(46 days)
No
The description focuses on the mechanical and optical aspects of the femtosecond laser system and its computer-controlled scanning, without mentioning any AI or ML capabilities for decision-making, image analysis, or adaptive control based on learned patterns.
Yes
The device is described as an "ophthalmic surgical laser" used for creating incisions and separating tissue during cataract and LASIK surgeries, which are medical treatments.
No
The device is an ophthalmic surgical laser used to create incisions and separate tissue during cataract and LASIK surgeries. It does not perform diagnostic functions.
No
The device description clearly outlines a physical laser system, patient interface accessories, and a computer-controlled scanning system, indicating it is a hardware-based medical device with integrated software for control and operation.
Based on the provided information, the LenSx Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's eye (creation of corneal cuts/incisions, anterior capsulotomy, laser phacofragmentation, creation of a corneal flap). IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a surgical laser system that directly interacts with and modifies tissue within the eye. This is consistent with a surgical device, not a diagnostic device that analyzes samples.
- Anatomical Site: The device operates on the lens capsule, crystalline lens, and cornea, which are parts of the living patient's eye. IVD devices work with samples taken from the body.
The information provided strongly indicates that the LenSx Laser is a surgical device used for ophthalmic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LenSx Laser is indicated for use:
- In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
OOE, HQC, HNO
Device Description
The LenSx Laser System is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create incisions and to separate tissue within the lens capsule, crystalline lens, and the cornea. A femtosecond light pulses 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. A computer-controlled scanning system directs the focused laser beam throughout a three-dimensional pattern to produce an incision. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation.
The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the position of the eye with respect to the delivery system. Two models of the Patient Interface accessory are offered for use with the LenSx Laser System: the LenSx Laser Patient Interface and the LenSx SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system. The LenSx SoftFit Patient Interface model is offered with three different sizes of soft contact lenses that are positioned against the internal surface of the patient Interface glass. For cataract procedures, the LenSx SoftFit Patient Interface is used. For corneal flap procedures, the LenSx Laser Patient Interface is used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea, lens capsule, crystalline lens
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 performance data supporting substantial equivalence of the SoftFit Patient Interface accessory includes evaluation of the accuracy and reproducibility of the depths and geometry of each of the previously cleared cataract treatment patterns for the LenSx Laser when the SoftFit Patient Interface is used with the new insert sizes. Performance testing on the new sizes show that the device is as safe and as effective as the predicate device.
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
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
Alcon Laboratories, Inc. Mr. James Arganda Director Global Regulatory Affairs 20511 Lake Forest Dr. Lake Forest, CA 92630
Re: K163551
Trade/Device Name: LenSx Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE, HQC, HNO Dated: December 13, 2016 Received: December 19, 2016
Dear Mr. Arganda:
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.
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21 CFR 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 Industry and Consumer Education 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,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163551
Device Name LenSx Laser System
Indications for Use (Describe)
The LenSx Laser is indicated for use:
· In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
Submitter 1.
Applicant:
Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099
Contact Person:
James Arganda Alcon Research, Ltd. 20511 Lake Forest Dr. Lake Forest, CA 92630 james.arganda@alcon.com Tel: (949) 505-7038 Fax: (949) 505-6237
Date Prepared:
February 2, 2017
2. Device
| Trade/Proprietary Name: | LenSx Laser System |
|---|---|
| Common/Usual Name: | Femtosecond laser system |
| Classification Name: | Laser Instrument, Surgical, Powered |
| Regulatory Class: | II |
| Classification Code(s): | 21 CFR 886.4390; OOE, HQC, HNC |
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3. Predicate Device
LenSx Laser System, K161288
Device Description 4.
The LenSx Laser System is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create incisions and to separate tissue within the lens capsule, crystalline lens, and the cornea. A femtosecond light pulses 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. A computer-controlled scanning system directs the focused laser beam throughout a three-dimensional pattern to produce an incision. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation.
The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the position of the eye with respect to the delivery system. Two models of the Patient Interface accessory are offered for use with the LenSx Laser System: the LenSx Laser Patient Interface and the LenSx SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system. The LenSx SoftFit Patient Interface model is offered with three different sizes of soft contact lenses that are positioned against the internal surface of the patient Interface glass. For cataract procedures, the LenSx SoftFit Patient Interface is used. For corneal flap procedures, the LenSx Laser Patient Interface is used.
5. Indications for Use
The following indications for use for the LenSx Laser System are unchanged from the previously cleared device (K161288):
- . In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
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- In the creation of a corneal flap in patients undergoing LASIK surgery or other . treatment requiring initial lamellar resection of the cornea.
Technological Characteristics Comparison 6.
The subject of this 510(k) Premarket Notification is the offering of two additional sizes of the soft contact lens insert used with the SoftFit Patient Interface accessory that is currently sold for use with the LenSx Laser System. These additional sizes are being offered to better accommodate variations in corneal curvature and enhance patient comfort during docking of the laser objective prior to treatment. The original universal size (nominal) remains unchanged with a central base curve of 7.6 mm. The additional sizes will include:
- a contact lens insert with a central base curve of 7.2 mm for steeper corneas with an . average K-reading greater than >46 D; and
- a contact lens insert with a central base curve of 8.1 mm for flatter corneas with an . average K-reading of 46 D |
| Method of
Sterilization | Steam Autoclave | Same |
| Use | Single Use | Same |
Brief Summary of Performance Test Results 7.
The performance data supporting substantial equivalence of the SoftFit Patient Interface accessory includes evaluation of the accuracy and reproducibility of the depths and geometry of each of the previously cleared cataract treatment patterns for the LenSx Laser when the SoftFit Patient Interface is used with the new insert sizes.
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8. Conclusions
The subject of this 510(k) Premarket Notification is the addition of two new SoftFit Insert sizes and the labeling and risk analysis changes to support these additional models. Performance testing on the new sizes show that the device is as safe and as effective as the predicate device.