VIRTUAL MEDICAL SYSTEMS MODEL VT3000

K052904 · Scientific Imaging, Inc. · JXE · Oct 27, 2005 · Neurology

Device Facts

• Record ID: K052904
• Device Name: VIRTUAL MEDICAL SYSTEMS MODEL VT3000
• Applicant: Scientific Imaging, Inc.
• Product Code: JXE · Neurology
• Decision Date: Oct 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1550
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).

Device Story

Virtual Medical Systems VT 3000 performs Nerve Conduction Studies (NCS) and Evoked Potentials (EP). Device captures physiological signals related to nerve conduction and evoked responses; processes data to provide diagnostic measurements for clinical evaluation. Used in clinical settings by healthcare professionals to assess neurological function. Output assists clinicians in diagnosing nerve-related conditions. Benefits include objective assessment of nerve conduction velocity and evoked potential pathways.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Nerve conduction velocity measurement device (21 CFR 882.1550, Product Code JXF). System designed for NCS and EP signal acquisition and processing.

Indications for Use

Indicated for patients requiring Nerve Conduction Studies (NCS) and Evoked Potentials (EP) testing. Prescription use only.

Regulatory Classification

Identification

A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scientific Imaging, Inc. c/o Neil E. Devine, Jr. Responsible Third Party Official Intetek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K052904

Trade/Device Name: Virtual Medical Systems VT 3000 Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: JXF Dated: October 13, 2005 Received: October 14, 2005

Dear Mr. Devine:

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 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) 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 gettoral conable and would be and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Neil E. Devine, Jr.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manceing your and equivalence of your device to a legally premarket notification. The PDA maing of castion 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), please If you desire specific advice for Jour ac [phone]. Also, please note the regulation entitled, Colliact the Office of Complanes in (21CFR Part 807.97). You may obtain Misolanding by reference to premainters with the Act from the Division of Small other general information on your responsionation with toll-free number [phone] or Manufacturers, International and Conson http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 1.7.1 – Indications for Use

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Device Name: Virtual Medical Systems VT 3000

Indications: The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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