(57 days)
No
The description focuses on the hardware components, laser technology, and user interface for manual control of laser parameters. There is no mention of AI or ML for image analysis, treatment planning, or automated control.
Yes
The device is described as being used for ophthalmic laser procedures, including "retinal and macular photocoagulation, iridotomy, and trabeculoplasty," which are all therapeutic interventions targeting specific medical conditions.
No
The device is described as a "Photocoagulator" and its intended use is for "ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty," which are all treatment procedures, not diagnostic ones. The device description also states it delivers "therapeutic green laser light."
No
The device description explicitly lists multiple hardware components including a headset, tablet, footswitch, and cables, and describes the physical delivery of laser light.
Based on the provided information, the Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ophthalmic laser procedures performed on the patient (in vivo), not for testing samples from the patient (in vitro).
- Device Description: The device is a laser photocoagulator used to deliver therapeutic laser light directly to tissue within the eye. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing biological specimens (like blood, urine, tissue samples, etc.).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is a therapeutic device used directly on the patient.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retinal, macular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, health care professionals
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)
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.
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 test methods - Part 1: Light hazard protection
- IEC 60601-1 Medical electrical equipment- General requirements for basic safety and essential performance
- IEC 60601-1-2 Electromagnetic disturbances
- IEC 60601-2-22 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
- IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirements [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
Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:
- 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
- Bench testing specific to ophthalmic devices in compliance with the standard cited above
- 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
- 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.
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.
0
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
1
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
2
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
3
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 ApS
Brydehusvej 30
2750 Ballerup
Denmark |
|-----------------------|-------------------------------------------------------------|
| 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 Photocoagulator
21CFR 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:
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
5
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 Predicate
Norlase LEAF
Photocoagulator
K190083 | Reference Predicate
Iridex TruFocus LIO
K170718 | Subject Device
Norlase Laser
Indirect
Ophthalmoscope
(LIO)
Photocoagulator | SE |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indications for
Use | Intended to be used
in ophthalmic laser
procedures
including retinal
and macular
photocoagulation,
iridotomy, and
trabeculoplasty. | The Iridex TruFocus LIO
Premiere Laser Indirect
Ophthalmoscope with the
Family of Iridex® IQ Laser
Systems is intended for soft
and fibrous tissue, including
osseous tissue incision,
excision, coagulation,
vaporization, ablation and
vessel hemostasis in the
medical specialties of,
dermatology, ear, nose and
throat (ENT)/
otolaryngology, and
ophthalmology | Intended to be
used in ophthalmic
laser procedures
including retinal
and macular
photocoagulation,
iridotomy, and
trabeculoplasty. | Yes |
| Manufacturer | Norlase | Iridex Corp. | Norlase | N/A |
| 510(k) number | K190083 | K170718 | TBD | N/A |
| Regulation
medical
specialty | Ophthalmic | General and Plastic Surgery | Ophthalmic | YES |
| Review panel | Ophthalmic | Ophthalmic | Ophthalmic | YES |
| Product code | HOF | GEX | HOF | YES |
6
| 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 and |
| essential performance | |
| IEC 60601-1-2 | Electromagnetic disturbances |
| IEC 60601-2-22 | Medical electrical equipment - Part 2: Particular requirements for the |
| safety of diagnostic and therapeutic laser equipment | |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification, and |
| requirements [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
7
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:
-
- 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.
-
- 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
-
- 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.