(177 days)
Not Found
No
The summary describes a mechanical device for enteral feeding and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing enteral nutrition and/or medication to patients requiring nutritional support, which aligns with therapeutic intervention.
No
The device is intended for percutaneous endoscopic gastrostomy or jejunostomy placement to provide enteral nutrition and/or medication, and gastric decompression, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components such as silicone and polyurethane tubes, site preparation components, introduction components, and 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 for percutaneous endoscopic gastrostomy and jejunostomy placement to provide enteral nutrition and/or medication and gastric decompression. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a feeding tube and associated components for insertion. It is a physical device used for delivering substances into the body, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (tensile strength, leak testing, flow rate, etc.), which are relevant to a medical device used for delivery, not for diagnosis.
IVD devices are specifically designed 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 Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
Product codes (comma separated list FDA assigned to the subject device)
KNT, PIF
Device Description
The Entuit PEG includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters. The PEG tube is supplied sterile and is intended for single use in adults. Entuit PEGJ includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is available for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube.
There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has two feeding adapters that are ENFit compatible and two feeding adapters that are compatible with Christmas tree or slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit). The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG are available in standard, safety, and international versions. The PEGJ tubes are sold as a separate kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrostomy, jejunum
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)
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended:
- Functional Validation
- Tensile Testing
- Leak testing
- Shelf Life Testing
- Packaging Validation
- Enteral Connector Misconnection
- ENFit Performance Testing
- Feeding Adapters Tensile Testing
- Biocompatibility Testing
- Flow Rate
- Radiopacity
- Corrosion
- Bolster Separation Forces
- Force required to Pull the Bolster Through the Stoma Testing
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1 "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process."
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
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May 29, 2019
Wilson-Cook Medical, Inc. Tiffany A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K183336
Trade/Device Name: Entuit PEG, Entuit PEGJ Regulation Number: 21 CFR$ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIF Dated: April 25, 2019 Received: April 29, 2019
Dear Tiffany A. 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 (QS) 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.
for Shani P. Haugen, Ph.D. Acting, Assistant Division 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) K183336
Device Name Entuit PEG Entuit PEGJ
Indications for Use (Describe)
The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
| 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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Summary
Entuit PEG /Entuit PEGJ
Traditional 510(k) Premarket Notification November 30, 2018
Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy
4900 Bethania Station Road
Winston-Salem, North Carolina 27105 |
|------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist |
| Phone: | (336) 744-0157 |
| Fax: | (336) 201-5994 |
Device Information
| Trade Name: | Entuit PEG/ Entuit PEGJ |
|---|---|
| Common Name: | Gastrointestinal Feeding Tube |
| Classification Name: | Gastrointestinal tubes and accessories |
| Regulation Number: | 21 CFR 876.5980 |
| Product Code: | KNT, PIF |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Predicate Device
K920703 Gastrointestinal Feeding Tube (PEG 24 Fr/ PEGJ 12 Fr)
Device Description
The Entuit PEG includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters. The PEG tube is supplied sterile and is intended for single use in adults. Entuit PEGJ includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is available for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube.
There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has two feeding adapters that are ENF it compatible and two feeding adapters that are compatible with Christmas tree or slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit). The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG are available in standard, safety, and international versions. The PEGJ tubes are sold as a separate kit.
4
Intended Use
The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
Comparison to Predicate Device
The subject Entuit PEG and Entuit PEGJ are substantially equivalent to the predicate device, the Gastrointestinal Feeding Tube (K920703) with respect to the indications for use, methods of placement, designs, and fundamental technological characteristics. The minor differences between the subject devices and the predicate devices include: feeding tube outer diameter, updated feeding adapters to meet ISO 80369-1 and ISO 80369-3 with ENFit connector design, dilator design, and packaging configuration.
Summary of Non-Clinical Testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.
- Functional Validation
- Tensile Testing
- Leak testing
- Shelf Life Testing ●
- . Packaging Validation
- Enteral Connector Misconnection
- ENFit Performance Testing
- Feeding Adapters Tensile Testing ●
- Biocompatibility Testing ●
- Flow Rate ●
- Radiopacity ●
- Corrosion
- Bolster Separation Forces
- Force required to Pull the Bolster Through the Stoma Testing ●
5
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1 "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process."
Conclusions:
We believe that the subject device is substantially equivalent to the predicate device in terms of intended use, key operating principles, materials 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 safety or effectiveness of the device.