(101 days)
Not Found
No
The summary describes a light source and associated components for trans-illumination and fluorescence imaging, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device is intended for visualization (trans-illumination, imaging) during surgical procedures to aid surgeons in identifying anatomical structures, vessels, or bile ducts. It does not directly treat a disease or condition.
No
The device is primarily used to trans-illuminate anatomical structures and provide real-time endoscopic visible and near-infrared fluorescence imaging to aid surgeons during procedures, rather than to diagnose medical conditions. Its purpose is to help visualize structures like vessels and bile ducts or the ureter, not to identify or characterize disease.
No
The device description explicitly lists hardware components: a light source console and a Ureteral Kit containing catheters and fiber assemblies. While software validation is mentioned, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "trans-illuminate anatomical structures during open or laparoscopic surgical procedures" and for "real-time endoscopic visible and near-infrared fluorescence imaging" to visualize structures like vessels, blood flow, tissue perfusion, and bile ducts. It also mentions trans-illuminating the ureter. These are all procedures performed on the patient's body during surgery.
- Device Description: The description details a light source console and a Ureteral Kit used for trans-illumination during surgical procedures.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body, such as blood, tissue samples, or other bodily fluids. IVDs are specifically designed for testing these types of samples in a laboratory or clinical setting to provide information about a patient's health status.
The device is an in vivo medical device, meaning it is used within or on the living body. The fluorescence imaging and trans-illumination are performed directly on the patient's tissues and structures during surgery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FCS, FCW
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 fibers, one fiber assembly containing two light emitting fibers, one catheter dispenser, one light emitting fiber dispenser, two luer connectors, and two drape clips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anatomical structures, vessels, blood flow, related tissue perfusion, extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons; open or laparoscopic surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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
1
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.
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)
| 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 Court |
| San Jose, CA 95138 | |
| FDA Registration Number | 2936485 |
| Correspondence Person | Golnaz Moeini |
| Sr. Regulatory Affairs Analyst | |
| Stryker Endoscopy | |
| Contact Information | Email: golnaz.moeini@stryker.com |
| Phone: 408-754-2755 | |
| Date Prepared | 6/24/2015 |
2. Proposed Device
Proposed Device:
| Proprietary Name | Stryker® Infrared Illuminating System (IRIS)[Consisting of AIM Light
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
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).
5
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).
6
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.