STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]

K151243 · Stryker Endoscopy · FCS · Aug 20, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K151243
• Device Name: STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
• Applicant: Stryker Endoscopy
• Product Code: FCS · Gastroenterology, Urology
• Decision Date: Aug 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4020
• Device Class: Class 2

Indications for Use

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

System provides real-time endoscopic visible and near-infrared (NIR) fluorescence imaging; utilizes light source console and ureteral kit with light-emitting fibers. Surgeons use device during open or laparoscopic procedures to trans-illuminate ureters; enables visual assessment of vessels, blood flow, tissue perfusion, and extra-hepatic bile ducts. Input consists of light signals transmitted through fibers; output is visual image displayed for surgeon. Used in OR; operated by surgeons. Enhances anatomical identification; aids in surgical navigation; reduces risk of accidental injury to ureters or biliary structures. Complements standard white light and intraoperative cholangiography.

Clinical Evidence

No human clinical trials. Evidence includes bench performance testing, biocompatibility assessment per ISO 10993-1, electrical safety/EMC testing per IEC 60601-1/1-2, and cadaver testing to validate ureteral trans-illumination capability.

Technological Characteristics

System includes light source console and ureteral kit (catheters, fiber assembly, dispenser, luer connectors, drape clips). Sterilization via ethylene oxide per ISO 11135:2014. Connectivity includes light-emitting fibers for trans-illumination and NIR fluorescence imaging. Software developed per IEC 62304.

Indications for Use

Indicated for patients undergoing open or laparoscopic surgical procedures of the lower abdomen or pelvic areas requiring ureteral trans-illumination, or minimally invasive surgery requiring real-time endoscopic visible and near-infrared fluorescence imaging for assessment of vessels, blood flow, tissue perfusion, and major extra-hepatic bile ducts.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Stryker Ureteral Illumination System IV (K061548)
• Stryker® Infrared Fluorescence (IRF) Imaging System (K142310)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: overline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"></span> 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 Court<br>San Jose, CA 95138 |
| FDA Registration Number | 2936485 |
| Correspondence Person | Golnaz Moeini<br>Sr. Regulatory Affairs Analyst<br>Stryker Endoscopy |
| Contact Information | Email: [e-mail]<br>Phone: [phone] |
| Date Prepared | 6/24/2015 |

### 2. Proposed Device

Proposed Device:

| Proprietary Name | Stryker® Infrared Illuminating System (IRIS)[Consisting of AIM Light<br>Source 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 Infravision<br>Illuminator 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

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 । 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.

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.

#### 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.