(189 days)
The Prizm Medical, Inc. Micro-Z™ Stimulation System is intended for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems.
The Prizm Medical, Inc. Micro-Z™ Stimulation System is also used for Neuromuscular Electrical Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. These uses were previously cleared under K951727.
Prizm Medical, Inc. Micro-Z™ Stimulation System is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for chronic or intractable pain (see indications for use statement). It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the Micro-ZTM Stimulator can be found in Appendix A. The stimulator is wearable with the Velcro® strip that attaches the device to the Velcro® arm/leg strap. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked patient intensity buttons.
The provided text is a 510(k) summary for the Prizm Medical, Inc. Micro-Z™ Stimulation System, which is a Transcutaneous Electronic Nerve Stimulator (TENS) device. This document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a regulatory submission for substantial equivalence to a predicate device, not a performance study report.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory classification, indications for use, device description, and claiming substantial equivalence to a legally marketed device (Empi Focus). It does not present data from performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
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JUN 2 6 2003
Prizm Medical, Inc.
510(k) SUMMARY of SAFETY and EFFECTIVENESS
GENERAL INFORMATION I.
| Trade or (Proprietary) Name: | Prizm Medical, Inc. Micro-ZTMStimulation System |
|---|---|
| Common or usual name: | Transcutaneous Electronic NerveStimulator (TENS) |
| Classification Name: | FDA has classified TranscutaneousElectronic Nerve Stimulator (TENS) asClass II devices. (21 C.F.R. §882.5890) |
| Submitter's NameAnd Address: | Cathryn N. Cambriafor Prizm Medical, Inc.Regulatory Resources Group5536 Trowbridge DriveDunwoody, GA 30338 |
| Submission Date: | December 17, 2002 |
| Legally Marketed DeviceTo Which Claim SubstantialEquivalence: | Empi Focus |
II. INDICATIONS FOR USE
The Prizm Medical, Inc. Micro-Z™ Stimulation System is intended for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems.
The Prizm Medical, Inc. Micro-Z™ Stimulation System is also used for Neuromuscular Electrical Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. These uses were previously cleared under K951727.
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Prizm Medical, Inc.
III. DEVICE DESCRIPTION
Prizm Medical, Inc. Micro-Z™ Stimulation System is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for chronic or intractable pain (see indications for use statement). It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the Micro-ZTM Stimulator can be found in Appendix A. The stimulator is wearable with the Velcro® strip that attaches the device to the Velcro® arm/leg strap. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked patient intensity buttons.
Please refer to the Operations Manual (Exhibit A) for photographs and a more thorough description of the device.
The Prizm Medical, Inc. Micro-Z™ Stimulation System is intended for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems.
The primary function of the Micro-Z™ Stimulation System is the same as the Empi Focus and raises no new questions of safety and effectiveness.
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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 stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2003
Prizm Medical, Inc c/o Ms. Cathryn N. Cambria Regulatory Resources Group, Inc. 5536 Trowbridge Drive Dunwoody, GA 30338
Re: K024181 Trade/Device Name: Micro-Z™ Stimulation System Regulation Numbers: 21 CFR 890.5850, 21 CFR 882.5890 Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: IPF, GZJ Dated: March 26, 2003 Received: March 28, 2003
Dear Ms. Cambria:
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. Iisting 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
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Page 2 - Ms. Cathryn N. Cambria
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) 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) 594-4659. 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. Millherson
Celia M. Witten, 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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Page 1 of 1
KOZY4181
510(k) Number (if known):
Device Name:
Prizm Medical, Inc. Micro-ZTM Stimulation System
Indications for Use:
The Prizm Medical, Inc. Micro-Z™ Stimulation System is intended for
-
- Transcutaneous Electrical Nerve Stimulation for the symptomatic relief and management of chronic (longterm) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems.
-
- Neuromuscular Electrical Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CFR 801.109)
OR Over-The-Counter
Mark N. Millman
102418
Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number -
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).