(83 days)
No
The summary describes a laser photocoagulator with pattern scanning and voice control, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty, which are medical treatments.
No
Explanation: The device is described as a photocoagulator intended for ophthalmic laser procedures (e.g., retinal and macular photocoagulation, iridotomy, trabeculoplasty), which are therapeutic, not diagnostic. It delivers therapeutic laser light to target tissue based on a doctor's identification of the area.
No
The device description explicitly states it consists of a laser unit, wireless control unit, and foot switch, in addition to the software on the tablet. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Norlase ECHO Photocoagulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for ophthalmic laser procedures performed on the patient (retinal and macular photocoagulation, iridotomy, and trabeculoplasty). IVD devices are used to examine specimens from the body (like blood, urine, tissue samples) to diagnose or monitor conditions.
- Device Description: The description details a laser system used to deliver therapeutic light to ophthalmic tissue. This is a treatment device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Norlase ECHO Photocoagulator is a therapeutic medical device used for ophthalmic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Product codes
HOF
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ophthalmic tissue (related to retinal and macular photocoagulation, iridotomy, and trabeculoplasty)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Doctor / Not Found
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 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 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 electrical safety and 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
-
- Bench testing for verification and validation of the specified performance of the pattern scanning feature for the subject device.
-
- 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.
-
- Human factors evaluation 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary - K222157 Prepared September 16, 2022
| Sponsor: | Norlase ApS
Brydehusvej 13
2750 Ballerup
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
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 ।
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. 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
Norlase LEAF green
laser photocoagulator
K190083 | Subject Device
Norlase ECHO green
laser photocoagulator | Substantial
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
specialty | Ophthalmic | Ophthalmic | Identical |
| Review panel | Ophthalmic | Ophthalmic | Identical |
| Product code | HQF | HQF | Identical |
| Regulation number | 886.4390 | 886.4390 | Identical |
| Regulation description | Ophthalmic
photocoagulator | Ophthalmic
photocoagulator | Identical |
| Classification | 2 | 2 | Identical |
| Indication for use and
Intended use | The Norlase LEAF
Photocoagulator is intended
to be used in ophthalmic
surgical procedures
including retinal and
macular photocoagulation,
iridotomy and
trabeculoplasty | The Norlase ECHO
Photocoagulator is intended
to be used in ophthalmic
surgical procedures
including retinal and
macular photocoagulation,
iridotomy and
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
5
| 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 |
| Other specifications: | |||
| Attachable slit lamp delivery unit | For HAAG 900BM/900BQ and similar | ||
| Zeiss 30SL, SL130 and similar | For HAAG 900BM/900BQ and similar | ||
| 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 |
| 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 |
6
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 electrical safety and 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
-
- Bench testing for verification and validation of the specified performance of the pattern scanning feature for the subject device.
-
- 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.
-
- 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