(330 days)
Not Found
Not Found
No
The description mentions a microprocessor for control and parameter setup, but there is no mention of AI, ML, or any learning or adaptive capabilities. The device appears to be a standard electrical stimulator with pre-set or user-adjustable parameters.
Yes.
The device's intended use is for symptomatic relief and management of pain in the upper and lower extremities, which is a therapeutic purpose.
No
The device description indicates its purpose is for symptomatic relief and management of pain through electrical stimulation, not for identifying, monitoring, or predicting diseases or conditions.
No
The device description explicitly states it is a "compact battery operated transcutaneous electrical stimulator" and mentions "patented conductive Silver-Thera E.M. garment electrodes," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain in the upper and lower extremities through electrical stimulation. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a transcutaneous electrical stimulator that delivers micro-current to the body surface. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
Therefore, the 5000Z System (OTC) is a therapeutic device, specifically a transcutaneous electrical nerve stimulator (TENS) or similar pain relief device, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 5000Z System (OTC) is intended for the symptomatic relief and management of pain in the upper and lower extremities (arms and legs).
Product codes
NUH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities (arms and legs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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).
1
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.
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2
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.
3
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
4
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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