The INTRALASE® FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LA'SIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

The INTRALASE FS Laser is a precision ophthalmic surqical laser designed for use in performing lamellar corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

AI/ML Overview

The provided text is a 510(k) summary for the INTRALASE FS Laser, which is an ophthalmic surgical laser. The submission focuses on demonstrating substantial equivalence to a predicate device (Pulsion FS Laser, K013941) rather than presenting a study to prove acceptance criteria based on specific performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not explicitly available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for the INTRALASE FS Laser. Instead, it asserts equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance (INTRALASE FS Laser)
Not explicitly defined as quantitative performance metrics. The primary criterion is substantial equivalence to the predicate device for lamellar corneal resections.	"found to perform equivalently to the predicate Laser, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies."
Compliance with applicable safety standards.	"has undergone testing and is in compliance with applicable safety standards."
The slight changes to technological characteristics do not alter performance or indication.	"The slight changes made to the technological characteristics of the Laser do not alter the performance or indication of this device."

Note: The 510(k) process for this type of device often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or if the technological characteristics are different, that the differences do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device. Quantitative performance metrics as acceptance criteria are typical for de novo or PMA submissions, or specific performance standards.

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

The document mentions "extensive ex vivo and in vivo studies" but does not provide specific sample sizes or details about data provenance (e.g., country of origin, retrospective or prospective nature) for these studies.

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

Not applicable. The document does not describe a study involving expert readers establishing ground truth for a test set in the context of diagnostic accuracy or a similar evaluation that would require expert consensus. The device is a surgical laser, and its performance evaluation likely centered on surgical outcomes or physical properties, not diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no indication of an adjudication method as it relates to expert review of a test set, as this is not a diagnostic imaging device undergoing such an evaluation.

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

Not applicable. The document does not describe a MRMC comparative effectiveness study, as the device is a surgical laser, not a diagnostic tool requiring human-in-the-loop performance evaluation in that context. The "comparative effectiveness" mentioned is in relation to the predicate device's overall safety and performance, not specifically human reader improvement with AI assistance.

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

Not applicable in the typical sense for AI/diagnostic devices. The INTRALASE FS Laser is a surgical device. Its "performance" would be assessed in terms of its ability to create corneal resections, not as a standalone algorithm analyzing data. The "ex vivo and in vivo studies" likely assessed the physical outcomes of the laser's operation.

7. Type of Ground Truth Used

The term "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not explicitly defined here for the "extensive ex vivo and in vivo studies." However, given the nature of the device (a surgical laser creating corneal resections), the "ground truth" would likely relate to objective measurements of the quality and accuracy of the resections created, which could involve:

Histopathology or microscopy: To assess the precision, smoothness, and depth of the resections.
Biomechanical testing: To evaluate the integrity of the created flap.
Clinical outcomes in vivo: Such as flap characteristics, healing, and refractive results, compared against expected outcomes or those achieved by the predicate device.

8. Sample Size for the Training Set

Not applicable/Not provided. The document does not describe an AI/machine learning model with a training set. The "extensive ex vivo and in vivo studies" are likely performance validation studies, not training of an algorithm.

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

Not applicable/Not provided. As there is no mention of a training set for an AI/machine learning model, the establishment of ground truth for such a set is not discussed.

Summary

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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.

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE 1. SUMMARY PREPARED
- a. Applicant:

IntraLase Corp. 3 Morgan Irvine, CA 92618

b. Contact Person:
Judy F. Gordon, D.V.M.

Judy Harder/DD

c. Date Summary Prepared:
June 20, 2003

2. NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME:

INTRALASE FS Laser a. Trade/Proprietary Name:
b. Classification Name: Laser
1. IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:

COMPANY:	IntraLase Corp.
Device:	Pulsion FS Laser
510(k):	K013941
Date Cleared:	February 27, 2001

1. A DESCRIPTION OF THE DEVICE THAT IS THE SUBJECT OF THE 510(K), INCLUDING EXPLANATION OF HOW THE DEVICE FUNCTIONS, BASIC SCIENTIFIC CONCEPTS, SIGNIFICANT PHYSICAL AND PERFORMANCE CHARACTERISTICS (DESIGN, MATERIAL, PHYSICAL PROPERTIES):
  The INTRALASE FS Laser is a precision ophthalmic surqical laser designed for use in performing lamellar corneal resections. The cutting action of the

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Section 11 SUMMARY OF SAFETY AND EFFECTIVENESS

INTRALASE FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

5. STATEMENT OF INTENDED USE:

The INTRALASE FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK 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 technological characteristics of the INTRALASE FS Laser have already been cleared under K013941 for lamellar corneal resections. The slight changes made to the technological characteristics of the Laser do not alter the performance or indication of this device.

7. BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:

The INTRALASE FS Laser has undergone testing and is in compliance with applicable safety standards. In addition, the INTRALASE FS was found to perform equivalently to the predicate Laser, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies. Thus, the INTRALASE FS Laser and the predicate device have similar safety, effectiveness or performance profiles.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized human figure with three faces in profile, representing health, services, and people. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2003

IntraLase Corporation c/o Judy F. Gordon, D.V.M. Clinreg Consulting Services, Inc. 2 Delphinus Irvine, California 92612

Re: K031960 Trade/Device Name: INTRALASE™ FS Laser Keratome Regulation Number: 21 CFR 878.4810, 886.4370 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Keratome Regulatory Class: II Product Code: GEX, HNO Dated: June 20, 2003 Received: July 2, 2003

Dear Dr. Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ k 031 9 6 D ______________________________________________________________________________________________________________________________________

Device Name: INTRALASE FS Laser

Indications for Use:

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031960

(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.