The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric/ oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.

Device Description

The Kentec Medical Enteral Feeding Extension Set (EFES) is a sterile disposable device for single patient use only. The device is designed to connect existing feeding tubes (nasogastric, oralgastric, gastric, etc) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector.

The device consist of flexible PVC tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.

The basic set (OC-ENT-60) consists of tubing with a step connector (catheter tip) and an oral syringe connector not compatible with intravencus (I.V.) tubing or stopcocks. Other variations include:

The basic set with shorter tubing (OC-ENT-36) t
The basic set with step connector changed into oral syringe connector . (20C-ENT-60)
The basic set with the addition of a "Y" site with an oral syringe connector . to allow the clinician to attach other equipment.

AI/ML Overview

The provided documentation describes the Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set (EFES) and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for AI/algorithm performance. The document focuses on regulatory approval (510(k)) based on non-clinical testing for device function and safety.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and regulatory submission.

However, I can extract information related to the device's functional performance and general non-clinical testing.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Specific Tests" performed and states that these tests "demonstrated the EFES met the acceptance criteria." Specific quantitative acceptance criteria or detailed performance results (e.g., exact tensile strength achieved, precise leakage rates) are not provided in this summary. Instead, the document relies on comparison to predicate devices and adherence to relevant standards.

Specific Test Category	Reported Device Performance / Justification
Extension Set Connector Tensile Test	EFES, NeoMed Enteral Only Extension Set (K100288), and CORFLO EFES (K083791, K083786) were tested. (Implied: EFES performed comparably or acceptably).
Extension Set Liquid Leakage Test	EFES, NeoMed Enteral Only Extension Set (K100288), and CORFLO EFES (K083791, K083786) were tested. (Implied: EFES performed comparably or acceptably).
Luer Connection Testing (anti-IV test connection)	EFES tested. "demonstrated that the device functions according to its specifications (including the inability to connect to a Luer connection)". Specifically, the EFES female connector cannot physically fit into an ISO 594 rigid male Luer connector.
Flow Characteristics	EFES tested. (Implied: EFES performed acceptably according to specifications).
ISO 80369-1 requirements	EFES tested. The EFES' oral syringe female connector is not compliant with ISO 594 standard's (Luer) connector requirements and not compliant with other small-bore connectors listed in ISO 80369-1, except for enteral feeding tips.
Size and Material Inspection	EFES tested. (Implied: Met specifications).
Biocompatibility Test (EFES materials)	EFES tested. Confirmatory tests (cytotoxicity, sensitization, irritation) confirmed acceptable biocompatible status. Materials are substantially equivalent to predicate devices.
Biocompatibility Test (orange colorant)	EFES tested. Confirmed acceptable biocompatible status.
Sterilization Related Test	EFES tested. (Implied: Device and packaging integrity maintained).
Storage and Shelf Life Test (accelerated-time aging)	EFES tested. (Implied: Device and packaging integrity maintained over shelf life).
Package Related Test	EFES tested. (Implied: Packaging integrity maintained).
Connector Dimenstions	Analytical comparison and lab testing to ISO 80369-1. EFES connectors are substantially equivalent to NeoMed and CORPAK. EFES female connector's inner diameter is much larger than ISO 594 Male Luer Connector OD, making connection impossible.
Compatibility with Enteral Syringes	Evaluated against two commercially available oral enteral feeding syringes (Philips Children's Medical Venture Oral/Enteral Syringe (K100099), Kentec Medical Oral/Enteral Syringe (K110853)). Demonstrated that EFES fits well within male connectors of these syringes.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical "sample size" for the various engineering tests (e.g., how many units were subjected to tensile testing). It states "EFES" was tested, implying representative samples of the manufactured device.

