(48 days)
Not Found
Unknown
The summary mentions an "Algorithm" for determining cyclotorsion angle and includes performance metrics, but it does not explicitly state that this algorithm utilizes AI or ML. The description of the device and its intended use focuses on automated precision control via a pulsed laser, which doesn't inherently imply AI/ML. While an algorithm is present, the summary lacks details about its nature (e.g., training data, model type) that would confirm AI/ML.
Yes
The device is used in cataract surgery for removal of the crystalline lens and performs actions within the body to treat a medical condition, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is for use in ophthalmic surgery and performs actions like cutting, fragmenting, and creating incisions. While it interacts with other diagnostic devices (topographers) and details performance metrics related to angle determination, the device itself is a surgical tool, not a diagnostic one.
No
The device description explicitly states it utilizes a pulsed laser and is a medical device for use in ophthalmic surgery, indicating it is a hardware-based system, not software-only.
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.
- Device Function: The LENSAR Laser System - fs 3D is a surgical device that uses a laser to perform procedures directly on the patient's eye (anterior lens capsule and cornea) during cataract surgery. It is an in vivo device, meaning it operates within the living body.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient, not laboratory testing of samples.
The information about "Iris Registration Feature" and its performance metrics (cyclotorsion angle determination) relates to the device's ability to accurately align and target the laser during the surgical procedure, which is a function of the surgical device itself, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Product codes
OOE; HQC
Device Description
The LENSAR Laser System - fs 3D (LLS-fs 3D) is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multiplane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser phaco fragmentation treatment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Nidek OPD Scan Topographer, i-Optics Cassini Topographer
Anatomical Site
Crystalline lens, 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
Performance Evaluation of the Iris Registration Feature: Verification and validation testing were completed to demonstrate that the device performance complies with the previously defined specifications and requirements identified for the LENSAR Iris Registration feature. All criteria were met and the results demonstrate that the LENSAR Iris Registration feature meets all performance specifications and requirements. The evaluation specifically addressed performance of the Nidek OPD Scan Topographer as a validated topographer for use with the Iris Registration feature of the LLS-fs 3D.
Key Metrics
Iris Registration Comparison Results:
Nidek OPD Scan Topographer
Algorithm determines the correct cyclotorsion angle: ≥ 99.26%
Algorithm cannot determine an angle:
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2015
LENSAR, Inc. c/o Mohinder Merchea, OD, Ph.D., MBA VP. Clinical & Regulatory Affairs 2800 Discovery Drive, Suite 100 Orlando, FL 32826
Re: K152453
Trade Name: LENSAR Laser System - fs 3D (LLS-fs 3D) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE; HQC Dated: September 5, 2015 Received: September 15, 2015
Dear Dr. Merchea:
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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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 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" (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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
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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) K152453
Device Name
LENSAR Laser System - fs 3D (LLS-fs 3D)
Indications for Use (Describe)
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
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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510(k) SUMMARY
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER I.
| Submitter: | Contact Person: |
|---|---|
| LENSAR, Inc. | Mohinder Merchea |
| 2800 Discovery Drive, Suite 100 | 888-536-7271 (Office) |
| Orlando, FL 32826 | 407-386-7228 (Fax) |
Summary Preparation Date: August 28, 2015
DEVICE II.
| Device Name(s): | LENSAR Laser System - fs 3D (LLS-fs 3D) |
|---|---|
| Common or Usual Name: | LENSAR Laser System |
| Classification Name(s): | Ophthalmic Laser (21 CFR 886.4390), |
| Phacofragmentation System (21 CFR 886.4670) | |
| Regulatory Class: | II |
| Product Code(s): | OOE; HQC |
III. PREDICATE DEVICE(S)
| 510(k) Number | Date Cleared | Device |
|---|---|---|
| K143010 | 03/20/2015 | LENSAR Laser System – fs 3D (LLS-fs 3D |
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The LENSAR Laser System - fs 3D (LLS-fs 3D) is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multiplane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser phaco fragmentation treatment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions.
V. INDICATIONS FOR USE
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract
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surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
The indication for use of the subject device is unchanged from that of the predicate device.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
All elements of the proposed laser system remain unchanged from that cleared in K143010 with the addition of the validation of the Nidek OPD Scan Topographer for use with the Iris Registration feature of the LLS-fs 3D.
VII. PERFORMANCE DATA
The following performance data were undertaken in support of the substantial equivalence determination.
Performance Evaluation of the Iris Registration Feature:
Verification and validation testing were completed to demonstrate that the device performance complies with the previously defined specifications and requirements identified for the LENSAR Iris Registration feature. All criteria were met and the results demonstrate that the LENSAR Iris Registration feature meets all performance specifications and requirements. The evaluation specifically addressed performance of the Nidek OPD Scan Topographer as a validated topographer for use with the Iris Registration feature of the LLS-fs 3D.
| Iris Registration Comparison Results | ||||
|---|---|---|---|---|
| Description | Nidek OPD Scan | |||
| Topographer | i-Optics Cassini | |||
| Topographer | ||||
| Algorithm determines the correct cyclotorsion angle | ≥ 99.26% | ≥ 97.44% | ||
| Algorithm cannot determine an angle |