Kangaroo Feeding Tube with IRIS Technology
Device Facts
| Record ID | K163002 |
|---|---|
| Device Name | Kangaroo Feeding Tube with IRIS Technology |
| Applicant | Covidien (Dba Medtronic) |
| Product Code | KNT · Gastroenterology, Urology |
| Decision Date | May 16, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Kangaroo™ Feeding Tube with IRIS Technology utilizes a video stream to aid a trained user during placement into the stomach or small bowels for the administration of nutrition, fluids, and medications by the naso-enteric route for patients aged 18 years and older who have an intact gastrointestinal tract, but are physically unable to manage nutritional intake through normal mastication and deglutition. Prior to commencing administration, confirm correct tube placement per institutional protocol. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement.
Device Story
Small-bore nasogastric enteral access catheter; includes proximal ENFit port for nutrition/medication delivery. Distal tip contains LED light and camera; connects to external console via interface cable to provide real-time video stream for visual guidance during tube placement. Used by clinicians in clinical settings to confirm placement in stomach or small bowel. Radiopaque material and hydrophilic coating assist insertion; centimeter markings aid length estimation. Output is visual video feed on console; assists clinician in navigating tube to target location; reduces risk of malpositioning; facilitates safe enteral access.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-2), mechanical performance (tensile, insertion force, leak tests), optical performance (field of view, depth of field), and animal testing (porcine tissue temperature testing).
Technological Characteristics
Small-bore nasogastric catheter; radiopaque material; hydrophilic coating; ENFit proximal connector (ISO 80369-3). Integrated LED and camera at distal tip. Connectivity via interface cable to console. Non-sterile, single-use. Electrical safety per IEC 60601-1/1-2. Sizes: 8Fr, 10Fr, 12Fr; Lengths: 36", 43", 55".
Indications for Use
Indicated for patients aged 18+ with intact GI tract unable to manage nutritional intake via mastication/deglutition. Used for naso-enteric administration of nutrition, fluids, and medications.
Regulatory Classification
Identification
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
Special Controls
*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Predicate Devices
- Kangaroo™ Feeding Tube with IRIS Technology (K123555)
Submission Summary (Full Text)
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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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
Covidien (dba Medtronic) Alexis Erazo Sr. Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K163002
Trade/Device Name: Kangaroo™ Feeding Tube with IRIS Technology Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIF Dated: April 12, 2017 Received: April 13, 2017
Dear Alexis Erazo:
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 (reporting of medical device
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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 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,
# 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) K163002
Device Name Kangaroo™ Feeding Tube with IRIS Technology
#### Indications for Use (Describe)
The Kangaroo™ Feeding Tube with IRIS Technology utilizes a video stream to aid a trained user during placement into the stomach or small bowels for the administration of nutrition, fluids, and medications by the naso-enteric route for patients aged 18 years and older who have an intact gastrointestinal tract, but are physically unable to manage nutritional intake through normal mastication and deglutition. Prior to commencing administration, confirm correct tube placement per institutional protocol. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510(k) Summary Kangaroo™ Feeding Tube with IRIS Technology
### Preparation date:
May 9, 2017
## Manufacturer's Name:
- Covidien 15 Hampshire Street Mansfield, MA 02048
## Corresponding Official:
Alexis Erazo Sr. Regulatory Affairs Specialist Phone: 508-452-4673 Alexis.erazo@medtronic.com
#### Name of Medical Device:
| Trade Name: | Kangaroo™ Feeding Tube with IRIS Technology |
|----------------------|---------------------------------------------|
| Common Name: | Tubes, gastrointestinal |
| Classification Name: | Gastrointestinal tube and accessories |
| Regulation Number: | 21 CFR 876.5980 |
| Product Code: | KNT |
| | PIF (Secondary) |
| Class: | II |
## Identification of Predicate Device:
| 510(k) Number | K123555 |
|--------------------|---------------------------------------------|
| Device Description | Kangaroo™ Feeding Tube with IRIS Technology |
| Submitter | Covidien |
## Device Description:
The Kangaroo™ Feeding Tube with IRIS Technology is a small-bore nasogastric enteral access catheter. The gastrointestinal tube includes an external proximal access port for connection to enteral feeding sets and to syringes with ENFit connector. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube. The stylet is made of
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specially designed metal wire, which may be utilized to assist with tube placement. The tube is equipped with external markings in units of centimeters to assist in estimating the length of tube inserted into the alimentary tract. The device may be connected to a console, which allows for viewing a video stream and capture of camera images an interface cable connects the feeding tube to the console. LED light is incorporated into the distal tip of the tube and the light will power on only when properly connected to the console with the interface cable.
