(294 days)
The Scrambler Therapy MC-5A TENS Device is indicated for:
- . Symptomatic relief of chronic, intractable pain, post surgical and posttraumatic acute pain
- Symptomatic relief of acute pain .
- Symptomatic relief of post-operative pain .
The Scrambler Therapy MC-5A TENS Device is a multi-channel TENS device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.
The provided text is a 510(k) Summary for the Scrambler Therapy MC-5A TENS Device. It outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, it explicitly states that the device meets "design and performance specifications" but does not contain detailed information about specific acceptance criteria or the results of a clinical study demonstrating performance against those criteria.
Therefore, I cannot fulfill all parts of your request with the provided information.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not detailed in the provided text. The document broadly states "design and performance specifications" were met, but doesn't list them.
- Reported Device Performance: Not detailed in the provided text. No specific performance metrics or outcomes are reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is irrelevant as no clinical study with ground truth establishment is described. The device is a TENS device, and the 510(k) focuses on substantial equivalence based on technological characteristics and intended use, not clinical trial performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical study requiring adjudication is described.
5. 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 applicable. This device is not an AI-based diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a TENS device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable, as no clinical study requiring ground truth is described.
8. The sample size for the training set:
- Not applicable, as no machine learning algorithm with a training set is described.
9. How the ground truth for the training set was established:
- Not applicable, as no machine learning algorithm with a training set is described.
Summary of available information from the text:
The document states:
- "Competitive Technologies, Inc. claims substantial equivalence of the Scrambler Therapy MC-5A TENS Device to the predicate devices based on the intended use, fundamental technology, and operation characteristics." (Section 6)
- "Testing of the Scrambler Therapy MC-5A TENS Device demonstrates that the device meets design and performance specifications." (Section 7)
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, which is a common pathway for TENS devices. It does not present detailed acceptance criteria or the results of a clinical performance study that would typically involve test sets, ground truth, experts, or the other specific elements you requested. The "Performance Testing" section only broadly states the device meets its design and performance specifications without providing specifics.
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510(k) Summary for the Competitive Technologies, Inc. Scrambler Therapy MC-5A TENS Device (per 21CFR 807.92)
SUBMITTER/510(K) HOLDER 1.
FEB 2 0 2009
Competitive Technologies, Inc. 777 Commerce Drive Fairfield, CT 06825
Contact Person: Aris Despo Telephone: 203-368-6044
Date Prepared: May 1, 2008
2. DEVICE NAME
Proprietary Name: Scrambler Therapy MC-5A TENS Device Common/Usual Name: Electrical Nerve Stimulator Classification Names: Transcutaneous Electrical Nerve Stimulator
3. PREDICATE DEVICES
4. DEVICE DESCRIPTION
The Scrambler Therapy MC-5A TENS Device is a multi-channel TENS device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.
ഗ് INTENDED USE
The Scrambler Therapy MC-5A TENS Device is indicated for:
- . Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
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- Symptomatic relief of acute pain .
- Symptomatic relief of post-operative pain .
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Competitive Technologies, Inc. claims substantial equivalence of the Scrambler Therapy MC-5A TENS Device to the predicate devices based on the intended use, fundamental technology, and operation characteristics. A side-by-side comparison of the Scrambler Therapy MC-5A TENS Device and the cited predicate devices is included in the 510(k).
PERFORMANCE TESTING 7.
Testing of the Scrambler Therapy MC-5A TENS Device demonstrates that the device meets design and performance specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Competetive Technologies, Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Affairs Specialist 49 Plain Street North Attleboro, Massachusetts 02760
FEB 2 0 2009
Re: K081255
Trade/Device Name: Competitive Technologies, Inc. Scrambler Therapy MC-5A TENS Device
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous, electrical nerve stimulator for pain relief
Regulatory Class: II
Product Code: GZJ
Dated: February 6, 2009
Received: February 9, 2009
Dear Ms. McNamara-Cullinane:
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 - Ms. Mary McNamara-Cullinane, RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Mark N. Melkerson
Mark N. Me kerson 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): K081255
Device Name: Competitive Technologies, Inc. Scrambler Therapy MC-5A TENS Device.
Indications for Use:
The Scrambler Therapy MC-5A TENS Device is indicated for:
- . Symptomatic relief of chronic, intractable pain, post surgical and posttraumatic acute pain
- Symptomatic relief of acute pain .
- Symptomatic relief of post-operative pain .
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
SERVER PRES Division of General, Restorative, and Neurological Devices
510(k) Number 4081255
§ 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).