(106 days)
- Primary lymphedema .
- Secondary lymphedema .
- . Venous insufficiency
- Venous stasis ulcers .
- Dysfunction of the muscle pump .
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Practical Compression Device (PCD) 901A and 901B." This type of document confirms that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective as existing devices.
Crucially, this document is a regulatory clearance letter and does not contain information about acceptance criteria or the specifics of a study proving the device meets acceptance criteria.
The FDA 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, which often involves comparing technical characteristics, materials, and intended use, rather than extensive clinical efficacy studies with predefined acceptance criteria and performance metrics described in such detail.
Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report submitted to the FDA as part of a premarket approval (PMA) application or a de novo classification request, or even a detailed 510(k) submission summary that voluntarily includes such study details.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 an abstract symbol resembling an eagle or bird in flight, depicted with stylized, flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
19
2012
Mego Afek AC Ltd. c/o Mr. Alex Rapel QA & RA Manager Kibbutz Afek Afek Israel 30042
Re: K121962
Trade/Device Name: Practical Compression Device (PCD) 901A and 901B Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: September 13, 2012 Received: September 17, 2012
Dear Mr. Rapel
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.
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Page 2 - Mr. Alex Rapel
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 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" (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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M.A. Killehen
Bram D. Zuckerman. MD 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): K121962
Device Name: PCD 901A&B
Indications for Use:
- Primary lymphedema .
- Secondary lymphedema .
- . Venous insufficiency
- Venous stasis ulcers .
- Dysfunction of the muscle pump .
The device is intended to be used by patient at home, as well as by physicians at clinic.
Prescription Use__X__
AND/OR
Over-The Counter Use_
(Part 21 CFR 801 subpart D)
(21 CFR 801 subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mestillehen
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number 1-121962
§ 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).