(30 days)
Not Found
No
The document describes a laser photocoagulator system and its intended uses, but there is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The description focuses on the hardware components and the laser treatment capabilities.
Yes
The device is intended for the treatment of various ocular pathologies, which is a therapeutic purpose.
No
The device is described as a "Photocoagulator" intended for "treatment of ocular pathology," performing procedures like "retinal photocoagulation" and "iridotomy, iridectomy and trabeculoplasty." This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly states it is an "integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of ocular pathology using photocoagulation. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a photocoagulator system comprising lasers, control electronics, a user interface, slit lamp, and table. This aligns with a therapeutic device used directly on the patient's eye.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to treat conditions, not to diagnose them through in vitro analysis.
N/A
Intended Use / Indications for Use
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- 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 .
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.
Product codes
GEX, HQF
Device Description
The PASCAL Streamline Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
All necessary bench testing was conducted on the proposed PASCAL Streamline Photocoagulator to support a determination of substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OPTIMEDICA CORPORATION
PASCAL® STREAMLINE™ PHOTOCOAGULATOR SPECIAL 510(k) PREMARKET NOTIFICATION
SECTION 6 510(k) SUMMARY (CONT.)
| 510(k) Notification K_09262 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|---|
| -- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
GENERAL INFORMATION
Applicant:
OptiMedica Corporation 3130 Coronado Drive Santa Clara, CA 95054 U.S.A. Pone: 408-850-8600 FAX: 408-850-8595
Contact Person:
Darlene Crockett-Billig President Experien Group 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 U.S.A. Phone: 408-400-0856 ext. 105 FAX: 408-400-0865 Email: dcb(@experiengroup.com
Date Prepared: August 25, 2009
Classification:
21 CFR§878.4810, Class II 21 CFR§886.4390, Class II
Product Code: GEX, HQF
Trade Name: PASCAL® Streamline™ Photocoagulator
Generic/Common Name: Laser instrument, surgical, powered
Laser, ophthalmic
Predicate Device
PASCAL Photocoagulator (K091666)
SEP 2 5 2009
1
OPTIMEDICA CORPORATION
SECTION 6 510(k) SUMMARY (CONT.)
Intended Use
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- 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 .
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.
Product Description
The PASCAL Streamline Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Substantial Equivalence
The PASCAL Streamline Photocoagulator is substantially equivalent to the predicate device with regard to function, intended use and performance. Any differences in the technological characteristics between the two devices do not raise any new issues of safety or efficacy. Thus, the proposed PASCAL Streamline Photocoagulator is substantially equivalent to the predicate device.
Testing in Support of Substantial Equivalence Determination
All necessary bench testing was conducted on the proposed PASCAL Streamline Photocoagulator to support a determination of substantial equivalence to the predicate device.
Summary
The PASCAL Streamline Photocoagulator is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 5 2009
OptiMedica Corporation % Experien Group, LLC Ms. Darlene Crocket-Billig 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089-1330
Re: K092621
Trade/Device Name: PASCAL Streamline Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: August 25, 2009 Received: August 26, 2009
Dear Ms. Crocket-Bilig:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Darlene Crocket-Billig
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
- ok
Sincerely yours,
Williain A. Gray.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
OPTIMEDICA CORPORATION
PASCAL® STREAMLINE™ PHOTOCOAGULATOR SPECIAL 510(k) PREMARKET NOTIFICATION
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 0 92621
Device Name: PASCAL Streamline Photocoagulator
Indications for Use:
ﺎ ﻟﻠﻤﺴﺎﺭ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
The PASCAL Streamline Photocoagulator indications for use are the following:
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- . proliferative and nonproliferative diabetic retinopathy
- 트 macular edema
- 트 choroidal neovascularization
- I branch and central retinal vein occlusion
- K age-related macular degeneration
- 트 lattice degeneration
- retinal tears and detachments 트
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle E glaucoma.
Prescription Use X (21 CFR Part 801 Subpart D) and/Or
Over the Counter Use · (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil K Ogden for men
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092621