(323 days)
Not Found
No
The summary describes a device for measuring blood flow velocity in the retina using laser technology. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The focus is on direct measurement and presentation of velocity and flow rate data.
No.
The device is used for observation and measurement of blood flow and is intended to help doctors. It does not provide any therapy or treatment.
Yes
The device is described as observing the patient's fundus (retina) and providing information on blood flow (velocity) in a retinal vessel, which is intended to help doctors' reading of retinal images. This information aids in understanding the physiological state of the retina, fitting the definition of a diagnostic device that identifies or characterizes a disease or condition.
No
The device description explicitly states it is a "Canon Laser Blood Flowmeter (CLBF) Model 100" which implies a physical device that performs fundus observation and velocity measurement, not just software. The performance studies mention "Software evaluation" but also "Documented non-clinical studies" and a "published clinical study" which are typical for hardware devices.
Based on the provided information, the Canon Laser Blood Flowmeter CLBF model 100 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside the body.
- CLBF model 100 function: The CLBF model 100 is used for observing the patient's fundus (retina) and measuring blood flow directly within the retinal vessels. This is an in vivo (within the living body) measurement and observation.
The device is used to gather information about the patient's condition by directly interacting with their body, not by analyzing samples taken from the body. Therefore, it falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
86 HLI
Device Description
The Canon Laser Blood Flowmeter (CLBF) Model 100 allows for fundus observation with velocity measurement of retinal blood flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fundus (retina), retinal vessel, retina (one or both eyes)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
A published clinical study was included to support a claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1570 Ophthalmoscope.
(a)
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.(b)
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.
0
JUN 2 1 2000
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: (516) 328-5602 Fax Number: (216) 328-2169
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.
1
mparison with the similar product of the other company (1/2)
Approved product : Heidelberg Engineering, Heidelberg Retina Flowmeter
July 15, 1999
| | Manufacturer
product name | Intended use | specification /
function | fundus
observation | method | observation angle | illumination light | diopter
compensation range
for examinee's eye | principle | velocity
measurement | measurement laser | Product Name | specification /
function | fundus
observation | measurement
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.
Canon Laser Blood Flowmeter
CLBF model 100 | Fundus observation with
retinal blood flow measurement
similar to conventional fundus
camera with eye drop
(through optical finder /
on PC monitor (optional)) | | | 30 | 560 - 650 nm
Halogen lamp | -10 - +10 Diopter or more | | laser Doppler | 675 nm / max. 300uW
(usually 200uW)
laser diode | | Canon Laser Blood Flowmeter
CLBF model 100 | | | 2 sec
for data acquisition | given in a real dimension
i.e. velocity: [mm/sec],
flow rate: [ul/min] | numerically: velocity
flow rate
vessel diameter
graphically: time variation of velocity,
flow rate | retina (one or both eyes) | general population | limit exposure to laser light | UL 544, IEC 825
pending 510(k) | | main unit: 320 x 560 x 620
power control unit: 230 x 390 x 465 | main unit: 30
power control unit: 31 | |
| Heidelberg Engineering
Heidelberg Retina Flowmeter | | | laser scanning ophthalmoscope
with no eye drop
(displayed on PC monitor) | | max. 20x 20 | 670 nm / 100 uW
laser diode | -12 - +12 Diopter | | laser Doppler | 785 nm / 100uW
laser diode | Heidelberg Retina Flowmeter | | | 2 sec | given as relative value | numerically: velocity,
flow,
blood volume
graphically: perfusion map of retina
velocity / flow / volume | same | same | same | unknown
post-amendment device, K943955 | | main unit: 300 x 360 x 530
power control unit: 330 x 160 x 125
control panel: 155 x 200 x 100 | main unit: 13
power control unit: 1
control panel: 0.8 | |
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2
Comparison with the similar product of the other company (2/2)
: |
.
:
3
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.
4
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 (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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):
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