(135 days)
No
The summary describes a laser system for ophthalmic procedures with no mention of AI or ML capabilities. The device relies on physician control and laser physics for its function.
Yes
The device performs medical procedures such as posterior capsulotomy, pupillary membranectomy, iridotomy, and Selective Laser Trabeculoplasty, which are therapeutic interventions aimed at treating ocular conditions.
No
The device is described as an ophthalmic surgical laser designed for performing treatments like photodisruption and Selective Laser Trabeculoplasty using laser energy. It is explicitly for performing procedures, not for diagnosing conditions.
No
The device description clearly indicates it is a physical laser system designed to emit light energy for surgical procedures, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser for treating ocular tissue through photodisruption and Selective Laser Trabeculoplasty. These are direct treatments performed on the patient's eye.
- Device Description: The device description details a laser system that delivers energy to the eye for therapeutic purposes. It describes the wavelengths, pulse characteristics, and how the laser is used to interact with ocular tissue.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The provided text does not mention any analysis of specimens or diagnostic purposes in this manner.
The device is a therapeutic medical device used for surgical procedures on the eye.
N/A
Intended Use / Indications for Use
- OPTIMIS FUSION YAG: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
- OPTIMIS FUSION SLT: Selective Laser Trabeculoplasty
- OPTIMIS FUSION YAG/SLT: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy; and Selective Laser Trabeculoplasty
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
The QUANTEL MEDICAL OPTIMIS FUSION is an ophthalmic surgical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of the pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser Trabeculoplasty.
The Family of OPTIMIS FUSION Ophthalmic Lasers. Delivery Device and Accessories consists of the following models:
- OPTIMIS FUSION YAG a Nd: YAG Laser providing-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy/iridectomy). The 1064 treatment beam delivers 4 ns, 0.3 -10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned trough beam shaping optics to generate a photodisruption micro pulse of plasma at a precision adjustable location relative to the visual focal plane (located at slit lamp center of rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 10 um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 150um in the posterior direction and -150um in the anterior direction by the physician relative to this convergence of the twin aiming beams.
- OPTIMIS FUSION SLT a Nd: YAG Laser providing Q-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. The treatment beams delivers a 4 nsec. 0.3-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focussed by the slit lamp objective to a 400um spot at the focal point of the lens.
- OPTIMIS FUSION YAG/SLT a Nd: YAG Laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or O-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. depending upon the mode selected. The OPTIMIS FUSION YAG/SLT contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.
For each OPTIMIS FUSION model, the physician controls delivery of laser energy from the OPTIMIS FUSION control display unit and activates the treatment laser beam with a footswitch or joystick pushbutton. In addition, a laser slit lamp adaptor may be coupled to each of the above OPTIMIS FUSION models and connected to a currently cleared QUANTEL MEDICAL 532nm photocoagulator (VITRA (K04236), SUPRA (K07776), VITRA MULTISPOT (K122251)) to allow to the physician to use the Slit Lamp Adaptor to deliver 532 nm continuous wave laser energy for retinal photocoagulation.
The OPTIMIS FUSION produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye.
When the photodisruptor mode is selected, the treatment wavelength is 1064nm. A twinaiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue.
When the SLT mode is selected, the treatment wavelength is 532nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular tissue, posterior capsule of the eye, pupillary membranes, iridotomy, trabecular meshwork.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was conducted to validate and verify that the Family of OPTIMIS FUSION Ophthalmic Laser Systems, Delivery Device and Accessories met all design specifications and was substantially equivalent to the predicate devices.
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.
K04236, K07776, K122251, K992836
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
510(k) Summary for the Quantel Medical
Family of OPTIMIS FUSION Ophthalmic Laser Systems, (OPTIMIS FUSION SLT/YAG, OPTIMIS FUSION YAG, OPTIMIS FUSION SLT) and Delivery Device (Slit lamp adaptor) and Accessories
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Quantel Medical |
|---|---|
| 11 Rue du Bois Joli – CS 40015 | |
| 63808 Cournon D'Auvergne Cedex | |
| FRANCE | |
| 33-473 745 745 | |
| 33-473 745 700 (Fax) |
| Contact Person: | Maureen O'Connell |
|---|---|
| O'Connell Regulatory Consultants, Inc. | |
| 5 Timber Lane | |
| North Reading, MA 01864 | |
| Telephone: 978-207-1245 | |
| Fax: 978-824-2541 |
Summary Preparation Date: June 13, 2014
2. Names
Family of OPTMIS FUSION Ophthalmic Laser Device Trade Name: Systems, Delivery Device and Accessories OPTIMIS FUSION SLT/YAG OPTIMIS FUSION YAG OPTIMIS FUSION SLT
| Common Name: | Ophthalmic Laser |
|---|---|
| Classification Names: | Laser Instrument, Surgical, Powered and Laser, |
| Ophthalmic | |
| Product Code: HQF (21 CFR 886.4390) | |
| Panel: Ophthalmology |
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3. Predicate Device
- Lumenis Family of Selecta Ophthalmic laser Systems. Delivery Device and . Accessories : (K081704)
- Carl Zeiss Meditec VISULAS YAG III (K042139) -
- Quantel Medical Solutis (K130933) -
4. Device Description
The QUANTEL MEDICAL OPTIMIS FUSION is an ophthalmic surgical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of the pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser Trabeculoplasty.
