(106 days)
VISULAS green is intended for use in photocoagulating ocular tissues of the treatment of diseases of the eve, including
- · Photocoagulation of the retina
- Trabeculoplasty
- · Iridotomy
VISULAS green is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength. 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 SL Imaging Solution, contact lenses or Applanation Tonometer.
The provided FDA 510(k) summary for the VISULAS green device (K232051) focuses on establishing substantial equivalence to a predicate device (VISULAS green, K181682) rather than presenting a study demonstrating the device meets a specific set of clinical performance acceptance criteria. Therefore, much of the requested information regarding a comparative effectiveness study, standalone performance, ground truth, and expert involvement is not present in this document.
However, I can extract information about the types of testing performed and the general conclusion of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria for clinical performance that the device was tested against. Instead, it states that the device underwent various forms of testing to demonstrate equivalence and compliance with standards.
| Type of Testing/Evaluation | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Align with current recognized standards; meet or exceed testing performed on the predicate device. | Biocompatibility testing demonstrated equivalency between the subject device and the predicate device. |
| Laser Safety | Compliance with ANSI/AAMI ES60601-1, ANSI Z80.36, IEC 60825-1, IEC 60601-2-22. | VISULAS green was found to comply with ANSI/AAMI ES60601-1:2005/(R) 2012, ANSI Z80.36-2016, IEC 60825-1:2007, IEC 60601-2-22:2012. |
| Electrical Safety | Compliance with ANSI/AAMI ES60601-1. | VISULAS green was found to comply with ANSI/AAMI ES60601-1:2005/(R) 2012. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | VISULAS green was found to comply with IEC 60601-1-2:2014. |
| Battery Safety | Compliance with IEC 62133. | VISULAS green was found to comply with IEC 62133: 2012 (likely related to any rechargeable components). |
| Software Verification & Validation | Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"; works as designed. | Software verification and validation testing was conducted, and documentation was provided. Verification and validation of VISULAS green demonstrated that the product works as designed. |
| Bench Testing (Functional & System-level) | Meet defined system specifications. | Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the subject device and the predicate device. |
| Overall (Substantial Equivalence) | Similar in technological characteristics, performance, principles of operation, and identical indications for use as the predicate device; no new issues of safety or effectiveness. | The VISULAS green is substantially equivalent to the predicate device, VISULAS green (K181682). Differences do not raise any new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes engineering and software verification and validation, as well as biocompatibility testing, but does not detail a clinical test set for evaluating device performance against diseases of the eye. The focus is on demonstrating equivalence to a predicate device through technical specifications and non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical test set is described, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set is described.
5. 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. The device (VISULAS green) is an ophthalmic laser for photocoagulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The VISULAS green is a medical device (laser system), not a standalone algorithm. Its performance is inherent to its physical operation and interaction with ocular tissues, guided by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical testing detailed (biocompatibility, safety, software, bench testing), the "ground truth" would be the established engineering specifications, recognized industry standards, and the performance characteristics of the predicate device. No clinical "ground truth" (e.g., pathology, outcomes) is described as being directly used to measure the subject device's efficacy in treating specific diseases in a clinical study.
8. The sample size for the training set
Not applicable. This device is a laser system, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. This device is a laser system, not an AI/ML algorithm.
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October 24, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Carl Zeiss Meditec Tanesha Bland Sr. Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94568
Re: K232051
Trade/Device Name: VISULAS green Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 26, 2023 Received: August 28, 2023
Dear Tanesha Bland:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Elvin Y. Ng -S
Elvin Ng 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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Enclosure
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Indications for Use
510(k) Number (if known) K232051
Device Name VISULAS green
Indications for Use (Describe)
VISULAS green is intended for use in photocoagulating ocular tissues of the treatment of diseases of the eve, including
- · Photocoagulation of the retina
- Trabeculoplasty
- · Iridotomy
This device is Prescription Use (Rx) only.
| 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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Image /page/4/Picture/0 description: The image shows the logo for ZEISS. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The blue background is in the shape of a rectangle with a curved bottom edge.
