ECHO Photocoagulator

K222157 · Norlase · HQF · Oct 11, 2022 · Ophthalmic

Device Facts

• Record ID: K222157
• Device Name: ECHO Photocoagulator
• Applicant: Norlase
• Product Code: HQF · Ophthalmic
• Decision Date: Oct 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ECHO Photocoagulator is an ophthalmic laser system consisting of a laser unit, wireless control unit (tablet), and foot switch. It attaches to a clinician-supplied slit lamp. The clinician identifies treatment areas via the slit lamp and targets tissue using a visible red aiming laser. The system delivers therapeutic green laser light (~520 nm) in continuous wave mode, with electronically pulsed durations (50 µsec to 1 second). The ECHO modification adds pattern scanning capabilities. The clinician controls parameters via a touchscreen interface or optional voice control. A mechanically fixed eye safety filter protects the clinician from stray/reflected light. Used in clinical settings by ophthalmologists to perform photocoagulation, iridotomy, and trabeculoplasty; the device benefits patients by enabling precise, controlled laser delivery for retinal and macular conditions.

Clinical Evidence

No clinical data was required for this device. Substantial equivalence is supported by bench testing, including electrical/mechanical safety (IEC 60601-1, IEC 60601-2-22), laser performance (IEC 60825-1, ANSI Z136), software verification/validation (IEC 62304), and human factors evaluation in a simulated use environment.

Technological Characteristics

Laser diode source, 520 nm wavelength, 1.5W max output, continuous wave mode. Air-cooled. Wireless connectivity between laser unit and tablet control unit. Includes pattern scanning feature. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366-1, ANSI Z136-1, and ANSI Z136-3.

Indications for Use

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

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

• Norlase Leaf Photocoagulator (K190083)

Reference Devices

• Topcon PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System (K170409)

Submission Summary (Full Text)

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October 11, 2022

Norlase Jan Forstberg Vice President of Regulatory Affairs and Quality Assurance Brydehusvej 13 Ballerup, Hovedstaden DK-2750 Denmark

Re: K222157

Trade/Device Name: ECHO Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: July 15, 2022 Received: July 20, 2022

Dear Jan Forstberg:

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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices 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) K222157

Device Name ECHO Photocoagulator

#### Indications for Use (Describe)

The Norlase ECHO 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):

| Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary - K222157 Prepared September 16, 2022

| Sponsor: | Norlase ApS<br>Brydehusvej 13<br>2750 Ballerup<br>Denmark |
|-----------------------|-----------------------------------------------------------|
| Contact Person: | Jan Forstberg |
| Telephone: | + 45-40-109302 |
| Submission Date: | September 16, 2022 |
| Device Name: | ECHO Photocoagulator |
| Common Name: | Photocoagulator |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Ophthalmology Photocoagulator<br>21CFR 886.4390 (HQF) |
| Classification Panel: | Ophthalmology |

### A. Legally Marketed Predicate Devices

The predicate device is the Norlase Leaf Photocoagulator (K190083) also classified according to 21CFR 886.4390 (HQF).

### B. Device Description:

The Norlase ECHO device is a modification to the Norlase Leaf Photocoagulator (K190083) and also 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 ECHO 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 eve 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 Echo 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. The ECHO modification consists of capability for pattern scanning.

### C. Intended Use

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

| Device Name | Primary Predicate Device<br>Norlase LEAF green<br>laser photocoagulator<br>K190083 | Subject Device<br>Norlase ECHO green<br>laser photocoagulator | Substantial<br>Equivalence |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Manufacturer | Norlase | Norlase | Identical |
| 510(k) number | K190083 | K222157 | N/A |
| 510(k) decision date | 05/03/2019 | N/A | N/A |
| Regulation medical<br>specialty | Ophthalmic | Ophthalmic | Identical |
| Review panel | Ophthalmic | Ophthalmic | Identical |
| Product code | HQF | HQF | Identical |
| Regulation number | 886.4390 | 886.4390 | Identical |
| Regulation description | Ophthalmic<br>photocoagulator | Ophthalmic<br>photocoagulator | Identical |
| Classification | 2 | 2 | Identical |
| Indication for use and<br>Intended use | The Norlase LEAF<br>Photocoagulator is intended<br>to be used in ophthalmic<br>surgical procedures<br>including retinal and<br>macular photocoagulation,<br>iridotomy and<br>trabeculoplasty | The Norlase ECHO<br>Photocoagulator is intended<br>to be used in ophthalmic<br>surgical procedures<br>including retinal and<br>macular photocoagulation,<br>iridotomy and<br>trabeculoplasty. | Identical |
| User interface | Manual and voice control | Manual and voice control | Identical |
| Connectivity | Wireless | Wireless | Identical |
| Treatment Beam | | | |
| Laser type | Laser diode | Laser diode | Identical |
| Wavelength | 520 nm | 520 nm | Identical |
| Laser mode | Continuous wave (CW) | Continuous wave (CW) | Identical |
| Power output | 50 to 1500 mW | 50 - 1500 mW | Identical |
| Exposure time | 0.05 ms to 1 s. | 0.05 ms to 1 s. | Identical |
| Interval time | 50msec-3sec | 50msec-3sec | Identical |
| Cooling method | Air cooled | Air cooled | Identical |
| Single spot | Yes | Yes | Identical |
| Pattern scanning | No | Yes | Similar |

### D. Substantial Equivalence

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| Pulse counter | 0 - 9,999 | 0 - 9,999 | Identical |
|------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-----------|
| Laser beam diameter at focus | 50, 100, 200, 300, and 500 μm | 50, 100, 200, 300, and 500 μm | Identical |
| <b>Other specifications:</b> | | | |
| Attachable slit lamp delivery unit | For HAAG 900BM/900BQ and similar<br>Zeiss 30SL, SL130 and similar | For HAAG 900BM/900BQ and similar<br>Zeiss 30SL, SL130 and similar | Identical |
| Spot size | 50 to 500 μm | 50 to 500 μm | Identical |
| Voltage | 100 to 240 Vac 50/60 Hz | 100 to 240 Vac 50/60 Hz | Identical |
| Power consumption | 120 VA | 120 VA | Identical |
| Dimension | 253 (H) x 153 (W) x 43 (D) mm | 253 (H) x 153 (W) x 43 (D) mm | Identical |
| Weight | 4 kg | 4 kg | Identical |

In summary, based on the comparison of indications for use and technological characteristics of the subject device is substantially equivalent to the predicate device. 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 ECHO 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 |

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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 electrical safety and 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
- 4. Bench testing for verification and validation of the specified performance of the pattern scanning feature for the subject device.
- 5. 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 and the software used to implement the patten scanning feature for the subject device.
- 6. Human factors evaluation to demonstrate usability in a simulated use environment when used by health care professionals

To address the added capability for pattern scanning, an additional comparison was provided to a reference device. the Topcon PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System (K170409).

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 ECHO 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