(269 days)
Not Found
No
The summary describes a laser device with different treatment modes controlled by software licenses, but there is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on safety, biocompatibility, and software validation, not on the performance of an AI/ML algorithm.
Yes
The device is used to photocoagulate and photodisrupt ocular tissues to treat eye diseases, which is a therapeutic action.
No
The device is described as an ophthalmic laser used for photocoagulating and photodisrupting ocular tissues, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states that the VISULAS combi consists of hardware components such as a laser console, touch control panel, applicators, foot switch, and instrument table, in addition to software.
Based on the provided information, the VISULAS combi is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for "photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye." This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a laser system used for treating ocular tissues with specific wavelengths. This is a therapeutic device, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device is used for treatment.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VISULAS combi does not fit this description.
N/A
Intended Use / Indications for Use
VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina
- Trabeculoplasty
- • Iridotomy
- • Posterior capsulotomy
- Posterior membranectomy
This device is Prescription Use (Rx) only.
Product codes
HQF
Device Description
VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:
- single-spot mode (software license VERTE) -
- multi-spot mode (software license VITE)
- YAG disruption mode (software license YAG). -
VISULAS combi 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular tissues, eye, retina
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
Biocompatibility Testing: ZEISS conducted biocompatibility testing on patient-contacting accessories in accordance with ISO 10993-1. The evaluations addressed cytotoxicity, sensitization, aligning with the recommendations delineated in the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process". 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 (EMC): VISULAS combi 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
- IEC 60601-4-2
Software Verification and Validation Testing: The software of this device is considered to have an Enhanced Documentation Level. 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 combi 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2024
Carl Zeiss Meditec AG Tanesha Bland Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, California 94568
Re: K233911
Trade/Device Name: VISULAS combi Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 2, 2024 Received: August 5, 2024
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.
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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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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,
Claudine H. Krawczyk -S
Claudine Krawczyk 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
3
Indications for Use
510(k) Number (if known) K233911
Device Name VISULAS combi
Indications for Use (Describe)
VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina
- Trabeculoplasty
- · Iridotomy
- · Posterior capsulotomy
· Posterior membranectomy
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 word "ZEISS" in white text on a blue background. The text is in a bold, sans-serif font. The blue background is a solid color, and the word "ZEISS" is centered on the background. The bottom of the blue background is curved.
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for VISULAS combi is provided below.
SUBMITTER 1.
| Applicant: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Ling Ren
Regulatory Affairs Manager
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52 07745 Jena, Germany
Phone: +49 7364 2062845
E-mail: tanesha.bland@zeiss.com (preferred) |
| Primary Correspondent | Tanesha Bland
Sr. Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
Phone: (925) 216-7963 Fax: (925) 557-4259
E-mail: tanesha.bland@zeiss.com (preferred) |
| Date Prepared: | August 30, 2024 |
Page 1 of 8
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SUBJECT DEVICE 2.
| Device Trade Name: | VISULAS combi |
|---|---|
| 510(k) number: | K233911 |
| Classification: | 21CFR886.4390 laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |
PREDICATE DEVICE 3.
Table 1. Primary Predicate Device- VISULAS green
| Predicate Device: | VISULAS green |
|---|---|
| 510(k) Number: | K232051 |
| Classification: | 21CFR886.4390 Laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |
| Table 2. Secondary Predicate Device- VISULAS yag | ||
|---|---|---|
| Predicate Device: | VISULAS yag |
|---|---|
| 510(k) Number: | K230350 |
| Classification: | 21CFR886.4390 Laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |
DEVICE DESCRIPTION 4.
VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:
- single-spot mode (software license VERTE) -
- multi-spot mode (software license VITE)
- YAG disruption mode (software license YAG). -
VISULAS combi 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.
ನ. INDICATIONS FOR USE
VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including
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Image /page/6/Picture/0 description: The image shows the word "ZEISS" in white letters against a blue background. The word is in a bold, sans-serif font. The blue background is a solid color, and the white letters stand out clearly against it. The logo is simple and modern.
- . Photocoagulation of the retina
- Trabeculoplasty
- Iridotomy •
- Posterior capsulotomy •
- Posterior membranectomy .
This device is Prescription Use (Rx) only.
6. SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE
Table 1. Subject to Primary Predicate Device Comparison Table – Indications for Use
| VISULAS combi | VISULAS green | |
|---|---|---|
| K number | Subject Device | K232051 |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Indications for Use Statement | VISULAS combi is intended for use | |
| in photocoagulating and | ||
| photodisrupting ocular tissues in the | ||
| treatment of diseases of the eye, | ||
| including | ||
| • Photocoagulation of the retina | ||
| • Trabeculoplasty | ||
| • Iridotomy | ||
| • Posterior capsulotomy | ||
| • Posterior membranectomy | 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 | ||
| 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, laser endoprobes, LIO | LSL, laser endoprobes, 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) | 50-200 mW (10 mW steps), 200- | |
| 500 mW (20 mW steps), 500-1500 | ||
| mW (50 mW steps) | ||
| Laser spot size setting | Continuously adjustable from | |
| 50 μm to 1000 μm | Continuously adjustable from | |
| 50 μm to 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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Table 2. Subject to Primary Predicate Device Comparison Table - Laser Slit Lamp
The Laser Slit Lamp (LSL) is an optional component of the VISULAS laser.
| LSL green combi | LSL green comfort | |
|---|---|---|
| K number | Component of subject device | |
| VISULAS combi | Component of predicate device | |
| VISULAS green (K232051) | ||
| 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) | 0 mm to 14 mm (continuously) |
| Slit length | 1/3/5/9/14 mm | 1/3/5/9/14 mm |
| Slit image rotation | 0°, ±45°, 90° | 0°, ±45°, 90° |
| Magnification | 5 magnifications, in steps of 5x, 8x, | |
| 12x, 20x, 32x | 5 magnifications, in steps of 5x, 8x, | |
| 12x, 20x, 32x | ||
| Light source | LED illumination, continuously | |
| adjustable brightness | LED illumination, continuously | |
| adjustable brightness | ||
| Micromanipulator | yes | yes |
The subject device VISULAS combi and the primary predicate device VISULAS green are both intended as ophthalmic lasers for photocoagulation treatments, the indications for use are within the same intended use as the predicate device and do not raise different questions of safety and effectiveness.
The subject device VISULAS combi and the primary predicate laser system share the same fundamental parameters and 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.
For photocoagulation treatments, the subject device VISULAS combi is substantially equivalent to the primary predicate laser system presented in the 510(k) premarket notification in terms of indications for use and technological characteristics. Differences between subject devices do not raise any new issues of safety or effectiveness.
| Table 3. Subject to Secondary Predicate Device Comparison Table - Indications for Use | ||||
|---|---|---|---|---|
| VISULAS combi | VISULAS yag | |
|---|---|---|
| K number | Subject Device | K230350 |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Indications for Use Statement | VISULAS combi is intended for use | |
| in photocoagulating and | ||
| photodisrupting ocular tissues in the | ||
| treatment of diseases of the eye, | ||
| including | ||
| Photocoagulation of the retina Trabeculoplasty | VISULAS yag is intended for use in | |
| photodisrupting ocular tissues in the | ||
| treatment of diseases of the eye, | ||
| including Posterior capsulotomy Iridotomy Posterior membranectomy |
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Page 5 of 8
| Iridotomy Posterior capsulotomy Posterior membranectomy | ||
|---|---|---|
| General Laser Specifications | ||
| Optic principle | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser |
| Wavelength of treatment beam | 1064 nm | 1064 nm |
| Pulse duration |