The Orion Series Surgical Laser System consists of a movable containing power supplies, a treatment laser on a solid optical deck, and a cooling system to dissipate the heat generated by the system. A keypad control panel with CRT enables the user to control the laser system operating parameters. Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics. Five configurations are currently available: 12W KTP only, 208 VAC 12W KTP/30W Nd:YAG, 208 VAC 20W KTP only, 208 VAC 20W KTP/50W Nd:YAG,208 VAC 50W Nd:YAG only, 208 VAC

AI/ML Overview

This document is a 510(k) summary for the Laserscope Orion Series Surgical Laser System. It is a premarket notification for a medical device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and a study proving the device meets them as requested.

The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It states that the device "conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems" and that "Safety and effectiveness are reasonably assured." However, it does not provide specific acceptance criteria values or the results of a study to demonstrate performance against those criteria.

Here's why the requested information cannot be extracted from this document:

Acceptance Criteria and Reported Device Performance: This document states the device conforms to standards, but it doesn't list specific performance metrics (e.g., energy output tolerance, pulse duration accuracy, spot size consistency) as acceptance criteria, nor does it provide detailed test results showing the device achieved those criteria.
Sample Size and Data Provenance: There is no mention of a test set, sample size, or data provenance because no specific clinical or performance study details are included.
Number of Experts and Qualifications: This applies to studies involving human reading or interpretation, which is not relevant for this laser system's performance evaluation as presented here.
Adjudication Method: Not applicable for this type of device submission.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is a surgical laser, not an imaging or diagnostic device requiring human interpretation of results.
Standalone (Algorithm Only) Performance: Not applicable as it's a hardware device, not an algorithm.
Type of Ground Truth: Not applicable in the context of this device and submission.
Sample Size for Training Set: Not applicable as there's no mention of a training set or machine learning components.
How Ground Truth for Training Set was Established: Not applicable.

Instead, the document highlights:

Regulatory Compliance: Conformance with 21 CFR 1040.10 and 1040.11 for medical laser systems. These are general performance standards for laser products.
Substantial Equivalence: The primary strategy for clearance is demonstrating that the Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is substantially equivalent to the Medlite™ Q-switched Nd:YAG Laser System. This means it is considered as safe and effective as a legally marketed predicate device without the need for new clinical studies to prove efficacy.
Indications for Use: Removal of dark tattoo ink (blue and black).

To find the specific acceptance criteria and performance data, one would typically need to refer to:

Internal design specifications and verification/validation reports from the manufacturer.
Detailed test protocols and results submitted to the FDA during the 510(k) process, which are not usually publicly available in this summary format.
Relevant ISO or ANSI standards that apply to medical laser systems, as 21 CFR 1040.10 and 1040.11 are general regulations, and specific performance details would come from recognized consensus standards.

This 510(k) summary provides a high-level overview for regulatory clearance, not a detailed technical performance study report.

Summary

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K 964818

JUN 17 1997

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE ORION SERIES SURGICAL LASER SYSTEM

REGULATORY AUTHORITY

Safe Medical Device Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT:

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

DEVICE TRADE NAME:

Orion Series Surgical Laser System

DEVICE COMMON NAME:

Laser Instrument, Surgical, Powered

DEVICE DESCRIPTION:

Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics.

Five configurations are currently available:

12W KTP only, 208 VAC 12W KTP/30W Nd:YAG, 208 VAC 20W KTP only, 208 VAC 20W KTP/50W Nd:YAG,208 VAC 50W Nd:YAG only, 208 VAC

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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2

DEVICE CLASSIFICATION:

The Orion Series Surgical Laser System has been classified as a Class II medical device by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.

PERFORMANCE STANDARDS:

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The Orion Series Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.

INDICATIONS FOR USE STATEMENT:

The Orion Series Surgical Laser System (Q-switched Nd: YAG configuration) is indicated for removal of dark tattoo ink, including blue and black.

COMPARISON WITH PREDICATE DEVICE:

The Orion Series Surgical Laser System (Q-switched Nd:Y AG configuration) is substantially equivalent to the Medlite™ Q-switched Nd: Y AG Laser System, manufactured by Continuum Biomedical, Inc.

The risks and benefits for the Orion Series Surgical Laser System are comparable to the predicate device when used for similar clinical applications.

Since the Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of several curved lines that create the shape of the bird's wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 1 7 1997

Re:

K964818 Trade Name: Orion Series Surgical Laser System (Q-switched Nd: Y AG configuration) Regulatory Class: II Product Code: GEX Dated: March 18, 1997 Received: March 19, 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 vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Lisa McGrath

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 anvertising 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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INDICATIONS FOR USE STATEMENT

510(K) Number: 964818

Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) Device Name:

Indications for Use:

The Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is intended for removal of dark tattoo ink, including blue and black

今

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (

uation (ODE)

(Division Sign-Off
Division of General Restorative Devices
510(k) Number K964818

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use

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.