(118 days)
Not Found
No
The description focuses on the mechanical and optical aspects of the femtosecond laser system and its computer-controlled scanning for precise tissue manipulation. There is no mention of AI or ML for decision-making, image analysis, or adaptive control based on learned patterns.
Yes
The device is used to perform surgical procedures on the eye, such as creating corneal cuts/incisions, anterior capsulotomy, laser phacofragmentation during cataract surgery, creation of corneal flaps for LASIK, and creation of corneal pockets/tunnels, all of which are considered therapeutic interventions.
No
The LenSx Laser System is described as an "ophthalmic surgical laser" used to create incisions and separate tissue during surgical procedures, such as cataract surgery and LASIK. Its intended use and device description focus entirely on performing therapeutic actions (cutting, incising, separating tissue) rather than diagnosing conditions or identifying diseases.
No
The device description clearly outlines a physical laser system with hardware components (laser, scanning system, applanating lens, suction ring assembly) that perform the surgical procedures. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The LenSx Laser System is a surgical laser used to perform procedures directly on the eye (cornea, lens capsule, crystalline lens). It physically alters tissue through laser pulses.
- Intended Use: The intended uses described are surgical procedures (creating cuts, capsulotomy, phacofragmentation, corneal flaps, pockets, and tunnels). These are not diagnostic tests performed on samples.
The device is a surgical instrument, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The LenSx Laser System is indicated for use:
- · In the creation of corneal cuts/incisions (single-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.
- · In the creation of corneal pockets for placement/insertion of a corneal inlay device and for creation of corneal tunnels for the placement of corneal rings.
Product codes (comma separated list FDA assigned to the subject device)
OOE, HOC, 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 location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.
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)
- Evaluation of the accuracy and reproducibility of the depths and geometry of the previously cleared treatment patterns using the modified LenSx Laser in comparison to acceptance criteria established for the predicate LenSx Laser.
- Evaluation of the accuracy and reproducibility of the depths and geometry of the proposed new corneal pocket treatment patterns using the modified LenSx Laser.
- Evaluation of the accuracy and reproducibility of the depths and geometry of the proposed new corneal tunnel treatment patterns using the modified LenSx Laser.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 27, 2018
Alcon Laboratories, Inc. James Arganda Director Global Regulatory Affairs 20511 Lake Forest Dr Lake Forest, CA 92630
Re: K173660
Trade/Device Name: LenSx Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE, HOC, HNO Dated: February 15, 2018 Received: February 16, 2018
Dear James 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.
1
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 devicerelated 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173660
Device Name LenSx Laser System
Indications for Use (Describe)
The LenSx Laser System is indicated for use:
- · In the creation of corneal cuts/incisions (single-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.
- · In the creation of corneal pockets for placement/insertion of a corneal inlay device and for creation of corneal tunnels for the placement of corneal rings.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
I. Submitter of the 510(k)
| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099, USA |
|-------------------------|-----------------------------------------------------------------------------------------|
| Primary Contact Person: | James Arganda
Alcon Research, Ltd.
20511 Lake Forest Dr.
Lake Forest, CA 92630 |
| Phone: | (949) 505-7038 |
| Fax: | (949) 505-6237 |
| Email: | james.arganda@alcon.com |
| Back up Contact Person: | Kim Regis |
| Phone: | (949) 505-7232 |
| Fax: | (949) 505-6237 |
| Email: | kim.regis@alcon.com |
| Date Prepared: | 28 November 2017 |
II. Devices Subject to this 510(k)
| Trade/Device Name: | LenSx Laser System |
|---|---|
| Regulation Number | 21 CFR 886.4390 |
| Regulation Name: | Ophthalmic Laser |
| Device Classification: | Class II |
| Product Code: | OOE, HQC, HNO |
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| Primary Predicate Device | Additional Predicates | |
|---|---|---|
| 510(k) | ||
| Clearance | K163551 | K141852 |
| K141476 | ||
| Device Name | LenSx Laser System | iFS Laser System |
| WaveLight FS200 | ||
| Manufacture | Alcon Laboratories, Inc. | AMO Manufacturing |
| USA, LLC | ||
| Alcon Laboratories, Inc. |
III. Predicate Device
IV. 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 location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.
Indications for Use v.
The following indications for use for the LenSx Laser System are unchanged from the previously cleared device (K163551):
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.
- . In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
VI. Comparison to Technological Characteristics with the Predicate Device
The modified LenSx Laser System is substantially equivalent to the primary predicate device (K163551) and additional predicate devices (K141852, K141476) in terms of indications for use, technological characteristics and fundamental scientific technology. The subject and predicate laser systems share the same design principle and mode of operation in that they all deliver femtosecond pulses through a computer-controlled delivery system to produce a pattern of photodisruption to create incisions in the ophthalmic tissue. The means of fixation of the patient contact portion of the devices are all substantially equivalent in that the suction vacuum affixes a suction ring to the corneal surface prior to use.
No changes to the LenSx Laser System's operating principles, system specifications or disposable Patient Interface were required to support the additional indications for use. Software updates were implemented to support the new functionality along with associated graphical user interface functionality. While no changes are proposed to the LenSx Laser system hardware, new painted skin colors that are intended to harmonize the appearance of the LenSx Laser console appearance with other Alcon commercial products are proposed.
