IFS LASER SYSTEM
Device Facts
| Record ID | K113151 |
|---|---|
| Device Name | IFS LASER SYSTEM |
| Applicant | Abbott Medical Optics, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Mar 8, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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
Device Story
iFS Laser System is a precision ophthalmic surgical laser; uses focused femtosecond laser pulses to create corneal incisions and separate tissues. Operates via precise micro-photodisruptions at laser focus; system scans thousands of pulses per second to produce continuous incisions. Delivered through disposable applanation lens contacting cornea under low vacuum. Used in clinical settings by physicians. Output is physical corneal tissue separation/incision. Assists surgeons in LASIK, keratoplasty, and arcuate incision procedures; benefits patients by enabling precise, controlled corneal surgery.
Clinical Evidence
Clinical trial enrolled 21 subjects in a non-randomized, two-arm study. Primary safety endpoint (adverse events) met. No eyes with baseline BSCVA 20/20 or better had post-op BSCVA worse than 20/40. No induced refractive astigmatism >2.00D. No statistically significant differences in endothelial cell counts or worsening of ophthalmic symptoms (glare, halos, dry eye) compared to fellow eyes. Bench testing confirmed pattern fidelity for depth, position, angle, and diameter at 95% confidence interval. Animal studies (rabbits) confirmed safety of penetrating and intrastromal incisions.
Technological Characteristics
Femtosecond laser system; uses focused laser pulses for photodisruption. Includes disposable applanation lens. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22. Biocompatibility per ISO 10993-5 and ISO 10993-10. Sterilization per AAMI 11137-1/2. System performs automated scanning of laser pulses to create incisions.
Indications for Use
Indicated for patients undergoing ophthalmic surgery requiring corneal lamellar resection, corneal flap creation for LASIK, corneal ring segment tunnel creation, lamellar/penetrating keratoplasty, corneal harvesting, or arcuate incisions (penetrating or intrastromal).
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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:
| <b>510(k) #</b> | <b>Trade Name</b> | <b>Manufacturer</b> |
|-----------------|------------------------|-----------------------------------------|
| K101626 | LenSx 550 Laser System | LenSx Lasers |
| K073404 | IntraLase FS Laser | IntraLase Corp. |
| K863725 | Cataract Diamond Knife | Medical Technology<br>Development 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
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- . 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
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- · 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.
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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.
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# 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.
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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.
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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
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# 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 |
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