SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD

K965187 · Sparta Surgical Corp. · GZJ · Aug 1, 1997 · Neurology

Device Facts

• Record ID: K965187
• Device Name: SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
• Applicant: Sparta Surgical Corp.
• Product Code: GZJ · Neurology
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For symptomatic relief and management of chronic pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Story

Spectrum II, Spectrum Plus, and Spectrum MAX-SD are Transcutaneous Electrical Nerve Stimulation (TENS) devices. These devices deliver electrical impulses through electrodes placed on the skin to provide pain relief. Used in clinical or home settings, they are operated by patients or healthcare providers to manage chronic pain or post-surgical/post-traumatic acute pain. The device functions by modulating nerve signals to alleviate pain symptoms, serving as an adjunctive therapy. Output is controlled by the user to adjust stimulation parameters for comfort and efficacy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the established nature of TENS technology for pain management.

Technological Characteristics

TENS device; electrical stimulation output; portable form factor; intended for symptomatic pain relief.

Indications for Use

Indicated for symptomatic relief and management of chronic pain, and as adjunctive treatment for post-surgical and post-traumatic acute pain in patients.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Thomas J. Bouchard
Official Correspondent for
Sparta Surgical Corporation
MDI Consultants, Inc.
55 Northern Boulevard
Great Neck, New York 11021

AUG - 1 1997

Re: K965187
Trade Name: Spectrum II, Spectrum Plus, and Spectrum MAX-SD TENS Devices
Regulatory Class: II
Product Code: 84GZJ
Dated: May 9, 1997
Received: May 14, 1997

Dear Mr. Bouchard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Thomas J. Bouchard

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K965187

Device Name: Spectrum II, Spectrum Plus, and Spectrum MAX-SD TENS devices

Indications For Use: For symptomatic relief and management of chronic pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)