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, Inc.5300 Central ParkwayDublin, CAUSA |
|---|---|
| Primary Correspondent: | Tanesha BlandSr. Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 216-7963 Phone (925) 557-4259 FaxE-mail: tanesha.bland@zeiss.com (preferred) |
| Development Center Contact: | Dr. Ling RenRegulatory Affairs ManagerCarl Zeiss Meditec AGGoeschwitzer Strasse 51-52 Jena, Germany 07745E-mail: ling.ren@zeiss.com (preferred) |
Date Prepared: October 12, 2023
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2. SUBJECT DEVICE
| Device Trade Name: | VISULAS green |
|---|---|
| 510(k) Number: | K232051 |
| Classification: | 21CFR886.4390 Optic Ophthalmic laser |
| Regulatory Class: | II |
| Product Code: | HQF |
| Common Name: | Laser, Ophthalmic |
3. PREDICATE DEVICE
| Predicate Device: | VISULAS green |
|---|---|
| 510(k) Number: | K181682 |
| Classification: | 21CFR886.4390 Optic Ophthalmic laser |
| Regulatory Class: | II |
| Product Code: | HQF |
DEVICE DESCRIPTION 4.
VISULAS green is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength. 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 SL Imaging Solution, contact lenses or Applanation Tonometer.
ട. INDICATIONS FOR USE
VISULAS green is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye, including
- Photocoagulation of the retina
- Trabeculoplasty
- Iridotomy
This device is Prescription Use (Rx) only.
SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE 6.
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Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| VISULAS green | VISULAS green | |
|---|---|---|
| K number | K232051 | K181682 |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Indications for Use Statement | VISULAS green is intended for usein photocoagulating ocular tissuesin the treatment of diseases of theeye, including• Photocoagulation of the retina• Trabeculoplasty• Iridotomy | The VISULAS green is intended foruse in photocoagulating oculartissues in the treatment of diseases ofthe eye, including-Photocoagulation of the retina-Trabeculoplasty for treatment ofglaucoma-Iridotomy for treatment ofglaucoma |
| General laserSpecifications | ||
| 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, laser endoprobes, LIO | LSL, VISULINK 532/U, laserendoprobes, LIO |
| Multi-spot treatment mode | yes | yes |
| Increments of power | 50-200 mW (10 mW steps), 200-500 mW (20 mW steps), 500-1500 mW(50 mW steps) | 50-100 mW (10 mW steps), 100-1500 mW (50 mW steps) |
| Laser spot size settings | Continuously adjustable from 50 µm to1000 µm | 50 µm,100 µm, 200 µm, 300 µm,500 µm, 1000 µm |
| Conditions of Use | ||
| Site in the body | eye | eye |
| Principle of operation | Photocoagulation of ocular tissue | Photocoagulation of ocular tissue |
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Image /page/7/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The blue background is in the shape of a rectangle with a curved bottom edge.
Table 2. Subject to Predicate Device Comparison Table - Laser Slit Lamps
The Laser Slit Lamps (LSL) are optional components of the subject device VISULAS green (K232051) and the predicate device VISULAS green (K181682).
| LSL green classic,LSL green comfort | LSL green classic,LSL green comfort | |
|---|---|---|
| K number | Component of subject deviceVISULAS green (K232051) | Component of predicate deviceVISULAS green (K181682) |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Design | ||
| Slit lamp type | ZEISS type | ZEISS type |
| Tube system | Parallel or convergent | Parallel or convergent |
| Power supply | Via laser console | Via laser console |
| Specifications | ||
| Slit width | 0 mm to 14 mm (continuously) | LSL green classic:0.2 mm / 0.6 mm / 1.6 mm / 4.4 mm /15.0 mmLSL green comfort:0 mm to 14 mm (continuously) |
| Slit length | 1/3/5/9/14 mm | LSL green classic:1/3/5/7/10/12/14/15 mmLSL green comfort:1/3/5/9/14 mm |
| Slit image rotation | 0°, ±45°, 90° | 0°, ±45°, 90° |
| Magnification | LSL green classic:3 magnifications in steps of 8x, 12x, 20xLSL green comfort:5 magnifications, in steps of 5x, 8x, 12x, 20x, 32x | LSL green classic:3 magnifications in steps of 8x, 12x, 20xLSL green comfort:5 magnifications, in steps of 5x, 8x, 12x, 20x, 32x |
| Light source | LED illumination, continuouslyadjustable brightness | Halogen 12V/30W, brightnesscontinuously adjustable |
| Micromanipulator | LSL green classic: noLSL green comfort: yes | LSL green classic: noLSL green comfort: yes |
The VISULAS green and predicate devices are both intended as ophthalmic lasers for photocoagulation. The indications for use are within the same intended use as the predicate devices and do not raise different questions of safety and effectiveness.
