Leaf Photocoagulator

K190083 · Norlase Aps · HQF · May 3, 2019 · Ophthalmic

Device Facts

• Record ID: K190083
• Device Name: Leaf Photocoagulator
• Applicant: Norlase Aps
• Product Code: HQF · Ophthalmic
• Decision Date: May 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

Device Story

Leaf Photocoagulator is an ophthalmic laser system comprising a laser unit, wireless control unit (tablet), and shrouded foot switch. The laser unit attaches to a user-supplied slit lamp. The physician identifies target tissue via the slit lamp and uses a visible red aiming laser (635 nm) for guidance. Therapeutic green laser light (520 nm) is delivered in continuous wave mode, with electronic pulsing for durations from 50 usec to 1 second. The tablet interface allows parameter selection; an optional voice control feature assists in parameter adjustment. A mechanically fixed eye safety filter protects the physician from reflected laser light. The device is used in clinical settings by ophthalmologists to perform photocoagulation, iridotomy, and trabeculoplasty, providing therapeutic benefit through precise tissue coagulation.

Clinical Evidence

No clinical data was required. Evidence consists of bench testing for electrical/mechanical safety, laser performance, and ophthalmic device standards (ISO 15004-2). Software verification and validation were performed per IEC 62304, including cybersecurity. Human factors testing was conducted in a simulated use environment to demonstrate usability by healthcare professionals.

Technological Characteristics

Laser diode source (520 nm treatment, 635 nm aiming); continuous wave mode; 1.5W max output. Air-cooled. Dimensions: 253x153x43 mm; weight ~1.5 kg. Wireless connectivity between laser unit and tablet control unit. Power: 100-240 Vac. Standards: ISO 14971, ISO 15004-2, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366-1, ANSI Z136-1, ANSI Z136-3.

Indications for Use

Indicated for ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty in patients requiring such interventions.

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

• NIDEK Green Laser Photocoagulator GYC-500 (K152603)

Submission Summary (Full Text)

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Mav 3, 2019

Norlase ApS % Sheila Pickering Consultant Sheila Pickering Consulting Group 2081 Longden Circle Los Altos, CA 94024

Re: K190083

Trade/Device Name: Leaf Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: January 16, 2019 Received: February 04, 2019

Dear Sheila Pickering:

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 and Part 809 ): medical device 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.htm); 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 ([e-mail]) or phone [phone] 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

| Form | Appr |
|----------|------------|
| 09100120 | Exp |
| 31, 2017 | See below. |

| 510(k) Number (if known) | K190083 |
|--------------------------|---------|
|--------------------------|---------|

| Device Name | Norlase Leaf Photocoagulator |
|-------------|------------------------------|
|-------------|------------------------------|

Indications for Use (Describe)

The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="text-decoration: overline;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 510(k) Summary Prepared January 16, 2019

| Sponsor: | Norlase ApS<br>Brydehusvej 30<br>2750 Ballerup<br>Denmark |
|-----------------------|-----------------------------------------------------------|
| Contact Person: | Jan Forstberg |
| Telephone: | [phone] |
| Submission Date: | January 16, 2019 |
| Device Name: | Leaf Photocoagulator |
| Common Name: | Photocoagulator |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Ophthalomology Photocoagulator<br>21CFR 886.4390 (HQF) |
| Classification Panel: | Ophthalmology |

#### A. Legally Marketed Predicate Devices

The predicate device is the NIDEK Green Laser Photocoagulator GYC-500 ("NIDEK"). (K152603)

#### B. Device Description:

The Norlase Leaf device consists of a laser unit, a wireless control unit and a foot switch. The laser unit must be attached to the Doctors own compatible slit lamp to work as a full system. The Norlase Leaf Device is controlled by the wireless control unit that allows the Doctor to set the desired parameters for treatment. A shrouded foot switch is connected to the laser unit to control the emission of laser light.

The Doctor will use the user supplied slit lamp to identify the area to be treated and after setting the appropriate parameters, will target the ophthalmic tissue utilizing a visible red aiming laser. The foot switch will be pressed by the Doctor to deliver therapeutic green laser light to the target tissue. A mechanically fixed eye safety filter is built into the Laser Unit to protect the Doctor from any stray or reflected green laser light travelling along the visual path of the slit lamp.

