LIGHTMED TRUSCAN 577

K142172 · Lightmed Corp. · HQF · Feb 27, 2015 · Ophthalmic

Device Facts

• Record ID: K142172
• Device Name: LIGHTMED TRUSCAN 577
• Applicant: Lightmed Corp.
• Product Code: HQF · Ophthalmic
• Decision Date: Feb 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LightMed TruScan 577 Laser System is intended for use 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: - 1. Proliferative and Severe and very severe nonproliferative diabetic retinopathy - 2. Clinically Significant Macular edema - 3. Choroidal neovascularization - 4. Branch and central retinal vein occlusion - 5. The treatment of choroidal neovascularization associated with wet age-related macular degeneration - 6. Lattice degeneration - 7. Retinal tears and detachments

Device Story

LightMed TruScan 577 is an ophthalmic laser system for posterior segment photocoagulation. System components: 577nm OPSL laser console, integrated CSO slit lamp delivery system, LCD touch panel, and instrument table. Operated by ophthalmologists in clinical settings. Device delivers laser energy to retinal/choroidal tissue via single-spot or semi-automated pattern generation. Input: user-defined parameters (spot size 50-400µm, pulse duration 10ms-3s) via touch panel. Output: 577nm laser pulses for photocoagulation. Clinical utility: treats vascular/structural abnormalities; enables precise retinal tissue coagulation. Benefits: targeted treatment of diabetic retinopathy, macular edema, and retinal tears; reduces risk of vision loss. System includes safety filters and aiming beam (635nm).

Clinical Evidence

Bench testing only. Performance data included final assembly inspection, system calibration, and laser console/delivery unit testing. Electrical safety and EMC testing confirmed compliance with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2. Software verification and validation were performed per FDA guidance for 'major' level of concern devices.

Technological Characteristics

577nm Optically Pumped Semiconductor Laser (OPSL); 635nm red diode aiming beam. Power output 50-2000mW; pulse duration 10ms-3s. Integrated CSO slit lamp delivery system with safety filter. Spot sizes 50-400µm. Cooling via fan and TECs. LCD touch panel interface. Electrical input 100-230 Vac. Standards: 21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2.

Indications for Use

Indicated for patients with posterior segment ocular pathologies including proliferative/nonproliferative diabetic retinopathy, clinically significant macular edema, choroidal neovascularization (including wet age-related macular degeneration), branch/central retinal vein occlusion, lattice degeneration, and retinal tears/detachments.

Regulatory Classification

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.

Predicate Devices

• PASCAL Streamline 577 (K111108)

Reference Devices

• CSO Slitlamp (K992836)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2015

Lightmed Corp. Ms. Angel Hsieh Regulatory Affairs Coordinator No.1-1, Ln1,Pao-An St., Shulin Dist New Taipei City, 23861 Taiwan, R.O.C.

Re: K142172 Trade/Device Name: Lightmed Truscan 577 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: January 27, 2015 Received: January 28, 2015

Dear Ms. Hsieh:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

for Malvina B. Eydelman, MD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K142172

Device Name

LightMed TruScan 577 Laser System

The LightMed TruScan 577 Laser System is intended for use 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:

- 1. Proliferative and Severe and very severe nonproliferative diabetic retinopathy
- 2. Clinically Significant Macular edema
- 3. Choroidal neovascularization
- 4. Branch and central retinal vein occlusion
- 5. The treatment of choroidal neovascularization associated with wet age-related macular degeneration
- 6. Lattice degeneration
- 7. Retinal tears and detachments

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 is 510(K) summery in accordance with 21 CFR 807.92.

### I. SUBMITTER

LightMed Corporation No1-1, Ln1, Sec. 3 Pao-An St., Shulin Dist., New Taipei City 23861, Taiwan, R.O.C. TEL: [phone] FAX: [phone] Establishment registration number: 3008156177 Contact person in Taiwan: Angel Hsieh, Regulatory Affairs Coordinator Summary Preparation Date: February 25 2015

### II. DEVICE

Trade name: LightMed TruScan 577 Laser System The common name of the device: Laser Instrument, surgical, powered & Laser, ophthalmic The classification name: 21 CFR 886.4390, Class II Product code: HQF Performance Standards: 21 CFR 1040.10 & 21 CFR 1040.11

### III. PREDICATE DEVICE

PASCAL Streamline 577 (with Accessories), K111108 This predicate has not been subject to a design-related recall .

### IV. DEVICE DESCRIPTION

LightMed TruScan 577 is an integrated system consisting of Laser Console utilizing a 577nm Optically Pumped Semiconductor (OPSL; solid state) laser cavity, TruScan integrated Slit Lamp technology controlled via a LCD touch panel and wheel chair accessible ophthalmic instrument table.

