Vitra 2

K191962 · Quantel Medical · GEX · Dec 5, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191962
• Device Name: Vitra 2
• Applicant: Quantel Medical
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vitra 2 is for use in the treatment of ocular pathology of anterior and posterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including: - Proliferative and nonproliferative diabetic retinopathy - Choroidal neovascularization - Branch retinal vein occlusion - Treatment of choroidal neovascularization associated with wet Age-related macular degeneration - Retinal tears and detachments - Macular edema

Device Story

Vitra 2 is a 532 nm frequency-doubled Nd:YAG laser system for ophthalmic photocoagulation. It delivers laser energy to ocular tissues via slit lamp, indirect ophthalmoscope, operating microscope, or endocular probe. A scanning laser delivery system allows for automated delivery of predetermined spot patterns (square, circle, triple arcs). The device is operated by trained medical personnel in a clinical setting. The user initiates treatment via footswitch, with the ability to abort at any time. The system includes a resume function. By photocoagulating vascular and structural abnormalities, the device treats conditions like diabetic retinopathy and macular edema, potentially preserving or improving patient vision.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-2-22 (laser safety), and IEC 60825-1 (laser product safety), alongside hardware and software validation activities.

Technological Characteristics

Frequency-doubled Nd:YAG laser; 532 nm wavelength; 1500 mW max power; 10 ms to continuous pulse duration; 635-650 nm aiming beam; Peltier cooling. Delivery via fiber optic to slit lamp, indirect ophthalmoscope, operating microscope, or endocular probe. Includes scanning motor system for pattern delivery. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for patients with ocular pathology of anterior and posterior segments, including proliferative/nonproliferative diabetic retinopathy, choroidal neovascularization (including wet AMD), branch retinal vein occlusion, retinal tears/detachments, and macular edema.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Quantel Medical Vitra Multispot (K122251)

Submission Summary (Full Text)

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December 5, 2019

Quantel Medical % Maureen O'connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180

Re: K191962

Trade/Device Name: Vitra 2 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: October 31, 2019 Received: November 4, 2019

Dear Maureen O'Connell:

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 control's 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.

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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 devicerelated 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/guidanceregulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-devicesafety/medical-device-reporting-mdr-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/medical-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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Tieuvi Nguyen, Ph.D. 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

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# Indications for Use

510(k) Number (if known) K191962

Device Name Vitra 2®

Indications for Use (Describe)

The Vitra 2 is for use in the treatment of ocular pathology of anterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including:

- · Proliferative and nonproliferative diabetic retinopathy
- Choroidal neovascularization
- · Branch retinal vein occlusion
- · Treatment of choroidal neovascularization associated with wet Age-related macular degeneration
- · Retinal tears and detachments
- · Macular edema

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) SUMMARY K191962

## Quantel Medical Vitra 2®

### 510(k) Owner

Quantel Medical 11 rue Bois Joli CS40015 63808 Cournon D'Auvergne-Cedex France 33 04 73 745 732 Phone: Contact Person: Bruno Pagès

### Submission Correspondent:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 Phone: [phone]

Date Prepared: November 25, 2019

## Trade Name of Device

Vitra 2 ®

### Common or Usual Name

Ophthalmic Lasers

### Classification Name

Lasers, Ophthalmic; 21 C.F.R. 878.4810 Class II Product Code: GEX

### Predicate Device

Quantel Medical Vitra Multispot (K122251)

### Device Description

The Vitra 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.Laser energy is delivered to opaque structures within the eye by means of delivery systems including slit lamp, indirect ophthalmoscope, operating microscope and endocular probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser

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spot in the plane of observation of the slit lamp, for example. It also includes a Multispot delivery system made by scanner motors which can deliver several spots to the retina in a pattern. The laser energy is delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.

The Quantel Medical VITRA 2 includes a Scanning Laser Delivery System adaptor with scanner controls that may be coupled to a slit lamp. Once activated by the user, the VITRA 2 delivers a predetermined pattern by sequentially scanning the placement of the laser spots and the emission of the individual pulses of laser light. Treatment is initiated by pressing the footswitch and may be aborted by releasing the footswitch.

## Intended Use / Indications for Use

The Vitra 2 is for use in the treatment of ocular pathology of anterior and posterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including:

- · Proliferative and nonproliferative diabetic retinopathy
- · Choroidal neovascularization
- · Branch retinal vein occlusion
- · Treatment of choroidal neovascularization associated with wet Age-related macular degeneration
- · Retinal tears and detachments
- Macular edema

## Substantial Equivalence

Ouantel Medical believes that the Vitra 2 described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device regulated under product code GEX (21 C.F.R. 878.4810) . The predicate device is the Quantel Medical Vitra Multispot laser system cleared by FDA in K122251 and intended for use in photocoagulation of the posterior and anterior segments of the eye.

