(15 days)
The Microware 200 Tens device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.
In particular, this device is indicated for use for:
- Symptomatic relief and management of chronic (long term) intractable pain. .
- Adjunctive treatment in the management of post surgical and post traumatic acute pain . problems.
Not Found
The provided text is a clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device (Microware 200, Microware 200 TENS, Microware TENS 200). It establishes the device's substantial equivalence to a predicate device.
However, the letter does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, or any details about a study design (sample sizes, ground truth, experts, adjudication, MRMC, or standalone performance).
The FDA clearance for this type of device (Transcutaneous Electrical Nerve Stimulator) is based on substantial equivalence to a predicate device, as stated in the letter: "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This typically means that the device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate. Clinical studies with detailed performance metrics and acceptance criteria for classification purposes are not always required for 510(k) clearances.
Therefore, I cannot populate the table or provide the requested study details from the given text.
Here's why each specific piece of information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not present. The letter doesn't mention specific performance metrics like sensitivity, specificity, or any quantitative measures for pain relief.
- Sample sized used for the test set and the data provenance: Not present. No study data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study data is mentioned.
- Adjudication method: Not present. No study data is mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This is not an AI device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is not an AI device, and no standalone performance data is mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No study data is mentioned.
- The sample size for the training set: Not present. No training set is relevant for this type of device and clearance process mentioned.
- How the ground truth for the training set was established: Not present. No training set is relevant.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
APR 6 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Microware Inc. c/o Underwriters Laboratories, Inc. Attn: Ms. Michelle S. Lee 2600 NW Lake Road Camas, Washington 98607
Re: K050740
Trade/Device Name: Microware 200, Microware 200 TENS, Microware TENS 200 Regulation Numbers: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: II Product Codes: GZJ Dated: March 21, 2005 Received: March 22, 2005
Dear Ms.Lee:
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 corply 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.
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Page 2 - Ms. Michelle S. Lee
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypt Clurdu
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Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Microware 200, Microware 200 TENS, Microware TENS 200
Indications for Use:
The Microware 200 Tens device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.
In particular, this device is indicated for use for:
- Symptomatic relief and management of chronic (long term) intractable pain. .
- Adjunctive treatment in the management of post surgical and post traumatic acute pain . problems.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H. L. Clarke
Division of General, Restorative, and Neurological Devices
510(k) Number_KOSO740
§ 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).