(133 days)
Not Found
No
The description focuses on pattern scanning technology and hardware components, with no mention of AI or ML.
Yes
The device is indicated for use in the treatment of various ocular pathologies, including retinal photocoagulation and treatment of conditions like diabetic retinopathy and macular degeneration. This direct therapeutic action classifies it as a therapeutic device.
No
The device is described as a "scanning laser delivery system" used for the "treatment of ocular pathology." Its purpose is to deliver therapeutic laser treatment, not to diagnose conditions.
No
The device description explicitly lists hardware components: a Scanning Laser Delivery System adapter, a scanner control module with LCD/Touch screen, power supply, electronics, and electrical connections. It is a hardware system that utilizes software for its functionality.
Based on the provided information, the SUPRA SCAN™ Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of ocular pathology using a laser system. IVD devices are used for the diagnosis or monitoring of diseases or conditions by examining specimens taken from the human body (like blood, urine, tissue).
- Device Description: The device is a scanning laser delivery system that couples with a laser platform to deliver laser energy for treatment. It does not involve the analysis of biological specimens.
- Anatomical Site: The device is used directly on the eye, not on specimens taken from the eye or body.
Therefore, the SUPRA SCAN™ Delivery System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including:
- · Proliferative and nonproliferative diabetic retinopathy;
- · Choroidal neovascularization;
- · Branch retinal vein occlusion;
- · Age-related macular degeneration;
- · Retinal tears and detachments
- · Macular edema
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
Product codes
GEX
Device Description
SUPRA SCAN™ Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology when coupling with laser platforms. This offers existing commercially available laser platform the ability to deliver a full spectrum of pattern scanning options.
The Quantel Medical SUPRA SCAN™ Delivery System consists of the following system components:
-
- Scanning Laser Delivery System adapter with scanner controls that may be coupled to a slit lamp type Haag Streit or similar models, and connected to a currently cleared Quantel Medical 532nm retinal photocoagulator (SUPRA 532).
-
- Scanner control module with LCD/Touch screen, power supply, electronics and electrical connections.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
anterior and posterior segments of the eye, retina, choroids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained ophthalmologist
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 proposed device, SUPRA SCAN™ Delivery System met all design specifications and was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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JUL 2-1 2010
Executive Summary 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
f
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
I. General information
| Applicant: | Quantel Medical |
|---|---|
| ------------ | ----------------- |
Address:
QUANTEL MEDICAL 21 rue Newton Z.I. du Brezet 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 +33 (0)473 745 700 (Fax)
| Contact Person: | Mr. Patrick QUERO |
|---|---|
| Quality Director & Regulatory Affair | |
| (+33) 473 74 57 45 | |
| (+33) 473 74 57 00 | |
| Summary Preparation Date: | July 2009 |
II. Name
Name:
SUPRA SCANTM Delivery System Device Name:
Common Name: SUPRA SCANTM Delivery System
Classification Laser instrument, surgical, powered (see 21CFR 878.4810)
Product Code: GEX ; Panel: 79
III. Predicate Device
OptiMedica PASCAL Synthesis™ Delivery System (K081744)
IV. Product Description
SUPRA SCAN™ Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology when coupling with laser platforms. This offers existing commercially available laser platform the ability to deliver a full spectrum of pattern scanning options.
The SUPRA SCAN™ Delivery System is intended for use by trained ophthalmologist for diagnosis and treatment of ocular pathology.
The Quantel Medical SUPRA SCAN™ Delivery System consists of the following system components:
-
- Scanning Laser Delivery System adapter with scanner controls that may be coupled to a slit lamp type Haag Streit or similar models, and connected to a currently cleared Quantel Medical 532nm retinal photocoagulator (SUPRA 532).
-
- Scanner control module with LCD/Touch screen, power supply, electronics and electrical connections.
Image /page/0/Picture/23 description: The image shows the number 052 in a bold, slightly distorted font. The numbers are black against a white background. The digits are closely spaced, giving the impression of a single unit.
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V. Indications for Use
The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including:
- · Proliferative and nonproliferative diabetic retinopathy;
- · Choroidal neovascularization;
- · Branch retinal vein occlusion;
- · Age-related macular degeneration;
- · Retinal tears and detachments
- · Macular edema
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
VI. Device Technological Characteristics and comparison to Predicate Device
Predicate Product Comparison Table:
| Manufacturer | QUANTEL MEDICAL | OPTIMEDICA Corporation |
|---|---|---|
| Model | SUPRA SCAN™ Delivery System | PASCAL Synthesis™ Delivery System |
| 510 (K) Number | K081744 | |
| Intended Use | Photocoagulation of both anterior and posterior | |
| segments of the eye by generation of patterns of | ||
| laser spots. | Photocoagulation of both anterior and posterior | |
| segments of the eye by generation of patterns of | ||
| laser spots. | ||
| Type of Delivery System | Slit lamp adaptor with optical fiber connected to a | |
| laser | Slit lamp with laser integrated | |
| Laser Energy source | Frequency doubled Nd : YAG | Frequency doubled Nd : YAG |
| Laser Energy Delivery | Single spot & Multi spot | Single spot & Multi spot |
| Spot placement | Centered on Guide Beam | Centered on Guide Beam |
| Laser energy Intensity | Selected by Physician | Selected by Physician |
| Pulsing System | Continuous | Continuous |
| Power requirements : Current | 1 A | --- |
| Computer control | Yes | Yes |
| Can user change computer | ||
| program ? | No | No |
VI - 1 - GENERAL SPECIFICATIONS COMPARISON TABLE -
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| Manufacturer | QUANTEL MEDICAL | OPTIMEDICA Corporation |
|---|---|---|
| Model | SUPRA 532 | Pascal ™ Photocoagulator |
| 510 (K) Number | K070776 | K043486 |
| Lasing Medium | Frequency doubled Nd : YAG | Frequency doubled Nd : YAG |
| Pulsing System | Continuous | Continuous |
| Output Wavelength | 532 nm | 532 nm |
| Average Power (AP) | 2W with SUPRA Scan | 2 W |
| Laser Safety Class | 4/IV | 4/IV |
| Exposure Selections (t) | 0.007s to continuous | 0.01s to continuous |
| Cooling Method | Solid State Cooling with | |
| thermoelectric | ||
| (Peltier) heat pump | Air cooled | |
| Aiming Beam : | Coaxial with treatment beam | |
| Aiming Beam : Type | Red diode | Red diode |
| Aiming Beam : Wavelength | 635 nm | 635 nm |
| Aiming laser power |