The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared.

Device Description

The Cook Holmium Laser Fiber is intended for incision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared. The devices are supplied sterile in peel-open packages. The multi-use fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in six sizes, and will be sold in boxes of three.

AI/ML Overview

The provided text describes a 510(k) submission for the Cook Holmium Laser Fiber. This type of submission is for medical devices, not AI/ML algorithms, so many of the requested fields are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Tensile Testing	Results provide reasonable assurance of design and conformance to intended use.
Bend Radius Testing	Results provide reasonable assurance of design and conformance to intended use.
Energy Loss Testing	Results provide reasonable assurance of design and conformance to intended use.
Accelerated Aged Testing	Results provide reasonable assurance of design and conformance to intended use.
Biocompatibility Testing	Results provide reasonable assurance of design and conformance to intended use.

Note: The document states "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria and detailed performance metrics are not provided in this summary document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. The tests listed are for verifying the physical and functional properties of the laser fiber itself, not for assessing performance on a dataset of patient data.

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

This information is not applicable as the device is a laser fiber and it does not use a ground truth established by experts in the context of medical image analysis or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of device and testing 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

This information is not applicable as the device is a medical instrument (laser fiber), not an AI/ML diagnostic or assistive technology.

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

This information is not applicable as the device is a medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. The "ground truth" for a physical device like a laser fiber typically involves engineering specifications and performance standards rather than clinical diagnostic ground truth.

8. The sample size for the training set

This information is not applicable as there is no training set for a physical medical device.

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

This information is not applicable as there is no training set involved in the development or clearance of this type of medical device.

Summary

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K124030 Page 1 of 2

510(k) SUMMARY

Submitted By:

David Chadwick, Ph.D., RAC, FRAPS Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812)339-2235 Ex. 2330 Fax: (812)332-0281

Device:

Trade Name: Common Name: Classification Name: Cook Holmium Laser Fiber Laser Fiber Laser Instrument, Surgical, Powered GEX (21 CFR §878.4810)

Indications for Use: .

Predicate Device:

The Cook Holmium Laser Fiber is similar to the predicate device (OptiLite™ Holmium Laser Fibers; K073496) in terms of intended use, principles of operation, materials of construction, and technological characteristics.

Comparison to Predicate Device:

Cook Incorporated (formally Cook Urological, Inc.) currently markets the predicate OptiLite™ Holmium Laser Fiber cleared for marketing on January 23, 2008 (K073496). The similar indications for use, principles of operation, and technological characteristics of the Cook Holmium Laser Fibers as compared to the predicate device support a determination of substantial equivalence.

Device Description:

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K124030 Page 2 of 2

Test Data:

The proposed Cook Holmium Laser Fiber was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

Tensile Testing .
Bend Radius Testing .
Energy Loss Testing .
. Accelerated Aged Testing
. Biocompatibility Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use. .

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes above three wave-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 1, 2013

Cook Incorporated % Ms. Connie Rice, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404

Re: K124030

Trade/Device Name: Cook Holmium Laser Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology

Regulatory Class: Class II Product Code: GEX Dated: June 11, 2013 Received: June 12, 2013

Dear Ms. Rice:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Connie Rice, RAC

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K.124030

Device Name: Cook Holmium Laser Fiber

Indications for Use for the Cook Holmium Laser Fiber:

Prescription Use XX

Over-the-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Neil R Ogden
2013.07.01 14:51:48 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number K 124030

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.