HIGH SPEED EMG MODULE

K031930 · Medical Measurement Systems B.V. · GWF · Mar 3, 2004 · Neurology

Device Facts

• Record ID: K031930
• Device Name: HIGH SPEED EMG MODULE
• Applicant: Medical Measurement Systems B.V.
• Product Code: GWF · Neurology
• Decision Date: Mar 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.

Device Story

Solar Neuro Module performs electro-physiological testing of pelvic organs; inputs include electrical signals from motor nerve conduction, sacral reflex, and free-run EMG tests; device processes these signals to provide diagnostic data for clinicians; used in clinical settings by healthcare professionals to assess pelvic organ function; output assists in clinical decision-making regarding pelvic health; benefits patients by enabling objective assessment of nerve and muscle function in pelvic region.

Technological Characteristics

The device is an electro-physiological measurement system for pelvic organs. It functions as a nerve conduction velocity measurement device and evoked response electrical stimulator. It operates under 21 CFR 882.1870, 882.1550, and 876.1620.

Indications for Use

Indicated for electro-physiological testing of pelvic organs in patients requiring motor nerve conduction, sacral reflex, and free-run EMG tests.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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## MAR - 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karin Ogink-Somhorst Quality Assurance and Regulatory Affairs Manager Medical Measurement Systems, B.V. Colosseum 25, 7521 PV Enschede P.O. Box 580, 7500 AN Enschede THE NETHERLANDS

Re: K031930

Trade/Device Name: Solar Neuro Module Regulation Number: 21 CFR §882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: 84 GWF Regulation Number: 21 CFR §882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: 84 JXE Regulation Number: 21 CFR 876.§1620 Regulation Name: Urodynamics measurement system Regulatory Class: II Exempt Product Code: 78 FEN Dated: January 29, 2004 Received: February 2, 2004

Dear Ms. Ogink-Somhorst:

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 for are navaior 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 (sce 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 (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (scctions 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocglif marketing your antial equivalence of your device to a legally premarket notification. The FDA inding of sacculting of saccomments of this, 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 on If you desire specific advice for your device on our are of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of the production and and the regulation entitled, "Misbranding
Office of Compliance at [phone]. Othce of Compliance at [phone]. Tass, part 807.97) you may obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtain of Sma by reference to premarket notification (21Gr Act on 1) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } information on your responsibilities unect Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-demoments htt Manufacturers, International and Consumior Pissional Posted on the Marian an html.
[phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K031930

Device Name:

Solar Neuro Module

Indications For Use:

The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.

Prescription Use
(Part 21 CFR 801 Subpart D)
Yes

AND/OR

Over-The-Counter Use (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 (ODE)

Nancy C. Gordon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Page 1 of __

No