Data Provenance: The tests were conducted internally by Kentec Medical, Inc. or contractors on their behalf. The manufacturing facility is in Kunshan, China. These are non-clinical, in-vitro engineering tests, not clinical studies involving human patients or retrospective/prospective data from healthcare settings.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is an engineering device submission. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant here. The ground truth for these tests is defined by engineering specifications, relevant ISO standards (e.g., ISO 80369-1, ISO 594), and comparison to predicate devices' known characteristics.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for expert consensus, which is not relevant to non-clinical engineering device testing. Test results are compared against predefined engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. MRMC studies are for evaluating the performance of diagnostic devices or algorithms with human readers. This device is an enteral feeding extension set, not a diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. There is no algorithm involved in this device. The "standalone performance" refers to the device's functional performance as an engineered product, which was indeed tested (e.g., Luer connection testing, leakage, tensile strength, flow).

7. The Type of Ground Truth Used

The "ground truth" for these engineering tests is established by:

Predefined engineering specifications for the device.
Relevant international standards such as ISO 80369-1 (for small-bore connectors) and ISO 594 (for Luer connectors).
The known functional and material characteristics of legally marketed predicate devices (NeoMed Enteral Only Extension Set K100288 and CORFLO Anti-I.V. Enteral Feeding Extension Set K083786/K083791).
Analytical comparison and lab testing to objectively measure physical properties and fit.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

Summary

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K120272 Page 1 of 5

Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions

FEB 1 7 2012

SECTION 5 510(k) SUMMARY

Date of Submission: September 26, 2011
Official Contact: Keith Rooks RA/QA Manager Kentec Medical, Inc.

Address of Manufacturing

Facility: Kentec Medical Technology Co. 90 Gao Xin Road, ZhouZhuang Kunshan 215325, China T: 86 512 5720 0500
Proprietary Name: Kentec Medical Ameritus® Enteral Feeding Extension Set (EFES)
Common/ Usual Name: Gastrointestinal tubes and accessories

Classification Reference: 21 CFR 876.5980

KNT Product Code:

Predicate Devices: NeoMed Enteral Only Extension Set (K100288) CORFLO Anti-I.V. Enteral Feeding Extension Set (K083786) CORFLO Anti-I.V. Enteral Feeding Extension Set 20-1060AIV-S (K083791, K083786)

Indication for Use:

Patient Population/ Environment of Use:

The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

The Enteral Feeding Extension Set is a sterile disposable for single patient use only.

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K120272 Page 245

Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Ouestions

Substantial Equivalence

The EFES is substantially equivalent to many commercially available enteral feeding extension sets.

The EFES' indications for use and FDA Product Code/ Classification Codes are identical to the NeoMed Enteral Only Extension Set (K100288) and are substantial equivalent to both the CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension Set (K083786) and the CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set Model # 21-1060AIV-S (K083791).

The Kentec Medical EFES components' biocompatible materials are either identical to, or substantially equivalent to:

The NeoMed Enteral Only Extension Set (K100288), .
. The CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension Set (K083786) and/ or
The CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set . Model # 21-1060AIV-S (K083791).

The EFES' Technical Characteristics, Packaging and Ethylene Oxide Sterilization Characteristics, as well as Labeling Characteristics, are substantially equivalent to:

The NeoMed Enteral Only Extension Set (K100288), .
The CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension . Set (K083786) and/or
The CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set . Model # 21-1060AIV-S (K083791).

The EFES and its components successfully completed in-vitro testing which demonstrated that the device functions according to its specifications (including the inability to connect to a Luer connection) and is thus substantially equivalent in function to

The NeoMed Enteral Only Extension Set (K100288), .
The CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension . Set (K083786) and/ or
The CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set . Model # 21-1060AIV-S (K083791).

Design verification tests were performed on the EFES as a result of the risk analysis and product requirements. The following tests and analysis were conducted demonstrating the EFES met the acceptance criteria.

