(62 days)
Not Found
No
The summary describes a laser system for photocoagulation and does not mention any AI or ML capabilities. The performance studies focus on compliance with electrical and laser safety standards.
Yes
The device is intended for "retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy," which are all therapeutic medical procedures. The "Device Description" also explicitly states, "The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye."
No
The device is described as a laser system intended for photocoagulation to treat diseases of the eye, not to diagnose them.
No
The device description explicitly states it is a "laser system" and details hardware components like a laser, fiber optic, and delivery systems (slit lamp, indirect ophthalmoscope, etc.). It also mentions hardware and software validation activities.
Based on the provided information, the Vitra 810 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy. These are all therapeutic procedures performed directly on the patient's eye.
- Device Description: The device description confirms it is a laser system that emits a treatment beam to photocoagulate ocular tissues. This is a direct intervention on the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Vitra 810 does not perform any such analysis of biological specimens.
The Vitra 810 is a therapeutic medical device used for treating various eye conditions.
N/A
Intended Use / Indications for Use
The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:
· Retinal photocoagulation for the treatment of:
- o Diabetic retinopathy including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- o Retinal Tears, Detachments and Holes
- o Lattice degeneration
- o Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
- o Retinopathy of prematurity
- o Sub-retinal (choroidal) neovascularization
- o Central and Branch Retinal Vein Occlusion
· Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including:
- o Primary open angle
- o Closed angle
- o Refractory Glaucoma (recalcitrant/uncontrolled)
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma.
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the anterior and posterior segments of the eye. The laser is particularly well suited for treating the eye because it has minimal effect on transparent tissues and materials. This means that the laser can be efficiently delivered to opaque structures of the eye through the transparent cornea, aqueous humor, lens, and vitreous humor. This allows many conditions to be treated by non-invasive techniques.
Laser energy is delivered to opaque structures within the eye by means of laser delivery systems including slit lamp, indirect ophthalmoscope, operating microscope, cyclophotocoagulation probe and laser 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. The laser energy is delivered to the 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 may have mirrors so that laser energy can be delivered to areas of the retina behind the iris, or into the angle so that the trabecular meshwork can be treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular tissues, retina, eye, anterior and posterior segments of the eye, cornea, aqueous humor, lens, vitreous humor, iris, trabecular meshwork
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 major level of concern was provided.
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
August 6, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Quantel Medical % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K201502
Trade/Device Name: Vitra 810 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: June 4, 2020 Received: June 5, 2020
Dear Ms. 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 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) 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-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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K201502
Device Name Vitra 810
Indications for Use (Describe)
The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:
· Retinal photocoagulation for the treatment of:
- o Diabetic retinopathy including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- o Retinal Tears, Detachments and Holes
- o Lattice degeneration
- o Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
- o Retinopathy of prematurity
- o Sub-retinal (choroidal) neovascularization
- o Central and Branch Retinal Vein Occlusion
· Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including:
- o Primary open angle
- o Closed angle
- o Refractory Glaucoma (recalcitrant/uncontrolled)
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Exporting to (Part 374.11(a) Subject to Prior |
|---|
| ☐ On-Site Consumption (Part 374.11(a) Subject to |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K201502
Quantel Medical Vitra 810®
510(k) Owner
Quantel Medical 11 rue Bois Joli CS40015 63808 Cournon D'Auvergne-Cedex France Phone: 33 04 73 745 732 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: August 4, 2020
Trade Name of Device
Vitra 810 ®
Common or Usual Name
Powered Surgical Laser
Classification Name
Powered Laser Surgical Instrument; 21 C.F.R. 886.4390 Class II Product Code: HQF
Primary Predicate Device
Quantel Medical Supra Twin Ophthalmic Laser (K081946) Product Code: HQF
Secondary Predicate Device
Iridex IQ 810 (K071687) Product Code: GEX
4
Device Description
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eve. The laser is used to treat the retinal diseases and glaucoma.
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the anterior and posterior segments of the eye. The laser is particularly well suited for treating the eye because it has minimal effect on transparent tissues and materials. This means that the laser can be efficiently delivered to opaque structures of the eve through the transparent cornea, aqueous humor, lens, and vitreous humor. This allows many conditions to be treated by non-invasive techniques.
