(43 days)
Not Found
No
The summary describes a laser delivery device for ophthalmic treatment and does not mention any AI or ML capabilities.
No.
The device is a delivery system for a laser that performs the treatment, not a therapeutic device itself.
No
Explanation: The device is described as a "delivery device" used in conjunction with a compatible ophthalmoscopic examination lens to "view and treat" the patient's retina. Its intended use focuses on the treatment of various ocular pathologies rather than diagnosis.
No
The device description explicitly states it is a "delivery device that is worn on the physician's head" and is used "in conjunction with a compatible hand held ophthalmoscopic examination lens," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The PASCAL Laser Indirect Ophthalmoscope is a delivery device used in conjunction with a laser to treat ocular pathology by applying laser energy directly to the eye. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states treatment of ocular pathology, not diagnosis.
- Device Description: The description details a head-worn delivery device for viewing and treating the retina, consistent with a therapeutic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the PASCAL Laser Indirect Ophthalmoscope is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used in the treatment of ocular pathology in the posterior segment; retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
532nm
- macular edema
- age-related macular degeneration
- lattice degeneration
- retinal tears and detachments
577nm
- proliferative and nonproliferative diabetic retinopathy
- macular edema
- choroidal neovascularization
- branch and central retinal vein occlusion
- age-related macular degeneration
- lattice degeneration
- retinal tears and detachments
- retinopathy of prematurity
Intended for use in the treatment of ocular pathology in the anterior segment including:
577nm
- iridotomy
- trabeculoplasty
Product codes
HQF
Device Description
The PASCAL Laser Indirect Ophthalmoscope (LIO) with eye safety filter is a non-sterile, multiple use, delivery device that is worn on the physician's head and is used in conjunction with a compatible hand held ophthalmoscopic examination lens to view and treat the patient's retina. LIOs are used to treat patients in a supine position or who could not otherwise be treated using a slit lamp delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular (posterior segment, anterior segment, retina)
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)
Not Found
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 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
I. General Information
NOV 1 3 2012
| 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 |
October 22, 2012 Summary Preparation Date:
II. Names
| Device Name(s): | PASCAL® Laser Indirect Ophthalmoscope |
|---|---|
| Classification Name(s): | Laser Surgical Instrument for use in General and Plastic |
| Surgery and Dermatology |
III. Predicate Devices
- Optimedica Laser Indirect Ophthalmoscope (K062336) .
- . Topcon Laser Indirect Ophthalmoscope (K111108)
IV. Product Description
The PASCAL Laser Indirect Ophthalmoscope (LIO) with eye safety filter is a non-sterile, multiple use, delivery device that is worn on the physician's head and is used in conjunction with a compatible hand held ophthalmoscopic examination lens to view and treat the patient's retina. LIOs are used to treat patients in a supine position or who could not otherwise be treated using a slit lamp delivery system.
V. Intended Use & Indications for Use
The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used in the treatment of ocular pathology in the posterior segment; retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
1
532nm
- . macular edema
- age-related macular degeneration .
- lattice degeneration .
- . retinal tears and detachments
577nm
- proliferative and nonproliferative diabetic retinopathy .
- macular edema .
- choroidal neovascularization .
- . branch and central retinal vein occlusion
- . age-related macular degeneration
- . lattice degeneration
- retinal tears and detachments .
- retinopathy of prematurity .
Intended for use in the treatment of ocular pathology in the anterior segment including:
577nm
- iridotomv .
- trabeculoplasty .
Summary of Technological Characteristics VI.
The technological characteristics of the PASCAL® Laser Indirect Ophthalmoscope are substantially equivalent to those of the predicate devices.
| K062336 | K111108 | ||
|---|---|---|---|
| The PASCAL® Laser Indirect | Topcon LIO | LIO | |
| Ophthalmoscope Topcon | (formerly Optimedica; now | Accessory to Topcon PASCAL | |
| Medical Laser Systems | Topcon Medical Laser | Streamline Laser System | |
| Characteristics | Systems | ||
| Treatment Length | 577 ±2 nm or 532 ±2 nm | 532 ±2 nm | 577 ±2 nm |
| Aiming | 635 +10 nm | 635 +10 nm | 635 +10 nm |
| Wavelength | |||
| Eye Filter OD | > 5 @ 532 mm or > 5 @ 577 | ||
| nm | > 5 @ 532 nm | > 5 @ 577 nm | |
| Working Distance | 280 mm | 280 mm | 280 mm |
| Fiber Length | 5 meters | 5 meters | 5 meters |
| Aerial Spot Size | 1060 µm | 1060 µm | 1060 µm |
| Illumination | LED and DC Battery | Halogen Cabled to DC Base | Halogen Cabled to DC Base |
| Source | Station | Station | |
| Cooling System | Convection Cooled Air | Convection Cooled Air | Convection Cooled Air |
| Weight |