PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT

K974285 · Perimed, Inc. · DPW · May 28, 1998 · Cardiovascular

Device Facts

• Record ID: K974285
• Device Name: PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
• Applicant: Perimed, Inc.
• Product Code: DPW · Cardiovascular
• Decision Date: May 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.

Device Story

PeriFlux System 5000 is a modular laser Doppler flowmeter; consists of PF 5001 main unit and PF 5010 laser Doppler perfusion monitor (LDPM) units. System uses probes to collect microvascular perfusion data; data processed via PeriSoft analysis software. Device measures perfusion and total backscatter (TB); calculates perfusion using concentration of moving blood cells (CMBC) and velocity. Designed for clinical use to monitor microvascular blood flow; provides quantitative perfusion metrics to healthcare providers for clinical assessment. Modular design allows configuration of up to four function units; probes are interchangeable with previous generation (PeriFlux System 4000).

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Modular laser Doppler flowmeter; consists of PF 5001 main unit and PF 5010 LDPM function units. Uses laser Doppler sensing principle. Probes are interchangeable with PeriFlux System 4000. System is software-controlled via PeriSoft analysis program. Modular architecture allows up to four function units.

Indications for Use

Indicated for measuring microvascular perfusion in human skin and muscle, and in all tissues of animals.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Predicate Devices

• PeriFlux PF 4001 Laser Doppler Flowmeter (K922368)
• 400-series Probes (K935495)

Submission Summary (Full Text)

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## Section 2: 510(k) Summary or Statement

## 2.1. 510(k) Summary

PERIMED

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Laser Doppler Flowmeter (Blood Flow Meter).

PeriFlux System 5000 Modular Laser Doppler Flowmeter,

including: PF 5001 Main Unit, PF 5010 LDPM Unit, PF 5990 Blank Panel", PeriSoft

PeriFlux PF 4001 Laser Doppler Flowmeter: K 922368, plus additional

PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000

consists of a PF 5001 Main Unit, which can accommodate up to four Function Units. The first available Function Unit is the PF 5010 LDPM (Laser Doppler Perfusion Monitor) Unit. A PF 5990 Blank Panel takes the place of a Function Unit if less than four Units are required. Probes are attached to collect the information, which is analysed, using the PeriSoft

Assigned 510(k) no .:

Kjell Bakken*, President, Perimed Inc and Perimed AB. Applicant/Contact:

Address Perimed Inc 821 West Jericho Turnpike, Suite A Smithtown New York 11787 USA Phone: [phone] Fax: [phone]

Perimed AB Datavägen 9 A, Box 564 S-175 26 Järfälla, Stockholm Sweden Tel: [phone] Fax: [phone] e-mail: [e-mail]

Date Prepared:

20/10/97

probes: K935495.

analysis program.

Laser Doppler Flowmeter

Analysis Software and 400-series Probes.

Classification Name: Common/Usual Name: Trade/Proprietary Name:

Predicate Device:

Device description:

Intended Use:

The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.

Summary of the technological characteristics of the PeriFlux System 5000 compared with the PeriFlux System 4000:

The PeriFlux System 5000 Modular Laser Doppler Flowmeter is developed directly from the PeriFlux System 4000. The technology is the same but the design has been modified to simplify use of the instrument and allow customers to more easily choose the number of channels they need. Whereas the PeriFlux System 4000 presented the parameters Perfusion, CMBC (Concentration of Moving Blood Cells), Velocity and TB (Total Backscatter) to the user the PeriFlux System 5000 presents only Perfusion and TB (CMBC and Velocity are measured by the instrument to calculate Perfusion). The probes which are used with the PF 5010 LDPM Unit are identical in every way with those used for the PeriFlux System 4000 laser Doppler Flowmeter - they are interchangeable between the two systems.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUM SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

MAY 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kjell Bakken President Perimed, Inc. 821 West Jericho Turnpike Suite A Smithtown, NY 11787

Re: K974285 PeriFlux System 5000 Modular Laser Doppler Flowmeter Requlatory Class: II (Two) Product Code: DPW Dated: May 2, 1998 May 7, 1998 Received:

Dear Mr. Bakken:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Kjell Bakken

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html. "

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K974285 |
|---------------------------|-----------------------|
| Device Name: | Peri Flux System 5000 |

Indications For Use:

The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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Spee

Division of Cardiovascular, Respiratory, and Neurological Devices < 91428 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-9(