The Kangaroo Feeding Tube with IRIS Technology will continue to be available in three (3) sizes and three (3) lengths: 8 Fr, 10 Fr, 12 Fr and 36", 43″ and 55″. The Kangaroo Feeding Tube with IRIS Technology is not made with DEHP and are nonsterile. The product and packaging is not made with natural rubber latex.
#### Intended Use/Indications for Use:
The Kangaroo™ Feeding Tube with IRIS Technology utilizes a video stream to aid a trained user during placement into the stomach or small bowels for the administration of nutrition, fluids, and medications by the naso-enteric route for patients aged 18 years and older who have an intact gastrointestinal tract, but are physically unable to manage nutritional intake through normal mastication and deglutition. Prior to commencing administration, confirm correct tube placement per institutional protocol. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement.
#### Product Comparison Summary:
The modified Kangaroo™ Feeding Tube with IRIS Technology has the same intended use and improved visual optics as compared to the predicate device (K123555). Verification testing completed on the modified Kangaroo™ Feeding Tube with IRIS Technology demonstrates that the modifications do not raise new questions of safety and efficacy and that the proposed device is as safe and effective as the legally marketed K123555 Kangaroo™ Feeding Tube with IRIS Technology.
| | Predicate<br>Kangaroo Feeding Tube with<br>IRIS Technology (K1235555) | Proposed<br>Kangaroo Feeding Tube with IRIS<br>Technology |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for<br>Use | The Kangaroo™ Feeding Tube with<br>IRIS Technology utilizes a video<br>stream to aid a trained user during<br>placement into the stomach or small<br>bowels for the administration of<br>nutrition, fluids, and medications by | The Kangaroo™ Feeding Tube with<br>IRIS Technology utilizes a video<br>stream to aid a trained user during<br>placement into the stomach or small<br>bowels for the administration of<br>nutrition, fluids, and medications by |
| | Predicate<br>Kangaroo Feeding Tube with<br>IRIS Technology (K123555) | Proposed<br>Kangaroo Feeding Tube with IRIS<br>Technology |
| | the naso-enteric route for patients<br>aged 18 years and older who have an<br>intact gastrointestinal tract, but are<br>physically unable to manage<br>nutritional intake through normal<br>mastication and deglutition. Prior to<br>commencing administration, confirm<br>correct tube placement per<br>institutional protocol. Placement of<br>the tip of the device into the small<br>bowel should only be attempted by<br>clinicians with expertise in small<br>bowel placement. | the naso-enteric route for patients<br>aged 18 years and older who have an<br>intact gastrointestinal tract, but are<br>physically unable to manage<br>nutritional intake through normal<br>mastication and deglutition. Prior to<br>commencing administration, confirm<br>correct tube placement per<br>institutional protocol. Placement of<br>the tip of the device into the small<br>bowel should only be attempted by<br>clinicians with expertise in small<br>bowel placement. |
| Classification<br>Name | Tubes, Gastrointestinal (and<br>Accessories) | Tubes, Gastrointestinal (and<br>Accessories) |
| Regulation<br>Reference | 21 CFR 876.5980 | 21 CFR 876.5980 |
| Product Code | KNT | KNT, PIF |
| Classification | II | II |
| Prescription Use | Rx | Rx |
| Sterilization | Non-Sterile | Non-Sterile |
| Labeled Single<br>Use | Single Use | Single Use |
| Shelf Life | 2 Years | 2 Years |
| French Sizes | 8Fr<br>10Fr<br>12Fr | 8Fr<br>10Fr<br>12Fr |
