(9 days)
The Bio Protech, Inc. PROTENS are designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS). The PROTENS electrodes provide the conductive interface between the TENS generator and the patient's skin.
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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called the "PROTENS electrode." This type of document establishes substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device that was on the market prior to May 28, 1976, or has been reclassified.
A 510(k) premarket notification does not typically include detailed information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as you would find in an approval for a novel device or a PMA. Instead, the substantial equivalence determination for devices like this electrode often relies on comparisons of design, materials, performance specifications, and safety testing to a predicate device, rather than extensive clinical efficacy trials.
Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because this information is not present in the FDA 510(k) clearance letter. This letter is a notification of substantial equivalence to a predicate device, not a detailed report of clinical trials or performance studies with specific acceptance criteria.
The document indicates:
- Device Name: PROTENS electrode
- Intended Use: Designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS) to provide the conductive interface between the TENS generator and the patient's skin.
- Regulatory Class: II
- Product Code: GXY (Cutaneous electrode)
A 510(k) clearance evaluates a device's substantial equivalence to a predicate device, meaning it is as safe and effective as a legally marketed device. This process typically involves demonstrating that the new device has the same intended use and similar technological characteristics to the predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This usually involves bench testing, biocompatibility testing, and electrical safety testing, but generally not extensive clinical efficacy studies with the kind of details requested in your prompt.
Therefore, I cannot fill out the requested table or provide the specific details you asked for regarding:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study and effect size
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2004
Bio Protech, Inc. C/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K042301
Trade/Device Name: PROTENS electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: August 25, 2004 Received: August 25, 2004
Dear Mr. Devine:
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Ned E. Devine, Jr.
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 it you attire of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark A. 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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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ____ PROTENS electrode
Indications for Use:
The Bio Protech, Inc. PROTENS are designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS). The PROTENS electrodes provide the conductive interface between the TENS generator and the patient's skin.
Caution: Federal law restricts this device to sale by or on the order of a physician.
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 OF NEEDED)
Concurrence of CDRA, Office of Device Evaluation (ODE)
Page of
Division Sign-Off) Division of General, Restorative.
and Neurological Devices
510(k) Number K042301
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).