(119 days)
The PASCAL Streamline Photocoagulator indications for use are the following: Intended for use 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: - 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 Intended for use in the treatment of ocular pathology in the anterior segment including: - iridotomy - trabeculoplasty
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.
The PASCAL® Streamline™ Photocoagulator is designed for treating ocular pathology in both the posterior and anterior segments of the eye. Its indications for use include retinal photocoagulation, panretinal photocoagulation, focal photocoagulation, and grid photocoagulation for various vascular and structural abnormalities of the retina and choroid, such as proliferative and nonproliferative diabetic retinopathy, macular edema, choroidal neovascularization, branch and central retinal vein occlusion, age-related macular degeneration, lattice degeneration, and retinal tears and detachments. Additionally, it is indicated for use in the anterior segment for iridotomy and trabeculoplasty.
The document provided (K100019) is a 510(k) summary for the PASCAL® Streamline™ Photocoagulator, submitted by OptiMedica Corporation. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the PASCAL Streamline Photocoagulator (K092621), and not to conduct a study proving the device meets specific acceptance criteria with performance metrics.
Therefore, the provided text does not contain information regarding
acceptance criteria, device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) studies, standalone performance studies, types of ground truth, or details about the training set used in the development of the device.
Instead, the document focuses on demonstrating substantial equivalence based on function, intended use, and technological characteristics without raising new issues of safety or efficacy compared to the predicate device.
The document states:
- "All necessary bench testing was conducted on the modified PASCAL Streamline Photocoagulator to support a determination of substantial equivalence to the predicate device."
This indicates that internal bench testing was performed to justify the claim of substantial equivalence, but the specifics of these tests, including acceptance criteria and how they directly quantify "device performance" in the context of clinical outcomes or diagnostic accuracy, are not detailed.
Consequently, I cannot fill out the requested table or provide specific answers to questions 1-9 based on the provided text. The information needed to address those points, such as clinical study results, performance metrics like sensitivity/specificity, or details about AI algorithms and their validation studies, is not present in this 510(k) summary. This document is a regulatory submission for market clearance, not a report on a clinical trial or performance study against specific acceptance criteria.
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PASCAL® STREAMLINE™ PHOTOCOAGULATOR
SECTION 6 510(k) SUMMARY
510(k) Notification K100019
GENERAL INFORMATION
Applicant:
.
. *.
OptiMedica Corporation 3130 Coronado Drive Santa Clara, CA 95054 U.S.A. Pone: 408-850-8600 FAX: 408-850-8595
MAY - 4 2010
Contact Person:
Darlene Crockett-Billig President Experien Group, LLC 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:
April 12, 2010
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 Streamline Photocoagulator (K092621)
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SECTION 6 510(k) Summary
Intended Use
The PASCAL Streamline Photocoagulator indications for use are the following:
Intended for use 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:
- proliferative and nonproliferative diabetic retinopathy 지
- 트 macular edema
- 포 choroidal neovascularization
- branch and central retinal vein occlusion 트
- age-related macular degeneration 트
- 트 lattice degeneration
- retinal tears and detachments 에
Intended for use in the treatment of ocular pathology in the anterior segment including:
- iridotomy ■
- ı trabeculoplasty
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 modified 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 modified 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 modified 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.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY ~ 4 2010
OptiMedica Corporation % Experien Group, LLC Ms. Darlene Crockett-Billig President 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089-1330
Re: K100019
Trade/Device Name: PASCAL® Streamline™ Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Opthalmic laser Regulatory Class: Class II Product Code: HQF Dated: April 12, 2010 Received: April 13, 2010
Dear Ms. Crockett-Billig:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Darlene Crockett-Billig
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M. Millers
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K100019
Device Name: PASCAL Streamline Photocoagulator
Indications for Use:
The PASCAL Streamline Photocoagulator indications for use are the following:
Intended for use 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:
- l proliferative and nonproliferative diabetic retinopathy
- 트 macular edema
- י choroidal neovascularization
- 피 branch and central retinal vein occlusion
- צ age-related macular degeneration
- lattice degeneration
- retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including:
- 트 iridotomy
- M trabeculoplasty
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 RP Ohle for MXA
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100019
§ 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.