In the creation of a corneal flap in patients undergoing LASIK 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
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 lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal

Device Description

The iFS Laser System intended use is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser. The iFS Laser System uses focused femtosecond laser pulses to create incisions and separates tissues in the cornea. Corneal dissection with the iFS Laser is achieved through precise individual micro-photodisruptions of tissue, which are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce continuous incisions or tissue separation. These laser pulses are delivered through a disposable applanation lens that contacts the cornea while fixating the eye under low vacuum.

AI/ML Overview

Acceptance Criteria and Device Performance for iFS Laser System

The provided text describes the 510(k) summary for the iFS Laser System, focusing on its safety and effectiveness, particularly for additional indications like arcuate incisions. While explicit acceptance criteria values for clinical outcomes are not presented in a direct table format, the document outlines various tests and their successful completion, implying meeting predefined safety and performance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly met by the reported results. The document states that "All results met the 95% confidence acceptance criteria" for pattern fidelity tests. For clinical trials, safety variables were met, and no statistically significant worsening of symptoms was observed.

Acceptance Criterion Category	Specific Criterion (Implicitly Met)	Reported Device Performance
Pattern Fidelity (Arcuate Incisions)	Depth Pattern Fidelity (95% CI)	All results met the 95% confidence acceptance criteria.
	Position Pattern Fidelity (95% CI)	All results met the 95% confidence acceptance criteria.
	Angle Pattern Fidelity (95% CI)	All results met the 95% confidence acceptance criteria.
	Diameter Pattern Fidelity (95% CI)	All results met the 95% confidence acceptance criteria.
Clinical Safety (Intrastromal Arcuate Incisions)	Rate of Adverse Events	Met. No eyes experienced an adverse event.
	Post-operative BSCVA (worse than 20/40 for eyes 20/20 or better at baseline)	No eyes in this study with a BSCVA of 20/20 or better at baseline had a post-operative BSCVA of worse than 20/40.
	Induced Manifest Refractive Astigmatism (> 2.00 diopters)	No eyes in this study had induced manifest refractive astigmatism of greater than 2.00 diopters.
	Endothelial Cell Counts (no statistically significant differences with fellow eyes)	No statistically significant differences were observed.
	Ophthalmic Symptoms (no statistically significant worsening of symptoms or quality of vision)	No statistically significant worsening symptoms or quality of vision.
Overall Effectiveness	Ability to create arcuate incisions safely and effectively	The study indicates that the iFS Laser System can create single or paired arcuate incisions with appropriate depth in glass settings, and intrastromal incision without risking perforation. The results indicated the system can safely perform intrastromal arcuate incisions.

2. Sample Size and Data Provenance

Sample Size for Test Set:
- Human Cadaver Eye Testing: The exact sample size is not specified, but it involved multiple human cadaver eyes used to create intrastromal and penetrating arcuate incisions.
- Animal Testing (Rabbits): A "series of studies" were conducted, including a "GLP rabbit study." The exact number of rabbits is not specified beyond "rabbits."
- Clinical Trial: A total of 21 subjects (presumably 21 eyes) were enrolled.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were conducted under U.S. or international standards recognized by the FDA.
- Retrospective or Prospective: The "Clinical Trial" section describes a study with "baseline and post-operative visits," indicating a prospective study design. The human cadaver and animal studies would also be prospective in nature.

3. Number of Experts and Qualifications for Ground Truth

The document primarily describes engineering and performance characteristics, as well as clinical safety outcomes. It does not mention the use of human experts to establish "ground truth" for the test set in the way one might for diagnostic imaging devices (e.g., radiologists interpreting images).
For the clinical trial, the "ground truth" was established by objective clinical measurements and assessments (e.g., BSCVA, astigmatism, endothelial cell counts, adverse event reporting, symptom questionnaires) and the "Adjudication of outcomes" would be based on the pre-defined study endpoints and statistical analysis.

4. Adjudication Method for the Test Set

For the clinical trial, the adjudication method is not explicitly detailed in the provided text in terms of reader consensus (e.g., 2+1, 3+1).
However, standard clinical trial methodology would involve:
- Objective measurements: Data for outcomes like BSCVA, astigmatism, and endothelial cell counts are objective and would not require reader adjudication in the same sense as image interpretation.
- Adverse event reporting: Likely adjudicated by the investigative site and/or sponsor according to predefined criteria.
- Symptom questionnaires: Patient-reported outcomes.
The phrase "AMO directed study" and "one investigative site" suggests internal oversight and data collection, rather than a multi-center adjudication panel for subjective measures.