The Norlase Leaf device consists of the following modules:

- -Laser unit + power supply + power cable
- Foot switch + cable -
- Control unit (Tablet computer with installed Software) + power supply + USB cable -

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The wavelength of the treatment beam is centered around ~520 nm, and the maximum optical output power is 1.5W (to tissue). The laser is operated in continuous wave (CW) mode and electronically pulsing the laser output power to achieve durations from 50 usec to 1 second. Laser parameters are controlled by a Control Unit (tablet) User Interface that utilizes a touchscreen control to select or change a setting. Voice Control of selected parameters is an optional feature that can assist in the increment or selection of a parameter,

## C. Intended Use

The Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

| Device Name | Norlase LEAF green laser<br>photocoagulator | Green Laser Photocoagulator<br>GYC-500 | Substantially<br>Equivalent |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer | Norlase | Nidek | N/A |
| 510(k) number | - | K152603 | N/A |
| 510(k) clearance date | - | 05/02/2016 | N/A |
| Review panel | Ophthalmic | Ophthalmic | YES |
| Product code | HQF | HQF | YES |
| Regulation number | 886.4390 | 886.4390 | YES |
| Regulation description | Ophthalmic laser | Ophthalmic laser | YES |
| Classification | II | II | YES |
| Indication for use and<br>Intended use | The Norlase Leaf Photocoagulator<br>is intended to be used in<br>ophthalmic laser procedures<br>including retinal and macular<br>photocoagulation, iridotomy and<br>trabeculoplasty. | The NIDEK Green Laser<br>Photocoagulator GYC-500 is<br>intended to be used in ophthalmic<br>surgical procedures including retinal<br>and macular photocoagulation,<br>iridotomy and trabeculoplasty. | YES |
| User interface | Manual and voice control | Manual | YES |
| Connectivity | Wireless | Hard wired | YES |
| Laser type | Laser diode | Diode-Pumped Solid-State laser | YES |
| Wavelength | 520 nm | 532 nm | YES |
| Laser mode | Continuous wave | Continuous wave | YES |
| Power output | 50 to 1500 mW | 50 to 1700 mW | YES |
| Exposure time<br>(Duration time) | 0.05 ms to 1 s | 0.01 s to 3 s | YES |
| Interval time | 50 ms to 3 s | 50 ms to 1 s | YES |
| Cooling method | Air cooled | Air cooled | YES |
| Aiming beam: | | | |
| Type | Laser diode | Laser diode | YES |
| Wavelength | 635 nm | 635 nm | YES |
| Laser mode | Continuous wave | Continuous wave | YES |
| Power output | <1 mW (adjustable) | <0.4 mW (adjustable) | YES |
| Voltage | 100 to 240 Vac 50/60 Hz | 100 to 240 Vac 50/60 Hz | YES |
| Power consumption | 120 VA | 250 VA | YES |
| Dimension | 253 (H) x 153 (W) x 43 (D) mm | 237 (W) x 318 (D) x 90 (H) mm | YES |
| Weight | ~1.5 kg (excluding control unit,<br>foot switch and power supply) | 6.2 kg (excluding the control box) | YES |

# D. Substantial Equivalence

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In summary based on the comparison of indications for use and technological characteristics of the subject device is substantially equivalent to the predicate. Based on the performance data provided in the submission these differences do not introduce new issues related to safety and efficacy.

## E. Performance Data

Every specification of the Leaf Photocoagulator device has been verified and validated according to the company's documented development and test procedures. The verification and validation testing included testing to the following applicable standards:

| ISO 14971 | Application of risk management to medical devices |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 15004-2 | Ophthalmic instruments - Fundamental requirements and<br>test methods - Part 1: Light hazard protection |
| IEC 60601-1+ | Medical electrical equipment- General requirements for<br>basic safety and essential performance |
| IEC 60601-1-2 | Electromagnetic disturbances |
| IEC 60601-2-22 | Medical electrical equipment - Part 2: Particular<br>requirements for the safety of diagnostic and therapeutic<br>laser equipment |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification,<br>and requirements [Including: Technical Corrigendum 1<br>(2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2<br>(2007)]11 |
| IEC 62304+ | Medical device software - Software life-cycle processes |
| IEC 62366-1 | Application of usability engineering to medical devices |
| ANSI Z136-1 | American National Standard for Safe Use of Lasers |
| ANSI Z136-3 | American National Standard for Safe Use of Lasers in<br>Health Care |

Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:

- 1. Bench testing for electrical and mechanical safety in compliance with the laser standards cited above
- 2. Bench testing for laser performance in compliance with the laser standards cited above
- 3. Bench testing specific to ophthalmic devices in compliance with the standard cited above

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- 4. Software testing, consisted of verification and validation testing in compliance with ISO 62304, including test cases related to off the shelf software as well as cybersecurity features
- 5. Human factors testing to demonstrate usability in a simulated use environment when used by health care professionals

Clinical data was not required for this type of device.

# F. Conclusion

Potential risks were identified according to the ISO 14971 Standard. The risks were analyzed with regard to risk/benefit category and mitigations were implemented and tested as part of the performance testing described above. All risk mitigations were satisfactorily verified and validated. Where there were technological differences from the predicate, these were shown not to result in any new issues of safety or efficacy according to the performance data submitted.

Therefore, the Leaf Photocoagulator is substantially equivalent to the predicate device with regards to intended use and technological characteristics. Results of performance testing demonstrated that the device met the design requirements and as well as the user needs