(253 days)
Not Found
No
The description focuses on the laser technology and its operational modes (single-spot, multi-spot). There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, decision-making, or automation beyond standard laser control. The performance studies listed are standard for medical devices and do not indicate AI/ML validation.
Yes
The device is used for photocoagulation of tissues in the eye, which is a therapeutic treatment.
No
The device description indicates that the VISULAS green is an ophthalmic laser used for "photocoagulation of tissues" and "treatments of ocular tissue," which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists hardware components such as a laser console, touch control panel, laser light applicators, foot switch, and instrument table. While software verification and validation were performed, the device is clearly a hardware system with integrated software, not a software-only medical device.
Based on the provided information, the VISULAS green device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for photocoagulation of tissues in the eye. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser system used for treating ocular tissue. It involves delivering laser energy to the eye.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The VISULAS green does not perform this function.
The VISULAS green is a therapeutic medical device used for ophthalmic treatment.
N/A
Intended Use / Indications for Use
VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.
Product codes (comma separated list FDA assigned to the subject device)
HOF
Device Description
VISULAS green is an ophthalmic laser with a 532 nm wavelength used for standard photocoagulation treatments of ocular tissue. VISULAS green is operated in single-spot mode or in multi-spot mode.
VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as laser endoprobes, or the SL cam 5.0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior and anterior segments of the eye
Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Biocompatibility Testing
The materials and manufacturing of the subject device is identical to the predicate device and currently marketed devices. Therefore, no new biocompatibility testing is needed for this device.
Laser safety, electrical safety and electromagnetic compatibility (EMC)
VISULAS green was evaluated against the following requirements and was found to comply with:
- ANSI/AAMI ES60601-1:2005/(R) 2012
- IEC 60601-1-2:2014
- ANSI Z80.36:2016
- . IEC 60825-1:2007
- IEC 60601-2-22:2012
- IEC 62133: 2012
Software Verification and Validation Testing
The software of this device is considered as a "Major" level of concern. Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification and validation of VISULAS green demonstrated that the product works as designed.
Bench Testing
Not Applicable. Bench testing was not necessary to establish the substantial equivalence of this device.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this 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
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March 6, 2019
Carl Zeiss Meditec AG % Lisa Granev Senior Consultant Biologics Consulting Group, Inc. 1555 King Street. Suite 300 Alexandria, VA 22314
Re: K181682
Trade/Device Name: VISULAS green Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: January 31, 2019 Received: January 31, 2019
Dear Lisa Graney:
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): medical device reporting (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.html; 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 yours, Alexander Beylin -S 2019.03.06 10:50:35 -05'00' for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181682
Device Name VISULAS green
Indications for Use (Describe)
VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.
| 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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3
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for VISULAS green is provided below.
1. SUBMITTER
| Applicant: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena
Germany
Phone: +49 3641 2200 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Christian Münster
Director Regulatory and Clinical Affairs
Phone: +49 7364 20 6985
christian.muenster@zeiss.com |
| Submission Correspondent: | Lisa Graney
Senior Consultant
Biologics Consulting Group
1555 King Street, Suite 300
Alexandria, VA 22314
lgraney@biologicsconsulting.com)
Phone: (571) 777-9518
Fax: (703) 548-7457 |
| Date Prepared: | June 25 2018 |
2. DEVICE
| Device Trade Name: | VISULAS green |
|---|---|
| Device Common Name: | Laser, Ophthalmic |
| Classification Name | 21 CFR 886.4390, Ophthalmic Laser |
| Regulatory Class: | Class II |
| Product Code: | HQF |
3. PREDICATE DEVICE
Predicate Device:
VISULAS 532s Laser System with the VITE option (K100035)
4
DEVICE DESCRIPTION 4.
VISULAS green is an ophthalmic laser with a 532 nm wavelength used for standard photocoagulation treatments of ocular tissue. VISULAS green is operated in single-spot mode or in multi-spot mode.
VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as laser endoprobes, or the SL cam 5.0.
ડ. INTENDED USE/INDICATIONS FOR USE
VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye, including trabeculoplasty and iridotomy.
TECHNOLOGICAL COMPARISON 6.
A technological comparison between the subject and predicate devices is shown in Table 1. The cited predicate device is VISULAS 532s Laser System with the VITE option (herein after called VISULAS 532s), cleared under K100035.
5
| VISULAS green | VISULAS 532s | |
|---|---|---|
| K number | Subject Device | K100035 |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Indications for Use Statement | VISULAS green is intended for use in photocoagulating ocular | |
| tissues in the treatment of diseases of the eye, including | ||
| trabeculoplasty and iridotomy. | The VISULAS 532s Laser System with the VITE option is | |
| intended for use in retinal, pan-retinal, focal and grid | ||
| photocoagulation of ocular tissues in the treatment of diseases of | ||
| the eye including: | ||
| -Proliferative and non-proliferative diabetic retinopathy | ||
| -Macular edema | ||
| -Branch and central retinal vein occlusion | ||
| -Lattice degeneration | ||
| -Retinal tears and detachments | ||
| General Laser Specifications | ||
| Laser type | solid state laser, frequency-doubled | solid state laser, frequency-doubled |
| Wavelength | 532 nm | 532 nm |
| Power (cw laser) | 50 to 1500 mW | 50 to 1500 mW |
| Length of pulse | 10 - 2500 ms and cw | 10 - 2500 ms and -cw |
| Repeat Mode | Yes | Yes |
| Laser spot size settings | 50 μm to 1000 μm | 50 μm to 1000 μm |
| Aiming beam | 620-650 nm | 620-650 nm |
| Types of laser applicators | LSL, VISULINK 532/U, Endoprobes, LIO | LSL, VISULINK 532/U, Endoprobes, LIO |
| Multi spot treatment mode | Yes | Yes |
| Conditions of Use | ||
| Site in the body | Eye | Eye |
| Principle of operation | Photocoagulation of ocular tissue | Photocoagulation of ocular tissue |
Table 1. Technological characteristics comparison table of VISULAS green and VISULAS 532s
6
VISULAS green and the predicate device are intended as ophthalmic lasers for photocoagulation. The indications for use are within the same intended use as the predicate device and do not raise different questions of safety and effectiveness.
VISULAS green and the predicate laser system have minor parameter differences but share the same fundamental principle of operation:
Photocoagulation: Continuous wave operation in which thermal energy created by the absorption of the laser energy by ocular tissue causes coagulation.
VISULAS green is substantially equivalent to the predicate laser system presented in the 510(k) premarket notification with respect to indications for use and technological characteristics. Differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness.
7. PERFORMANCE DATA
Biocompatibility Testing
The materials and manufacturing of the subject device is identical to the predicate device and currently marketed devices. Therefore, no new biocompatibility testing is needed for this device.
Laser safety, electrical safety and electromagnetic compatibility (EMC)
VISULAS green was evaluated against the following requirements and was found to comply with:
- ANSI/AAMI ES60601-1:2005/(R) 2012 ●
- IEC 60601-1-2:2014 ●
- ANSI Z80.36:2016 ●
- . IEC 60825-1:2007
- IEC 60601-2-22:2012
- IEC 62133: 2012 ●
Software Verification and Validation Testing
The software of this device is considered as a "Major" level of concern. Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification and validation of VISULAS green demonstrated that the product works as designed.
Bench Testing
Not Applicable. Bench testing was not necessary to establish the substantial equivalence of this device.
7
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
CONCLUSION 8.
The VISULAS green is substantially equivalent to the predicate device, VISULAS 532s (K100035).
The VISULAS green is similar in technological characteristics, performance, principles of operation (photocoagulation) and has similar indications for use as the predicate device. Any differences between the proposed device and the predicate device do not raise any new issues of safety or effectiveness. Thus VISULAS green is substantially equivalent to the predicate device.