(76 days)
Not Found
No
The summary describes a laser photocoagulator system with standard components and does not mention any AI or ML capabilities.
Yes
The device is intended for the "treatment of ocular pathology" and lists several specific conditions it treats, confirming its therapeutic purpose.
No
The device description and indications for use clearly state that the Pascal Photocoagulator is intended for "treatment of ocular pathology," not for diagnosis.
No
The device description explicitly states it is an "integrated system comprising solid state aiming and treatment lasers, control electronics, graphical user interface, slit-lamp, and table," indicating it includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This process happens outside the body ("in vitro").
- Pascal Photocoagulator Function: The Pascal Photocoagulator is a laser system used for treating ocular pathology directly on the patient's eye. It applies laser energy to tissue to achieve a therapeutic effect (photocoagulation). This is an in vivo (within the living body) procedure.
The provided information clearly describes a device used for surgical treatment, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Pascal 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
- 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 (comma separated list FDA assigned to the subject device)
GEX, HOF
Device Description
The Pascal laser photocoagulator is an integrated system comprising 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular (posterior and anterior segments)
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)
Performance test results, as well as system and software hazard analysis information and system and software verification and validation information, have been submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based on the comparison of the technical characteristics between the Pascal Retimal Photocoagulator and the predicate laser systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K022181, K972514, K020374, K960971, K971950
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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
MAR 3 - 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's name, address, telephone number, contact person, and date 1. summary prepared:
- a. Applicant:
SECTION 11
OptiMedica Corporation 1793 Lafayette Street Suite 105 Santa Clara, Ca. 95051
- b. Contact Person:
Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc.
Rudy Dordon
Date Summary Prepared: c.
December 10, 2004
2. Name of device, including trade name and classification name:
Trade/Proprietary Name:
Classification:
Pascal™ Photocoagulator
GEX 21 CFR 878.4810 Laser instrument, surgical, powered
HOF 21 CFR 886.4390 Laser, ophthalmic
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
510(K) | Company | Device Name |
---|---|---|
K022181 | Lumenis, Inc. | Lumenis Novus Varia |
K972514 | Laserex Systems | Laserex LP1 532 |
K020374 | Iridex Corporation | Iridex Oculight SL/SLx |
K960971 | Iridex Corporation | Iridex Medical Oculight GL |
K971950 | Infinitech, Inc. | Infinitech Slit Lamp Laser Adapter |
1
4. A description of the device that is the subject of the 510(k):
The Pascal laser photocoagulator is an integrated system comprising 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.
5. Statement of intended use:
The Pascal 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
- macular edema
- 트 choroidal neovascularization
- . branch and central retinal vein occlusion
- age-related macular degeneration
- . lattice degeneration
- 이 retinal tears and detachments
- 에 Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.
6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.
The Pascal™ Retinal Photocoagulator system shares the same intended use, indications for use and the same or similar technological characteristics (including treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot size, semi-automatic repeat mode, controls and displays, laser energy delivery control (foot switch), and slit lamp delivery, and therefore is substantially equivalent to the predicate devices referenced in Item 3.
7. Brief summary of nonclinical tests and results:
Performance test results, as well as system and software hazard analysis information and system and software verification and validation information, have been submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based on the comparison of the technical characteristics between the Pascal Retimal Photocoagulator and the predicate laser systems.
8. Conclusion
The Pascal Retinal Photocoagulator is substantially equivalent to similar predicate laser devices and slit lamp delivery systems. The Pascal Retinal Photocoagulator shares the same intended use, indications for use, and technological characteristics as the predicate ophthalmic laser systems.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 - 2005
OptiMedica Corporation c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, California 92612
Re: K043486
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: II Product Code: GEX Dated: December 14, 2004 Received: December 17, 2004
Dear Dr. Gordon:
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 such 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, I'DA 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 complics 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); 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 - Judy F. Gordon, D.V.M.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ocgin manistang , .
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated on: "The classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spoonly and 101-10-10115. Also, please note the regulation entitled, Connact the Oriece of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uriam C. Parret
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
KO43486 510(k) Number (if known):
Pascal™ Photocoagulator Device Name:
Indications for Use:
The Pascal 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
- 포 macular edema
- 해 choroidal neovascularization
- branch and central retinal vein occlusion 트
- 트 age-related macular degeneration
- 이 lattice degeneration
- 트 retinal tears and detachments
- Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma. I
Muriam C. Provost
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K043456
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use X
OR
Over-The-Counter Use (Optional Format 1-2-96)
OptiMedica TMCorporation Pascall M Photocogoulator
Volume I, Page 5