(330 days)
The 5000Z System (OTC) is intended for the symptomatic relief and management of pain in the upper and lower extremities (arms and legs).
"To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities."
The 5000Z System (OTC) 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 pain. It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the 5000Z Stimulator can be found in Exhibit E. 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 intensity buttons.
The provided text is a 510(k) Summary for the Prizm Medical, Inc. 5000Z System (OTC), a Transcutaneous Electronic Nerve Stimulator (TENS). This summary describes the device, its intended use, and indicates its substantial equivalence to a predicate device.
However, the submission does not contain a study or data proving the device meets acceptance criteria in the way a clinical trial or performance study would for a novel medical device. Instead, the 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device.
Therefore, many of the specific questions regarding acceptance criteria, study data, sample sizes, expert ground truth, and comparative effectiveness related to a performance study cannot be answered from the provided document.
Here's a breakdown of what can be inferred and what is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new performance study. The core "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The document states: "The primary function of the 5000Z System (OTC) is the same as the Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit and Woodside Biomedical ReliefBand® and raises no new questions of safety and effectiveness." This is the "performance" claim in the context of a 510(k) – that its performance is equivalent to established devices in terms of safety and efficacy for its intended use. Specific quantitative performance metrics (e.g., pain reduction scores, error rates) from a new study are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. There is no mention of a test set or associated data from a performance study for the 5000Z System.
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)
- Not applicable/Not provided. Ground truth for a performance study is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication for a performance study is not discussed.
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. The device is a Transcutaneous Electronic Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical TENS unit, not an algorithm. Its function is to deliver electrical stimulation for pain.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. Ground truth for a performance study is not discussed. The "truth" in a 510(k) is the demonstration of substantial equivalence to a predicate, meaning it performs as safely and effectively as an already legally marketed device.
8. The sample size for the training set
- Not applicable/Not provided. There is no mention of a training set as this is not an AI/Machine Learning device requiring such data.
9. How the ground truth for the training set was established
- Not applicable/Not provided. Same as above.
Summary based on the document:
The provided document details a 510(k) premarket notification for the Prizm Medical, Inc. 5000Z System (OTC). The mechanism for "proving" the device meets acceptance criteria in this context is through demonstrating substantial equivalence to existing, legally marketed predicate devices (Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit, and Woodside Biomedical ReliefBand®).
The document explicitly states: "The primary function of the 5000Z System (OTC) is the same as the Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit and Woodside Biomedical ReliefBand® and raises no new questions of safety and effectiveness." This declaration serves as the basis for its "acceptance."
The FDA's letter (APR 1 5 2005) confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the "proof" required for a 510(k) pathway, rather than a clinical study with detailed performance metrics against pre-defined acceptance criteria. The FDA, however, did add specific warnings/limitations to the labeling regarding potential underlying serious conditions that the device should not be used for without physician consultation.
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Prizm Medical, Inc.
510(k) SUMMARY of SAFETY and EFFECTIVENESS
GENERAL INFORMATION I.
Trade or (Proprietary) Name: 5000Z System (OTC)
Common or usual name:
Transcutaneous Electronic Nerve Stimulator (TENS)
Classification Name:
FDA has classified Transcutaneous Electronic Nerve Stimulator (TENS) as Class II devices. (21 C.F.R. § 882.5890)
Submitter's Name And Address:
Cathryn N. Cambria for Prizm Medical, Inc. Regulatory Resources Group 5536 Trowbridge Drive Dunwoody, GA 30338
Submission Date:
September 29, 2003
INDICATIONS FOR USE II.
The 5000Z System (OTC) is intended for the symptomatic relief and management of pain in the upper and lower extremities (arms and legs).
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Prizm Medical, Inc.
DEVICE DESCRIPTION III.
The 5000Z System (OTC) 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 pain. It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the 5000Z Stimulator can be found in Exhibit E. 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 intensity buttons.
Please refer to the Operations Manual (Exhibit A) for photographs and a more thorough description of the device.
The 5000Z System (OTC) is intended for the symptomatic relief and management of pain in the upper and lower extremities (arms and legs).
The primary function of the 5000Z System (OTC) is the same as the Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit and Woodside Biomedical ReliefBand® and raises no new questions of safety and effectiveness.
$\partial SD$
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Prizm Medical, Inc. c/o Ms. Cathryn N. Cambria Regulatory Resources Group, Inc. 5536 Trowbridge Drive Dunwoody. GA 30338
APR 1 5 2005
Re: K033122 Trade Name: Prizm Medical, Inc. 5000-Z System Regulatory Name: 21 CFR 882.5890 Regulatory Class: II Product Code: NUH Dated: February 10,2005 Received: February 10,2005
Dear Ms. Cambria:
We have reviewed your Section 510(k) preinarket 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitations must appear in the Warnings section of the device labeling immediately following the indications for use section:
- Warning: If you have numbness, tingling or loss of feeling/sensation in your 1. arms, hands, legs or feet. this may represent a more serious problem like diabetic neuropathy. Consult your physician before using the device.
- Warning: If you have swelling of the arm or leg, it may be more serious than 2. simple muscle pain from overuse. Consult your doctor before using the device.
- Warning: Use the glove or stocking only on healthy skin. Do not use on open wounds or rashes, or over swollen, red, infected or inflamed skin.
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Page 2 - Ms. Cathryn N. Cambria
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device'and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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 vours.
Walter
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO?3122
Device Name: Prim Medical, Inc. 5000
Indications For Use: "To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities."
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use x (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 (
ce Evaluation (ODE),
4/15/05
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§ 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).