Modifications proposed in this 510(k) premarket notification were tested to show substantial equivalence to the predicate device. The following summarizes the substantial equivalence between the modified device and the predicate device.
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TECHNOLOGICAL COMPARISON LENSX LASER SYSTEM – PREDICATE DEVICES
| | SYSTEM
PROPOSED | PRIMARY PREDICATE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Clearance | | K163551 | K141852 | K141476 |
| Device Name | LenSx Laser System | LenSx Laser System | iFS Laser System | WaveLight FS200 |
| Manufacture | Alcon Laboratories | Alcon Laboratories | AMO Manufacturing
USA, LLC | Alcon Laboratories |
| Indication
for Use | The LenSx Laser
System 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 | The LenSx Laser
System 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 | □ 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 patients
undergoing
ophthalmic surgery
or other treatment
requiring arcuate
cuts/incisions in the
cornea, penetrating
and/or intrastromal | The WaveLight FS200
Laser System is an
ophthalmic surgical
laser indicated for use:
□ In the creation of a
corneal flap in
patients undergoing
LASIK surgery or
other surgery or
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. |
| | SYSTEM
PROPOSED | PRIMARY PREDICATE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE |
| | lamellar resection of
the cornea.
□ (New) In the creation
of corneal pockets
for
placement/insertion
of a corneal inlay
device; and for
creation of corneal
tunnels for the
placement of corneal
rings. | lamellar resection of
the cornea. | □ In lamellar IEK 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
IEK and for the
creation of a
penetrating
cut/incision for
penetrating IEK
□ In patients
undergoing
ophthalmic surgery
or other treatment
requiring the
creation of corneal
channels for
placement/insertion
of a corneal inlay
device | □ In the creation of a
lamellar
cut/resection of the
cornea for lamellar
keratoplasty.
□ In the creation of a
penetrating
cut/incision for
penetrating
keratoplasty and for
corneal harvesting.
□ In patients
undergoing
ophthalmic surgery
or other treatment
requiring arcuate
cuts/incisions in the
cornea.
□ In patients
undergoing
ophthalmic surgery
or other treatment
requiring pocket
cuts/incisions in the
cornea. |
| Operating
Principle | Femtosecond laser
photodisruption | Femtosecond laser
photodisruption | Femtosecond laser
photodisruption | Femtosecond laser
photodisruption |
| | SYSTEM
PROPOSED | PRIMARY PREDICATE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE |
| Mechanism
of Action | Cutting and resection
surfaces are created by
scanned patterns of
femtosecond laser
micro-photodisruptions
in tissue | Cutting and resection
surfaces are created by
scanned patterns of
femtosecond laser
micro-photodisruptions
in tissue | Cutting and resection
surfaces are created by
scanned patterns of
femtosecond laser
micro-photodisruptions
in tissue | Cutting and resection
surfaces are created by
scanned patterns of
femtosecond laser
micro-photodisruptions
in tissue |
| Laser
Wavelength | 1030 nm | 1030 nm | 1053 nm | 1030 nm |
| Maximum
Pulse
Energy | 15 µJ for cataract
2.6 µJ for corneal
flaps, pockets and
tunnels | 15 µJ for cataract
2.6 µJ for corneal flaps
for LASIK | 2.5 µJ | 2.4 µJ |
| Accessory
Design | Cone with curved
contact lens with
integrated suction ring | Cone with curved
contact lens with
integrated suction ring | Cone with flat contact
lens and separate
suction ring | Cone with flat contact
lens and separate
suction ring |
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8
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VII. Performance Data
The performance data supporting substantial equivalence of the LenSx Laser with the above modifications include:
- . Evaluation of the accuracy and reproducibility of the depths and geometry of the previously cleared treatment patterns using the modified LenSx Laser in comparison to acceptance criteria established for the predicate LenSx Laser.
- . Evaluation of the accuracy and reproducibility of the depths and geometry of the proposed new corneal pocket treatment patterns using the modified LenSx Laser.
- . Evaluation of the accuracy and reproducibility of the depths and geometry of the proposed new corneal tunnel treatment patterns using the modified LenSx Laser.
The LenSx Laser system underwent medical electrical equipment testing and was found in compliance with the following application safety standards:
- ANSI AAMI ES 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility
- . IEC 60601-2-22 – Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
- IEC 60825-1 Safety of Laser Products Part 1: Equipment Classification and . Requirements
- IEC 62304 Medical Device Software Software Life Cycle Processes .
- . IEC 62366 – Medical Devices - Application of Usability Engineering to Medical Devices
Verification and validation of the software updates were conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005, and demonstrated that the functional and safety critical requirements are fulfilled.
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VIII. Software Verification and Validation
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
IX. Conclusions
The subject of this 510(k) Premarket Notification is to seek clearance for additional new indications for the creation of corneal tunnels and corneal pockets. The LenSx Laser System is essentially the same device as the predicate LenSx Laser System. All modifications were tested to show substantial equivalence to the predicate device as safe and as effective as the predicate device.