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

No MRMC study was conducted or reported.
This device is a surgical laser, not an AI-assisted diagnostic tool for image interpretation, so an MRMC study comparing human readers with and without AI assistance is not applicable to the context of this device. The study focuses on the device's ability to perform surgical actions and the resulting clinical outcomes.

6. Standalone (Algorithm Only) Performance

This concept is not directly applicable in the same way as for an AI diagnostic algorithm. The iFS Laser System is a surgical instrument. Its "performance" is inherent in its ability to execute precise laser cuts.
The "Pattern Fidelity Testing" could be considered a form of standalone performance evaluation for the device's mechanical and optical precision, demonstrating that the laser itself performs according to its design specifications (e.g., depth, position, angle, diameter).

7. Type of Ground Truth Used

Engineering/Physical Ground Truth: For "Pattern Fidelity Testing," the ground truth was established by precise measurements of the actual laser cuts against predefined specifications.
Clinical/Physiological Ground Truth: For the "Human Cadaver Eye Testing" and "Animal Testing," the ground truth was the observable ability of the laser to create the desired incisions in biological tissue and the safety profile (e.g., no perforation, tissue response).
Clinical Outcome Ground Truth: For the "Clinical Trial Results," the ground truth was based on:
- Objective clinical measurements: BSCVA, manifest refractive astigmatism, endothelial cell counts.
- Patient-reported outcomes: Ophthalmic symptoms and vision quality.
- Adverse events: Clinically observed and reported events.

8. Sample Size for the Training Set

The text does not provide information on a "training set" in the context of machine learning or AI.
This 510(k) summary describes a traditional medical device (a surgical laser) and its validation through engineering tests, ex-vivo studies (cadaver/animal), and a clinical trial. It does not appear to involve an AI algorithm that would require a separate training set.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of an AI algorithm or a training set, the question of how its ground truth was established is not applicable based on the provided document. The device's development and validation follow conventional medical device pathways rather than AI model development pathways.

Summary

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

KI13151

14.0 510(k) SUMMARY

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

Submitter's name, address, telephone number, contact person, and date summary prepared:

a. Applicant:

Abbott Medical Optics Inc. 1700 East St. Andrew Place Santa Ana, CA 92705 · Tel: 714-247-8930

b. Contact Person:

Keslev Gallagher, MS Regulatory Affairs Manager 1700 East St. Andrew Place Santa Ana, CA 92705 Tel: 714-247-8930 Fax: · · 714-247-8784 Email: kesley.gallagher@amo.abbott.com

c. Date of Summary Preparation: March 7, 2012

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME:

Trade/Proprietary Name: iFS Laser System Common/Usual Name: Laser Classification Name: Keratome Classification Code(s): 79 GEX, 86 HNO

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

510(k) #	Trade Name	Manufacturer
K101626	LenSx 550 Laser System	LenSx Lasers
K073404	IntraLase FS Laser	IntraLase Corp.
K863725	Cataract Diamond Knife	Medical TechnologyDevelopment Corp.

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 iFS Laser System intended use is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser. It is indicated for use as follows:

. In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
14

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

. 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 seaments
. In lamellar keratoplasty and corneal harvesting
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
In patients undergoing ophthalmic surgery or other treatment requiring arcuate . cuts/incisions, both penetrating and intrastromal

The iFS Laser System uses focused femtosecond laser pulses to create incisions and separates tissues in the cornea. Corneal dissection with the iFS Laser is achieved through precise individual micro-photodisruptions of tissue, which are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce continuous incisions or tissue separation. These laser pulses are delivered through a disposable applanation lens that contacts the cornea while fixating the eye under low vacuum.

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

The technological characteristics of the iFS Laser System are substantially equivalent to those cleared under K101626 and K073404 for corneal resections and incisions. No new software and/or hardware were required for the additional indication for arcuate incisions for the iFS Laser System.

BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:

The iFS Laser System has undergone testing and is in compliance with applicable safety standards. The iFS Laser System was able to create arcuate incisions, both penetrating and intrastromal, safely and effectively. Thus, the iFS Laser System and the predicate devices have similar safety, effectiveness and performance profiles.

APPLICABLE STANDARDS (LASER AND PATIENT INTERFACE):

IEC 60601-1 Medical Electrical Equipment General Requirements for Safety, . 2nd edition, Amendment 2
IEC 60601-1-2 Medical Electrical Equipment -- Electromagnetic Compatibility, . 200 Edition, Amendment 1
· IEC 60601-2-22 Medical Electrical Equipment Safety of Diagnostic and Therapeutic Laser Equipment, 2nd Edition, Amendment 2

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

· ISO 10993-10:2002 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Delayed Type Hypersensitivity
· ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5 Tests for In Vitro Cytotoxicity
AAMI 11137-1:2006/(R) 2010 Sterilization of Health Care Products Radiation - Part 1: Requirements for Development
· AAMI 11137-2:2006/(R) 2010 Sterilization of Health Care Products Radiation - Part 2: Establishing the Sterilization Dose

Pattern Fidelity Testing:

Data were collected from the iFS Laser System to measure depth pattern fidelity for arcuate incisions at the 95% confidence interval. All results met the 95% confidence acceptance criteria. Data were additionally collected from the iFS Laser System to measure pattern fidelity for position, angle and diameter for arcuate incisions at the 95% confidence interval. All results met the 95% confidence acceptance criteria.

