The Laserseope VELA Erbium: YAG Laser System and Accessories are intended for the surgical incision. vaporization and congulation of soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage menus membranc, lymph vessels and nodes, organs and glands.

DermatologyPlastic Surgery: Indications include, cpidcrmal nevi, teleagiestasia, soider veins, scinic chailitis, keloids, verrucee, skin togs, keratoses, sear revision, debulking banign tumors, decubitis ulcers and skin resurfacing.

General Surgery: The Erbium: YAG lass is intended for the surgical incision, vaportuation and coagulation of soft tissue during any general surgery application where skin incision, tissue of external lumors and lesions, complete or partial resection of internal organs, tissue abletion and/or vessel coagulation may be indicated.

Genitourinary: Indications include lesions of the external genitalia, welcon and anus, penis, scrown and urchire (includes condyloma acuminata, gian perined condyloma und verrucous carcinoma), valvar lesions, polyps and familial polyps of the colon.

Gynecology: Indications include cervical intraepithelial neoplusia (CDV), herpes simplex, endometrial adhesions, cysts and condyloms.

ENT: Indications include car, nose and throat lessions, polyps, cysts, hyperkeratosis; excision of carcinogenic lissue, oral leukoplakia.

Oral/Maxillofacial: Indications include benign oral tunnors, oral and glossel lessions and gingivectory.

Ophthalmology: Indications include soft tissue surrounding the eye and orbit and unterior capsulotomy.

Podiatry: Indications include warts, plantar verrucae, large mossic verrucae and matrixectory .

Device Description

The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissipate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium:YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 8 mm.

AI/ML Overview

The Laserscope Erbium:YAG Laser System and Accessories received 510(k) clearance based on substantial equivalence to a predicate device, the Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System. Therefore, specific acceptance criteria and a detailed study proving the device meets those criteria, as you've requested regarding performance metrics like sensitivity, specificity, or improvement with AI, are not typically part of a substantial equivalence determination for this type of device in 1997.

Instead, the "study" demonstrating the device meets the acceptance criteria is the comparison to the predicate device, establishing that the Laserscope Erbium:YAG Laser System and Accessories has comparable risks and benefits and is substantially equivalent in terms of indications for use, materials, method of operation, and physical construction.

Here's a breakdown of the available information based on your numbered questions, with explanations for what is not present in a 510(k) submission focused on substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Equivalent safety profile to predicate device	Risks and benefits are comparable to the predicate device. Conforms to federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
Equivalent effectiveness profile to predicate device	Indicated for similar clinical applications (cutting, vaporizing, coagulating soft tissue) as the predicate device. Substantially equivalent in method of operation.
Similar Indications for Use	Indications for use are identical to or comparable with the predicate device (various soft tissue procedures in different specialties).
Similar performance standards compliance	Conforms with federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.

Explanation: For a 510(k) clearance based on substantial equivalence, the "acceptance criteria" are implicitly met if the device is found to be as safe and effective as a legally marketed predicate device. There are no explicit quantitative performance metrics like sensitivity or specificity typically defined or "reported" in the way you might see for a diagnostic device or an AI algorithm.

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

Not applicable. This 510(k) submission does not describe a clinical study with a "test set" in the context of evaluating performance metrics. The clearance is based on comparison to a predicate device.

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)

Not applicable. No ground truth establishment by experts for a test set is described in this submission, as it's not a performance study in the traditional sense.

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

Not applicable. No adjudication method is mentioned as there is no "test set" or performance study 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

Not applicable. This device is a surgical laser system, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant to this submission.

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

Not applicable. This is a physical medical device (laser system), not an algorithm.

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

Not applicable. No ground truth is mentioned or used for device evaluation in this substantial equivalence submission. The "ground truth" for showing safety and effectiveness is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a training set or its ground truth establishment.

Summary

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K971843

JUL 23 1997

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE ERBIUM:YAG LASER SYSTEM AND ACCESSORIES

REGULATORY AUTHORITY:

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT:

Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 Phone: 408 943-0636 408 943-1454 FAX:

DEVICE TRADE NAME:

Laserscope Erbium:YAG Laser System and Accessories

DEVICE COMMON NAME:

Erbium:YAG Laser System

DEVICE DESCRIPTION:

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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2

DEVICE CLASSIFICATION:

Erbium:YAG Laser Systems and Accessories have not been specifically classified; however Nd:YAG, CO2, and Argon Surgical Lasers have been classified as Class II medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.

PERFORMANCE STANDARDS:

All Laserscope Erbium:YAG Surgical Laser Systems and Accessories conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.

INDICATION FOR USE STATEMENT:

The Laserscope Erbium: YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue.

All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

Clinical Applications:

Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry

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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3

COMPARISON WITH PREDICATE DEVICE:

The Laserscope Erbium:YAG Laser System and Accessories is substantially equivalent to the Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System.

The risks and benefits for the Laserscope Erbium:YAG Laser System and Accessories are comparable to the predicate device when used for similar clinical applications.

Since the Laserscope Erbium:YAG Laser System and Accessories are substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa McGrath Sr. Regulatory Affairs Specialist Laserscope . . .. .. . . . . . . . . . . 3052 Orchard Drive San Jose, California 95134-2011

JUL 23 1997

Re: K971843

Trade Name: Laserscope VELA Erbium: YAG Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: May 12, 1997 Received: May 14, 1997

Dear Ms. McGrath:

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.

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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,

fo collafe

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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INDICATIONS FOR USE STATEMENT page I

510(k) Number:

971843

Device Name: . . . . . . _ .. .

Laserscope Erbium: YAG Laser. System and Accessorics . . . . . . . . . . . . .

Indications for Use:

Gynecology: Indications include cervical intraepithelial neoplusia (CDV), herpes simplex, endometrial adhesions, cysts and condyloms.

ENT: Indications include car, nose and throat lessions, polyps, cysts, hyperkeratosis; excision of carcinogenic lissue, oral leukoplakia.

Oral/Maxillofacial: Indications include benign oral tunnors, oral and glossel lessions and gingivectory.

Ophthalmology: Indications include soft tissue surrounding the eye and orbit and unterior capsulotomy.

Podiatry: Indications include warts, plantar verrucae, large mossic verrucae and matrixectory .

Prescription Use
(Per 21 CFR 801.109)

bcsolles

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General Restorative Devices

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.