(36 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and software modifications for performance enhancement, not AI/ML capabilities.
Yes
The 'Intended Use' section clearly states that the device is "Intended for use in the treatment of ocular pathology" for various conditions like diabetic retinopathy, macular edema, glaucoma, etc., which are therapeutic purposes.
No
The device description and intended use/indications for use clearly state that the PASCAL Photocoagulator is "intended for use in the treatment of ocular pathology," implying a therapeutic rather than 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 laser photocoagulation. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The device is a laser system used for treatment. It does not involve analyzing biological samples (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic laser system.
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 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 proposed PASCAL Photocoagulator includes design modifications to the performance specifications, available scan patterns, outer housing and software to enhance product performance. No changes to the laser or the product safety have been made. The PASCAL Photocoagulator maintains the same indication for use as the predicate device, the PASCAL Photocoagulator (K043486).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular pathology in both the posterior and anterior segments (retina, choroid, angle)
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 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
§ 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.
0
OptiMedica Corporation
PASCAL® PHOTOCOAGULATOR SPECIAL 510(k) PREMARKET NOTIFICATION
SECTION 6 510(k) SUMMARY (CONT.)
510(k) Notification K ( 99 1666
5
GENERAL INFORMATION
Applicant:
OptiMedica Corporation 3130 Coronado Drive Santa Clara, CA 95054 USA Phone: 408-850-8600 FAX: 408-850-8595
Contact Person:
Darlene Crockett-Billig Regulatory Consultant for OptiMedica Corporation 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 USA Phone: 408-400-0856 ext. 105 FAX: 408-400-0865 Email: dcb@experiengroup.com
Date Prepared: June 5, 2009
Classification:
21 CFR§878.4810, Class II 21 CFR§886.4390, Class II
Product Code: GEX, HQF
GEAR, HQ1
Trade Name: PASCAL® Photocoagulator
Generic/Common Name: Laser instrument, surgical, powered Laser, ophthalmic
Predicate Device PASCAL Photocoagulator (K043486)
JUL 1 5 2009
CONFIDENTIAL
25
1
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 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 proposed PASCAL Photocoagulator includes design modifications to the performance specifications, available scan patterns, outer housing and software to enhance product performance. No changes to the laser or the product safety have been made. The PASCAL Photocoagulator maintains the same indication for use as the predicate device, the PASCAL Photocoagulator (K043486).
Substantial Equivalence
The PASCAL Photocoagulator is substantially equivalent to the predicate device with regard to function, intended use and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed PASCAL 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 Photocoagulator to support a determination of substantial equivalence to the predicate device.
Summarv
The PASCAL Photocoagulator is substantially equivalent to the predicate device.
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird-like figure with three curved lines forming its body and wings. The emblem is black, and the text is also in a dark color, likely black or a dark shade of gray.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2009
Optimedica Corporation c/o Experien Group LLC. Darlene Crockett-Billig 155-A Moffit Park Drive, Suite 210 Sunnyvale, CA 94089
Re: K091666
Trade/Device Name: PASCAL Photocoagulator Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II . Product Code: GEX Dated: June 30, 2009 Received: July 1, 2009
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.
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 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.
3
Page 2 - Darlene Crockett-Billig
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/cdrl/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.
Sincerely yours,
urs,
lkerson
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
OptiMedica Corporation
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K 09 166 b
Device Name: PASCAL® Photocoagulator
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.
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 Eya
$\frac{\text{RP} \text{Sale}}{\text{(Division Sign-Off)}}$
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091666