HUMAN CADAVER EYE TESTING:

An AMO directed study was executed to determine the effectiveness of laser parameters in the creation of arcuate incisions in the human cadaver eye model. The iFS Laser System was used to cut intrastromal and penetrating arcuate incisions in the human cornea. For comparison, a standard radial keratotomy diamond blade was used to create penetrating incisions. Results of the study indicate that the iFS Laser System can create single or paired arcuate incisions. With appropriate depth in glass settings, the intrastromal incision can be created without risking perforation of either corneal surface.

Animal Testing:

AMO conducted a series of studies in rabbits to evaluate the safety of penetrating and intrastromal incisions. The first studies assessed the initial safety of the intrastromal arcuate incisions. Subsequent studies, including a GLP rabbit study, were performed to demonstrate safety of penetrating and intrastromal arcuate incisions when performed by the iFS Laser System. The GLP study conclusively demonstrates the safety of arcuate incisions in the cornea, both penetrating and intrastromal, when performed by the iFS Laser System.

Clinical Trial Results:

A clinical trial assessed the iFS Laser System for demonstration of safety of the intrastromal arcuate incisions in the cornea. A total of 21 subjects were enrolled at one investigative site in a non-randomized, two-arm study design based on cataract status.

No eyes in this study with a BSCVA of 20/20 or better at baseline had a post-operative BSCVA of worse than 20/40. No eyes in this study had induced manifest refractive astigmatism of greater than 2.00 diopters. No eyes experienced an adverse event.

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

Endothelial cell counts (central and two peripheral endothelium locations) were compared between the study and non-study fellow eyes. No statistically significant differences were observed.

Ophthalmic symptoms such as glare, halos, clarity, dry eve, photophobia, gritty/scratchy/sandy feelings in eye and vision quality were assessed by each subject for both the study and non-study fellow eyes at baseline and post-operative visits. The changes in symptoms were evaluated and there were no statistically significant worsening symptoms or quality of vision.

The primary safety criterion of rate of adverse events was met, as well as other secondary variables of safety and surgical experience. The results of this study indicated that the iFS Laser System can safely perform intrastromal arcuate incisions in the cornea.

Conclusion:

The laboratory and animal study data support that the arcuate incisions can be executed by the iFS Laser System as prescribed by the physician. These data demonstrate the iFS Laser System is safe and effective when used in conjunction with the directions for use and inherent warnings.

. .

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

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the caduceus. The caduceus is depicted as a stylized human figure with outstretched arms, and the words are written in a simple, sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Abbott Medical Optics. Inc. c/o Ms. Keslev E. Gallagher Project Manager, Refractive Regulatory Affairs 1700 E. St. Andrew Place Santa Ana, CA 92705

MAR - 8 2012

Re: K113151

Trade/Device Name: iFS Laser System Regulation Number: 21 CFR 878.4810

Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in

Dermatology

Regulatory Class: Class II Product Code: GEX, HNO Dated: February 15, 2012 Received: February 17, 2012

Dear Ms. Gallagher:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

Page 2 - Ms. Kesley E. Gallagher

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 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,
Kesia Alexander

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

Enclosure

{6}------------------------------------------------

CDRH INDICATIONS FOR USE

510(k) Number (if known):

KII 315 l

Device Name(s):

iFS Laser System

Indications for Use:

The iFS Laser System is an ophthalmic surgical laser indicated for use:

In the creation of a corneal flap in patients undergoing LASIK surgery or other . in the Greation on initial lamellar resection of the cornea
In patients undergoing surgery or other treatment requiring initial lamellar . resection of the cornea
In patients undergoing surgery or other treatment requiring initial lamellar . m pallents undergoing Surgery of Unior treatment of corneal ring segments
· In lamellar keratoplasty and corneal harvesting
In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty . in the creation of a familiar sucting cutfincision for penetrating keratoplasty
In patients undergoing ophthalmic surgery or other treatment requiring arcuate ● cuts/incisions in the cornea, penetrating and/or intrastromal

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)

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number	K113151

Page 1 of 1

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.