Intended for stone fragmentation, incision, ablation, coagulation (hemostasis) when attached to the H-30 Holmium Laser System or Odyssey Holmium Laser System for the indications for which the lasers have been cleared.

Device Description

The Cook Holmium Laser Fibers 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 four different sizes, and will be sold in boxes of three.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Cook Holmium Laser Fiber." It details the device's indications for use, comparison to predicate devices, and performance testing. However, it does not describe acceptance criteria for an AI/Software as a Medical Device (SaMD), nor does it present a study proving a device meets acceptance criteria related to AI performance, ground truth establishment, expert review, or statistical measures typical for AI/SaMD studies.

The document is for a physical medical device (a laser fiber), and the "performance data" refers to engineering and compatibility tests (e.g., laser system compatibility, sterilization validation), not clinical performance or AI algorithm performance.

Therefore, I cannot extract the information required for your request from this document, as it pertains to a different type of medical device and regulatory submission.

Specifically, the document does not contain information on:

Table of acceptance criteria and reported device performance (for an AI/SaMD): The document lists performance tests related to physical properties (compatibility, sterilization) but no performance metrics like sensitivity, specificity, AUC, etc., nor acceptance thresholds for such metrics.
Sample size for test set and data provenance: Not applicable to a physical device performance test of this nature.
Number of experts and qualifications for ground truth: Not applicable.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: No ground truth in the AI/SaMD sense is established.
Sample size for training set: No AI model training is mentioned.
How ground truth for training set was established: Not applicable.

To answer your request, you would need a document detailing the regulatory submission for an AI/SaMD, which would typically include clinical study data, performance metrics, and details about the dataset and ground truth establishment.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

May 24, 2017

Cook Incorporated Mr. Colin Jacob Capital Equipment Specialist, Regulatory Affairs 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402

Re: K163197

Trade/Device Name: Cook Holmium Laser Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: May 12, 2017 Received: May 12, 2017

Dear Mr. Jacob:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

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) K163197

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/3/Picture/0 description: The image shows the Cook Medical logo, which is a red square with the word "COOK" in white letters. Below the word "COOK" is the word "MEDICAL" in white letters. Below the logo is the text "510(k) SUMMARY" in black letters. The text is centered below the logo.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Cook Holmium Laser Fiber (21 CFR §878.4810) Date Prepared: May 19, 2017

Submitted By:

Applicant:	Cook Incorporated
Contact:	Colin Jacob
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x 104965
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Cook Holmium Laser Fiber
Common Name:	Laser Instrument, Surgical, Powered
Classification Name/Panel:	Powered Laser Surgical Instrument - General & Plastic Surgery
Regulation:	21 CFR §878.4810
Product Code:	GEX

Predicate Devices:

트 Primary - Cook Holmium Laser Fiber (K124030, July 1, 2013)
י Secondary - Quanta System Surgical Laser Fibers (K131473, October 24, 2013)

Device Description:

COMPANY CONFIDENTIAL

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters on the top half of the logo. Below "COOK" and offset to the left is the word "MEDICAL" in smaller, white, sans-serif letters.

COOK INCORPORATED O DANIELS WAY P.O. BOX 489 W.COOKMEDICAL.COM

Indications for Use:

Intended for stone fragmentation, incision, excision, ablation, coagulation (hemostasis) when attached to the H-30 Holmium Laser System or Odyssey Holmium Laser System for the indications for which the lasers have been cleared.

Comparison to Predicates:

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

Differences between the proposed device and the primary predicate are:

트 Additional compatible laser system in indications for use
Extended STERRAD® cycles for resterilization
Additional indication for use for stone fragmentation - This indication for use for stone fragmentation has been cleared in the secondary predicate. This secondary predicate has similar technology to the proposed device.

Performance Data:

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

. Laser System Compatibility Testing - Testing shows that the Cook Holmium Laser Fiber is compatible with the Cook Medical Odyssey Holmium Laser System.
트 Steam Sterilization Validation - Testing shows that the fiber is compatible with recommended autoclave cycles for sterility and functionality.
. STERRAD® Sterilization Validation - Testing shows that the fiber is compatible with specified STERRAD® cycles for sterility and functionality.

Conclusion:

The results of these tests support a conclusion that the Cook Holmium Laser Fiber met the design input requirements based on the intended use and support a determination of substantial equivalence.

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.