(177 days)
Not Found
No
The summary does not mention AI, ML, or related concepts like image processing or specific algorithms that would indicate their use. The performance studies focus on hardware testing and animal studies comparing lesion appearance, not on the performance of any AI/ML component.
Yes
The device is described as "intended for use in the treatment of ocular pathology in both the posterior and anterior segments," indicating its purpose is to treat medical conditions.
No
The device is intended for the treatment of ocular pathology, not for diagnosis.
No
The device description explicitly states it is a "stand-alone laser delivery console" and mentions hardware components like a key switch, emergency off switch, footswitch, and door interlock connection. The performance studies also include extensive hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of ocular pathology in both the posterior and anterior segments. This involves directly applying laser energy to the patient's eye.
- Device Description: The description details a laser delivery system used with a slit lamp, LIO, or probe delivery. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic laser system used for surgical procedures on the eye.
N/A
Intended Use / Indications for Use
The PASCAL® Synthesis Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
(532nm)
- proliferative and non-proliferative diabetic retinopathy .
- . macular-edema
- choroidal neovascularization associated with wet age-related macular degeneration .
- age-related macular degeneration t
- . lattice degeneration
- retinal tears and detachments .
(577nm)
- proliferative and non-proliferative diabetic retinopathy ●
- . macular edema
- choroidal neovascularization associated with wet age-related macular degeneration
- age-related macular degeneration .
- lattice degeneration .
- . retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm)
- iridotomy .
- trabeculoplasty. .
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is a stand-alone laser delivery console for use with a slit lamp. LIO or probe delivery. Controls and displays include an I.CD/Touchscreen user interface and a slit lamp connector (SLC). The system is equipped with a three-position key switch that enables laser and controls as well as an emergency off switch. An externally connected wired footswitch activator is provided with a shrouded housing, and contains a set of redundant switches. An external door interlock connection allows the laser to be terminated with an open circuit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior and anterior segments (ocular)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Topcon utilized hardware testing (60601-1, -2-x; EN ISO14971-C; ASTM 4169-09&6653-01; ASTM D4169-09). electromagnetic testing (IEC 60601-1-2. 4. 6) software testing (EN 60601-1-41 62304 and animal testing to establish a basis for the determination of equivalence. The PASCAL® Synthesis performance characteristics were established by referencing the known performance characteristics of the predicate device. Specifications for the PASCAL® Synthesis system were established to assure that the predicate system and the Synthesis system performed in an equivalent manner. Performance specifications were set utilizing national and international standards for such devices with respect to output, indications for use, safety features and electromagnetic interference where it was established as suitable for the environment of use. All testing was conducted and established that the PASCAL® Synthesis system met or exceeded its design specifications and performed equally or better than the stated performance of the predicate.
The objective of the animal study was to compare the appearance of retinal laser lesions produced by the PASCAL Synthesis system with the predicate PASCAL Streamline system in an animal model. This prospective comparative study included delivery of laser lesions to two animals in accordance with Good Laboratory Practices (GLP) standards and the local Animal Institutional Review Board. Multiple lesions using varying spot sizes and intensities were created with each of the two lasers and assigned a clinical grade by the laser operator on a 5 point scale. When comparing lesions of the same clinical grades, the appearance of the lesions was similar. The diameter of the lesions was
§ 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 - K123542
General Information I.
Submitter:
Topcon Medical Laser Systems, Inc. 3130 Coronado Drive Santa Clara, CA 95054, USA
| Contact Person: | Pamela M. Buckman |
|---|---|
| Regulatory Consultant | |
| T 925 980 7007 | |
| F 925 705 7381 | |
| pmbuckman@gmail.com |
May 12, 2013 Summary Preparation Date:
Names II.
| Device Name(s): | PASCAL® Synthesis™ Ophthalmic Scanning Laser
System |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Laser, Ophthalmic |
| Classification Name(s): | Laser Surgical Instrument for use in General and Plastic
Surgery and Dermatology; Laser, Powered |
Predicate Devices III.
- Optimedica Ophthalmic Scanning Laser System (K092621) .
- . Topcon Ophthalmic Scanning Laser System (K111108)
- Iridex TxCell Adaptor/Photocoagulator System (K121475) .
Product Description IV.
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is a stand-alone laser delivery console for use with a slit lamp. LIO or probe delivery. Controls and displays include an I.CD/Touchscreen user interface and a slit lamp connector (SLC). The system is equipped with a three-position key switch that enables laser and controls as well as an emergency off switch. An externally connected wired footswitch activator is provided with a shrouded housing, and contains a set of redundant switches. An external door interlock connection allows the laser to be terminated with an open circuit.
1
V. Summary of Non Clinical Tests
Topcon utilized hardware testing (60601-1, -2-x; EN ISO14971-C; ASTM 4169-09&6653-01; ASTM D4169-09). electromagnetic testing (IEC 60601-1-2. 4. 6) software testing (EN 60601-1-41 62304 and animal testing to establish a basis for the determination of equivalence. The PASCAL® Synthesis performance characteristics were established by referencing the known performance characteristics of the predicate device. Specifications for the PASCAL® Synthesis system were established to assure that the predicate system and the Synthesis system performed in an equivalent manner. Performance specifications were set utilizing national and international standards for such devices with respect to output, indications for use, safety features and electromagnetic interference where it was established as suitable for the environment of use. All testing was conducted and established that the PASCAL® Synthesis system met or exceeded its design specifications and performed equally or better than the stated performance of the predicate.
The objective of the animal study was to compare the appearance of retinal laser lesions produced by the PASCAL Synthesis system with the predicate PASCAL Streamline system in an animal model. This prospective comparative study included delivery of laser lesions to two animals in accordance with Good Laboratory Practices (GLP) standards and the local Animal Institutional Review Board. Multiple lesions using varying spot sizes and intensities were created with each of the two lasers and assigned a clinical grade by the laser operator on a 5 point scale. When comparing lesions of the same clinical grades, the appearance of the lesions was similar. The diameter of the lesions was Sincerely yours, For
Peter D Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
| 510(k) Number: K123542 | |
|---|---|
| Device Name: | Topcon PASCAL® Synthesis Ophthalmic Scanning Laser System |
The PASCAL® Synthesis Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation. focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: .
- (532nm)
- proliferative and non-proliferative diabetic retinopathy
- macular edema t
- choroidal neovascularization associated with wet age-related macular degeneration .
- . age-related macular degeneration
- . lattice degeneration
- . retinal tears and detachments
(577nm)
- . proliferative and non-proliferative diabetic retinopathy
- . macular édema
- . choroidal neovascularization associated with wet age-related macular degeneration
- . age-related macular degeneration
- ◆ lattice degeneration
- � retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm)
- iridotomy �
- trabeculoplasty .
X Prescription Use
(Per 21CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 801 Subpart C) ·
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Neil R Ogdens 2013.05.15 11:05:52 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123542