(88 days)
No
The summary describes a laser photocoagulation system with different wavelengths and delivery methods. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for diagnosis, treatment planning, or automated operation. The performance studies focus on biocompatibility, electrical safety, EMC, and software verification/validation, none of which indicate AI/ML components.
Yes
The device uses specific laser wavelengths for various therapeutic interventions, such as pan-retinal photocoagulation, laser retinopexy, focal/grid photocoagulation for macular edema, and trabeculoplasty, to treat ocular pathologies.
No
The device description and intended use clearly state that this is a laser system for treatment (photocoagulation, trabeculoplasty), not for diagnosis.
No
The device description explicitly details hardware components such as a laser console, integrated slitlamp, optional LIO and endoocular probes, electronic control system, power supplies, PC interface platform, LCD touch display, and ophthalmic electrical table. While software is mentioned as part of the system, it is integrated with and controls significant hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser system used for treating various ocular pathologies through photocoagulation. It directly interacts with the patient's eye to perform a therapeutic procedure.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is to deliver laser energy to the eye.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
There are four selected wavelengths (532nm, 577mm, 810mm) in TruScan Pro Laser Console integrated with single/multi spots of TruScan module integrated with slitlamp or single spot of LIO or endo ocular probes.
The 532nm and 810nm laser wavelengths are intended to be used for:
- · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
- · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
- · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
- Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD)- with Slitlamp
- · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp
The 577nm laser wavelength is in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:
- · Proliferative and Severe and very severe nonproliferative diabetic retinopathy
- · Clinically Significant Macular edema
- · Choroidal neovascularization
- · Branch and central retinal vein occlusion
- · The treatment of choroidal neovascularization associated with wet age-related macular degeneration
- · Lattice degeneration
- · Retinal tears and detachments
The 670 nm laser wavelength is indicated for retinal and pan-retinal photocoagulation.
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
There are four selected laser wavelengths in TruScan Pro Laser console consists of integrated slitlamp for single and multi-spots laser delivery or optional LIO, Endoocular probes laser delivery units. The 532nm or 577nm laser wavelength is the primary treatment laser or configured with 670nm or 810nm secondary treatment laser to be used. Laser console is developed along with the Electronic Control system, Power Supplies, and PC Interface platform inside, and connect with 15'' LCD touch display and ophthalmic Electrical Table for use.
The TruScan Pro compatible Laser delivery units include:
TruScan module Integrated CSO SL980/SL9800 slitlamp (K992836)
Laser Indirect Ophthalmoscope using a Keeler All pupil II (K854244)
Endophotocoagulation handpieces (compatible with 510(k) cleared ophthalmic endo probes)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment; retina and choroid
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 following performance data were provided to support substantial equivalence determination.
Biocompatibility testing: There are no direct patient contact components in TruScan Pro Laser System but the integrated slitlamp supplied by original manufacturer with patient contact component such as chinrest and headrest were subjected to In vitro Cytotoxity, Irritation, and skin sensitization testing in accordance with FDA guidance - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
The patient contact materials for Chinrest and headrest are surface contact/skin device only. Contact duration is limited to less than 30 minutes. (which is shorten than 24 hours mentioned in ISO 10993 A-limited.) The Biocompatibility testing results showed patient contact materials of integrated slitlamp conform to ISO 10993-1, 10993-5, ISO 10993-10, and ISO 10993-12 standards.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on TruScan Pro. according to applicable federal and international safety and performance standards:
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012
- IEC 60825-1: 2014
- IEC 60601-2-22:2007+A1:2012
- IEC 60601-1-2:2014
- IEC 60601-1-6:2013
- EN ISO 14971:2012
- ISO15004-1:2006
The testing results demonstrate that TruScan Pro comply with all the required standards.
Software verification and validation testing: According to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)", the level of concern of TruScan Pro and its software is determined to be Major. The Software of TruScan Pro controls the delivery of laser energy. A failure of operation or latent flaw of TruScan Pro could directly result in serious injury to the patient or operator.
The software verification and validation results confirm the fulfillment of software requirement specifications.
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.
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, there is a seal with a stylized human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
May 24, 2019
Light-Med (USA), INC. Hedy Chiang Regulatory Affairs Administrator 1130 Calle Cordillera San Clemente, CA 92673
Re: K190448
Trade/Device Name: LightLas Pattern Scanning System - TruScan Pro Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: February 1, 2019 Received: February 25, 2019
Dear Hedy Chiang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190448
Device Name TruScan Pro
Indications for Use (Describe)
There are four selected wavelengths (532nm, 577mm, 810mm) in TruScan Pro Laser Console integrated with single/multi spots of TruScan module integrated with slitlamp or single spot of LIO or endo ocular probes.
