Used for incision/excision, ablation, and coagulation (hemostasis) when attached to a cleared Ho:Y AG laser system comprised of any standard SMA-type comector and an output power of up to 100 watts, for the indications for which the system has been cleared.

Device Description

The Cook Holmium Laser Fibers are supplied sterile in peel-open packages. The multiuse 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 sizes, and will be sold in boxes of three.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Cook Holmium Laser Fiber":

The document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for AI-based systems. As such, the information provided relates to engineering and performance testing for a medical device, not an AI or software-as-a-medical device (SaMD). Therefore, many of the requested points regarding AI/algorithm performance, ground truth, experts, and MRMC studies are not applicable.

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Tensile Testing	The tensile force during proper clinical use should not fracture the materials and/or bonds.	Testing shows the tensile force during proper clinical use should not fracture the materials and/or bonds. (Implies criteria met)
Bend Radius Testing	Fibers must meet minimum bend radius requirements.	Testing shows that the fibers met the minimum bend radius requirements. (Implies criteria met)
Energy Transmission Testing	Fibers must transmit laser energy with not more than 20% loss from laser output to fiber output.	Testing shows that fibers transmit laser energy with not more than 20% loss from laser output to fiber output. (Implies criteria met)
Accelerated Aged Testing	Devices accelerated-aged to the equivalent of three years must meet performance requirements for tensile, bend radius, and energy transmission testing.	Testing shows that devices accelerated-aged to the equivalent of three years meet performance requirements for tensile, bend radius, and energy transmission testing. (Implies criteria met)
Biocompatibility Testing (ISO 10993-1)	The device must be biocompatible in conformance with ISO 10993-1.	Testing, in conformance with ISO 10993-1, shows the device is biocompatible. (Implies criteria met)
Laser System Compatibility Testing	The Cook Holmium Laser Fiber must be compatible with other cleared Ho:YAG laser systems.	Testing shows that the Cook Holmium Laser Fiber is compatible with other cleared Ho:YAG laser systems. (Implies criteria met)
Steam Sterilization Validation	The Cook Holmium Laser Fiber must be compatible with recommended autoclave cycles for sterility and functionality.	Testing shows that the Cook Holmium Laser Fiber is compatible with recommended autoclave cycles for sterility and functionality. (Implies criteria met)
Sterrad Sterilization Validation	The fiber must be compatible with recommended Sterrad cycles for sterility and functionality.	Testing shows that the fiber is compatible with recommended Sterrad cycles for sterility and functionality. (Implies criteria met)
Cleaning Validation	The fiber must be compatible with recommended cleaning procedures.	Testing shows that the fiber is compatible with recommended cleaning procedures. (Implies criteria met)

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

Sample Size: Not explicitly stated for any of the individual tests. The document only mentions "testing shows" without detailing the number of units tested.
Data Provenance: Not applicable in the context of device performance testing. These are laboratory/bench tests, not clinical data from patients.

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. This is for a physical medical device, not an AI or diagnostic algorithm requiring expert ground truth in a clinical sense.

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

Not applicable. This is for a physical medical device, not an AI or diagnostic algorithm requiring adjudication of clinical results.

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. This is for a physical medical device (laser fiber), not an AI-assisted diagnostic tool.

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

Not applicable. This is for a physical medical device, not an AI algorithm. The device's performance is standalone in the sense that it functions physically, but it requires a human operator and a laser system.

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

Not applicable in the clinical sense. The "ground truth" for these engineering tests would be established engineering standards, material properties, and measurement results, not clinical diagnoses or outcomes. For example, for "Energy Transmission Testing," the ground truth is simply the measured laser energy loss.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2015

Cook Incorporated Mr. David E. Chadwick 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

Re: K133788

Trade/Device Name: Cook Holmium Laser Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: Class II Product Code: GEX Dated: March 2, 2015 Received: March 3, 2015

Dear Mr. Chadwick:

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 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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K133788

Device Name Cook Holmium Laser Fiber

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol next to it. Below the word "COOK" is the word "MEDICAL" in white. The background of the logo is a red color.

5. 510(k) Summary

COOK INCORPORA 50 DANIELS WAY, P.O. MINGTON IN 47 W.COOKM

Cook Incorporated Cook Holmium Laser Fiber 510(k) Summary 21 CFR 807.92

17 March 2015

Date Prepared:

Submitted By:

Applicant: Address:

Phone Number: Fax Number:

Contact: Contact Address:

Contact Phone Number: Contact Fax Number:

Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

1 (800) 468-1379 (812) 332-0281

David E. Chadwick Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

800-346-2686 or 812-339-2235 812-332-0281

Device Information:

Trade name: Common name: Classification: Regulation: Product Code:

Cook Holmium Laser Fiber Laser Instrument, Surgical, Powered Class II 21 CFR §878.4810 GEX

Predicate Device:

Cook Holmium Laser Fiber

K124030, July 1, 2013

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Image /page/4/Picture/0 description: The image features the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font, with a registered trademark symbol to the right of the word. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The background is a solid red color.

Indications for Use:

The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to a cleared Ho: Y AG laser system comprised of any standard SMA-type connector and an output power of up to 100 Watts, for the indications for which the system has been cleared.

Device Description:

Comparison to Predicate Device:

The proposed devices are substantially equivalent to the predicate in terms of intended use, duration of use, principles of operation, and technological characteristics.

Discussion of Tests and Test Results:

The device was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

1. Tensile Testing Testing shows the tensile force during proper clinical use should not fracture the materials and/or bonds.
1. Bend Radius Testing Testing shows that the fibers met the minimum bend radius requirements.
1. Energy Transmission Testing Testing shows that fibers transmit laser energy with not more than 20% loss from laser output to fiber output.
1. Accelerated Aged Testing Testing shows that devices accelerated-aged to the equivalent of three years meet performance requirements for tensile, bend radius, and energy transmission testing.
1. Biocompatibility Testing Testing, in conformance with ISO 10993-1, shows the device is biocompatible.
1. Laser System Compatibility Testing Testing shows that the Cook Holmium Laser Fiber is compatible with other cleared Ho: Y AG laser systems.

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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The logo is white text on a red background. The word "COOK" is in a large, bold font, and the word "MEDICAL" is in a smaller font below it.

1. Steam Sterilization Validation Testing shows that the Cook Holmium Laser Fiber is compatible with recommended autoclave cycles for sterility and functionality.
1. Sterrad Sterilization Validation Testing shows that the fiber is compatible with recommended Sterrad cycles for sterility and functionality.
1. Cleaning Validation Testing shows that the fiber is compatible with recommended cleaning procedures.

Conclusions Drawn from the Tests:

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.

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.