The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the Stryker® AIM Light Source and SafeLight Cable are intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

The Stryker IRIS Ureteral Kit when used with compatible Stryker is intended to trans-illuminate the ureter during surgical procedures. The catheter accepts up to 0.038" guide wire. The kit can be used for either open surgical or laparoscopic procedures.

Device Description

The Stryker® Infrared Illuminating System (IRIS) is used to trans-illuminate the ureter during laparoscopic or open surgical procedures. Trans-illumination is intended to help the surgeon identify the ureter(s) during open or laparoscopic surgical procedure of lower abdomen or pelvic areas. The Stryker® Infrared Illuminating System (IRIS) consists of the following main components (herein referred to as 'proposed devices'):

A light source console.
A Ureteral Kit that consists of two catheters, one fiber assembly containing two light emitting fibers, one catheter dispenser, one light emitting fiber dispenser, two luer connectors, and two drape clips.

AI/ML Overview

This document is a 510(k) premarket notification for the Stryker® Infrared Illuminating System (IRIS). It's a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared devices. It does not contain a study that proves the device meets acceptance criteria in the format you requested, typically found in clinical trial reports or detailed performance studies.

The document primarily focuses on demonstrating that the new device, IRIS, is substantially equivalent to existing predicate devices (Stryker Ureteral Illumination System IV and Stryker® Infrared Fluorescence Imaging System) in terms of its indications for use, design technology, and performance specifications.

Here's an analysis based on the provided text, addressing your questions where information is available, and noting when it's not:

1. Table of acceptance criteria and reported device performance:

The document mentions "Bench performance testing was conducted to ensure that the devices functioned as intended and met design specifications and acceptance criteria." and "Cadaver testing validated the ureteral trans-illumination capability of the Stryker Infrared Illuminating System (IRIS)." However, it does not provide specific acceptance criteria or detailed reported device performance in a quantitative table format. It only states that the device "met design specifications and acceptance criteria" and "validated the ureteral trans-illumination capability."

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

Bench Testing: The document does not specify the sample size for bench testing.
Cadaver Testing: The document does not specify the sample size (number of cadavers or ureters) used for "cadaver testing."
Data Provenance: Not specified, but generally, such testing for a 510(k) submission would be conducted by the manufacturer (Stryker) or
contracted labs within the U.S. or other regulated regions. The document implies this data is prospective, generated specifically for this submission.

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

Not applicable or not provided. This type of regulatory submission for a device without a diagnostic claim typically relies on engineering specifications and direct physical performance assessment, not expert interpretation of outputs against a ground truth from an expert consensus. The "validation" of trans-illumination in cadavers would be a direct observation, likely by the engineers and potentially surgeons involved in the study.

4. Adjudication method for the test set:

Not applicable or not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need to be resolved. The tests described (bench and cadaver) are more focused on direct physical performance and engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done or reported in this document. MRMC studies are typically used to compare the performance of human readers with and without AI assistance for diagnostic tasks. This device is an illumination system, not a diagnostic algorithm that would be evaluated in such a study.

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

This question is not directly applicable. The device is a physical illumination system (light source and ureteral kit), not a standalone algorithm. Its function is to provide illumination for human surgeons. The "standalone" performance would be its ability to emit light and trans-illuminate, which was assessed through bench and cadaver testing.

7. The type of ground truth used:

For bench testing, the "ground truth" would be the device's design specifications and established engineering parameters.
For cadaver testing, the "ground truth" for "ureteral trans-illumination capability" would be the direct visual confirmation of the ureter being illuminated by the device in the cadaveric model. This is a direct physical observation, not an expert consensus or pathology report.

8. The sample size for the training set:

Not applicable. This device is a hardware system, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

In summary:

This 510(k) submission details the regulatory pathway for a medical device (an infrared illuminating system) by establishing its substantial equivalence to previously cleared devices. It describes that performance testing (bench and cadaver) was conducted to ensure the device met design specifications and validated its intended function. However, it does not provide detailed quantitative acceptance criteria, specific performance metrics, sample sizes for testing, or information relevant to AI algorithm studies (like MRMC, training sets, or expert consensus on ground truth) which are not applicable to this type of device.

Summary

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

August 20, 2015

Stryker Endoscopy Golnaz Moeini Sr. Regulatory Affairs Analyst 5900 Optical Ct San Jose, CA 95138

Re: K151243

Trade/Device Name: Stryker Infrared Illumination System (IRIS) [AIM Light Source and Ureteral Kit] Regulation Number: 21 CFR 876.4020 Regulation Name: Fiberoptic Light Ureteral Catheter Regulatory Class: II Product Code: FCS. FCW Dated: June 26, 2015 Received: June 29, 2015

Dear Golnaz Moeini,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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 yours.

