(90 days)
THIS DEVICE IS INDICATED FOR USE TO PERFER 1 PHOTOCo.9 GULATION TREATHENTS INSUDE THE EYE LASER ાં. ૮ . PANKETINAL PHOTOCOAGULATION, MACULAR TREATHENTS, ENDO PHOTO COLLIATION TO CILIARY PROCESSES, LASER TRABECUPLASTY ) , DURING SURGEAL INTERVENTIONS e g .: TRANS PARS PLANA VITRECTOry Si4 To 532 nm THE OPERATING WAVELENGTH IS
This device consists of the following parts already connected to each other: - Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber. - A special connector that attaches the fiber end to the laser source. - A flexible plastic jacket covers the length of the fiber.
The provided text is a 510(k) summary for the "20g and 25g SMA Laser Fibers". It does not describe an AI/ML device or a study involving acceptance criteria for such a device. Instead, it demonstrates substantial equivalence to a predicate device based on technological characteristics.
Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth for training sets is not applicable to this document.
However, I can extract the relevant information from the provided text to demonstrate the comparison made for substantial equivalence.
Device: 20g and 25g SMA Laser Fibers (K021696)
Predicate Device: LightLas 532 Ophthalmic Photocoagulator Laser from Light med Corporation (K010372)
Acceptance Criteria and Reported Device Performance (Comparison for Substantial Equivalence):
The submission demonstrates substantial equivalence by comparing technological characteristics to a predicate device. The "acceptance criteria" here is met if the new device is shown to be "identical" or "similar" to the predicate in key areas, as summarized below.
| Characteristic | Predicate Device Performance / Status | New Device Performance (Comparison Result) |
|---|---|---|
| Indications for use | (Implied: as per predicate) | Identical |
| Target population | (Implied: as per predicate) | Identical |
| Design | (Implied: as per predicate) | Similar |
| Materials | (Implied: as per predicate) | Similar |
| Performance | (Implied: as per predicate) | Identical |
| Sterility | (Implied: as per predicate) | Similar (Ethylene Oxide) |
| Biocompatibility | (Implied: as per predicate) | Similar |
| Mechanical safety | (Implied: as per predicate) | Similar |
| Chemical safety | (Implied: as per predicate) | Similar |
| Anatomical sites | (Implied: as per predicate) | Identical |
| Human factors | (Implied: as per predicate) | Identical |
| Energy used and/or delivered | (Implied: as per predicate) | Identical |
| Compatibility with environment and other devices | (Implied: as per predicate) | Identical |
| Where used | (Implied: as per predicate) | Identical |
| Standards met | (Implied: as per predicate) | Similar |
| Electrical safety | (Implied: as per predicate) | Identical (not applicable) |
| Thermal safety | (Implied: as per predicate) | Identical (not applicable) |
| Radiation safety | (Implied: as per predicate) | Identical (not applicable) |
Since this is a 510(k) for a medical device (laser fiber) and not an AI/ML device, the following points are not applicable and cannot be extracted from the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable. This is a comparison of engineering characteristics, not a clinical study on a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of "ground truth" established by experts in this type of submission.
- Adjudication method for the test set: Not applicable.
- 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. This is not an AI/ML device.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
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510(k) Summary As Required by 21 section 807.92 ( c )
AUG 2 0 2002
1-Submitter Name: OphthalMed LLC
1308 Morningside Park Dr 2-Address:
Alpharetta, GA 30022 USA
3-Phone: (678) 908- 8180
(425) 795- 9341 4-Fax:
5-Contact Person: Jay Mansour
6-Date summary prepared: April 8th, 2002
7-Device Trade or Proprietary Name: 20g and 25g SMA Laser Fibers
8-Device Common or usual name: Ophthalmic laser
9-Device Classification Name: Ophthalmic laser
10-Substantial Equivalency is claimed against the following device:
LightLas 532 Ophthalmic Photocoagulator Laser from Light med Corporation (510k #K010372) Refer to Appendix 1 for details.
11-Description of the Device:
This device consists of the following parts already connected to each other:
- Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber.
- A special connector that attaches the fiber end to the laser source.
- A flexible plastic jacket covers the length of the fiber.
12-Intended use of the device:
This device is indicated for use to perform laser photocoagulation treatments inside the eye (i.e., panretinal photocoagulation, macular treatments, endophotocoagulation to ciliary processes, laser trabeculoplasty), during surgical interventions (e.g.: trans pars plana vitrectorny). The operating wavelength is 514 to 532 nm.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.
{1}------------------------------------------------
| FDA file reference number | 510k 010372 |
|---|---|
| Attachments inside notificationsubmission file | Appendix 1 to 5 |
| TECHNOLOGICALCHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide) |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environmentand other devices | Identical |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
.
24
P8
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2002
Mr. Jay Mansour Director, QA/RA OpthalMed LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K021696
Trade/Device Name: 20G SMA Laser Fiber, Model LF20; 25G SMA Laser Fiber, Model LF25 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: GEX Dated: May 16, 2002 Received: May 22, 2002
Dear Mr. Mansour:
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 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, 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); 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 - Mr. Jay Mansour
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html .
Sincerely yours,
Mark A. Wilkerson
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__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (il known): 502 1696 (20g & 25 g Device Name: SHA LASER FINER Indications For Use:
THIS DEVICE IS INDICATED FOR USE TO PERFER 1 PHOTOCo.9 GULATION TREATHENTS INSUDE THE EYE LASER ાં. ૮ . PANKETINAL PHOTOCOAGULATION, MACULAR TREATHENTS, ENDO PHOTO COLLIATION TO CILIARY PROCESSES, LASER TRABECUPLASTY ) , DURING SURGEAL INTERVENTIONS e g .: TRANS PARS PLANA VITRECTOry Si4 To 532 nm THE OPERATING WAVELENGTH IS
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliman
Division Sign Off
ivision Sign-Off) on of General, Restorative and Neurological
Prescription Use.............................................................................................................................................................. 216 9 Vest - 11
(Optional Formal 1-2-96)
p143
§ 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.