Laser energy is delivered to opaque structures within the eye by means of laser delivery systems including slit lamp, indirect ophthalmoscope, operating microscope, cvclophotocoagulation probe and laser 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. The laser energy is delivered to the 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 may have mirrors so that laser energy can be delivered to areas of the retina behind the iris, or into the angle so that the trabecular meshwork can be treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.
Intended Use / Indications for Use
The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:
- Retinal photocoagulation for the treatment of: .
- o Diabetic retinopathy including:
- . Nonproliferative retinopathy
- . Macular edema
- . Proliferative retinopathy
- Retinal Tears, Detachments and Holes o
- Lattice degeneration o
- Age-related macular degeneration (AMD) with choroidal neovascularization O (CNV)
- Retinopathy of prematurity O
- Sub-retinal (choroidal) neovascularization o
- Central and Branch Retinal Vein Occlusion o
- o Diabetic retinopathy including:
- Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the . treatment of glaucoma, including:
- Primary open angle o
- Closed angle o
5
- o Refractory Glaucoma (recalcitrant/uncontrolled)
Substantial Equivalence
Quantel Medical believes that the Vitra 810 described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to legally marketed predicate devices that are Class II medical devices. The primary predicate device is the Quantel Medical Supra Twin Ophthalmic Laser cleared by FDA in K081946. The secondary predicate device is the Iridex IO 810 laser system cleared by FDA in K071687. All three devices are intended for use in photocoagulation of ocular tissue including the retina and pigmented tissue. All three devices are prescription devices which are intended to be used by trained medical personnel. Therefore, the Vitra 810 has the same intended use as the identified primary predicate device and an identical indications for use statement to the secondary predicate device and may be found to be substantially equivalent to the predicate devices.
As shown in Table 1, the Vitra 810, the Supra Twin and the Iridex IQ 810 have the same technological characteristics. All three devices are laser diodes with a wavelength of 810 mm. The treatment power ranges from 50-3000 mW for all three devices. The pulse duration is 10 ms to continuous (up to 60 seconds) for continuous wave mode in the Vitra 810, the Supra Twin and Iridex IQ 810. For the Subthreshold mode the pulse duration is 0.1 ms with a 5% to 35% duty cycle which is within the pulse duration range for the Iridex IQ 810 which is 0.025 ms to 1.0 ms (0.5% to 50% duty cycle). All three device use an aiming laser with a wavelength of 635-650 nm with a 1 mW maximum power.
All the systems are compatible with a variety of delivery systems including a slit lamp, indirect ophthalmoscope, operating microscope, laser probes and cyclophotocoagulation probes.
Therefore, the Vitra 810 and the primary predicate device, the Quantel Medical Supra Twin, supported by the Iridex IO810 secondary predicate device. have the same intended use and similar technological characteristics and are therefore substantially equivalent.
6
| Table | 1 | ||
|---|---|---|---|
Vitra 810 Substantial Equivalence
| MANUFACTURER | QUANTEL MEDICAL | QUANTEL MEDICAL | IRIDEX |
|---|---|---|---|
| DEVICE NAME | Vitra 810 | Supra Twin | IQ 810 |
| 510(K) | - | K081946 | K071687 |
| PRODUCT CODE | HQF | HQF | GEX |
| INTENDED USE | Photocoagulation of ocular tissue including the retina and pigmented tissue | Photocoagulation of ocular tissue including the retina and pigmented tissue | Photocoagulation of ocular tissue including the retina and pigmented tissue |
| INDICATIONS FOR USE | The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following: Retinal photocoagulation for the treatment of: Diabetic retinopathy including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal Tears, Detachments and Holes Lattice degeneration Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Retinopathy of prematurity Sub-retinal (choroidal) neovascularization Central and Branch Retinal Vein | 810 nm Indications for Use: | |
