(190 days)
Management and symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named "TruWave," which is a transcutaneous electrical nerve stimulator (TENS) for pain relief. This type of document, while indicating regulatory approval, does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.
FDA 510(k) clearances are based on a determination of "substantial equivalence" to a legally marketed predicate device, not necessarily on new clinical studies demonstrating device performance against specific, pre-defined acceptance criteria in the same way a PMA (Pre-Market Approval) or novel device would require.
Therefore, I cannot extract the requested information (acceptance criteria, device performance table, sample sizes, ground truth details, MRMC study results, etc.) from the provided text. This information would typically be found in the 510(k) submission itself, accessible only through a Freedom of Information Act (FOIA) request or directly from the manufacturer, not in the public clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a human figure embracing or protecting another, possibly representing care and support.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2002
Mr. Thomas Sandgaard Dan Med, Inc. 4 West Dry Creek Circle, Suite 260 Denver, CO 80120
Re: K013210
Trade/Device Name: TruWave Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: January 4, 2002 Received: December 28, 2001
Dear Mr. Sandgaard:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered phortes riay 2018) 11:37 accordance with the provisions of the Federal Food, Drug, do noos mat ha v been rout do not require approval of a premarket approval application (PMA). and Cosmetic Hot (110) that to hevice, subject to the general controls provisions of the Act. The r ou may, aterers, mains 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 if your device to such additional controls. Existing major regulations affecting your device can may or subject to back as a sublimations, 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 r 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 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)
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Page 2 - Mr. Thomas Sandgaard
premarket notification. The FDA finding of substantial equivalence of your device to a legally promance notineation " 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 additionally =1 Cl = Additionally, for questions on the promotion and advertising of your Complanee at (301) 54 ( Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entitutes, which on your responsibilities under the Act may be obtained from the Ourision 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 H. Milken
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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Page 1 of 1
510(k) Number (if known): K 0/32/ O
Device Name:
TruWave
Indications for Use:
Management and symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X .
OR
for Mark n Millere
Sion-() vision of General, Restorative and Neurological Devices
510(k) Number -
Over-The-Counter Use
Optional Format 1-2-96)
§ 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).