Plus Model 912" strongly suggests a device that applies pressure, consistent with a therapeutic device for conditions like lymphedema.
- Absence of IVD-related information: The document lacks any mention of typical IVD characteristics such as:
- Analyzing biological samples
- Providing diagnostic information
- Using reagents or assays
In summary, the device's purpose is therapeutic (treating conditions) rather than diagnostic (identifying or monitoring conditions through sample analysis).
N/A
Intended Use / Indications for Use
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema
- Secondary lymphedema
- · Venous insufficiency
- Venous stasis ulcers
- · Dysfunction of the muscle pump
- Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reduction of wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema
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
The device is intended for use by medical professionals, and patients who are under medical supervision.
The device is intended for hospital, home, and clinic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
Public Health Service
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
May 31, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mego Afek Ac Ltd. % Ilan Sharon Consultant Ilan Sharon A 109 Neot Golf Caesarea, 3088900 IL
Re: K170658
Trade/Device Name: Lympha Press Optimal Plus Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 26, 2017 Received: March 3, 2017
Dear Ilan Sharon:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Fernando Aguel
-S
Fernando Aguel
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170658
Device Name
Lympha Press Optimal Plus Model 912
Indications for Use (Describe)
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema
- Secondary lymphedema
- · Venous insufficiency
- Venous stasis ulcers
- · Dysfunction of the muscle pump
- Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reduction of wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema
The device is intended for hospital, home, and clinic use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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