The IntraLase 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

The IntraLase 600C Laser Keratome is a precision ophthalmic surgical laser designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing anterior lamellar corneal resections. The materials, basic scientific concepts and physical properties of the IntraLase 600C are similar to those of the ISL OC2000, while the indication for use and the intended use are identical to those of the Hansatome microkeratome.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the IntraLase 600C Laser Keratome:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K993153) does not explicitly list quantifiable acceptance criteria in a table format. Instead, it claims substantial equivalence to a predicate device based on performance in "extensive ex vivo and in vivo studies."

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable criteria. The overarching acceptance criterion appears to be substantial equivalence to the predicate device (Hansatome Microkeratome) in creating corneal resections.	"The IntraLase 600C was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies."
	"The technological changes in the IntraLase 600C Laser Keratome do not raise any new issues of safety, effectiveness or performance of the product."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document uses the term "extensive ex vivo and in vivo studies" but does not specify the numerical sample size for either.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be pre-market clinical investigations. Given the context, they are likely to be prospective studies conducted by the manufacturer to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The filing focuses on the device's technical characteristics and equivalence to predicate devices rather than a detailed clinical study with expert-adjudicated ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Was it done? No. This type of study (MRMC) is typically associated with AI/CAD systems where human readers interpret medical images with and without AI assistance. The IntraLase 600C Laser Keratome is a surgical device, not an AI/CAD system.
Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Was it done? Not applicable in the context of an AI algorithm. If "standalone" refers to the device operating independently in the studies, the text implies that the device's performance in creating corneal resections was evaluated, presumably without a human "in the loop" for the creation process itself, but rather human oversight and evaluation of the results. However, this isn't an AI-specific standalone performance evaluation.

7. Type of Ground Truth Used:

The document implicitly uses the "performance...with respect to the creation of corneal resections" as the ground truth. This would likely involve:

Measurements: Direct measurements of the thickness and diameter of the corneal resections created by the device.
Visual Inspection/Histopathology: Evaluation of the quality, smoothness, and uniformity of the resections.
Comparison to Predicate: The ultimate "ground truth" for the submission is the performance of the legally marketed predicate device (Hansatome Microkeratome).

8. Sample Size for the Training Set:

This information is not applicable as the IntraLase 600C Laser Keratome is a physical surgical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

Summary

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K993153

DEC 1 7 1999

SECTION 15

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Submitter's name, address, telephone number, contact person, and date summary prepared;
- a. Applicant:

IntraLase Corporation 30 Hughes, Suite 206 Irvine, CA 92618

b. Contact Person:
J. Randy Alexander President

c. Date Summary Prepared: September 13, 1999

2. Name of device, including trade name and classification name:

Trade/Proprietary Name: a. IntraLase 600C Laser Keratome
b. Classification Name: Keratome
1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Bausch & Lomb Surgical
Device:	Hansatome Microkeratome
510(k):	K972808
Date Cleared:	October 31, 1997
Company:	Intelligent Surgical Lasers
Device:	ISL QC2000
510(k):	K892058
Date Cleared:	June 15, 1989

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A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

5. Statement of intended use:

The IntraLase 600C Laser Keratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

The IntraLase 600C Laser Keratome has technological characteristics very similar to those of the Intelligent Surgical Lasers QC2000, the laser predicate device. The design, materials, and characteristics of the IntraLase 600C Laser Keratome are similar to those of the Intelligent Surgical Lasers QC2000.

7. Brief summary of nonclinical tests and results:

The IntraLase 600C Laser Keratome has been designed and will be tested to applicable safety standards. In addition, the IntraLase 600C was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies. Thus, the technological changes in the IntraLase 600C Laser Keratome do not raise any new issues of safety, effectiveness or performance of the product.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 1999

IntraLase Corporation c/o Judy F. Gordon, D.V.M. Regulatory Consultant ClinReg Consulting Services, Inc. 18732 Saginaw Drive Irvine, California 92612

K993153 Re:

Trade Name: IntraLase 600C Laser Keratome Regulatory Class: II Product Code: GEX, HNO Dated: September 20, 1999 Received: September 21, 1999

Dear Dr. Gordon:

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 - Judy F. Gordon, D.V.M.

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,

. caillaux

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 -

510(k) Number (if known): 上一分 31 S10(k) 3

Device Name: IntraLase 600C Laser Keratome

Indications for Use:

The IntraLase 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

Division Sign-Off

(Division Sign-Oft)
Division of General Restorative Devices K993153
510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use (Optional Format 1-2-96) ·

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.