MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS

K083082 · Moor Instruments, Ltd. · GEX · Jan 13, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083082
• Device Name: MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
• Applicant: Moor Instruments, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.

Device Story

The moorVMS-LDF1 and moorVMS-LDF2 are laser Doppler monitors designed for clinical research settings. The devices utilize laser Doppler technology to measure microcirculatory blood flow and simultaneous tissue temperature. Inputs consist of optical signals from tissue; these are processed to derive perfusion and temperature metrics. The output is displayed for the clinician to monitor microvascular status. The devices are intended for use by researchers in clinical environments to assess blood flow dynamics. The system provides real-time data to assist in clinical research investigations regarding microcirculation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laser Doppler perfusion and temperature monitoring system. The device utilizes laser-based sensing for microcirculation assessment. It is a Class II device (21 CFR 878.4810).

Indications for Use

Indicated for clinical research use for the simultaneous measurement of tissue temperature and blood flow in the microcirculation.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• DRT4 Laser Doppler perfusion and temperature monitor (K011070)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains a logo and text. The logo is on the left and features a black and white sun-like design. To the right of the logo is the text "הווקשוווגרונג וועטווו laser Doppler blood flow assessment".

K083082_

#### 510(k) Summary 7

| Submitter: | Moor Instruments Ltd | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | Millwey<br>Axminster, Devon<br>EX13 5HU, United Kingdom | JAN 13 2009 |
| Telephone: | ([phone] | |
| Fax: | ([phone] | |
| Contact: | Xiabing Huang | |
| Contact title: | Technical Manager | |
| E-mail: | [e-mail] | |
| Date: | October 8th, 2008 | |
| Model Name: | moorVMS-LDF1 Laser Doppler perfusion and temperature<br>monitor<br>moorVMS-LDF2 Laser Doppler perfusion and temperature<br>monitor | |
| Model Number: | moorVMS-LDF1<br>moorVMS-LDF2 | |
| Common Name: | Laser Doppler perfusion and temperature monitor | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology, GEX, 21 CFR 878.4810 | |
| Regulatory Status: | Class II | |
| Establishment Reg No: | 8043564 | |
| Type of 510(k): | Traditional | |
| Reason for submission: | New devices | |
| Predicate Device: | DRT4 Laser Doppler perfusion and temperature monitor<br>510(k) Number K011070 | |

Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK tel [phone] fax [phone] email [e-mail] website www.moor.co.uk Company Registered in England No. 2209367 VAT Registration No. GB490667906

Image /page/0/Picture/5 description: The image contains two logos. The logo on the left is the SGS logo, which features a checkmark inside a circle. The logo on the right is the UKAS (United Kingdom Accreditation Service) logo, which features a crown above a checkmark. The UKAS logo also includes the text "UKAS QUALITY MANAGEMENT 005".

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Moor Instruments Ltd. % Xiabing Huang Millwey Axminster, Devon EX13 5HU, United Kingdom

## Re: K083082

Trade/Device Name: moorVMS-LDF1 Laser Doppler perfusion and temperature monitor moorVMS-LDF2 Laser Doppler perfusion and temperature monitor Regulation Number: 21 CFR 878.4810

JAN 1 8 2009

Regulation Name: Laser surgical instrument for use in general and plastic surgery and

in dermatology

Regulatory Class: II Product Code: GEX Dated: October 8, 2008 Received: October 16, 2008

## Dear Xiabing Huang:

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 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 (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 - Xiabing Huang

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 5 Indications for Use Statement

510(k) Number: _ K 083082

moorVMS-LDF1 Laser Doppler perfusion and temperature monitor Device name: moorVMS-LDF2 Laser Doppler perfusion and temperature monitor

Indications for use:

The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.

Prescription Use: Yes (Part 21 CFR 801 SubpartD)

AND/OR

Over-The-Counter Use: No (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krone for MKM

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K083082