The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

Device Description

The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system was developed to utilize advancements in visible green semiconductor (diode) laser technology and to provide a compact design to be incorporated in a lightweight headset worn by the physician. The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system consists of an indirect ophthalmoscope headpiece, a headset laser enclosure/casing, a wireless user interface tablet, a footswitch with a battery, and a cable extending from the footswitch to the headset. The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system is controlled by the wireless user interface tablet that allows the physician to set the desired parameters for treatment. A shrouded footswitch is connected to the headset to control the emission of laser light and the battery to power the device illumination and laser source. The physician uses the headset to locate the area to be treated and after setting the appropriate parameters, targets the desired tissue utilizing a visible red aiming beam. The foot switch is pressed by the physician to deliver therapeutic green laser light to the targeted tissue. Eye safety filters are built into the laser unit to protect the physician's eyes while providing a clear view of the target area.

AI/ML Overview

The document provided is a 510(k) summary for the Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator. It focuses on demonstrating substantial equivalence to predicate devices through engineering and bench testing, rather than clinical studies involving human patients or complex algorithms requiring extensive training and test sets.

Therefore, many of the requested categories related to medical AI/ML device studies (such as sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and specific ground truth types like pathology or outcomes data) are not applicable to the information provided in this document.

Here's a summary of the information available based on the provided document:

Acceptance Criteria and Device Performance

The device underwent verification and validation testing against several international standards. The acceptance criteria were met if the device demonstrated compliance with these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 14971: Application of risk management to medical devices	All identified potential risks were analyzed, and mitigations were implemented, verified, and validated satisfactorily.
ISO 15004-2: Ophthalmic instruments - Fundamental requirements and test methods - Part 1: Light hazard protection	Included in bench testing specific to ophthalmic devices; results demonstrated predetermined acceptance criteria were met.
IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance	Bench testing for electrical and mechanical safety was successfully completed.
IEC 60601-1-2: Electromagnetic disturbances	Bench testing for electrical and mechanical safety was successfully completed.
IEC 60601-2-22: Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment	Bench testing for laser performance was successfully completed.
IEC 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements	Bench testing for laser performance was successfully completed.
IEC 62304: Medical device software - Software life-cycle processes	Software testing, including verification and validation, was conducted in compliance with this standard, covering test cases related to off-the-shelf software and cybersecurity features.
IEC 62366-1: Application of usability engineering to medical devices	Human factors testing was conducted to demonstrate usability in a simulated use environment when used by healthcare professionals.
ANSI Z136-1: American National Standard for Safe Use of Lasers	Included in bench testing for laser performance; results demonstrated predetermined acceptance criteria were met.
ANSI Z136-3: American National Standard for Safe Use of Lasers in Health Care	Included in bench testing for laser performance; results demonstrated predetermined acceptance criteria were met.
21 CFR Part 820.30: Design Control process	Verification and validation testing was completed in accordance with the company's Design Control process; results demonstrated that predetermined acceptance criteria were met.
Overall Safety and Efficacy (via Substantial Equivalence)	The device demonstrated substantial equivalence to predicate devices (Norlase LEAF Green Laser Photocoagulator K190083 and Iridex TruFocus LIO K170718) with no new issues of safety or efficacy identified.

Study Details:

Sample size used for the test set and the data provenance: Not applicable. The submission relies on engineering bench tests and simulated use environments, not a clinical test set with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for expert consensus is not relevant for this type of engineering and human factor testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device requiring MRMC studies for diagnostic or interpretive tasks.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical laser photocoagulator, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical gold standard. The "ground truth" here refers to the specifications and safety requirements defined by the various engineering and medical device standards (e.g., laser power output accuracy, electrical safety, software functionality, usability in a simulated environment).
The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Note: The 510(k) summary explicitly states that "Clinical data was not required for this type of device." This further confirms that the assessment of this device for substantial equivalence did not involve clinical studies with human participants that would generate the types of data requested in many of the prompts. The approval is based on engineering, safety, software, and human factors testing demonstrating compliance with established standards and equivalence to predicate devices.

Summary

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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2021

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

Re: K201623

Trade/Device Name: Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX

Dear Sheila Pickering:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter sent August 11, 2020. Specifically, FDA is updating this SE Letter because the original letter sent was missing the date of clearance. This is an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LT Charles Chiang, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6459, Charles.Chiang@fda.hhs.gov.

Sincerelv.

Charles Chiang -S

LT Charles Chiang 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

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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K201623

Trade/Device Name: Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: July 6, 2020 Received: July 13, 2020

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.

