Schwartz Electro-Optics, Inc. is not requesting any additional indications or changing the indications as previously cleared in K954013 received 1/31/96. As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxiliofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated laser. Schwartz Electro-Optics, Inc. seeks no new indications for the CLR 2940 and is only requesting a modification.

Device Description

From a technology perspective, theory of operation the predicate device is the same as the Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase. The laser mediums are the same, the systems are similar both mechanically and electronically. Schwartz Electro-Optics, Inc. believes that the technological characteristics of the TriLase 2940 Erbium Laser are similar to the predicate device (Premier Centauri Erbium). The Premier Centauri Erbium has the ability to deliver laser energy at 2.94 microns (2940nm), average power of 5 watts at repetition rates of up to 50 pulses per second. These characteristics are very similar to the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document, the device described, the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser (referred to as CLR 2940 elsewhere), is being submitted for 510(k) clearance based on substantial equivalence to a predicate device, not through a performance study against specific acceptance criteria in the traditional sense of a clinical trial for a novel device.

The core of the submission relies on demonstrating that the new device has "similar" technological characteristics and that "slight differences in the performance characteristics of these devices raises no concerns." This is a key aspect of 510(k) submissions where a direct comparison to a legally marketed predicate device is made rather than de novo clinical studies establishing specific performance metrics.

Therefore, many of the requested categories for a new device's acceptance criteria and study information are not explicitly present in this type of submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by 510(k) Equivalence)	Reported Device Performance (Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser)
Delivery of laser energy at 2.94 microns (2940nm)	Ability to deliver laser energy at 2.94 microns (2940nm)
Average power of 5 watts	Similar to predicate device (Premier Centauri Erbium), which has 5 watts
Repetition rates of up to 50 pulses per second	Similar to predicate device (Premier Centauri Erbium), which has up to 50 pulses per second
Similar mechanical and electronic systems	Identified as similar to predicate device
Same laser mediums	Identified as the same as predicate device
No new indications for use	No new indications requested; aligns with predicate device's cleared indications

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided. The submission is based on a comparison to a predicate device's specifications and existing indications for use, not a clinical study on a test set.

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)

This information is not applicable/not provided. Ground truth in this context would refer to the established performance characteristics and safety profile of the predicate device, which is already legally marketed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There was no test set requiring adjudication in the context of this 510(k) submission.

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

This information is not applicable/not provided. This device is an erbium laser for surgical procedures, not an AI-assisted diagnostic or imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. This device is a surgical laser, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile and performance characteristics of the legally marketed predicate device (Premier Centauri Erbium and CRL 2940 Erbium CrystaLase), as determined by their prior FDA clearance. The company asserts that the new device's characteristics are "similar" to these predicate devices, making them substantially equivalent.

8. The sample size for the training set

This information is not applicable/not provided. There was no "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established

This information is not applicable/not provided.

Summary

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16971404

JUL - 9 1997

VII.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS:

In regards to safety and effectiveness of the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns.

Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, facing to the right. The eagle is stylized with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Timothy J. Shea Director of the Solid State Laser Division Schwartz Electro-Optics, Inc. 3404 North Orange Blossom Trail JUL - 9 1997 Orlando, Florida 32804

Re: K971404 Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase Regulatory Class: II Product Code: GEX Dated: April 16, 1997 Received: April 16, 1997

Dear Mr. Shea:

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 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

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Page 2 - Mr. Timothy J. Shea

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 requlations.

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,

[signature]

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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	K971404	Page 1 of 2
510(k) Number (if known):	K954013
Device Name:	CLR 2940
Indications For Use:	SEE ATTACHED

(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: K971404

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use________

(Optional Format 1-2-96)

SK-31

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Page 2 of 2

Food and Drug Administration Center of Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ - 401) 9200 Corporate Boulevard Rockville, Maryland 20850

Reference: K954013
K979404

Indication for Use

Specialties are:

- General Surgery
- Plastic Surgery,
- Podiatry
- Urology
- Gynecology
- Pulmonary Surgery
- Dermatology
- Gastroenterology
- Ophthalmology
- ENT
- Thoracic Surgery
- Oral and Maxiliofacial Surgery

These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated laser. Schwartz Electro-Optics, Inc. seeks no new indications for the CLR 2940 and is only requesting a modification.

Requesting a modification.

Prescription Use X
(Per 21 CFR 801.109)

Division Sign-Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971404

Regulation Number and Section

§ 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.