For use to perform endo-ocular laser photocoaguation treatments, with illumination, aspiration and back-wash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm.

Device Description

This device consists of the following parts already connected to each other: Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye. 8 ft fiber. A special connector that attaches the laser fiberoptic end to the laser source. A special connector that attaches the illumination fiberoptic end to the illumination source Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine A flexible plastic jacket covers the length of the fiberoptics and tubes. Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (OphthalMed 20g SMA Laser/Illumination/Aspiration/Back-wash probes, Model LF100). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with acceptance criteria and precise performance metrics in the way one might expect for a novel device requiring a full premarket approval (PMA) or de novo classification.

Therefore, the study described does not include typical acceptance criteria, a test set with ground truth, or an MRMC study. Instead, it relies on a comparative analysis against existing predicate devices to assert safety and effectiveness.

Here’s a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" defined in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) of the new device itself. Instead, the "acceptance criteria" are implicitly that the new device's technological characteristics and performance are "similar" or "identical" to those of the predicate devices.

Characteristic	Comparison Result to Predicate Devices (510k #K021696, #K982462, #K946135)
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Similar (Ethylene Oxide)
Biocompatibility	Similar (Identical for K021696 and K982462)
Mechanical safety	Similar
Chemical safety	Similar
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical (Similar for K021696 and K982462)
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical (not applicable)
Thermal safety	Identical (not applicable)
Radiation safety	Identical (not applicable)

The "reported device performance" is not quantified with specific numerical values for the new device. Instead, its performance is deemed similar to that of the predicate devices. The safety and effectiveness are "better expressed in the tabulated comparison" by showing these similarities.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This type of 510(k) submission does not typically involve a "test set" in the sense of a dataset used to evaluate a diagnostic algorithm. It relies on a comparison of design, materials, and intended use to existing devices. There is no mention of clinical data or studies involving human subjects in this summary for the purpose of demonstrating device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No test set or ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. No test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC study. The comparison is against predicate devices' characteristics, not a study involving human readers with and without AI assistance. The device itself is a surgical tool, not an AI diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. The device is a surgical probe, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. There is no mention of a ground truth in the context of device performance data. The "truth" in this submission is the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no mention of a training set or its ground truth.

Summary of the Study and Acceptance Criteria:

The "study" presented is a comparative analysis demonstrating substantial equivalence to legally marketed predicate devices. The acceptance criteria are that the new device's technological characteristics (indications, target population, design, materials, performance, safety features, etc.) are similar or identical to those of the predicate devices. The document tables these characteristics and directly states "Identical" or "Similar" for each, effectively demonstrating that these criteria are met. This approach avoids the need for new, extensive clinical trials to prove safety and effectiveness, as it leverages the established safety and effectiveness of the predicate devices.

Summary

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SEP 2 1 2005

K050807

510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name: OphthalMed LLC 1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA (678) 908- 8180 3-Phone: (678) 623- 3765 4-Fax: 5-Contact Person: Jay Mansour 6-Date summary prepared: July 14th, 2005

7-Device Trade or Proprietary Name: 20g SMA Laser/Illumination/Aspiration/Back-wash probes. Model LF100

8-Device Common or usual name: (1) Ophthalmic laser, (2) Endoillumination probe and (3) vitreous aspiration

(1) Ophthalmic laser, (2) Light, surgical, fiberoptic and 9-Device Classification Name: (3) Instrument, vitrous aspiration and cutting

10-Substantial Equivalency is claimed against the following device:

20g and 25g SMA Laser Fibers, Model LF20 and LF25 from OPHTHALMED LLC (510k #K021696), as well as 510k #K982462 and K946135.

11-Description of the Device:

This device consists of the following parts already connected to each other:

Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye.
8 ft fiber.
A special connector that attaches the laser fiberoptic end to the laser source.
A special connector that attaches the illumination fiberoptic end to the illumination source
Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine
A flexible plastic jacket covers the length of the fiberoptics and tubes.

Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation.

12-Intended use of the device:

For use to perform endo-ocular laser photocoagulation treatments, with illumination, aspiration and backwash during surgical interventions. The operating wavelength is 500 nm to 1,100 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:

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Please find below a tabulated comparison supporting that this device is substantially equivalent
and submit and the supportion distribution I fease find before a laes in commercial distribution.

FDA file referencenumber	TECHNOLOGICALCHARACTERISTICS	510k #K021696 forlaserComparison result	510k #K982462 forilluminationComparison result
Indications for use	Identical	Identical	Identical
Target population	Identical	Identical	Identical
Design	Similar	Similar	Similar
Materials	Similar	Similar	Similar
Performance	Similar	Similar	Similar
Sterility	Similar (EthyleneOxide)	Similar (Ethylene Oxide)	Similar (Ethylene Oxide)
Biocompatibility	Similar	Identical	Identical
Mechanical safety	Similar	Similar	Similar
Chemical safety	Similar	Similar	Similar
Anatomical sites	Identical	Identical	Identical
Human factors	Identical	Identical	Identical
Energy used and/ordelivered	Identical	Similar	Similar
Compatibility withenvironment and otherdevices	Identical	Identical	Identical
Where used	Identical	Identical	Identical
Standards met	Identical	Identical	Identical
Electrical safety	Identical (notapplicable)	Identical (not applicable)	Identical (not applicable)
Thermal safety	Identical (notapplicable)	Identical (not applicable)	Identical (not applicable)
Radiation safety	Identical (notapplicable)	Identical (not applicable)	Identical (not applicable)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OphthalMed LLC c/o Mr. Jay Mansour Director, QA and Regulatory Affairs 1308 Morningside Park Dr. Alpharetta, GA 30022

Re: K050807

KU50807
Trade/Device Name: OphthalMed 20G SMA Laser/Illumination/Aspiration/A Back-wash probe, Model LF100

Regulation Number: 21 CFR 886.4390 Regulation: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: August 31, 2005 Received: September 1, 2005

Dear Mr. Mansour:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premaintly equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and nave determined the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced promotions of the Federal Food. Device American Food. Drug commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reculted in accordance with as proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The Act. The
You may, therefore, market the device, subject to the gener You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements michronding and general controls provisions of the net network of the measure misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) the existing major regulations affecting your device and may be subject to such additional controlls. Existing may of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peachar Ingerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a backers on the other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decernmanon that Jour access as agencies. You must of of any Federal statutes and regulations as including, but not limited to: registration and listing comply with all the Act 3 requirements, meaths, good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the ologtrop (2) CFR Part 807); labelling (21 CFR Part 820); good art 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party 11 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Jay Mansour

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket nothication. The PDA miding of bassification 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
s antiled If you desire specific advice for your don'ter at (301) 827-8910. Also, please note the regulation entitled,
contact the Office of Compliance at (301) 827-8910. Also, pleas contact the Office of Complance at (501) 627 627 627 67 67 807.97). You may obtain " Misbranding by relectice to premance notifical varies and er the Act from the Division of Small other general Information on your responsible and its toll-free number (800) 638-2041 or Manufacturers, International and Oolisanter : 15566777 or and industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K050807

Device Name: Laser/Illumination/Aspiration/Back-wash probe, LF100

Indications For Use:

For use to perform endo-ocular laser photocoaguation treatments, with illumination,
the sub-For use to perform endo-ocular laser photocoaguation area.home, while havelength is 500nm
aspiration and back-wash during surgical interventions. The operating wavelength is to 1,100nm.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C. C. Claussen
(Division Sign-Off)
Division of Ophthalmic Ear

Division of Ophthalmic Ear, Nose and Throat Devises

K050807 510(k) Number _

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.