| Available Tube<br>Lengths | 36"<br>43"<br>55" | 36"<br>43"<br>55" |
| Proximal End<br>Connections | ENFit Connection System | ENFit Connection System |
| Proximal Access<br>Port (ENFit) | Yes, allows for irrigation (flushing),<br>manual fluid/ medication access,<br>and aspirate collection | Yes, allows for irrigation (flushing),<br>manual fluid/ medication access,<br>and aspirate collection |
| ISO 80369-3<br>Compliance (ENFit<br>Connection) | Yes | Yes |
| Placement Stylet<br>Included | Yes | Yes |
| Shaft Design | Single lumen | Single lumen |
| Shaft Flow Outlet | 2 eyes at distal end | 2 eyes at distal end |
| Measurement<br>Markings | Yes, cm units | Yes, cm units |
| | Predicate<br>Kangaroo Feeding Tube with<br>IRIS Technology (K123555) | Proposed<br>Kangaroo Feeding Tube with IRIS<br>Technology |
| Camera and<br>Electronics | Yes | Yes |
| Coating (tip) | Water-activated Hydromer<br>lubricant | Water-activated Hydromer lubricant |
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## Non-Clinical Performance Data:
Laboratory testing was completed to support substantial equivalence between the modified device and the predicate device. The modified device was evaluated to demonstrate compliance to the below standards.
- IEC 60601-1:2005 with corrigenda and U.S. national deviations were considered . against standard AAMI ES60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- . FDA's Guidance for Industry, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued on August 21, 2008
- . EN 1615:2000, Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
- . BS EN 1618:1997 Catheters Other than Intravascular Catheters - Test Methods for Common Properties
- AAMI/CN3 (PS):2014 Part 3 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
The following testing was conducted to demonstrate that the modified device continues to meet product specifications and support the determination of substantial equivalence.
## Electrical Safety
- . ISO 60601-1 3rd Ed.:2005 and ISO 60601-1-2 Ed. 3.0:2007 Medical Electrical Equipment Safety and Essential Performance
- Leakage Current Testing
- Dielectric Voltage Withstand
- Evaluation of Magnetic Field Interactions, Heating, and Artifacts
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## Storage and Stability
- Storage Stability ●
- . ISTA 2A Functional Evaluation
## Feeding Tube Bench Testing
- Feeding Tube Fluid Isolation Test Report ●
- Feeding Tube Wire Slip in Co-extrusion ●
- Feeding Tube Stylet Penetration Force
- Feeding Tube Conductors Break Strength
- Feeding Tube Anatomical Insertion Force Test
- Feeding Tube Placement and Useful Life
- Feeding Tube Water Leak Test (30 Day Gastric)
- Feeding Tube Distal Subassembly Tensile Test
- Stylet Introduction Force
- Stylet Removal Force
- Flow and Functionality Analysis
- Image Head Length Test Report
- Image Head Illumination Output
- Image Head External Temperature
- Electrical Continuity Analysis
## Optical Bench Testing
- Image Head Capture
- Image Head Depth of Field Test Report
- Image Head Field of View Test Report ●
- MRI Image Testing
## Animal Testing
- Temperature Testing of IRIS Technology Feed Tube in Porcine Tissue
## Clinical Data:
Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.
## Conclusion:
Based on the nonclinical tests performed on the proposed device, the modified Kangaroo Feeding Tube with IRIS Technology is as safe and effective as the legally marketed Kangaroo Feeding Tube with IRIS Technology (K123555). The information provided within this 510(k) demonstrates that the modified Kangaroo Feeding Tube with IRIS Technology is equivalent to the predicate device.
