K Number
K971250
Device Name
LASERSCOPE MICROBEAM IV MICROMANIPULATOR
Manufacturer
Date Cleared
1997-06-30

(90 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

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Not Found

No
The description focuses on the mechanical and optical aspects of a laser micromanipulator and does not mention any computational or algorithmic features indicative of AI/ML.

No
The device delivers laser energy in conjunction with a laser system for surgical procedures, indicating it is an accessory to a therapeutic device rather than a therapeutic device itself.

No

Explanation: The device is described as a micromanipulator that delivers laser energy to a localized area for surgical purposes. Its function is to facilitate precise laser application during surgery, not to diagnose conditions or diseases.

No

The device description clearly details physical components like an optical assembly, focusing adjustments (fine focus and rapid defocus knobs), and compatibility with microscopes and objective lenses, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's used in conjunction with a microscope for surgical laser systems. This indicates a therapeutic or surgical application, not a diagnostic one performed on in vitro samples.
  • Device Description: The description details how the device delivers laser energy to a surgical site and is used for focusing and adjusting the laser spot size on tissue. This is consistent with a surgical tool.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate surgical procedures using a laser.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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 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.

1

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:

్ల విద్యాల

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)

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