The primary differences between the subject device, VISULAS green (K232051), and the predicate device, VISULAS green (K181682), are listed in the following table with corresponding justification as to why the changes do not affect the safety and effectiveness of the subject device.
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Image /page/8/Picture/0 description: The image shows the word "ZEISS" in white letters on a blue background. The word is in a bold, sans-serif font. The blue background is a square shape with a curved bottom edge. The logo is simple and modern.
Page 5 of 6
Table 3. Differences between the subject device and the predicate device and justification of no impact on safety and effectiveness
| Differences between the subject device and thepredicate device | Justification of no impact on safety andeffectiveness |
|---|---|
| The illumination source of the Laser Slit Lamps ischanged from halogen lamp to LED. | The subject device went through the same Verificationand Validation Process as the predicate device andpassed the applicable testing. |
| The slit width of LSL green classic is changed fromavailable in 5 steps to continuously adjustable 0 – 14mm. | The slit width of LSL green classic is now the same asthat of LSL green comfort.The subject device went through the same Verificationand Validation Process as the predicate device andpassed the applicable testing. |
| The slit length of LSL green classic is changed fromavailable in 8 steps to available in 5 steps. | The slit length of LSL green classic is now the same asthat of LSL green comfort.The subject device went through the same Verificationand Validation Process as the predicate device andpassed the applicable testing. |
| New color scheme of the outer parts is applied. | The subject device went through the same Verificationand Validation Process as the predicate device andpassed the applicable testing. |
| The guidelines of ZEISS User Interface are applied tothe software. | The subject device went through the same Verificationand Validation Process as the predicate device andpassed the applicable testing. |
| The Instructions for Use is updated to reflect thechanges and to adapt to the editorial scheme. | The subject device went through the same Verificationand Validation Process as the predicate device andpassed the applicable testing. |
| Changes to tackle obsolescence issues. | The subject device went through the same Verificationand Validation Process as the predicate device andpassed the applicable testing. |
The VISULAS green subject device and the predicate laser systems 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 the ocular tissue is causing coagulation.
The subject VISULAS green is substantially equivalent to the predicate laser systems presented in the 510(k) premarket notification in terms of indications for use and technological characteristics. Differences between subject device and predicate devices do not raise any new issues of safety or effectiveness.
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Image /page/9/Picture/0 description: The image features the word "ZEISS" in bold, white letters against a solid blue background. The letters are stacked vertically, with the word "ZEISS" taking up the majority of the space. Below the word, there is a curved white line, suggesting a stylized representation of a lens or optical element, which is a common visual element associated with the Zeiss brand.
7. SUMMARY OF STUDIES
Biocompatibility Testing
Biocompatibility testing was performed on the appropriate components of the subject device. The testing performed aligns with current recognized standards and meets or exceeds testing performed on the predicate device. Biocompatibility testing demonstrated equivalency between the subject device and the predicate device.
Laser safety, electrical safety and electromagnetic compatibility (ENC)
VISULAS green was evaluated against the following requirements and was found to comply with:
- · ANSI/AAMI ES60601-1:2005/(R) 2012
- ANSI Z80.36-2016
- · IEC 60601-1-2:2014
- · 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
Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the subject device and the predicate 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.
CONCLUSION 8.
The VISULAS green is substantially equivalent to the predicate device, VISULAS green (K181682).
The VISULAS green is similar in technological characteristics, performance, principles of operation, and has identical indications for use as the predicate device. Any differences between the proposed device and the predicate devices do not raise any new issues of safety or effectiveness. Thus, the VISULAS green is substantially equivalent to the predicate devices.
§ 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.