(135 days)
Not Found
No
The description focuses on laser delivery systems and predetermined patterns, with no mention of AI or ML capabilities for image analysis, treatment planning, or adaptive control.
Yes.
The device is used for the treatment of various ocular pathologies, including retinal photocoagulation and treatment of vascular and structural abnormalities of the retina and choroids, which clearly indicates a therapeutic purpose.
No
Explanation: The device description clearly states "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." This indicates it is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "laser system" and details hardware components like a laser, delivery systems (slit lamp, indirect ophthalmoscope, etc.), a fiber optic, and a footswitch. It also mentions hardware and software validation activities.
Based on the provided information, the Vitra 2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Vitra 2 is for the treatment of ocular pathology using laser photocoagulation. IVD devices are used for the diagnosis of diseases or conditions by examining specimens taken from the human body (like blood, urine, tissue).
- Device Description: The description details a laser system that delivers energy to ocular tissues for treatment. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
The Vitra 2 is a therapeutic device used for surgical intervention (laser treatment) within the eye.
N/A
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
Product codes
GEX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular tissues, anterior segments, retinal, choroids, retina, posterior segments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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.
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 978-207-1245
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
4
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 | |
| Indirect ophthalmoscope | ||
| Endocular probe | ||
| Operating microscope | Slit lamp | |
| Indirect ophthalmoscope | ||
| 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.