SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE by SCHWARTZ ELECTRO-OPTICS, INC.

As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), 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, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, menisous, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Specialties are:

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

These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

Device Description

The Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is a medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 2940 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (laser system) and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for evaluating AI/algorithm-based diagnostic or screening devices.

Here's why the input does not allow for a complete answer to your request:

Device Type: This document pertains to a laser surgical device (Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase), not an AI/algorithm-based system.
Regulatory Pathway: The submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device. For non-diagnostic devices, this often relies on demonstrating similar technological characteristics and intended use, rather than extensive clinical performance studies comparing an algorithm's output to ground truth.
No New Indications/Clinical Data: The summary explicitly states: "No new indications were sought in this premarket notification and no clinical data was presented." This confirms that performance data based on clinical studies, which would involve acceptance criteria, test sets, ground truth, and expert evaluation, was not part of this submission.
Focus on Predicate Device Equivalence: The justification for safety and effectiveness is based on the "substantial equivalence" to existing, cleared predicate devices (K974039 and K971648) which already had their indications cleared.

Therefore, I cannot populate the table or answer questions 2-9 from the provided text. The information requested is relevant to AI/diagnostic/screening devices, which is not what this document describes.

Summary

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K980313

MAR 1 9 1998

510(k) Summary of Safety and Effectiveness The Schwartz Electro-Optics, Inc. Model CLR 2940 Erbium CrystaLase

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the following: the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase (K974039) and the Sharplan 4020 Erbium Surgical Laser (K971648).

Schwartz Electro-Optics, Inc. I. Company: 3404 North Orange Blossom Trail Orlando, FL 32804 Timothy J. Shea, Senior Director 1/15/98
Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase II. Model:
III. Predicate Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase (K974039), Devices: and the Sharplan 4020 Erbium Surgical Laser (K971648).
The Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is a IV. Description: medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 2940 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

V. Indications

The Schwartz Electro-Optics, Inc. CLR 2940 is indicated for all surgical for Use: 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, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. No new indications were sought in this premarket notification and no clinical data was presented.

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From a design and clinical perspective, the predicate and candidate laser VI. Summary: devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Schwartz Electro-Optics, Inc. believes that no significant differences exist. Therefore, the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase should not raise any concerns regarding its overall safety and/or effectiveness.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1998

Mr. Timothy J. Shea Senior Director Schwartz Electro-Optics, Incorporated 3404 North Orange Blossom Trail Orlando, Florida 32804

Re: K980313 Schwarts Electro-Optics, Inc. CLR 2940 Trade Name: Erbium CrystaLase Requlatory Class: II Product Code: GEX Dated: January 27, 1998 Received: January 27, 1998

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 The general controls provisions of the Act 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 Requlation (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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

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Page 2 - Mr. Shea

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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,

Stephen Rhodes

M. Witten, Ph.D., M.D. irector Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K9/03/3

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

300 / HAG

Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase Indications for Use

Specialties are:

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

Stephen Rhodes

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

Prescription Use X
(Per 21 CFR 801.109)

Over-the-Counter Use_

SK-28

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.