Both the Vitra 2 and the Vitra Multispot devices are intended for use in photocoagulation of the posterior and anterior segments. Additionally, both devices have the identical indications for use statement. Both devices are prescription devices which are intended to be used by trained medical personnel.

As shown in the table below, the Vitra 2 and the Vitra Multispot have the same technological characteristics. Both devices are frequency doubled Nd: YAG lasers with a wavelength of 532 nm. The maximum power at the tissue is 1500 mW for both systems with a pulse duration of 10 ms to continuous for both systems and the identical pulse repeat interval. Both the Vitra 2 and the Vitra Multispot use an aiming laser with a wavelength of 635-650 nm. Both systems are cooled by Peltier effect.

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For the Single Spot Slit Lamp Adapters, the emission modes available in both the Vitra 2 and the Vitra Multispot are single, repeat, painting and continuous with an identical spot size of 50 to 500 microns. For the MultiSpot Slit Lamp Adapters in the Multispot Mode, the emission modes available in both the Vitra 2 and the Vitra Multispot are square, circle, triple arcs and single spot. For the MultiSpot Slit Lamp Adapters in the Monospot Mode, the spot modes available in both the Vitra 2 and the Vitra Multispot are single, repeat, painting and continuous. For the MultiSpot Slit Lamp Adapters, both the Vitra Multispot are compatible with the same slit lamps and laser systems except the Vitra 2 is also compatible with the CSO 9800. Both systems can be used with the Keeler Vantage Plus laser indirect ophthalmoscope. The Vitra 2 can also be used with a commercially available sterile laser probe.

Therefore, as the Vitra 2 and the Vitra Multispot have the same intended use and similar technological characteristics, the Vitra 2 is substantially equivalent to the Vitra Multispot.

| SPECIFICATIONS | | |
|------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------|
| MANUFACTURER | QUANTEL MEDICAL | QUANTEL MEDICAL |
| 510(K) | - | K122251 |
| TYPE OF DELIVERY SYSTEM | Slit lamp<br>Indirect ophthalmoscope<br>Endocular probe<br>Operating microscope | Slit lamp<br>Indirect ophthalmoscope<br>Operating microscope |
| PULSING SYSTEM | Continuous | Continuous |
| LASER SOURCE | Frequency doubled Nd:YAG | Frequency doubled Nd:YAG |
| WAVELENGTH | 532 nm | 532 nm |
| MAXIMUM POWER | 1500mW (at tissue) | 1500mW (at tissue) |
| PULSE DURATION | 10 ms to continuous | 10 ms to continuous |
| REPEAT INTERVAL | 0.1 - 0.2 - 0.3 - 0.5 - 0.7s | 0.1 - 0.2 - 0.3 - 0.5 - 0.7s |
| AIMING BEAM WAVELENGTH | 635 – 650 nm | 635 – 650 nm |
| Delivery System-Single Spot Slit Lamp Adapters | | |
| SPOT MODE | Single, repeat, painting, continuous | Single, repeat, painting, continuous |
| SPOT SIZE | 50 µm to 500 µm | 50 µm to 500 µm |
| Delivery System-MultiSpot Slit Lamp Adapters | | |
| MONOSPOT MODE | | |
| EMISSION MODES | Single, repeat, painting, continuous | Single, repeat, painting, continuous |
| SPOT SIZE | 50 µm to 400 µm | 50 µm to 500 µm |
| MULTISPOT MODE | | |
| EMISSION MODES | Square, circle, triple arcs, single spot | Square, circle, triple arcs, single spot |
| SPOT SIZE | 100 µm to 400 µm | 100 µm to 500 µm |
| RESUME FUNCTION | Yes | Yes |

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## Performance Data

Performance testing was conducted in order to demonstrate compliance with recognized consensus standards and to demonstrate substantial equivalence:

- IEC 60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 Medical electrical ● equipment-Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment-Part 1-2: General requirements for ● basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General . requirements for safety-Collateral Standard Usability
- . IEC 60601-2-22: 2007 (Third Edition) + A1:2012 Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1 Safety of Laser Products-Part 1: Equipment Classification and . Requirements

Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the level of concern was provided.

In summary, the performance testing provided shows that the device performs as intended and is substantially equivalent to the predicate device.