The Laserscope Microbeam IV Micromanipulator is intended to be used in conjunction with a microscope for all cleared Laserscope indications for the KTP/532 and KTP/YAG Surgical Laser Systems.

Device Description

The Laserscope Microbeam IV is a micromanipulator that delivers KTP/532 laser energy to a very localized area. The Microbeam IV is used in conjunction with a microscope that allows the surgeon to accurately position the laser; the Microbeam IV can produce a spot size from 250 microns to 400 microns. The Microbeam IV system consists of an optical assembly which focuses the laser light from the fiber optic cable to the surgical site. The Microbeam IV delivers the laser energy in line with the viewing path. There are two focusing adjustments on the Microbeam IV; the fine focus and the rapid defocus. The fine focus adjustment is used to focus the laser beam at the tissue. The rapid defocus knob quickly increases the laser spot size at the tissue. The Microbeam IV is compatible with most microscopes and can be used with most objective lenses.

AI/ML Overview

The provided text is a 510(k) summary for the Laserscope Microbeam IV Micromanipulator. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information cannot be extracted directly from this document.

Here's the breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria: Not explicitly stated in the document. The filing focuses on "substantial equivalence" to a predicate device rather than specific performance metrics against pre-defined acceptance criteria.
Reported Device Performance: The document only states that "The Microbeam IV can produce a spot size from 250 microns to 400 microns." This is a descriptive feature, not a performance metric against a specific criterion.

Acceptance Criteria	Reported Device Performance
Not specified. The submission relies on substantial equivalence to a predicate device.	The Microbeam IV can produce a spot size from 250 microns to 400 microns.

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

Not applicable. This document does not describe a clinical performance study with a test set. The submission is based on substantial equivalence 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 test set or ground truth establishment by experts is described.

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

Not applicable. No test set or adjudication process 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

No. This is not an AI-assisted device and no MRMC comparative effectiveness study is described. The device is a micromanipulator for a surgical laser system.

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

Not applicable. This is not an algorithm-only device. It is a physical medical device (micromanipulator) used with a human surgeon.

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

Not applicable. No ground truth is mentioned as there is no performance study described in the context of diagnostic accuracy or similar metrics requiring ground truth.

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 ground truth for it.

In summary: The provided 510(k) filing for the Laserscope Microbeam IV Micromanipulator is a regulatory document focused on demonstrating "substantial equivalence" to an existing predicate device, not on presenting a clinical performance study with detailed acceptance criteria, test sets, or ground truth establishment. Therefore, most of the questions pertaining to performance studies and expert evaluation cannot be answered from this specific document.

Summary

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K971250

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE MICROBEAM IV MICROMANIPULATOR

REGULATORY AUTHORITY:

JUN 30 1997

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 FAX:

DEVICE TRADE NAME:

Laserscope Microbeam IV Micromanipulator

DEVICE COMMON NAME:

Microbeam IV Micromanipulator

DEVICE DESCRIPTION:

The Microbeam IV system consists of an optical assembly which focuses the laser light from the fiber optic cable to the surgical site. The Microbeam IV delivers the laser energy in line with the viewing path. There are two focusing adjustments on the Microbeam IV; the fine focus and the rapid defocus. The fine focus adjustment is used to focus the laser beam at the tissue. The rapid defocus knob quickly increases the laser spot size at the tissue. The Microbeam IV is compatible with most microscopes and can be used with most objective lenses.

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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2

DEVICE CLASSIFICATION:

To the best of our knowledge, Microbeam IV Micromanipulators have not been specifically classified, however, the surgical lasers for which they are intended have been classified as Class II medical devices by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.

PERFORMANCE STANDARDS:

The Laserscope KTP/532 and KTP/YAG Surgical Laser Systems conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. Laserscope is unaware of any specific standards for micromanipulators.

INDICATION FOR USE STATEMENT:

The Laserscope Microbeam IV Micromanipulator is intended to be used in conjunction with a microscope for all cleared Laserscope indications for the KTP/532 and KTP/YAG Surgical Laser Systems.

COMPARISON WITH PREDICATE DEVICE:

In the opinion of Laserscope, the Laserscope Microbeam IV is substantially equivalent to the existing family of Laserscope Microbeam Micromanipulators. The risks and benefits for the Laserscope Microbeam IV Micromanipulator are comparable to the predicate device when used for similar clinical applications.

Since the Laserscope Microbeam IV Micromanipulator 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 seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, human services, and well-being. 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

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

JUN 30 1997

Re: K971250

Trade Name: Laserscope Microbeam IV Micromanipulator Regulatory Class: II Product Code: GEX Dated: March 31, 1997 Received: April 1, 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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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. I wi

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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INDICATIONS FOR USE STATEMENT page 1

510(k) Number:

14911250

Device Name:

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Indications for Use:

Laserscope Microbeam IV Micromanipulator

The Laserscope MicroBeam IV Micromanipulator is a ... _ _ _ _ _ _ _ _ _ _ _ _ _ _ micromanipulator that delivers KTP/532 Laser energy to a very localized area.

The Laserscope Microbeam IV Micromanipulator is intended to be used in conjunction with a microscope for all cleared Laserscope indications for the KTP/532 and KTP/YAG Surgical Laser Systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use or Over-The-Counter Use (per 21 CFR 801.109)

000005

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.