The Family of OPTIMIS FUSION Ophthalmic Lasers. Delivery Device and Accessories consists of the following models:
-
- OPTIMIS FUSION YAG a Nd: YAG Laser providing-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy/iridectomy). The 1064 treatment beam delivers 4 ns, 0.3 -10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned trough beam shaping optics to generate a photodisruption micro pulse of plasma at a precision adjustable location relative to the visual focal plane (located at slit lamp center of rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 10 um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 150um in the posterior direction and -150um in the anterior direction by the physician relative to this convergence of the twin aiming beams.
-
- OPTIMIS FUSION SLT a Nd: YAG Laser providing Q-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. The treatment beams delivers a 4 nsec. 0.3-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focussed by the slit lamp objective to a 400um spot at the focal point of the lens.
-
- OPTIMIS FUSION YAG/SLT a Nd: YAG Laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or O-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. depending upon the mode selected. The OPTIMIS FUSION YAG/SLT contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.
2
For each OPTIMIS FUSION model, the physician controls delivery of laser energy from the OPTIMIS FUSION control display unit and activates the treatment laser beam with a footswitch or joystick pushbutton. In addition, a laser slit lamp adaptor may be coupled to each of the above OPTIMIS FUSION models and connected to a currently cleared QUANTEL MEDICAL 532nm photocoagulator (VITRA (K04236), SUPRA (K07776), VITRA MULTISPOT (K122251)) to allow to the physician to use the Slit Lamp Adaptor to deliver 532 nm continuous wave laser energy for retinal photocoagulation.
The OPTIMIS FUSION produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye.
When the photodisruptor mode is selected, the treatment wavelength is 1064nm. A twinaiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue.
When the SLT mode is selected, the treatment wavelength is 532nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork.
5. Indications for Use
• OPTIMIS FUSION YAG: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
- · OPTIMIS FUSION SLT: Selective Laser Trabeculoplasty
- · OPTIMIS FUSION YAG/SLT: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy; and Selective Laser Trabeculoplasty
6. Substantial Equivalence
The indications for use statement for the OPTIMIS FUSION FAMILY is exactly the same as the indications for use statement for the Lumenis Family of
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SELECTA Ophthalmic Laser Systems, Delivery Device and accessories (predicate device). Each of the families contains multiple configurations of the laser system with different indications for use statements. Both families include an SLT model, a YAG model and a model which combines the SLT and YAG. The indications for use statements for each version of the product are identical between the families. Additionally, the YAG model of the Optimis Fusion Family is also being compared to the Carl Zeiss Meditec VISULAS YAG III cleared in K042139. Both systems are cleared for performing posterior capsulotomy and peripheral iridotomy procedures while the Optimis Fusion YAG is also indicated for pupillary membranectomy. The SLT model of the Optimis Fusion Family is also being compared to the Quantel Medical Solutis cleared in K 130933. Both systems are cleared for Selective Laser Trabeculoplasty (SLT).
The OPTIMIS FUSION FAMILY and the predicate devices have the same technological characteristics. The OPTIMUS FUSION FAMIL Y and the Lumenis SELECTA family each include multiple models within the family. Both the OPTIMUS FUSION FAMILY and the Lumenis SELECTA family include an SLT model, a YAG model and a model that combines the SLT and YAG lasers in one unit. The VISULAS YAG III only includes a YAG model and therefore, will only be compared to the YAG model of the Optimis Fusion. The Quantel Medical Solutis has only a SLT model and therefore, will only be compared to the SLT model of the Optimis Fusion.
The Optimis Fusion SLT is a Q-Switched frequency doubled Nd: YAG laser with a wavelength of 532 nm as are the Selecta SLT model and Solutis. The Optimis Fusion SLT, the Selecta SLT model and Solutis all operate in single pulse modes. The energy range for both devices is 0.3-2.0 mJ and the Solutis is 0.2-2.0 mJ. The spot size in air is 400 microns with a focus angle of