HIGH SPEED EMG MODULE

• K Number: K031930
• Device Name: HIGH SPEED EMG MODULE
• Manufacturer: MEDICAL MEASUREMENT SYSTEMS,B.V.
• Date Cleared: 2004-03-03 ( 254 days)
• Product Code: GWF , FEN , JXE
• Regulation Number: 882.1870
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a regulatory clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input. The document primarily focuses on:

• Device Name: Solar Neuro Module
• Regulation Numbers and Names: Specifies its classification as an Evoked response electrical stimulator, Nerve conduction velocity measurement device, and Urodynamics measurement system.
• FDA Clearance: States that the device is substantially equivalent to legally marketed predicate devices.
• Indications For Use: Electro-physiological testing of pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.
• Prescription Use: Confirms it's a prescription-only device.

The letter advises the manufacturer on regulatory compliance but does not detail the technical performance studies.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 wavy lines extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services.

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

Page 2

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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

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
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.(b)
Classification. Class II (performance standards).