(216 days)
Not Found
K/DEN number is not found in the input text.
No
The provided 510(k) summary does not contain any mention of AI, ML, or related technologies. The description focuses solely on the intended use and indications for a device treating various conditions like lymphedema and venous insufficiency.
Yes
The device is clearly indicated for treating various medical conditions, such as lymphedema and venous insufficiency, which directly falls under the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" section states that the device is for "treating many conditions" and "reduction of pain and swelling," which indicates a therapeutic rather than a diagnostic purpose. There is no mention of identifying or diagnosing diseases.
Unknown
The provided text does not contain a device description, which is essential to determine if the device is software-only or includes hardware components.
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 body's circulatory and lymphatic systems, and the treatment described is likely a physical therapy or compression-based method.
- Lack of Diagnostic Purpose: An IVD is a device used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnostic, monitoring, or screening purposes. The provided text does not mention any such examination of specimens or a diagnostic function.
- Treatment Focus: The language used ("treating many conditions," "reducing wound healing time," "reduction of pain and swelling") clearly indicates a therapeutic or treatment-oriented device, not a diagnostic one.
Therefore, based solely on the provided text, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
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
- · Reducing 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.
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
medical professionals, and patients who are under medical supervision, in treating many conditions such as:
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)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
February 27, 2019
Mego Afek AC Ltd. % Ilan Sharon Consultant P.O. Box 4414 (A109) Caesarea, 3088900 Il
Re: K182003
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: January 20, 2019 Received: January 23, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Fernando Aguel - S
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) K182003
Device Name Lympha Press Optimal Plus
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
- · Reducing 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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