MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER

K122943 · Moor Instruments, Ltd. · DPT · Jan 3, 2013 · Cardiovascular

Device Facts

• Record ID: K122943
• Device Name: MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
• Applicant: Moor Instruments, Ltd.
• Product Code: DPT · Cardiovascular
• Decision Date: Jan 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

Intended Use

The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.

Device Story

The moorFLPI-2 is a non-contact imaging device for assessing microvascular blood perfusion; primarily used in clinical research settings. It illuminates tissue surfaces with a diverging infra-red laser beam, creating a laser speckle pattern. A CCD camera captures this pattern; internal image processing performs speckle contrast analysis to generate color-coded perfusion maps. The device provides clinicians with visual representations of blood flow, facilitating microcirculation assessment. It functions as an updated version of the predicate moorFLPI, incorporating secondary features to enhance ease of use while maintaining the same fundamental principle of operation.

Clinical Evidence

Bench testing only. Performance was evaluated via direct comparison to the predicate device using laboratory models and skin blood flow measurements on human volunteers. No clinical trials were required to establish substantial equivalence.

Technological Characteristics

Non-contact laser speckle contrast imaging system. Employs a diverging infra-red laser source and a CCD camera for image acquisition. Performs speckle contrast analysis to quantify microvascular perfusion. Device is a standalone imaging unit.

Indications for Use

Indicated for blood flow measurements in the microcirculation for clinical research purposes.

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

• moorFLPI Full-Field Laser Perfusion Imager (K063586)

Submission Summary (Full Text)

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K122943

Image /page/0/Picture/1 description: The image shows the logo for Moor Instruments. The logo consists of a circular graphic with radiating lines on the left, followed by the text "moor instruments" in a bold, sans-serif font. Below the company name, there is a tagline that reads "innovation in microvascular assessment" in a smaller, lighter font.

### 510(k) Summary 5

JAN 0 3 2013

## Submitter information

| Submitter: | Moor Instruments Ltd |
|-----------------------|------------------------------------------------------------------|
| Address: | Millwey rise<br>Axminster<br>Devon<br>EX13 5HU<br>United Kingdom |
| Telephone: | ([phone] |
| Fax: | ([phone] |
| Contact: | Stewart Lillington |
| Contact title: | Product Development Manager |
| E-mail: | [e-mail] |
| Establishment Reg No: | 8043564 |
| Date of preparation: | September 18th 2012 |

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/7 description: The image contains two logos. The logo on the left has a checkmark inside of a circle with the letters "SGS" to the right of the circle. The text "ISO 17065:2012" is on the left side of the circle. The logo on the right has a crown above a checkmark with the text "UKAS QUALITY MANAGEMENT 005" below the checkmark.

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### Device information

| Trade name: | moorFLPI-2 Full-Field Laser Perfusion Imager |
|----------------------|--------------------------------------------------------------------|
| Common name: | Full-Field Laser Perfusion Imager |
| Classification name: | Extravascular blood flow probe (21 CFR 870.2120, Product code DPT) |
| Predicate device: | moorFLPI Full-Field Laser Perfusion Imager, 510(k) number K063586 |

The moorFLPI-2 is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour coded images of the tissue blood perfusion in the microcirculation.

#### 5.1 Intended Use

The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.

#### 5.2 Technological comparison to predicate device

The moorFLPI-2 Full-Field Laser Perfusion Imager uses the same technology and principle of operation as the predicate device whilst adding secondary features to improve ease of use. The intended use of both devices is the same.

#### 5.3 Performance comparison to predicate device

The moorFLPI-2 was tested in direct comparison to the predicate device using laboratory models and skin blood flow measurements on volunteers.

#### 5.4 Conclusions from testing

The moorFLPI-2 demonstrated performance, safety and effectiveness equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Moor Instruments, Limited % Mr. Stewart Lillington Product Development Manager Mill Wey Axminster, Devon United Kingdom EX 135HU

January 3, 2013

Re: K122943

Trade/Device Name: moorFLPI-2 Full-Field Laser Perfusion Imager Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT Dated: November 07, 2012 Received: November 13, 2012

Dear Mr. Lillington:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see 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); medical device reporting (reporting of medical

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Page 2 - Mr. Stewart Lillington

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

K122943 510(k) Number:

Device name: moorFLPI-2 Full-Field Laser Perfusion Imager

Indications for use:

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The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.

Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Neil R Ogden 2012.12.28 15:53:16 -05'00'

(Division Sign-Off) Division of Surgical Devices

510(k) Number K122943