These devices are reprocessed laser probes from various original equipment manufacturers (OEMs). Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment.

Device Description

Laser probes are an accessory used as part of a laser delivery system. They consist of a probe handpiece, strain relief, fiber optic cable, and connector. A laser light pipe may or may not be part of the probe. The probes must be connected to a laser console in order to deliver energy. The laser probe delivers the energy to the treatment site through an opening at the probe tip. Note, this submission is only in regard to the laser probe itself. It does not pertain to any other part of a laser delivery system such as the console.

AI/ML Overview

The provided text describes a 510(k) premarket notification for SterilMed's Reprocessed Laser Probes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel medical device. Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC study, ground truth details, training set information) are not explicitly detailed in the provided summary.

Here's a breakdown of the information that can be extracted and a note on what is not available from the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Demonstration of substantial equivalence to predicate device(s) in terms of functional design, indications for use, and principles of operation.	"SterilMed's reprocessed laser probes are substantially equivalent to HGM Inc.'s Fleischman-Swartz Endo-Ocular Probe (K840590), and to the counterpart devices from the original manufacturers."
Reprocessed probes must maintain appropriate functional characteristics after reprocessing.	"Representative samples of reprocessed laser probes underwent bench testing to demonstrate appropriate functional characteristics."
Reprocessing procedures (cleaning and sterilization) must be validated.	"Process validation testing was done to validate the cleaning and sterilization procedures..."
Device packaging must be validated.	"...as well as the device packaging."
Manufacturing process must include visual and functional testing of all produced products.	"In addition, the manufacturing process includes visual and functional testing of all products produced."
Intended Use remains consistent with predicate: Part of a laser delivery system, used in ophthalmic procedures where laser energy is the mode of treatment.	Confirmed as the intended use for the reprocessed probes.
Device Description remains consistent with predicate: Consists of probe handpiece, strain relief, fiber optic cable, and connector. May or may not have a laser light pipe. Connects to a laser console.	Confirmed as the device description for the reprocessed probes.

2. Sample size used for the test set and the data provenance

The document mentions "Representative samples of reprocessed laser probes" were used for bench testing and process validation. It does not provide specific sample sizes for these tests. Data provenance is not specified (e.g., country of origin) and the study is for device reprocessing validation, not an AI/diagnostic study, so retrospective/prospective does not apply in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a 510(k) submission for a reprocessed medical device, not a study involving expert-established ground truth for diagnostic accuracy. The testing involves functional and sterilization validation.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies, which is not the nature of this submission.

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

N/A. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This is not an algorithm-based device. The "standalone" performance refers to the reprocessed device's inherent functional characteristics, as determined by bench and validation testing.

7. The type of ground truth used

For the functional and safety testing, the "ground truth" would be established engineering specifications and performance standards for laser probes. For cleaning and sterilization, it would be established microbiological and chemical validation standards.

8. The sample size for the training set

N/A. This is not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established

N/A. No training set for this device.

Summary

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K012682

SECTION 2. SUMMARY AND CERTIFICATION

510(k) SummaryA.	NOV 0 8 2001
Submitter:	SterilMed, Inc.
Contact Person:	Patrick Fleischhacker11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 888-856-4870Fax: 763-488-3350
Date Prepared:	August 10, 2001
Trade Name:	SterilMed Reprocessed Laser Probes
Classification Name:	Laser, Ophthalmic
Classification Number:	Class II, 21 CFR 886.4390
Product Code:	HQF
Predicate Device(s):	SterilMed's reprocessed laser probes are substantiallyequivalent to HGM Inc.'s Fleischman-Swartz Endo-OcularProbe (K840590), and to the counterpart devices from theoriginal manufacturers.
Device Description:	Laser probes are an accessory used as part of a laserdelivery system. They consist of a probe handpiece, strainrelief, fiber optic cable, and connector. A laser light pipemay or may not be part of the probe. The probes must beconnected to a laser console in order to deliver energy. Thelaser probe delivers the energy to the treatment site throughan opening at the probe tip. Note, this submission is only inregard to the laser probe itself. It does not pertain to anyother part of a laser delivery system such as the console.
Intended Use:	Reprocessed laser probes are part of a laser delivery systemand are used in ophthalmic procedures where laser energyis the mode of treatment.
Functional andSafety Testing:	Representative samples of reprocessed laser probesunderwent bench testing to demonstrate appropriate

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012682 2/2

functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

Conclusion:

SterilMed's reprocessed laser probes are substantially equivalent to HGM Inc.'s Fleischman-Swartz Endo-Ocular Probe (K840590), and to the counterpart devices from the original manufacturers. This conclusion is based upon the fact that these devices are essentially identical to the predicate device in terms of functional design, indications for use, and principles of operation.

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Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 82001

Mr. Patrick Fleischhacker Vice President Regulatory and Quality Control SterilMed, Inc. 11400 73rd Avenue, North Minneapolis, Minnesota 55369

Re: K012682

Trade Name: Reprocessed Laser Probe Regulation Number: 886.4390 Regulation Name: Laser, ophthalmic Regulatory Class: Class II Product Code: GEX; HQF Dated: August 10, 2001 Received: August 14, 2001

Dear Mr. Fleischhacker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, 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.

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Page 2 - Mr. Patrick Fleischhacker

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,

Susan Walker, MD

Image /page/3/Picture/5 description: The image contains a black and white drawing of a signature. The signature appears to be cursive and somewhat stylized. The first letter is a large loop, and the rest of the signature is a series of connected strokes.

Celia M. Witten, Ph.D., M.D. S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOi2682

Indications for Use Page

Device Name: Reprocessed Laser probes

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Walker

(Division Sign- Off) Division of Ge eral, Restorative and Neurological Devices

510(k) Number

K0126sf2

Regulation Number and Section

§ 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.