MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR

K032841 · Moor Instruments, Ltd. · DPT · Dec 10, 2003 · Cardiovascular

Device Facts

• Record ID: K032841
• Device Name: MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
• Applicant: Moor Instruments, Ltd.
• Product Code: DPT · Cardiovascular
• Decision Date: Dec 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

Intended Use

The moorLDI2-IR infrared Laser Doppler Imager is intended for blood flow measurements in the microcirculation.

Device Story

The moorLDI2-IR is an infrared laser Doppler imager used to quantify microcirculatory blood flow. It scans a low-power infrared laser beam across the skin in a raster pattern; a visible target beam assists in positioning. The device detects backscattered light to measure blood cell movement, transforming these signals into a two-dimensional, color-coded perfusion image. It includes a color video camera for visual reference. The device is intended for clinical use to assist healthcare providers in assessing tissue perfusion. By providing non-invasive, spatial mapping of blood flow, it aids in clinical decision-making regarding microvascular health. Safety features include a beam attenuator, visible aiming beam, and infrared emission indicator.

Clinical Evidence

Bench testing only. Performance was evaluated through flow model testing, single-point measurements, and image scans comparing the moorLDI2-IR to the predicate moorLDI. Results demonstrated that the subject device achieved performance equivalent to the predicate.

Technological Characteristics

Infrared laser Doppler imager; raster scanning mechanism. Features a low-power infrared laser source and integrated color video camera. Complies with IEC 825-1:1993 + A1:1997 + A2:2001 (Class 3R Medical Laser) and 21 CFR 1040.10/1040.11. Includes beam attenuator, visible aiming beam, and infrared emission indicator for safety.

Indications for Use

Indicated for blood flow measurements in the microcirculation. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

Identification

An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

Predicate Devices

• moorLDI Laser Doppler Perfusion Imager (K980383)

Submission Summary (Full Text)

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# Moor Instruments Ltd

DEC 1 0 2003

#### EDICAL AND OPTO-ELECTRONIC INSTRUMENTATION

Millwey, Axminster Devon EX13 5HU England

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TEL: [phone] FAX: [phone] E-MAIL: mail @moor.co.uk WEBSITE: http://www.moor.co.uk

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# Premarket Notification 510(k) Summary

Company Name:

Address:

Telephone No:

Fax No:

Contact Name:

Contact Title:

Date:

#### MOOR INSTRUMENTS LIMITED

MILLWEY AXMINSTER, DEVON U.K. EXI3 SHU

[phone]

[phone]

DAVE BOGGETT

Managing Director

02/12/2003

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Image /page/0/Picture/23 description: The image contains two logos. The logo on the left is the ISO 9001 quality standard logo, which is a circular seal with the text "QUALITY ASSURED FIRM" around the perimeter and "ISO 9001" in the center. The logo on the right is the UKAS Quality Management logo, which features a crown above a checkmark and the text "UKAS QUALITY MANAGEMENT" below. The number 605 is at the bottom of the UKAS logo.

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K03284|

510(k) Summary

Classification Name:

Blood Flow, Cardiovascular Product Code: DPT

Common/Usual Name:

Trade/Proprietary Name:

Establishment Registration No:

Classification:

Performance Standard:

CFR Section: 870.2120

Laser Doppler Perfusion Imager

moorLDI2-IR Infrared Laser Doppler Imager

8043564

Regulatory Class II

The equipment conforms to IEC 825:1:1993 + A1:1997 + A2:2001 Class 3R Medical Laser Product as per IEC 825:1:1993 + A1:1997 + A2:2001

The equipment complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50. Dated July 26, 2001

Reason for Submission:

Predicate Devices:

New Device

moorLDI Laser Doppler Perfusion Imager 510(k) Number - K980383

#### Description of the Device

The moorLD12-IR infrared laser Doppler imager is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the existing MK1 moorLDI laser Doppler imager, which use a low power visible red HeNe laser, the moorLDI2-IR has a low power infrared laser beam combined with a visible target beam to scan in a raster pattern over the skin surface to build up a colour coded image of blood flow.

#### Intended Use

The moorLDI2-IR infrared Laser Doppler Imager is intended for blood flow measurements in the microcirculation.

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### Technological Characteristics

#### . moorLDI2-IR Compared with moorLDI Laser Doppler Imager

The operation and design of the moor DI2-IR infrared laser Doppler image is based on the predicate device moorLDI. They both have the same intended use. Both devices rely on the same physical principle, i.e. the laser Doppler principle, to measure the tissue blood perfusion. Both instruments scan a low power laser beam over the tissue surface in a raster pattern to produce a two dimensional colour coded blood perfusion image. The main differences between two devices are the laser sources and inclusion of colour video camera in the moorLDI2-IR.

However, the potential hazards due to use of a near infrared lascr source is not considered to compromise the safety of the instrument since the moorLD12-IR has been designed to comply with all related safety standards and has implemented the extra safety precautions such as beam attenuator, visible aiming beam and infrared emission indicator to reduce the risks to an acceptable level.

## Performance Data

In order to evaluate the performance of the moorLD2-IR infrared laser Doppler perfusion imager, and determine its substantial equivalence to the predicate device moorLDI, a set of comparison tests has been carried out. These include flow model, single point measurement and image scan using both devices. The results suggest that moorl DI2-IR has achieved the same performance as the predicate device moorLD1 laser Doppler imager.

#### Conclusions

From the description of the technological characteristics and the performance data, it can be concluded that the moorLDI2-IR infrared laser Doppler imager is substantial cquivalence to the predicate device moorLDI in terms of effectiveness and safety.

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DEC 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. David Boggett Managing Director Moor Instrument Ltd Millwey Axminster Devon, EX 13 5HU United Kingdom

Re: K032841

Trade/Device Name: moorLD12-IR Infrared Laser Doppler Imager Regulation Number: 21 CFR 870.2120, 21 CFR 878.4810 Regulation Name: Extravascular blood flow probe; Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: DPT, GEX Dated: September 5, 2003 Received: September 11, 2003

Dear Dr. Boggett:

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 (Spccial 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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 - Dr. David Boggett

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K 032841

Device Name: moorLD12-1R Infrared Laser Doppler Imager

Indications For Use:

The moorLDI2-IR infrared laser Doppler Imager is intended for blood flow measurements in the microcirculation.

Prescription Use
(Part 21 CFR 801 Subpart D)

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)

Page 1 of 1

Miriam C. Provost

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

510(k) Number K632841