The 532nm and 810nm laser wavelengths are intended to be used for:
- · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
- · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
- · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
- Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD)- with Slitlamp
- · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp
The 577nm laser wavelength is in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:
- · Proliferative and Severe and very severe nonproliferative diabetic retinopathy
- · Clinically Significant Macular edema
- · Choroidal neovascularization
- · Branch and central retinal vein occlusion
- · The treatment of choroidal neovascularization associated with wet age-related macular degeneration
- · Lattice degeneration
- · Retinal tears and detachments
The 670 nm laser wavelength is indicated for retinal and pan-retinal photocoagulation.
| 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) ☐ |
|X | Prescription Use (Part 21 CFR 801 Subbart DI ne-Counter Use (21 CFR 801 Subbart Ci
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K190448
510(k) Summary
I. SUBMITTER
LIGHTMED USA, INC. 1130 Calle Cordillera, San Clemente, CA 92673, U.S.A. T: +1-949-218-9555 F: +1-949-218-9556 Contact Person: Hedy Chiang/Regulatory Affairs Coordinator Date Prepared: Apr. 26. 2019
II. DEVICE
Trade/Device Name: TruScan Pro Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF
III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows:
| Main Predicated Device | LIGHTMED Corp.
TruScan 577 | K142172 | Decision Date: 02/27/2015 |
|------------------------|------------------------------------|---------|---------------------------|
| Reference Device | LIGHTMED Corp.
LightLas 532/810 | K152688 | Decision Date: 06/15/2016 |
| Reference Device | LIGHTMED Corp.
LightLas 577/670 | K124043 | Decision Date: 9/26/2013 |
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IV. DEVICE DESCRIPTION
There are four selected laser wavelengths in TruScan Pro Laser console consists of integrated slitlamp for single and multi-spots laser delivery or optional LIO, Endoocular probes laser delivery units. The 532nm or 577nm laser wavelength is the primary treatment laser or configured with 670nm or 810nm secondary treatment laser to be used. Laser console is developed along with the Electronic Control system, Power Supplies, and PC Interface platform inside, and connect with 15'' LCD touch display and ophthalmic Electrical Table for use.
The TruScan Pro compatible Laser delivery units include:
TruScan module Integrated CSO SL980/SL9800 slitlamp (K992836)
Laser Indirect Ophthalmoscope using a Keeler All pupil II (K854244)
Endophotocoagulation handpieces (compatible with 510(k) cleared ophthalmic endo probes)
V. INDICATIONS FOR USE
There are four selected wavelengths (532nm, 577nm, 810nm) in TruScan Pro Laser Console integrated with single/multi spots of TruScan module integrated with slitlamp or single spot of LIO or endo-ocular probes.
The 532nm and 810nm laser wavelengths are intended to be used for:
- · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
- · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
- Focal or grid photocoagulation for clinically significant macular edema . (CSME)- with Slitlamp
- . Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD)- with Slitlamp
- Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp .
The 577nm laser wavelength is in the treatment of ocular pathology in the posterior segment: retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:
- Proliferative and severe and very severe non-proliferative diabetic retinopathy .
5
- . Clinically significant macular edema
- . Choroidal neovascularization
- Branch and central retinal vein occlusion .
- The treatment of choroidal neovascularization associated with wet age-related macular . degeneration
- Lattice degeneration .
- . Retinal tears and detachments
The 670nm laser wavelength is indicated for retinal and pan-retinal photocoagulation.
6
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary of TruScan Pro design characteristics that are identical as and differ from
| Device | Subject Device | Main predicated
device | Reference Device | Reference
Device | Comparison
of Same or
Difference |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------|
| Model name | TruScan Pro | TruScan 577 | LightLas532/810 | LightLas577/670 | |
| Company Name | LIGHT-MED(USA),
INC. | LIGHTMED Corp. | LIGHTMED Corp. | LIGHTMED
Corp. | |
| 510(k) Number | K190448 | K142172 | K152688 | K124043 | |
| Laser wavelength | Treatment: 532nm,
577nm, 670nm,
810nm
Aiming: 635nm | Treatment: 577nm
Aiming: 635nm | Treatment: 532nm,
810nm
Aiming: 635nm | Treatment:
577nm, 670nm
Aiming: 635nm | Same |
| Power Output | 532nm: 2000mW
577nm: 2000mW
670nm: 700mW
810nm: 3000mW
635nm: