CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100

K992606 · Canon USA, Inc. · HLI · Jun 21, 2000 · Ophthalmic

Device Facts

• Record ID: K992606
• Device Name: CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
• Applicant: Canon USA, Inc.
• Product Code: HLI · Ophthalmic
• Decision Date: Jun 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

Canon Laser Blood Flowmeter CLBF model 100 is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF model 100, and it is intended to help doctors' reading of retinal images.

Device Story

Canon Laser Blood Flowmeter (CLBF) Model 100 is an AC-powered ophthalmoscope used for fundus observation and retinal blood flow measurement. The device utilizes laser Doppler technology to measure blood flow velocity in retinal vessels. It captures data over a 2-second acquisition period. The system provides numerical outputs for velocity, flow rate, and vessel diameter, as well as graphical representations of time-variation in velocity and flow rate. The device is operated by clinicians in a clinical setting. The output assists physicians in reading retinal images and assessing retinal blood flow, potentially aiding in the evaluation of ocular health. The device includes a main unit and a power control unit.

Clinical Evidence

A published clinical study was provided to support the claim of substantial equivalence. No further details on sample size or specific performance metrics were provided in the summary documentation.

Technological Characteristics

Laser Doppler principle; 675 nm laser diode (max 300uW); 560-650 nm halogen illumination; -10 to +10 Diopter compensation range; 30-degree observation angle; AC-powered; complies with UL 544 and IEC 825 standards.

Indications for Use

Indicated for use in the general population for observing the fundus (retina) and measuring retinal blood flow velocity in a retinal vessel to assist clinicians in the interpretation of retinal images.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Heidelberg Retina Flowmeter (K943955)

Submission Summary (Full Text)

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# JUN 2 1 2000

K992606

# 510(k) Summary

# Prepared:

July 15, 1999

## Submitter:

Company Name: Canon USA, Inc. (U.S. designated agent for Canon Inc.) Company Address: One Canon Plaza Lake Success, NY 11042 Ken Shadoff, Senior Product Safety Engineer Contact Person: Phone Number: [phone] Fax Number: [phone]

# Proposed Device:

| Reason For 510(k): | New Model |
|----------------------|---------------------------------|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon Laser Blood Flowmeter |
| Model Name: | CLBF Model 100 |
| Classification Name: | HLI, Ophthalmoscope, AC-Powered |
| FDA 510(k) #: | To be assigned |

#### Predicate Device:

| Manufacturer: | Heidelberg Engineering Gmbh |
|----------------------|---------------------------------|
| Trade Name: | Heidelberg |
| Model Name: | Retina Flowmeter |
| Classification Name: | HLI, Ophthalmoscope, AC-Powered |
| FDA 510(k) #: | K943955 |

#### Description Of Device:

The Canon Laser Blood Flowmeter (CLBF) Model 100 allows for fundus observation with velocity measurement of retinal blood flow.

#### Intended Use:

This device is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF Model 100, and it is intended to help doctor's reading of retinal images.

## Technical Characteristics:

Please refer to the attached COMPARISON CHART.

# Non-clinical Tests:

Software evaluation has been performed to support a claim of substantial equivalence. Documented non-clinical studies have been included to support a claim of substantial equivalence.

#### Clinical Tests:

A published clinical study was included to support a claim of substantial equivalence.

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mparison with the similar product of the other company (1/2)

Approved product : Heidelberg Engineering, Heidelberg Retina Flowmeter

July 15, 1999

| | Manufacturer<br>product name | Intended use | specification /<br>function | fundus<br>observation | method | observation angle | illumination light | diopter<br>compensation range<br>for examinee's eye | principle | velocity<br>measurement | measurement laser | Product Name | specification /<br>function | fundus<br>observation | measurement<br>duration | measurement result | others | anatomical regions | target population | physical safety | compliance with standards | status of device | dimensions (W x D x H) | mass (kg) |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------|-----------------------|------------------------------|--------------------------------|--------------------|-----------------------------------------------------|-------------------------------------------------------|-------------------------------|-----------------------------------------------|--------------|-----------------------------|-------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------|-------------------------------|-------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------|
| Canon Inc.<br>Canon Laser Blood Flowmeter<br>CLBF model 100 | Fundus observation with<br>retinal blood flow measurement<br>similar to conventional fundus<br>camera with eye drop<br>(through optical finder /<br>on PC monitor (optional)) | | | 30 | 560 - 650 nm<br>Halogen lamp | -10 - +10 Diopter or more | | laser Doppler | 675 nm / max. 300uW<br>(usually 200uW)<br>laser diode | | Canon Laser Blood Flowmeter<br>CLBF model 100 | | | 2 sec<br>for data acquisition | given in a real dimension<br>i.e. velocity: [mm/sec],<br>flow rate: [ul/min] | numerically: velocity<br>flow rate<br>vessel diameter<br>graphically: time variation of velocity,<br>flow rate | retina (one or both eyes) | general population | limit exposure to laser light | UL 544, IEC 825<br>pending 510(k) | | main unit: 320 x 560 x 620<br>power control unit: 230 x 390 x 465 | main unit: 30<br>power control unit: 31 | |
| Heidelberg Engineering<br>Heidelberg Retina Flowmeter | | | laser scanning ophthalmoscope<br>with no eye drop<br>(displayed on PC monitor) | | max. 20x 20 | 670 nm / 100 uW<br>laser diode | -12 - +12 Diopter | | laser Doppler | 785 nm / 100uW<br>laser diode | Heidelberg Retina Flowmeter | | | 2 sec | given as relative value | numerically: velocity,<br>flow,<br>blood volume<br>graphically: perfusion map of retina<br>velocity / flow / volume | same | same | same | unknown<br>post-amendment device, K943955 | | main unit: 300 x 360 x 530<br>power control unit: 330 x 160 x 125<br>control panel: 155 x 200 x 100 | main unit: 13<br>power control unit: 1<br>control panel: 0.8 | |

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Comparison with the similar product of the other company (2/2)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2000

Ms. Sheila Driscoll Senior Product Safety Engineer Quality Management Department Canon U.S.A., Inc. One Canon Plaza Lake Success, NY 11042-1198

Re: K992606

> Trade Name: Canon Laser Blood Flowmeter (CLBF) Model 100 Regulatory Class: II Product Code: 86 HLI Dated: April 19, 2000 Received: April 20, 2000

Dear Ms. Driscoll:

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 Regulations, 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 assumptions. Failure to comply with the GMP regulation may result in 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 - Ms. Sheila Driscoll

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 regulation (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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon

Acting Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications Statement

--Page of

510(K)Number(if known):

K992606

Device Name:

CLBF MODEL 100

Indications for Use:

Canon Laser Blood Flowmeter CLBF model 100 is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF model 100, and it is intended to help doctors' reading of retinal images.

NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT F NEEDED

Concurrence of CDRH, Office of Device Evaluation(ODE) Over-The-Counter Use OR Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Denis L. Mᶜ Carthy

(Division Sign-Off) (Division of Ophthalmic D Kag2606 510(k) Number