(106 days)
Not Found
No
The description focuses on the laser technology, control unit, and standard safety features. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Voice Control" feature is mentioned as optional and likely a standard voice recognition technology, not necessarily AI/ML for medical decision support or image analysis.
Yes
The device is described as a photocoagulator intended for ophthalmic laser procedures to treat tissues, indicating a direct therapeutic action rather than diagnostic or supportive.
No
Explanation: The device is described as a "Photocoagulator" intended for "ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty," which are therapeutic treatments, not diagnostic procedures. The description also mentions "delivering therapeutic green laser light to the target tissue."
No
The device description explicitly states it consists of a laser unit, wireless control unit, and foot switch, which are hardware components. While it includes software on a tablet, it is not solely software.
Based on the provided information, the Norlase Leaf Photocoagulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for ophthalmic laser procedures performed directly on the patient's eye (in vivo). IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body (in vitro) to provide information about a person's health.
- Device Description: The device is a laser system used to treat tissue directly. It does not involve the analysis of biological samples.
- Anatomical Site: The device is used on ophthalmic tissue, which is part of the living body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with IVD testing.
The Norlase Leaf Photocoagulator is a therapeutic medical device used for surgical procedures on the eye.
N/A
Intended Use / Indications for Use
The Norlase Leaf 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
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retinal, macular, iris, trabecular meshwork (inferred from iridotomy, trabeculoplasty)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Doctor, healthcare 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 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 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)]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 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:
-
- Bench testing for electrical and mechanical safety in compliance with the laser 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.
Not Found
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary Prepared January 16, 2019
| Sponsor: | Norlase ApS
Brydehusvej 30
2750 Ballerup
Denmark |
|-----------------------|-----------------------------------------------------------|
| Contact Person: | Jan Forstberg |
| Telephone: | +4593977472 |
| Submission Date: | January 16, 2019 |
| Device Name: | Leaf Photocoagulator |
| Common Name: | Photocoagulator |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Ophthalomology Photocoagulator
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 -
4
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
photocoagulator | Green Laser Photocoagulator
GYC-500 | Substantially
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
Intended use | The Norlase Leaf Photocoagulator
is intended to be used in
ophthalmic laser procedures
including retinal and macular
photocoagulation, iridotomy and
trabeculoplasty. | The NIDEK Green Laser
Photocoagulator GYC-500 is
intended to be used in ophthalmic
surgical procedures including retinal
and macular photocoagulation,
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
(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 |