The TruScan module which is integrated Slitlamp with safety filter as Laser Delivery System, employs a traditional single spot treatment laser, as well as a semi-automated pattern generation method employing short 577mm laser pulse durations of typically 10ms; range of spot size from 50um to 400µm in a continuous adjustment.

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The LightMed TruScan 577 Laser System is intended for use by ophthalmologist for treatment of ocular pathology.

The LightMed TruScan 577 Laser System is comprised of the following functional components:

- LCD touch panel
- Laser Console ●
- Ophthalmic Instrument table
- TruScan integrated CSO Slitlamp (K992836)

## V. INDICATIONS FOR USE

The LightMed TruScan 577 Laser System is intended for use 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

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# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

TruScan 577 is compared with predicate as STANDARD type of Pascal Streamline 577 only.

| K number | K142172 | K111108 | Comparison of<br>Same or<br>Difference |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Company<br>name | LightMed Corporation | TOPCON Medical Laser<br>Systems | Similar |
| Device name | LightMed TruScan 577 | PASCAL Streamline 577 | |
| Indications<br>for Use | Proliferative and severe<br>and very severe<br>nonproliferative<br>diabetic retinopathy | The PASCAL® Streamline<br>577 (with Accessories) is<br>intended for use in the<br>treatment of ocular<br>pathology in the posterior<br>segment; Retinal<br>photocoagulation, panretinal<br>photocoagulation, focal<br>photocoagulation and grid<br>photocoagulation for<br>vascular and structural<br>abnormalities of the retina<br>and choroid including: | |
| | Macular edema | * proliferative and<br>nonproliferative diabetic<br>retinopathy | |
| | Clinically Significant<br>Choroidal<br>neovascularization | *macular edema | |
| | Branch and central<br>retinal vein occlusion | *choroidal<br>neovascularization | |
| | The treatment of<br>choroidal<br>neovascularization<br>associated with wet<br>age-related macular<br>degeneration | *branch and central retinal<br>vein occlusion | |
| | Lattice degenerationRetinal tears and<br>detachments | *the treatment of choroidal<br>neovascularization<br>associated with wet<br>age-related macular<br>degeneration<br>* lattice degeneration<br>*retinal tears and<br>detachments | |
| * retinopathy of prematurity<br>Intended for use in the<br>treatment of ocular<br>pathology in the anterior<br>segment including:<br>* iridotomy<br>* trabeculoplasty | | | |
| Treatment Laser | | | |
| Wavelength | 577nm | 577nm | Same |
| Laser Type | OPSL-Optically Pumped<br>Semiconductor Laser | OPSL-Optically Pumped<br>Semiconductor Laser | Same |
| Power Output | 50-2000mW | 30-2000mW | Difference |
| Pulse Duration | 10ms to 3s, continuous | 5-1000ms | Difference |
| Pulsing System | Continuous | Continuous | Same |
| Integrated Slitlamp<br>Multi Spot size | 50(single spot<br>only),100,200,300,400 μm<br>selectable on Zoom<br>assembly of Delivery unit | Slitlamp Microscope<br>(integrated)<br>60,100,200,300,400 μm<br>delivered to the focal plane<br>of the slitlamp in air | Difference |
| Laser Safety Class | Class IV | Class IV | Same |
| Cooling method | Fan cooled and TEC's for<br>Laser Diode and Crystal | TEC/ Air cooled | Same |
| Aiming Beam | | | |
| Wavelength | 635nm red laser diode | 635nm Direct Diode | Same |
| Power output | Maximum of 1.0mW | Adjustable to <1mW | Same |
| Laser Safety Class | Class II | Class II | Same |
| Other | | | |
| Interface | LCD Touch panel | LCD Touch panel | Same |
| General Electrical Input | 100-230 Vac | 100-240 Vac | Difference |
| Computer control | Yes | Yes | Same |
| Can user<br>change<br>computer<br>program | No | No | Same |

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The Indications for Use statement for the LightMed TruScan 577 device is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The performance data to account for the differences listed in the table are provided in Section VII of this summary below.

### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Bench Testing

Bench Testing were completed including the Finished Product final assembly quality Inspection, System Adjustment, Calibration and Testing for Laser console and TruScan laser delivery unit on TruScan 577 Laser System.

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the TruScan 577 device, consisting of the laser console and TruScan module integrated Slitlamp. The system complies with the IEC 60601-1, IEC 60601-2-22 and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.

### Software Verification and Validation Testing

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 was 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.

### VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the TruScan 577 Laser System should perform as intended in the specified use conditions. The clinical evaluation data demonstrate that the TruScan 577 Laser System performs comparably to the predicate device that is currently marketed for the same intended use.