The Amertius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

Device Description

The Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication.

The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.

The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Ameritus Entral™ Feeding Tube. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove device performance against those criteria in a typical AI/software context.

Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document, as it describes a physical medical device (feeding tube) and its bench testing for functional equivalence.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance. Instead, it states:

Acceptance Criterion (Implied)	Reported Device Performance
Functional equivalence to predicate devices	"Bench testing demonstrated that Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are functionally equivalent to the predicate devices and that any minor differences do not affect safety or effectiveness."
Performance as per intended use	"Both design verification and performance test results demonstrated that Ameritus Entral™ Feeding Tube two families made of either Polyurethane or Silicone performed as per their intended use and are equivalent to their respective predicate devices."
Delivery of fluids	Adheres to the "same method of operation, delivery of fluids including liquid nutrition media and medication through single lumen catheter" as predicate devices.
Radiopaque for X-ray visualization to confirm proper placement	"The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement." (This is a feature, not a performance metric itself from the tests, but suggests it performs as designed).
Marking for placement/migration	"French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration." (Feature, not a measured performance metric from tests).
Prevention of air/fluid ingress when not in use	"A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use." (Feature, not a measured performance metric from tests).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench testing," "design verification," and "performance test results." However, it does not specify the sample size for these tests. There's no information on data provenance (country of origin, retrospective/prospective) because this isn't a data-driven AI study; it's a physical device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device and study. "Ground truth" in the context of feeding tube performance and equivalence involves engineering and functional testing, not expert interpretation of outputs like in AI. The "truth" is whether the tube physically performs its functions (e.g., fluid delivery, radiopacity) as expected and comparably to predicates.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 are typically used in clinical or image-based studies where expert consensus is needed. Bench testing of a physical device does not involve such methods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is relevant for diagnostic imaging AI systems and involves evaluating human reader performance with and without AI assistance. This document is for a physical feeding tube.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This document describes a physical medical device. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be established through engineering specifications, physical measurements, and functional tests comparing the device's characteristics (e.g., flow rates, material integrity, radiopacity, resistance to kinking) directly against the predicate device and established industry standards. This is inherent to bench testing. The document doesn't explicitly state the methodology for establishing this "ground truth" but implies it through the mention of "bench testing," "design verification," and "performance test results."

8. The sample size for the training set

This is not applicable. There is no training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This is not applicable. There is no training set.

Summary

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Premarket Notification - Ameri

Image /page/0/Picture/1 description: The image shows the logo for KENTEC MEDICAL, INC. The logo features a stylized letter "A" on the left, with the company name "KENTEC" in bold, sans-serif font to the right. Below "KENTEC" is the text "MEDICAL, INC." in a smaller font size.

APR 2 2 2010

SUMMARY OF SAFETY & EFFECTIVENESS

This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

APPLICANT	Kentec Medical, Inc.17871 FitchIrvine, CA 92614Tel: 949-863-0810Fax: 949-833-9730
OFFICIAL	Keith Books
OFFICIAL	Keith Rooks
CORRESPONDENT	QA/RA Manager
	Tel: 949-863-0810
	Fax: 949-833-9730
	Kjrooks@kentecmedical.com

TRADE NAME	Ameritus® Entral™ Polyurethane Feeding Tube
	. Ameritus® Entral™ Silicone Feeding Tube

COMMON OR USUAL NAME	Feeding Tube
CLASSIFICATION NAME	Gastrointestinal Tubes and accessories
DEVICE CLASSIFICATION	Class II per 21CFR §876.5980
PRODUCT CODE	FPD
PREDICATE DEVICENAMES	NeoMed Polyurethane Enteral Feeding Tube (K082238)NeoMed Silicone Enteral Feeding Tube (K072881)

SUBSTANTIAL EQUIVALENCE

The Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are substantially equivalent to the Neomed Polyurethane and Silicone Enteral Feeding Tubes.

The devices have the same method of operation, delivery of fluids including liquid nutrition media and medication through single lumen catheter. Bench testing demonstrated that Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are functionally equivalent to the predicate devices and that any minor differences do not affect safety or effectiveness.

DESCRIPTION OF DEVICE

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Premarket Notification - Ameritu

Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.

The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.

INDICATIONS FOR USE

The Amerius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

PERFORMANCE DATA

Both design verification and performance test results demonstrated that Ameritus Entral™ Feeding Tube two families made of either Polyurethane or Silicone performed as per their intended use and are equivalent to their respective predicate devices.

CONCLUSION

Based on performance testing test results, Kentec Medical can conclude that the Ameritus Entral™ Feeding tube two families made of either Polyurethane or Silicone are equivalent to their respective predicate device with respect to intended use and technological characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a stamp or seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002

Mr. Keith Rooks RA/QA Manager Kentec Medical, Inc. 17871 Fitch IRVINE CA 92614

APR 2 2 2010

· Re: K100526 Trade/Device Name: Ameritus Entral" Feeding Tubes Regulation Number: 21 CFR §876.5980 · Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: April 13, 2010

Received: April 13, 2010

Dear Mr. Rooks:

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 of medical device-related

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Page 2 -

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100526 510(k) Number (if known):

Device Name: Ameritus Entral™ Feeding Tubes

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Device 510(k) Number

Kentec Medical, Inc.

CONFIDENTIAL

Page 17 of 77

Regulation Number and Section

§ 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.