| The Supra Twin Ophthalmic Laser Photocoagulator wavelength 810nm is indicated for use: | |||
| Photocoagulation or ablation of pigmented tissue within the eye, | |||
| Transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), | |||
| Transpupillary photocoagulation, | |||
| Endophotocoagulation, | |||
| Treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumben patients), transpupillary photocoagulation of choroidal | The Iridex IQ 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following: Retinal photocoagulation for the treatment of: Diabetic retinopathy including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal Tears, Detachments and Holes Lattice degeneration Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Retinopathy of prematurity Sub-retinal (choroidal) neovascularization Central and Branch Retinal Vein Occlusion | ||
| Occlusion | |||
| • Laser Trabeculoplasty, Iridotomy, | |||
| Transscleral Cyclophotocoagulation | |||
| for the treatment of glaucoma, | |||
| including: | |||
| o Primary open angle | |||
| o Closed angle | |||
| o Refractory Glaucoma | |||
| (recalcitrant/uncontrolled) | neovasculature, and Age related | ||
| macular degeneration (AMD) | |||
| treatments. | • Laser Trabeculoplasty, Iridotomy, | ||
| Transscleral Cyclophotocoagulation for | |||
| the treatment of glaucoma, including: | |||
| o Primary open angle | |||
| o Closed angle | |||
| • Refractory Glaucoma | |||
| (recalcitrant/uncontrolled) | |||
| TYPE | |||
| OF DELIVERY | |||
| SYSTEM | Slit lamp | ||
| Indirect ophthalmoscope | |||
| Operating microscope | |||
| Cyclophotocoagulation probes | |||
| Laser probes | Slit lamp | ||
| Indirect ophthalmoscope | |||
| Operating microscope | |||
| Endocular probe | Slit lamp | ||
| Indirect ophthalmoscope | |||
| Operating microscope | |||
| Cyclophotocoagulation probes | |||
| Laser probes | |||
| LASER SOURCE | Laser Diode | Laser Diode | Laser Diode |
| WAVELENGTH | 810 nm | 810 nm | 810 nm |
| TREATMENT POWER | 50-3000mW (depending upon delivery | ||
| device) | 50-3000mW (depending upon delivery | ||
| device) | 50-3000mW (depending upon delivery | ||
| device) | |||
| LASER SAFETY CLASS | 4/IV | 4/IV | 4/IV |
| PULSE DURATION | Continuous wave mode: 10 ms to | ||
| continuous (up to 60 seconds) | |||
| Subthreshold (Subliminal) mode (Ton): | |||
| 0.1 ms to1.0 ms (5% to 35% duty cycle) | Continuous wave mode: 10 ms to 60 | ||
| seconds | |||
| Repeat mode: 0.1, 0.15, 0.2, 0.3, 0.4, | |||
| 0.5, 0.6, 0.7 & 1s | Continuous wave mode: 10 ms to continuous | ||
| (up to 60 seconds) | |||
| Subthreshold mode (Ton): 0.025 ms to1.0 ms | |||
| (0.5% to 50% duty cycle) | |||
| TTT mode: 10 seconds to 1800 seconds | |||
| REPEAT INTERVAL | Continuous wave mode: 50 ms to 1000 ms | ||
| and one pulse | |||
| Subthreshold (Subliminal) mode (Toff): | |||
| 0.3 ms to 19 ms (duty cycle: 5% to 35%) | Repeat mode: 0.1 – 1 s | Continuous wave mode: 50 ms to 1000 ms | |
| and one pulse | |||
| Subthreshold mode (Toff): 1.0 ms to 9.5 ms | |||
| (duty cycle: 0.5% to 50%) | |||
| AIMING BEAM SOURCE | Red Laser Diode, 1 mW maximum | Red Laser Diode, 1 mW maximum | Red Laser Diode, 1 mW maximum |
| AIMING | |||
| BEAM | |||
| WAVELENGTH | 635 - 650 nm | 635-650 nm | 635 - 650 nm |
| SIZE | 18 (H) x 19.5 (W) x 30 (D) cm | ||
| 7.1" (H) x 7.7" (W) x 11.8" (D) | 14.6 cm High x 33 cm Wide x 30.7cm | ||
| WEIGHT | 5.6 kg / 12.3lbs | 9.5 kg / 21 lbs. | - |
| COOLING | By Peltier effect | By Peltier effect | Air cooled |
| POWER REQUIREMENT | 250 VA | 240 V | - |
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8
9
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 major level of concern was provided.
Conclusions
The Vitra 810 and the primary predicate device, the Quantel Medical Supra Twin, supported by the Iridex IQ810 secondary predicate device have the same intended use and similar technological characteristics and are therefore substantially equivalent.