(30 days)
Clinical Indications with a Slit Lamp Delivery System: This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including: Proliferative Diabetic retinopathy, macular degeneration, and retinal detachment. Clinical Indications with a Laser Indirect Ophthalmoscope Delivery System: This system has the same clinical indications as the slit lamp delivery system, but it can only be used for peripheral photocoagulation. Clinical Indications with an Endophotocoagulation (EPCP) Delivery System: The EPCP probe has been designed as a means for intraocular photocoagulation as an adjunct to vitrectomy surgery. Specific indications for use for the EPCP include treatment of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, and various retinal vascular tumors.
The devices that are subject to this Special 510(k) Premarket Notification are the Coherent Laser Indirect Ophthalmoscope, the Acculite Endokit/Endoprobe, the LaserLink HS and LaserLink Z Slip Lamp Laser Delivery Adapter and the Coherent Novus Verdi Frequency-Doubled Nd: Y AG Ophthalmic Photocoagulator.
The provided document is a 510(k) summary statement for a medical device and a subsequent FDA approval letter. It does not include information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed aspects of a clinical study that would lead to such data.
The document primarily focuses on establishing "substantial equivalence" of the new "Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator" to existing predicate devices. This means the device is considered safe and effective because it is similar in design, function, and intended use to devices already on the market.
Therefore, most of the requested information cannot be extracted from the provided text. I can only fill in the parts that are explicitly mentioned or can be inferred.
Here's what can be extracted and why other parts cannot be:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or other performance metrics) nor does it report specific device performance data from a dedicated study against such criteria. The basis for approval is substantial equivalence to predicate devices, not meeting novel performance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No specific test set, sample size, or data provenance from a performance study is mentioned. The submission relies on demonstrating similarity to already approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No "test set" requiring ground truth establishment by experts is described as part of this 510(k) submission for the device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No "test set" requiring adjudication 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 document is for a laser delivery system, not an AI-assisted diagnostic or treatment system. Therefore, no MRMC study or AI-related effectiveness data is present.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. As above, this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No performance study requiring ground truth is described.
8. The sample size for the training set
- Cannot be provided. This device does not involve machine learning or a "training set" in the context of AI.
9. How the ground truth for the training set was established
- Cannot be provided. As above, no training set or ground truth establishment for such a set is relevant to this device's approval process based on the provided text.
Summary of what is available from the document:
The regulatory approval for the Coherent Medical Group Delivery Devices relies on substantial equivalence to previously approved predicate devices, rather than a new clinical study demonstrating specific performance against predefined acceptance criteria. The document states:
- Rationale for Substantial Equivalence: "The Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd: YAG Photocoagulator share the same indications for use, similar design features, functional features and are therefore substantially equivalent to the predicate Viridis Surgical Laser (K960867) and Coherent Medical Group predicate devices (K913127, K885196, K812219)."
- Safety and Effectiveness: "Safety and effectiveness information was provided to demonstrate that the Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator are safe and effective for use in surgical procedures as indicated in K960867." (This implies that the demonstrated safety and effectiveness is tied to its similarity to the predicate devices and their known performance, not new performance data from this submission.)
Therefore, the "acceptance criteria" were effectively the criteria for establishing substantial equivalence, and the "study" proving it met these criteria was the comparison outlined in the 510(k) submission, not a new clinical performance trial with specific metrics.
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MAY 1 3 1939
II.
Attachment 13 Special 510(k) Summary Statement
I. General Information
| Submitter: | Coherent Medical Group2400 Condensa StreetSanta Clara, California, U. S. A.95051-0901 |
|---|---|
| Contact Person: | Kathy A. Maynor |
| Summary Preparation Date: | April 9, 1999 |
| Names: | |
| Device Names: | Coherent Medical Group Delivery Devices for usewith the Coherent Novus Verdi Frequency-DoubledNd:YAG Photocoagulator |
| Primary Classification Name: | Laser Powered Surgical Instrument and DeliveryDevice Accessories |
III. Predicate Devices
- B. V. International Viridis/Evergreen 532 nm Surgical Laser (K960867); ●
- Coherent Medical Group Slit Lamp Adapter System (K913127); ●
- Coherent Medical Group Indirect Ophthalmoscope (K885196); .
- Coherent Medical Group Endocoagulation Probe (K812219). .
Product Description IV.
The devices that are subject to this Special 510(k) Premarket Notification are the Coherent Laser Indirect Ophthalmoscope, the Acculite Endokit/Endoprobe, the LaserLink HS and LaserLink Z Slip Lamp Laser Delivery Adapter and the Coherent Novus Verdi Frequency-Doubled Nd: Y AG Ophthalmic Photocoagulator.
V. Indications For Use
The Intended Use for the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator is unchanged as indicated in the 510(k) Premarket Notification (K960867) for the Viridis Surgical Laser.
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VI. Rational for Substantial Equivalence
The Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd: YAG Photocoagulator share the same indications for use, similar design features, functional features and are therefore substantially equivalent to the predicate Viridis Surgical Laser (K960867) and Coherent Medical Group predicate devices (K913127, K885196, K812219).
VII. Safety and Effectiveness Information
Safety and effectiveness information was provided to demonstrate that the Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator are safe and effective for use in surgical procedures as indicated in K960867.
VIII. Conclusion
The Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd: YAG Photocoagulator were found to be substantially equivalent to similar currently marketed and predicate devices.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.
MAY 1 3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy A. Maynor Vice President of Regulatory, Compliance and Clinical Affairs Coherent, Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K991258 Trade Name: Novus Verdi Delivery Systems Regulatory Class: II Product Code: GEX Dated: April 9, 1999 Received: April 13, 1999
Dear Ms. Maynor:
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 - Ms. Kathy A. Maynor
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 vour 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.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Attachment 11
Indications for Use Statement
510(K) Number: K991258
Novus Verdi Delivery Systems Device Name :
Indications for Use:
Clinical Indications with a Slit Lamp Delivery System
This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including: Proliferative Diabetic retinopathy, macular degeneration, and retinal detachment.
Clinical Indications with a Laser Indirect Ophthalmoscope Delivery System This system has the same clinical indications as the slit lamp delivery system, but it can only be used for peripheral photocoagulation.
Clinical Indications with an Endophotocoagulation (EPCP) Delivery System The EPCP probe has been designed as a means for intraocular photocoagulation as an adjunct to vitrectomy surgery. Specific indications for use for the EPCP include treatment of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, and various retinal vascular tumors.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K991258 | |
| Prescription Use(Per 21 CFR 801.109) | X | |
| OR | Over-the-Counter Use |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.