(88 days)
The MediPhysics Pain Treatment System, Model 1, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
The McdiPhysics Pain Treatment System, Model 1, consists of a control console, two Treatment Probes (electrodes), and a Security Cartridge. The system operates on 115V wall current. Treatment, intended to take place under the supervision of a physician in a medical setting, consists of applying very low current to painful tissue and associated trigger points with the Treatment Probes.
The MediPhysics Pain Treatment System, Model 1, did not undergo a study to demonstrate its performance against specific acceptance criteria in the provided document. Instead, its market clearance (K032928) was based on a substantial equivalence determination to legally marketed predicate devices.
The document does not provide information on:
- Specific acceptance criteria used for validation.
- The results of any performance study against defined criteria.
- Sample sizes for test sets or training sets.
- Data provenance, expert qualifications, adjudication methods, or ground truth establishment.
- MRMC comparative effectiveness studies or standalone algorithm performance.
The key statement regarding performance testing is:
"The MediPhysics Pain Treatment System, Model 1, has been systematically tested and test results demonstrate that it fulfills design and performance specifications."
However, no details about these "design and performance specifications," the "systematic testing," or the "test results" are provided. The FDA's letter (K032928) explicitly states that clearance was granted because the device was found substantially equivalent to predicate devices for its intended use, based on its design and technological characteristics, and that "the differences between the MediPhysics Pain Treatment System, Model 1, and cited predicate devices are minor and raise no new issues of safety or effectiveness." This indicates that a head-to-head clinical performance study with predefined acceptance criteria, as typically seen for novel devices, was not required or submitted for this 510(k) clearance.
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510(k) Summary MediPhysics Pain Treatment System, Model 1
1. SPONSOR
MediPhysics Pain Centers of America 13 Orchard Road, Unit 108 Lake Forest, California 92630
Contact Person: James Rogers Telephone: (949) 215-0145, extension 10
Date Prepared: November 24, 2003
2. DEVICE NAME
| Proprietary Name: | MediPhysics Pain Treatment System, Model 1 |
|---|---|
| Common/Usual Name: | Electro-Magnetic Device for the Treatment of Pain |
| Classification Name: | Class II; 21CFR 882.5890; Product Code GZJ |
3. PREDICATE DEVICES
- Therapeutic Devices Inc. TENS (K894127) .
- . Empi Epix VT TENS (K970203)
- Electro-Acuscope 85 (K883911) .
- Medical Devices Matrix 1 TENS model 4700s (K895473) .
- . Well Life Health Care Mini TENS WL-2403 (K020020)
- CEFAR Primo (K020803) .
DEVICE DESCRIPTION 4.
The McdiPhysics Pain Treatment System, Model 1, consists of a control console, two Treatment Probes (electrodes), and a Security Cartridge. The system operates on 115V wall current. Treatment, intended to take place under the supervision of a physician in a medical setting, consists of applying very low current to painful tissue and associated trigger points with the Treatment Probes.
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5. INTENDED USE
The MediPhysics Pain Treatment System, Model 1, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
MediPhysics has determined that the MediPhysics Pain Treatment System, Model 1, is substantially equivalent to the cited predicate devices based on intended use, indications for use, design characteristics, and technological characteristics and that the differences between the MediPhysics Pain Treatment System, Model 1, and cited predicate devices are minor and raise no new issues of safety or effectiveness.
7. PERFORMANCE TESTING
The MediPhysics Pain Treatment System, Model 1, has been systematically tested and test results demonstrate that it fulfills design and performance specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Mr. Morten Simon Christensen Representing MediPhysics Pain Centers of America Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050-4169
Re: K032928
Device Name: MediPhysics Pain Treatment System, Model 1 Regulation Number: 21 CFR 882.5890 Regulation Names: TENS Device for Pain Relief Regulatory Class: Class 2 Product Codes: GZJ Dated: December 2, 2003 Received: December 4, 2003
Dear Mr. Christensen:
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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Page 2 - Mr. Morten Simon Christensen
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), please contact the Office of Compliance at (301) 594-4648. 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 vours.
h. Mark N. Millman
Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K032928
Device Name: MediPhysics Pain Treatment System, Model 1
Indications for Use: The MediPhysics Pain Treatment System, Model 1, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milhusan
IVISION (o General, Restorative and Neurological
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
MediPhysics Pain Centers of America, Traditional 510(k) MediPhysics Pain Treatment System, Model MPTS1 November 24, 2003 Page 1
§ 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).