(30 days)
Not Found
No
The summary describes a mechanical device for gastric access and fluid delivery, with no mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as being used for "gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication," which indicates a therapeutic purpose rather than just diagnostic or supportive. The mention of a predicate device that is a "gastric sump" further supports its therapeutic function.
No
The device is described as being for "gastric decompression and delivery of fluids," which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly describes a physical, multi-port device intended for gastric decompression and fluid delivery, which are hardware functions. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication." This describes a device used in vivo (within the body) for therapeutic and supportive purposes, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description mentions a "single lumen feeding tube," which is consistent with a device used for delivering substances directly into the stomach.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
- Predicate Devices: The predicate devices listed (Kendall Next Generation Salem Sump and Kendall E-Pump Enteral Feeding Sets) are also devices used for gastric management and feeding, not for in vitro diagnostic testing.
Therefore, the device described is a medical device used for patient care, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kendall GiEntriport with Universal Single Lumen Adaptor is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.
Product codes (comma separated list FDA assigned to the subject device)
FEG
Device Description
The GiEntriport with Universal Single Lumen Adaptor is a multiport adaptor suitable for connection with commonly used feeding tubes and irrigation syringes, enabling the delivery of fluids to, or removal of fluids from, the stomach or to a single lumen feeding tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Nonclinical Testing: Engineering evaluation, and testing were conducted to demonstrate that the design of the propose as uch devices, was equivalent to the predicate devices, and/or met the requirements as defined in EN1615:2000.
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
ict 2
15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-8000
510(k) Premarket Notification GiEntriport Single Lumen Adaptor
Section H - 510(K) Summary
| Date Summary
| Was Prepared: | December 5, 2005 |
|---|---|
| Submitter's | |
| Information: | The Kendall Company |
| Division of Tyco Healthcare Group, LP | |
| 15 Hampshire Street | |
| Mansfield, MA 02048 | |
| Phone: 508-261-8000 | |
| Fax: 508-261-8461 | |
| Contact: | Jim Welsh |
| Vice President, Regulatory Affairs | |
| The Kendall Company | |
| Division of Tyco Healthcare Group, LP | |
| Telephone: 508-261-8532 | |
| Fax: 508-261-8461 | |
| Device Trade | |
| Name: | GiEntriport with universal single lumen adaptor |
| Device Common | |
| Name: | Tube, double lumen for intestinal decompression and/or intubation |
Classification Panel: Gastroenterology
1
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K053410 |
1
K053410
2 of 2
KENDALL 15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-8000
510(k) Premarket Notification GiEntriport Single Lumen Adaptor
Section H – 510(K) Summary
Device Description: The GiEntriport with Universal Single Lumen Adaptor is a multiport Device Description. The GiEnthport with Offirstal Surges or to a single lumen feeding tube.
Intended Use: The Kendall GiEntriport with Universal Single Lumen Adaptor is intended for Intended USe. The Rendal Childring in Microal rrigation, nutritional supplements, and medication.
Product Comparison: The proposed device has the same technological characteristics as the used Product Companison. The proposed device and the predicate devices are intended to be used predicate devices. Dour the proposod donos an in the ding irrigation, nutritional supplements, for gastic decompression and delivery of naturing magazing migraticate devices is based upon a and medication. The construction of Both the proposes or connection with commonly
multifunction valve with external connection ports suitable for connection with commonly multilunction valve with external someon, feeding sets, and irrigation syringes.
Nonclinical Testing: Engineering evaluation, and testing were conducted to demonstrate that Nonchinical Testing. Engineening ovalation, was equivalent to the predicate devices, and/or met the the design of the propose as uch devices, as defined in EN1615:2000.
Lin Welch
Jim Welsh Vice President, Regulatory Affairs Tyco Healthcare/Kendall
12-5-0.5
Date
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/13 description: The image shows a logo with a stylized bird in the center. The bird is depicted with three curved lines suggesting movement or flight. The bird is surrounded by text that curves along the perimeter of the logo. The text is in a sans-serif font and appears to be part of the organization's name or motto.
JAN 6 2006
2006
Mr. James Welsh Vice President, Regulatory Affairs Tyco Healthcare/Kendall 15 Hampshire Street MANSFIELD MA 02048
Re: K053410
Trade/Device Name: GiEntriport with Universal Single Lumen Adaptor Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FEG Dated: December 5, 2005 Received: December 7, 2005
Dear Mr. Welsh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have 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 the cherosate) to regary man date of the Medical Device Amendments, or to devices that have been May 20, 1910, and chance 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 do inot require approval controls provisions of the Act. The general controls provisions of the Act device, subjoct to the general registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I tpp. rary, it the you be 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 I Drival statutes and regulations administered by other Federal agencies. You must comply with all the r ot's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maneling of substantial equivalence of your device to a legally premarket notheation: "The PDA maing of basis and thus, permits your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac roo of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation entired, "there and information on your responsibilities under the Act from the 607.77). Tournay ootain only guileral international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 ・ (508) 261-8000
510(k) Premarket Notification GiEntriport Single Lumen Adaptor
Appendix 1
Indications for Use Statement
Device Name:
GiEntriport with Universal Single Lumen Adaptor
Indications for Use:
The device is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.
Please Do Not Write Below This Line – Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
David M. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number