(76 days)
The device is intended as a laser delivery system for use by an opthalmologist in the treatment of ocular tissue.
- RETINAL PHOTOCOAGULATION
- TRABECULOPLASTY
When connected by fiber optic to a laser and properly attached to a 900 BQ or 900 BM slit lamp, the device directs and focuses laser energy on target tissue parfocally with the slit lamp image. An operator protective filter is incorporated into te device. The spot diameter is user adjustable, and the filter is removable to permit unimpaired viewing through the slit lamp microscope.
The provided text describes a 510(k) premarket notification for the "BQ/BM Integrated Laser Delivery System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided document.
The document states: "The BQ/BM Laser Delivery System does not raise new questions of safety and effectiveness and is substantially equivalent to the Rodenstock Ro 5000 AR/FDY and the Zeiss 130 SL." This indicates that A.R.C. Laser Corporation's submission relies on showing that their device has the same technological characteristics, intended use, materials, design, method of manufacture, and labeling as these previously cleared predicate devices.
Here's a breakdown of what can be extracted, and why the other information is missing:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria or detailed performance metrics from a dedicated study. The "performance" claimed is substantial equivalence to predicate devices, meaning it performs similarly in its intended function.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or clinical study data is mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. As there's no described test set or ground truth establishment, this information is not present.
4. Adjudication method for the test set:
- Cannot be provided. No test set or adjudication process is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This device is a laser delivery system, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of device and are not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This is a hardware device for laser delivery, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. No clinical study or ground truth establishment is detailed. The "ground truth" for a 510(k) in this context is the safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Cannot be provided. No machine learning or algorithm training is mentioned for this device.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set or ground truth establishment relevant to AI/ML is detailed.
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MAY 17 599
BQ/BM Integrated Laser Delivery System A.R.C. Laser Corporation March 1, 1999
510 (k) Summary
Requlatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact:
Daniel Hoefer A.R.C. Laser Corporation 1832 South 3850 West TEL (801) 972 1311, FAX (801) 972 5251
Name of Device
BQ/BM Integrated Laser Delivery Trade Name: System
Laser Slit Lamp adaptor Common Name:
Laser Adaptor for Classification Name: Biomicroscope, slit lamp, AC powered.
86 HJQ Product Code:
Predicate Devices:
The BQ/BM Integrated Laser Delivery System is substantially equivalent to the following legally marketed devices: The RO 5000 AR/FDY (K973220) manufactured by G. Rodenstock Instrumente GmbH and the Zeiss 130 SL Laser Slit Lamp manufactured by Carl Zeiss.
Device Description:
When connected by fiber optic to a laser and properly attached to a 900 BQ or 900 BM slit lamp, the device directs and focuses laser energy on target tissue parfocally with the slit lamp image. An operator protective filter is incorporated into te device. The spot diameter is user adjustable, and the filter is removable to permit unimpaired viewing through the slit lamp microscope.
{1}------------------------------------------------
BQ/BM Integrated Laser Delivery System A.R.C. Laser Corporation March 1, 1999
Intended Use:
The device is intended as a laser delivery system for use by an opthalmologist in the treatment of ocular tissue.
Technological Characteristics/Device Comparison:
The BO/BM Integrated Laser Delivery System is intended for attachment to slit lamps that are designed for use as diagnostic instruments, enabling them to be used in the delivery of therapeutic laser energy. Like the predicate devices, laser energy is transmitted through adjustable focusing optics, which allow the user to change the diameter of the laser spot from 50 to 1000 microns. As with the predicate devices, the laser energy is directed coaxially with the slit lamp illumination and focused on the same Each of the devices features operator plane. protective filters that prevent laser treatment radiation from reaching the eyes of the user. In each case, the position of the laser spot within the focal plane is moveable using a micromanipulater.
The technological characteristics, intended use, materials, design, method of manufacture, and labeling of the device is substantially equivalent to those of the predicate devices.
Conclusion:
The BQ/BM Laser Delivery System does not raise new questions of safety and effectiveness and is substantially equivalent to the Rodenstock Ro 5000 AR/FDY and the Zeiss 130 SL.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Public Health Service
MAY 17 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel Hoefer Regulatory Affairs American Laser Corporation 2417 South 3850 West Salt Lake City, Utah 84120
K990665 Re:
Trade Name: BQ/BM Integrated Laser Delivery System Regulatory Class: II Product Code: HQF Dated: March 1, 1999 Received: March 2, 1999
Dear Mr. Hoefer:
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 requirement, 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 – Mr. Daniel Hoefer
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) 594-4595. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 6 ol 7
• .
510(k) Number lif known): K 990 k b b
BQ/BM INTEGRATED LASER DELIVERY SYSTEM Device Name:_
Indications For Use:
..
.
- RETINAL PHOTOCOAGULATION
..
- TRABECULOPLASTY
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
| Concurrence of CORH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of General Restorative Devices | |||
| 510(k) Number | K990665 |
Prescription Use $\varnothing$ OR Over The-Counter Use ____
(Per 21 CFR 801.109)
:Optical Format 1-2-361
い
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.