(89 days)
SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
Not Found
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) clearance letter from the FDA for a Neuromuscular Stimulator (HMS-DHR-3). This letter confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use (symptomatic relief of chronic intractable pain).
A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on detailing specific performance acceptance criteria and a study proving those criteria are met for the new device. While a 510(k) submission would include data and information to support the claim of substantial equivalence, this specific FDA clearance letter does not contain the detailed study results or acceptance criteria you've requested.
Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth methods from this document.
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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" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 6 2002
C. A. Teklinski Home Medical Services 9393 Activity Road, Suite F San Diego, California 92126
Re: K021496
Trade/Device Name: HMS-DHR-3 Neuromuscular Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: May 6, 2002 Received: May 9, 2002
Dear Mr. Teklinski:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if
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applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milkenner
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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HMS NEUROMUSCULAR STIMULATOR (021496 (510 (k) #_
INDICATIONS FOR USE
THE INDICATION FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT IS AS FOLLOWS :
SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
Mark N. Millhuser
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number _
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).