(200 days)
Not Found
No
The summary describes a video stream and image capture capability but does not mention any analysis or processing of this data using AI or ML. The performance studies focus on electrical safety, mechanical properties, and optical performance, not algorithmic performance.
No.
The device facilitates the administration of nutrition, fluids, and medications, but it does not directly treat a disease or medical condition.
No
The device's intended use is for the administration of nutrition, fluids, and medications, and it uses a video stream to aid in tube placement, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like a feeding tube, stylet, console, interface cable, and LED light, indicating it is a hardware device with integrated technology, not software-only.
Based on the provided information, the Kangaroo™ Feeding Tube with IRIS Technology is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to aid in the placement of a feeding tube into the stomach or small bowels for the administration of nutrition, fluids, and medications. This is a procedural device used for direct intervention on the patient's body.
- Device Description: The device is a physical tube with a camera and light to visualize the internal anatomy during insertion. It's a tool for guiding a medical procedure.
- Lack of Diagnostic Function: The device does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status, disease, or condition. The video stream is used for visualization during placement, not for diagnosis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
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 codes (comma separated list FDA assigned to the subject device)
KNT, PIF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video stream
Anatomical Site
stomach or small bowels
Indicated Patient Age Range
patients aged 18 years and older
Intended User / Care Setting
trained user, clinicians with expertise in small bowel placement
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)
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
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.
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.
0
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
1
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
2
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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3
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
4
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
Kangaroo Feeding Tube with
IRIS Technology (K1235555) | Proposed
Kangaroo Feeding Tube with IRIS
Technology |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 |
| | Predicate
Kangaroo Feeding Tube with
IRIS Technology (K123555) | Proposed
Kangaroo Feeding Tube with IRIS
Technology |
| | 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. | 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. |
| Classification
Name | Tubes, Gastrointestinal (and
Accessories) | Tubes, Gastrointestinal (and
Accessories) |
| Regulation
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
Use | Single Use | Single Use |
| Shelf Life | 2 Years | 2 Years |
| French Sizes | 8Fr
10Fr
12Fr | 8Fr
10Fr
12Fr |
| Available Tube
Lengths | 36"
43"
55" | 36"
43"
55" |
| Proximal End
Connections | ENFit Connection System | ENFit Connection System |
| Proximal Access
Port (ENFit) | Yes, allows for irrigation (flushing),
manual fluid/ medication access,
and aspirate collection | Yes, allows for irrigation (flushing),
manual fluid/ medication access,
and aspirate collection |
| ISO 80369-3
Compliance (ENFit
Connection) | Yes | Yes |
| Placement Stylet
Included | Yes | Yes |
| Shaft Design | Single lumen | Single lumen |
| Shaft Flow Outlet | 2 eyes at distal end | 2 eyes at distal end |
| Measurement
Markings | Yes, cm units | Yes, cm units |
| | Predicate
Kangaroo Feeding Tube with
IRIS Technology (K123555) | Proposed
Kangaroo Feeding Tube with IRIS
Technology |
| Camera and
Electronics | Yes | Yes |
| Coating (tip) | Water-activated Hydromer
lubricant | Water-activated Hydromer lubricant |
5
6
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
7
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.