The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.

Device Description

The Karl Storz SCB/Covidien ForceTriad Interface Module is an accessory to integrate the third party device Covidien ForceTriad Energy Platform (K102913) into the SCB network and allow remote settings adjustment.

AI/ML Overview

The provided text describes a 510(k) summary for the Karl Storz SCB/Covidien ForceTriad Interface Module. This device is an accessory designed to integrate the Covidien ForceTriad Energy Platform into the Karl Storz SCB network, allowing for remote settings adjustment.

The submission is for a device that seems to be a hardware accessory with software that facilitates communication and control between two existing medical devices. The primary purpose of the supporting "study" (software testing) is to demonstrate that this integration functions as intended and is equivalent to a previously cleared predicate device.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from text)	Reported Device Performance (from text)
Performance equivalence to predicate device (Karl Storz SCB/ConMed ESU Interface Module)	"The Karl Storz SCB/Covidien ForceTriad Interface Module demonstrated performance equivalence by software verification and validation testing."
Ability of the SCB system to interface with the Covidien ForceTriad Energy Platform	"In which the device was installed into the SCB control device and the system's ability to interface with the Covidien ForceTriad Energy Platform was tested."
No new issues of safety and effectiveness compared to predicate device	"The differences between the SCB/Covidien ForceTriad Interface Module and the predicate device are minor and raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices."
Substantial equivalence to predicate device	"The Karl Storz SCB/Covidien ForceTriad Interface Module was found to be substantially equivalent to the predicate Karl Storz SCB/ConMed ESU Interface Module." and "The Karl Storz SCB/Covidien ForceTriad Interface Module is substantially equivalent to the predicate device, as both devices have the same intended use and basic design."

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

Sample Size: Not explicitly stated. The document mentions "software verification and validation testing," but does not specify the number of test cases, test runs, or the amount of data used in these tests.
Data Provenance: Not explicitly stated. It's internal company testing ("software verification and validation testing"). It's highly likely to be a prospective test conducted by the manufacturer, but no country of origin for the data is mentioned.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

Given the nature of the device (an interface module for control), the "ground truth" would likely be defined by specific functional requirements and expected outputs, which would be established by internal engineering and quality assurance teams, rather than medical experts in a clinical context.

4. Adjudication method for the test set:

Adjudication Method: Not mentioned. For software verification and validation, adjudication typically involves comparing test results against predefined expected outcomes or specifications.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation of medical images or data is involved. The device described here is an interface module for controlling surgical equipment, not an AI or diagnostic tool.

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

Standalone Performance: Not directly applicable in the terms of an "algorithm only" performance study as commonly understood for AI/diagnostic devices. The software component of this device is operating "standalone" in the sense that it carries out its programmed functions (interfacing and remote control) without continuous human intervention during its operation. However, the performance is in the context of its function as an interface, not as a decision-making algorithm. The "software verification and validation testing" did evaluate the device's functional integrity.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for this device would be based on functional specifications and expected operational behavior. Essentially, the device functions correctly if:
- It successfully integrates the Covidien ForceTriad Energy Platform into the SCB network.
- It allows for accurate remote adjustment of settings of the ForceTriad Energy Platform via the SCB-RUI.
- It performs these actions reliably and without errors that could compromise safety or effectiveness.
  This is established through engineering design, requirements specifications, and direct testing against those specifications.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is an interface module, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is hard-coded or configured based on engineering design.

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

Ground Truth for Training Set: Not applicable as there is no "training set" for this type of device. The "ground truth" for its design and functionality is established through engineering principles, regulatory requirements, and the specifications of the devices it is designed to interface with.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.