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

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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-devices/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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer N. Brown -S

for LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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) K201623

Device Name

Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator

Indications for Use (Describe)

The Norlase Laser Indirect Ophthalmoscope (LIO) 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)

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510(k) Summary K201623 Prepared June 12, 2020

Sponsor:	Norlase ApSBrydehusvej 302750 BallerupDenmark
Contact Person:	Jan Forstberg
Telephone:	+4593977472
Submission Date:	June 12, 2020
Device Name:	Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator
Common Name:	Photocoagulator
Trade Name:	Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator
Classification:
Regulatory Class:	II
Review Category:	Ophthalmology Photocoagulator21CFR 886.4390 (HQF)
Classification Panel:	Ophthalmology

A. Legally Marketed Predicate Devices

The primary predicate device is the Norlase LEAF Green Laser Photocoagulator (K190083). The reference predicate is the Iridex TruFocus LIO (K170718).

B. Device Description:

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utilizing a visible red aiming beam. The foot switch is pressed by the physician to deliver therapeutic green laser light to the targeted tissue. Eye safety filters are built into the laser unit to protect the physician's eyes while providing a clear view of the target area.

C. Intended Use / Indications for Use

The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

D. Substantial Equivalence

The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system is substantially equivalent to the original device. the Norlase Leaf Green Laser Photocoagulator cleared per K190083, as well as the Iridex TruFocus LIO (K170718) They are both laser photocoagulators for the purpose of Ophthalmology treatment. The indications for use and the core technology of the primary Norlase predicate have not changed. The core difference is the change of device configuration from a stationary slit lamp mounted device to a headset mounted LIO configuration. The reference predicate has a broader indication for use for multiple applications but has substantially equivalent technological characteristics.

Device Name	Primary PredicateNorlase LEAFPhotocoagulatorK190083	Reference PredicateIridex TruFocus LIOK170718	Subject DeviceNorlase LaserIndirectOphthalmoscope(LIO)Photocoagulator	SE
Indications forUse	Intended to be usedin ophthalmic laserproceduresincluding retinaland macularphotocoagulation,iridotomy, andtrabeculoplasty.	The Iridex TruFocus LIOPremiere Laser IndirectOphthalmoscope with theFamily of Iridex® IQ LaserSystems is intended for softand fibrous tissue, includingosseous tissue incision,excision, coagulation,vaporization, ablation andvessel hemostasis in themedical specialties of,dermatology, ear, nose andthroat (ENT)/otolaryngology, andophthalmology	Intended to beused in ophthalmiclaser proceduresincluding retinaland macularphotocoagulation,iridotomy, andtrabeculoplasty.	Yes
Manufacturer	Norlase	Iridex Corp.	Norlase	N/A
510(k) number	K190083	K170718	TBD	N/A
Regulationmedicalspecialty	Ophthalmic	General and Plastic Surgery	Ophthalmic	YES
Review panel	Ophthalmic	Ophthalmic	Ophthalmic	YES
Product code	HOF	GEX	HOF	YES

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Regulation number	886.4390	878.4810	886.4390	YES
Regulation description	Ophthalmic photocoagulator	Ophthalmic photocoagulator	Ophthalmic photocoagulator	YES
Classification	II	II	II	YES
Treatment beam
Laser type	Laser diode	Laser diode	Laser diode	YES
Wavelength	520 nm	532mm	520 nm	YES
Laser mode	Continuous wave	Continuous wave	Continuous wave	YES

Based on the comparison of indications for use and technological characteristics, the subject device is substantially equivalent to the primary predicate device as well as the reference predicate. Based on the performance data provided in the submission the differences do not introduce new issues related to safety and efficacy.

E. Performance Data

Every specification of the Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system has been verified and validated as required by the risk analysis. All design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.

ISO 14971	Application of risk management to medical devices
ISO 15004-2	Ophthalmic instruments - Fundamental requirements and test methods -Part 1: Light hazard protection
IEC 60601-1	Medical electrical equipment- General requirements for basic safety andessential performance
IEC 60601-1-2	Electromagnetic disturbances
IEC 60601-2-22	Medical electrical equipment - Part 2: Particular requirements for thesafety of diagnostic and therapeutic laser equipment
IEC 60825-1	Safety of laser products - Part 1: Equipment classification, andrequirements [Including: Technical Corrigendum 1 (2008),Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
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 Health Care

The verification and validation testing included testing to the following applicable standards:

Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Norlase certifies that all verification and validation activities provided in this submission were performed by designated individuals and

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results demonstrate that predetermined acceptance criteria were met. 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 standards cited above
Bench testing for laser performance in compliance with the laser standards cited above 2.
Bench testing specific to ophthalmic devices in compliance with the standard cited above 3.
1. 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
1. 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 and ISO 62366 Standards. 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 predicates, these were shown not to result in any new issues of safety or efficacy according to the performance data submitted.

Therefore, the Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is substantially equivalent to the predicate devices 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.

Regulation Number and Section

§ 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.