(30 days)
No
The device description and performance studies focus on the physical components and mechanical performance of a feeding tube system, with no mention of AI or ML technologies.
No
The device delivers nutrition and/or medications, it does not treat or cure a disease or condition.
No
The device is intended for "short-term enteral access for delivery of nutrition and/or medications to small bowel," which describes a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly lists physical components such as a nasal feeding tube, nasal transfer tube, wire guide, and feeding adapters, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide "short-term enteral access for delivery of nutrition and/or medications to small bowel." This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The components (feeding tube, transfer tube, wire guide, adapters) are all designed for physical access and delivery, not for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of any components or functions related to analyzing blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (connector testing, design verification of adapters), not on diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is entirely focused on delivering substances into the body.
N/A
Intended Use / Indications for Use
This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to small bowel. This device is indicated for adult use only.
Product codes
PIF, KNT
Device Description
The subject device is packaged with: a nasal feeding tube, a nasal transfer tube, a wire guide, and two feeding adapters. The single lumen nasal feeding tube is composed of radiopaque polyvinyl chloride with ink markings that are endoscopically visible and assist with tube placement. The nasal feeding tube is available in two diameters, 8 Fr and 10 Fr. with a length of 240 cm and 10 feeding ports. The nasal transfer tube has a diameter of 14 Fr, is composed of clear PVC and is 20 inches in length. The wire guide is stainless steel coated with polytetrafluoroethylene (PTFE) and is 250 cm in length. Two feeding adapters are provided; one as a friction fit version and one ENFit compatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bowel
Indicated Patient Age Range
adult use only
Intended User / Care Setting
Not Found
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)
Performance testing consisting of non-clinical bench testing demonstrates the subject device meets the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirms that the subject device performs as intended.
- ENFit Connector Testing per ISO 80369-3: 2016
- Design Verification of Feeding Adapters
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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June 17, 2020
Wilson-Cook Medical, Inc Tiffanny Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K201322
Trade/Device Name: Entuit Nasal Jejunal Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, KNT Dated: May 15, 2020 Received: May 18, 2020
Dear Tiffanny Thomas:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201332
Device Name Entuit Nasal Jejunal Feeding Tube
Indications for Use (Describe)
This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to small bowel. This device is indicated for adult use only.
| 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
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | (336) 744-0157 |
| Fax: | (336) 201-5994 |
| Contact: | Theresa de Prat, Regulatory Affairs Specialist II |
| Tiffanny A. Thomas, Global Regulatory Affairs Specialist | |
| Date: | May 15, 2020 |
| Trade Names: | Entuit Nasal Jejunal Feeding Tube |
| Common Name: | Nasal Jejunal Feeding Tube |
| Classification Name: | Gastrointestinal Tube and Accessories 21 CFR §876.5980, KNT, PIF |
| Device: | Class II |
| Predicate Device: | Nasal Jejunal Feeding Tube Cleared May 11, 2005 K043203 |
Intended Use: This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to the small bowel. This device is indicated for adult use only.
Device Description:
The subject device is packaged with: a nasal feeding tube, a nasal transfer tube, a wire guide, and two feeding adapters. The single lumen nasal feeding tube is composed of radiopaque polyvinyl chloride with ink markings that are endoscopically visible and assist with tube placement. The nasal feeding tube is available in two diameters, 8 Fr and 10 Fr. with a length of 240 cm and 10 feeding ports. The nasal transfer tube has a diameter of 14 Fr, is composed of clear PVC and is 20 inches in length. The wire guide is stainless steel coated with polytetrafluoroethylene (PTFE) and is 250 cm in length. Two feeding adapters are provided; one as a friction fit version and one ENFit compatible.
Substantial Equivalence:
The main modification is adding a feeding adapter that has an ENFit connector and conforms to ISO 80369-3. The device subject to this 510k has the same intended use, methods of operation, and the fundamental technological characteristics as the cleared predicate.
Performance Data:
Performance testing consisting of non-clinical bench testing demonstrates the subject device meets the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.
4
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirms that the subject device performs as intended.
- ENFit Connector Testing per ISO 80369-3: 2016 ●
- Design Verification of Feeding Adapters
Conclusion:
We believe that the subject device is substantially equivalent to the predicate device with respect to intended use, key operating principles, materials of construction, and technological characteristics. We consider the risks associated with the modifications to the subject device to have been adequately addressed through our Design Control Processes and do not affect the safety or effectiveness of the device.