Submitter:	Karl Storz Endoscopy-America, Inc.2151 E. Grand AvenueEl Segundo, CA 90245-5017Phone: (424) 218-8381Fax: (424) 218-8519	JAN - 6 201
Contact Person:	Crystal HaganRegulatory Affairs SpecialistEmail: chagan@ksea.com
Date Prepared:	April 25, 2011
Device Trade Name:	Karl Storz SCB/Covidien ForceTriad Interface Module
Common Name:	Endoscope and/or accessories
Classification Name:	Endoscopic central control unit
Regulation Number:	21 CFR 876.1500
Product Code:	ODA

Predicate Device(s): Karl Storz SCB/ConMed ESU Interface Module (K080410)

Device Description:

Intended Use:

The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB me RARE STORE OOD OOMGER Poloo mad intentato we the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.

Technological Characteristics:

The "module" is an accessory which is installed and housed within a Karl Storz SCB contraction was a The Through is an accessory while in Cantrol device is connected is connected the Covidien ForceTriad Energy Platform via an RS232 connection. Once installed, the Kan Storz SCB/Covidien ForceTriad Interface Module allows the user interface of the ForceTriad Energy Platform to be displayed Porce mad Interiace Moune another the ason intention of the Covidien can be renotely adjusted via the SCB-RUI. For a summary of technological characteristics of the Karl Storz SCB/Covidien ForceTriad Interface Module as compared to the predicate device, please refer to the attached substantial equivalence table.

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Image /page/1/Picture/0 description: The image shows the logo for STORZ KARL STORZ ENDOSKOPE. The word "STORZ" is written in large, bold letters with a circular design in the middle of the "O". Below the word "STORZ", the words "KARL STORZ ENDOSKOPE" are written in smaller letters. The background of the image is grainy and appears to be a black and white photograph.

KIII65 AG. 2/2

Software Testing;

The Karl Storz SCB/Covidien ForceTriad Interface Module demonstrated performance equivalence by software verification and validation testing, in which the device was installed into the SCB control device and the system's ability to interface with the Covidien ForceTriad Energy Platform was tested. The performance of the Karl Storz SCB/Covidien Force Triad Interface Module was found to be substantially equivalent to the predicate Karl Storz SCB/ConMed ESU Interface Module.

Determination of Substantial Equivalence:

The Karl Storz SCB/Covidien ForceTriad Interface Module is substantially equivalent to the predicate device, as both devices have the same intended use and basic design. The differences between the SCB/Covidien ForceTriad Interface Module and the predicate device are minor and raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.

Conclusions:

The Karl Storz Scalp Dura Retractor is substantially equivalent to the identified predicate devices and does not raise any new issues of safety and efficacy.

Att: Substantial Equivalence Table for Karl Storz SCB/Covidien ForceTriad Interface Module

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Image /page/2/Picture/0 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 or bird with outstretched wings. The bird is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ankit Shah Regulatory Affairs Associate Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245

JAN - 6 - 2012

Re: K111165

Trade/Device Name: Karl Storz SCB/Covidien Force Triad Interface Module Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA Dated: December 8, 2011 Received: December 9, 2011

Dear Mr. Shah:

We have reviewed your Section 510(k) premarket notification of intent to market the devices we nave leviewed your bection of the device is substantially equivalent (for the indications felerenced above und nave actionship and and and and interstant devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, merelore, market the device, basjon to morements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDICT does not ovaluation must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), and If your device is classified (sec above) ... Existing major regulations affecting your device can be it may be subject to additional controllations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I casia stoganian 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 FDA s issualler of a sacomines with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemination administered by other Federal agencies. You must of any Pederal statutes and regulacions annlinited to registration and listing of median of media comply with all the Act STEquilements, morading, occaso mainer reporting (reporting of medical

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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 11 Joa atti.il/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 now the regulations 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 Tou thay 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/ResourcesforYowIndustry/default.htm.

Sincerely yours;

Benjamin K. Fisher, Ph.D., Director

Benjam R. Fisher, Ph.D., Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KIIII65

INDICATIONS FOR USE

510(k) Number (if known): Not yot assigned

Karl Storz SCB/Covidien ForceTriad Interface Module Device Name:

Indications for Use: The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.

Prescription Use: X (21 CFR 801 Subpart D)

AND/OR .Over-The-Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices K111165
510(k) Number

Page 1 of 1

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.