(76 days)
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.
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.
This document describes a 510(k) premarket notification for the Pascal™ Photocoagulator. A 510(k) submission seeks to demonstrate "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a study proving device performance is not applicable in this context.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This 510(k) submission does not establish or report against specific performance acceptance criteria from a clinical trial in the way a PMA submission might. Instead, it seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "performance" demonstrated is that the device has "the same or similar technological characteristics" as the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical "test set" and corresponding sample size are mentioned for proving specific performance criteria of the Pascal™ Photocoagulator in this document. The submission relies on non-clinical tests and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment by experts for a clinical study is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. The Pascal™ Photocoagulator is a laser surgical instrument, not an AI-assisted diagnostic or assistive device that would typically involve a multi-reader multi-case study for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (laser photocoagulator) and not an AI algorithm. Therefore, a "standalone algorithm performance" study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As no clinical study to prove novel performance criteria is detailed, no specific ground truth for such a study is mentioned. The "truth" in a 510(k) context is that the device is substantially equivalent to legally marketed predicate devices, based on technological characteristics and intended use.
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning algorithm or a "training set."
9. How the ground truth for the training set was established
- Not Applicable. Not applicable as there is no training set mentioned.
Summary of what is available from the document:
- Device Name: Pascal™ Photocoagulator
- Intended Use: Treatment of ocular pathology in both the posterior and anterior segments (detailed list provided).
- Basis for Clearance: Substantial equivalence to predicate devices (Lumenis Novus Varia, Laserex LP1 532, Iridex Oculight SL/SLx, Iridex Medical Oculight GL, Infinitech Slit Lamp Laser Adapter).
- Technological Characteristics Compared: 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.
- Nonclinical Tests: Performance test results, system and software hazard analysis information, and system and software verification and validation information were submitted. These are non-clinical and relate to safety and basic functional performance, not clinical efficacy or specific acceptance criteria met in a patient study.
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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 |
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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.
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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.
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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
§ 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.