In patients undergoing surgery or other treatment requiring intial lamellar resection of the cornea
In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of the corneal ring segments
In lamellar keratoplasty and corneal harvesting
In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty

Device Description

The INTRALASE FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual micro-photodisruptions 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 a medical device for ophthalmic surgery. This document primarily focuses on establishing substantial equivalence to predicate devices for expanded indications for use. It does not contain information about explicit acceptance criteria or a study designed to prove the device meets specific performance metrics in the way modern AI device submissions do.

Instead, the submission relies on the fact that the technological characteristics of the INTRALASE FS Laser were already cleared for a primary indication (corneal harvesting under K002890) and that the design, materials, and characteristics of the laser are the same regardless of the indication. The "study" mentioned implicitly is essentially a comparison to predicate devices, asserting equivalent performance based on existing safety standards and the device's inherent characteristics.

Therefore, many of the requested categories cannot be directly answered from the provided text, as they pertain to a different type of performance validation (e.g., for AI or diagnostic devices).

Here's an attempt to answer as much as possible based on the provided text, with clear indications where information is not present:

Acceptance Criteria and Device Performance Study (K041893: INTRALASE FS Laser)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Equivalence to Predicate Devices for Corneal Resections: The device must perform equivalently to predicate devices (K981063 Automated Corneal Trephine, K013151 ASMOTOM Automated Corneal Trephine) with respect to the creation of partial or full thickness corneal resections for lamellar keratoplasty and penetrating keratoplasty.	The INTRALASE FS Laser was found to perform "equivalently" to the predicate devices with respect to the creation of partial or full thickness corneal resections for lamellar keratoplasty and penetrating keratoplasty. The submission states, "Thus, the INTRALASE FS Laser and the predicate device have similar safety, effectiveness and performance profiles."
Safety Standards Compliance: The device must have undergone testing in accordance with applicable safety standards.	The INTRALASE FS Laser "has undergone testing in accordance with applicable safety standards." (Specific standards or results not detailed in this summary).
Technological Characteristics Equivalence: For the expanded indications, the technological characteristics of the device must be the same as those cleared under its original 510(k) (K002890 for corneal harvesting).	The technological characteristics of the INTRALASE FS Laser are "already been cleared under K002890 for corneal harvesting. The design, materials, and characteristics of the laser keratome are the same irrespective of the indication for use."

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

Sample Size: Not applicable/Not provided. The submission describes nonclinical testing and comparison to predicates, not a clinical study with a specified "test set" in the context of AI or diagnostic device evaluation.
Data Provenance: Not applicable/Not provided. The evaluation is based on technical characteristics and equivalence, not patient data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not provided. This type of evaluation (expert consensus for ground truth) is not relevant for this device's 510(k) submission, which focuses on substantial equivalence of a physical surgical laser tool.

4. Adjudication Method for the Test Set

Not applicable/Not provided. This concept is typically relevant to clinical studies involving human observers or diagnostic assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study was not conducted as this is a surgical laser device, not a diagnostic imaging device or an AI-assisted interpretation tool. The submission does not mention human readers or AI assistance.

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

No. This device is a surgical laser, not an algorithm. The concept of "standalone performance" for an algorithm is not applicable here.

7. The Type of Ground Truth Used

Equivalence/Performance to Predicate Devices and Safety Standards: The "ground truth" implicitly used for this submission is the established performance and safety of legally marketed predicate devices, along with compliance with applicable safety standards for the device itself. The assessment relies on the device's ability to perform the same surgical cuts as the predicates and its adherence to safety requirements.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is not an AI algorithm that requires a "training set."

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

Not applicable/Not provided. This device is not an AI algorithm.

Summary

{0}------------------------------------------------

K041893

JUL 29 2005 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 Corp.
	3 Morgan
	Irvine, CA 92618

b. Contact Person: Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, CA 92603
c. Date Summary Prepared: May 9, 2005

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

Trade/Proprietary Name: INTRALASE FS Laser a.
b. Classification Name: Laser

3. IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:

510(k)	Applicant	Name of Device	Date Cleared
K981063	Laser CenterDevelopmentCorporation	Automated CornealTrephine	June 23, 1998
K013151	BKG OphthalmicsUSA, Inc.	ASMOTOM AutomatedCorneal Trephine	December 14,2001
K002890	IntraLase Corporation	Femtosecond LaserKeratome	August 9, 2001

{1}------------------------------------------------

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 surgical laser designed for use in performing lamellar and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual micro-photodisruptions 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 Laser is an ophthalmic surgical laser with the following indications for use:

. In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
. In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments
. In lamellar keratoplasty and corneal harvesting
In the creation of a corneal flap in patients undergoing LASIK surgery or . other treatment requiring initial lamellar resection of the cornea.
. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty.

These additional indications for use are identical to those of the predicate devices.

STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6. COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE.

The technological characteristics of the INTRALASE FS Laser have already been cleared under K002890 for corneal harvesting. The design, materials, and characteristics of the laser keratome are the same irrespective of the indication for use.

{2}------------------------------------------------

7. BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:

The INTRALASE FS Laser has undergone testing in accordance with applicable safety standards. In addition, the INTRALASE FS was found to perform equivalently to the predicate devices with respect to the creation of partial or full thickness corneal resections in the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty. Thus, the INTRALASE FS Laser and the predicate device have similar safety, effectiveness and performance profiles.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Intralase Corporation c/o Judy F. Gordon, D.V.M. Regulatory Consultant to IntraLase ClingReg Consulting Services, Inc. 2 Delphinus Irvine, CA 92603

JAN 2 5 2011

Re: K041893

Trade/Device Name: INTRALASE FS Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: July 6, 2005 Received: July 7, 2005

Dear Dr. Gordon:

This letter corrects our substantially equivalent letter of July 29, 2005.

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 (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 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); medical device reporting (reporting of medical

{4}------------------------------------------------

Page 2 - Judy F. Gordon, D.V.M.

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K041893

INTRALASE FS Laser Device Name(s):

Indications for Use:

The INTRALASE® FS Laser is an ophthalmic surgical laser with the following indications for use:

In patients undergoing surgery or other treatment requiring intial lamellar ● resection of the cornea
In patients undergoing surgery or other treatment requiring initial lamellar o resection of the cornea to create tunnels for placement of the corneal ring segments
� In lamellar keratoplasty and corneal harvesting
. In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
In the creation of a lamellar cut/resection of the cornea for lamellar . keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

S. Calloway

(Division Sign-Off)

Page 1 of __ 1 ___

Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

510(k) Number K041893

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.