(143 days)
No
The summary describes a surgical laser system and its function in creating corneal cuts. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance studies focus on safety standards and equivalence to predicate devices based on the physical cutting action.
No
This device is an ophthalmic surgical laser used for procedures like creating corneal flaps and resections, which are surgical interventions rather than therapeutic treatments aimed at restoring or improving health.
No
The device description and intended use clearly state that the iFS Laser System is an ophthalmic surgical laser used for procedures like creating corneal flaps, lamellar resection, and tunnels, which are all treatment actions, not diagnostic.
No
The device description explicitly states it is a "precision ophthalmic surgical laser" and describes the physical mechanism of action ("precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly"). This indicates a hardware-based device, not software only.
Based on the provided information, the iFS Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- iFS Laser System Function: The iFS Laser System is a surgical laser used to perform procedures directly on the patient's cornea. It creates cuts and resections in the eye tissue.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is to physically alter tissue.
Therefore, the iFS Laser System falls under the category of a surgical device, not an IVD.
N/A
Intended Use / 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 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 0
- 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
Product codes
79 GEX, 86 HNO
Device Description
The iFS Laser System is a precision ophthalmic surgical laser designed for use as 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:
- . 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.
Corneal dissection with the iFS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The iFS Laser System has undergone testing and is in compliance with applicable safety standards. The iFS Laser and the accessory IntraLase Patient Interface were found to perform equivalently to the predicate laser and patient interface for the creation of corneal resections. Thus, the iFS Laser System and the predicate device have similar safety, effectiveness and performance profiles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(K) SUMMARY 14.0
APR 2 5 2008
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).
Fax: 949.461.3323
Email: maureen.weiner(a)amo-inc.com
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED:
| a. Applicant: | IntraLase Corp.
9701 Jeronimo Road
Irvine, CA 92618
Tel: 949.859.5230 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| b. Contact Person: | Maureen Weiner, R.N.
Regulatory Affairs Consultant
5 Grindlay Pl
Aliso Viejo, CA 92656
Ph: 949.584.5771 |
December 3, 2007 c. Date of Summary Preparation
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 |
|---|---|---|
| K060372 | IntraLase FS Laser | IntraLase Corp. |
| K063682 | IntraLase Fusion Laser | IntraLase Corp. |
| K032910 | Carriazo Pendular Microkeratome | Schwind Eye Tech Solutions |
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 is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser indicated for use:
14
1
- . 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.
Corneal dissection with the iFS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
STATEMENT OF INTENDED 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 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.
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 are substantially equivalent to those cleared under K060372, K063682, and K032910 for corneal resections and incisions.
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 and the accessory IntraLase Patient Interface were found to perform equivalently to the predicate laser and patient interface for the creation of corneal resections. Thus, the iFS Laser System and the predicate device have similar safety, effectiveness and performance profiles.
2
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 a stylized image of a human figure with outstretched arms, which is meant to represent the department's mission of protecting the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the figure. The logo is simple and recognizable, and it is used on a variety of government documents and websites.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 5 2011
Intralase Corporation c/o Maureen Weiner, R.N. 5 Grindlay Pl. Aliso Viejo, CA 92656 USA
Re: K073404
Trade/Device Name: iFS Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: II Product Code: GEX, HNO Dated: April 8, 2008 Received: April 10, 2008
Dear Ms. Weiner:
This letter corrects our substantially equivalent letter of April 25, 2008.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Maureen Weiner, R.N.
forth in the quality systems (OS) 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,
Kevin 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
4
Indications for Use
510(k) Number (if known): K073404
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 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 0
- � 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)
Doc Callaway
Page 1 of
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K073404