Benjamin R. Fisher -S

Benjamin 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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Indications for Use

510(k) Number (if known) K151243

Device Name

Stryker® Infrared Illuminating System (IRIS)[AIM Light Source and IRIS Ureteral Kit]

Indications for Use (Describe)

The Stryker AIM Light Source is intended to trans-illuminate anatomical structures during open or laparoscopic surgical procedures.

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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Section 5. 510(k) Summary

General Information 1.

510(k) Sponsor	Stryker Endoscopy
Address	5900 Optical CourtSan Jose, CA 95138
FDA Registration Number	2936485
Correspondence Person	Golnaz MoeiniSr. Regulatory Affairs AnalystStryker Endoscopy
Contact Information	Email: golnaz.moeini@stryker.comPhone: 408-754-2755
Date Prepared	6/24/2015

2. Proposed Device

Proposed Device:

Proprietary Name	Stryker® Infrared Illuminating System (IRIS)[Consisting of AIM LightSource and IRIS Ureteral Kit ]
Common Name	Light Source, Illuminator
Classification Name	Fiberoptic light ureteral catheter, Light Source, Fiberoptic, Routine
Regulation Number	21 CFR 876.4020, 21 CFR 876.1500
Product Code	FCS, FCW
Regulatory Class	II

3. Predicate Device

Primary Predicate Device:

Proprietary Name	Stryker Ureteral Illumination System IV [Consisting of InfravisionIlluminator and Universal Ureteral Kit ]
Premarket Notification	K061548
Classification Name	Fiber Optic Light Ureteral Catheter
Regulation Number	21 CFR 876.4020
Product Code	FCS
Regulatory Class	II

Secondary Predicate Device:

Proprietary Name	Stryker® Infrared Fluorescence (IRF) Imaging System
Premarket Notification	K142310
Classification Name	Confocal Optical Imaging
Regulation Number	21 CFR 876.1500
Product Code	OWN
Regulatory Class	II

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4. Device Description

A light source console. ।
A Ureteral Kit that consists of two catheters, one fiber assembly containing two । catheters, one fiber assembly containing two light emitting fibers, one catheter dispenser, one light emitting fiber dispenser, two luer connectors, and two drape clips.

5. Indications for Use

Indications for Use for Light Source

The Stryker AIM Light Source is intended to trans-illuminate the ureter during open or laparoscopic surgical procedures.

The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide realtime endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Indications for Use for Ureteral Kit

The Stryker IRIS Ureteral Kit when used with compatible Stryker Infrared sources is intended to trans-illuminate the ureter during surgical procedures. The catheter accepts up to 0.038" guide wire. The kit can be used for either open surgical or laparoscopic procedures.

6. Comparison of Technological Characteristics with the Predicate Device

As noted above, the Stryker® Infrared Illuminating System (IRIS) is equivalent to the following cleared device in terms of its indications for use, design technology and performance specification:

With respect to the indications for use of the light source console, the proposed Stryker light source console is substantially equivalent to Stryker Ureteral Illumination System IV (K061548) and Stryker® Infrared Fluorescence (IRF) Imaging System (K142310).

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With respect to the design technology and performance specifications, the Stryker proposed light source console is substantially equivalent to Stryker Ureteral Illumination System IV (K061548).

With respect to the Ureteral Kit, the proposed Stryker Ureteral Kit is substantially equivalent to Stryker Ureteral Illumination System IV (K061548) since they are both the same in design and indication for use with very minor modification to the proposed device to improve usability of the light fibers.

7. Performance Data

Safety and performance of the Stryker® Infrared Illuminating System (IRIS) has been evaluated and verified in accordance with design specifications and applicable performance standards through biocompatibility assessment, electrical safety and EMC testing, software validation, bench testing and animal testing. The following performance testing were conducted and are summarized in this submission:

Biocompatibility was assessed in accordance to ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and related collateral standards for patient contacting materials.
The proposed Ureteral Kit is provided sterile. Ethylene oxide sterilization was verified per -ISO 11135:2014: Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of sterilization process for medical devices (see Section 14, Sterilization and Shelf Life).
Electrical Safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:2005+A1:2012 - Medical electrical equipment-Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2:2007- Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances – Requirement and tests, respectively. Testing indicates that the proposed device conforms to the aforementioned voluntary standards.
The software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software – Software life cycle processes as well as the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Bench performance testing was conducted to ensure that the devices functioned as intended and met design specifications and acceptance criteria. Test results obtained verified the safety and effectiveness of the devices per design specifications and applicable standards.
Cadaver testing validated the ureteral trans-illumination capability of the Stryker Infrared Illuminating System (IRIS).

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Conclusion 8.

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the Stryker® Infrared Illuminating System (IRIS) raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.

Regulation Number and Section

§ 876.4020 Fiberoptic light ureteral catheter.

(a)
Identification. A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.