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K120272 Page 3 of 5

Kentec Medicał, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions

Specific Test	Test Model	Justification
Extension SetConnector Tensile Test	Kentec Medical EFES,NeoMed Enteral OnlyExtension Set (K100288) andCORFLO EFES (K083791,K083786) tested	Actual proposed device,predicate (K100288) andpredicate (K083791) tested
Extension SetLiquid Leakage Test	EFES, NeoMed Enteral OnlyExtension Set (K100288) andCORFLO EFES (K083791,K083786) tested	Actual proposed device,predicate (K100288) andpredicate (K083791) tested
Luer Connection Testing(anti-IV test connection)	EFES	Actual proposed device tested
Flow Characteristics	EFES	Actual proposed device tested
ISO 80369-1 requirements	EFES	Actual proposed device tested
Size and Material Inspection	EFES	Actual proposed device tested
Biocompatibility Test (EFESmaterials)	EFES	Actual proposed device tested
Biocompatibility Test (orangecolorant)	EFES	Actual proposed device tested
Sterilization Related Test	EFES	Actual proposed device andpackaging integrity tested
Storage and Shelf Life Test(accelerated-time aging)	EFES	Actual proposed device andpackaging integrity tested
Package Related Test	EFES	Actual proposed devicepackaging integrity tested

Device Description

The basic set (OC-ENT-60) consists of tubing with a step connector (catheter tip) and an oral syringe connector not compatible with intravencus (I.V.) tubing or stopcocks. Other variations include:

The basic set with shorter tubing (OC-ENT-36) t
The basic set with step connector changed into oral syringe connector . (20C-ENT-60)

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K120272 Page 4 of 5

Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions

The basic set with the addition of a "Y" site with an oral syringe connector . to allow the clinician to attach other equipment.

Connectors

The Enteral Feeding Extension Set (EFES) incorporates safety oral syringe connectors which eliminate the risk of I.V. administration through the feeding tube, i.e., the safety connectors do not mate with Luer Lock or Luer slip fittings.

Analytical comparison and lab testing of the EFES' connector's dimensions to others devices listed in ISO 80369-1 allow the conclusions that:

The EFES' connectors are substantial equivalent to the NeoMed (K100288) and the CORPAK (K083786, K083791) devices.
· The EFES' oral syringe female connector is not compliant with the ISO 594 standard's (Luer) connector requirements (i.e., does not connect).
The EFES' oral syringe female connector is not compliant with other small-bore connectors listed in the ISO 80369-1, except for enteral feeding tips.

The EFES connector analytical engineering evaluation demonstrated that the width (inner diameter, ID) of the EFES female connector is much larger than the ISO 594 Male Luer Connector standard I.V. connector outside diameter (OD) dimension [Φ3.925mm-Φ4.027 mm].Thus, the EFES female connector cannot physically fit into an ISO 594 rigid male Luer connector or naturally disengaged without any force, and does not conform to the ISO 594 standard's requirements.

While Kentec Medical has searched for an applicable standard for the dimensions of oral enteral feeding syringes' rigid male connectors, none were found. However, in order for hospital to purchase feeding syringes from a variety of manufactures and be assured that these different devices will all be compatible with the hospitals' existing equipment, the industry utilizes the same male connector OD dimensions, e.g., a "common use" industry standard. To ensure these "common use" dimensions were tested, the EFES was evaluated against two (2) commercially available oral enteral feeding syringes in relation to their connectors.

These analyses demonstrated that the Kentec Medical Enteral Feeding Extension Set dimensions fit well within the male connector of commercially available feeding syringes, e.g., the Philips Children's Medical Venture Oral/Enteral Syringe (K100099)), the Kentec Medical Oral/Enteral Syringe (K110853).

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K120272 Page 575

Kentec Medical; Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions

Materials

The Enteral Feeding Extension Sets are manufactured from polyvinyl chloride (PVC) tubing. The connectors, caps, and slide clamps are manufactured of several plastics: PVC, Polypropylene (PP), and Polyethylene (PE). All materials have been evaluated in accordance with ISO 10993-1 Biological Evaluation of Medical Device – Part 1: Evaluate and Testing. Based on comparisons to these materials used in other devices, no additional biocompatibility testing was necessary; however, Kentec Medical conducted three confirmatory tests (cytotoxicity, sensitization, and irritation) which confirmed the acceptable biocompatible status of these materials.

The EFES' component materials are substantial equivalent to the materials utilized in the NeoMed (K100288) and the CORPAK (K083786, K083791) devices.

Conclusion

The conclusions drawn from the actual conducted (as well as the referenced) analytical engineering evaluations, the nonclinical tests and the commercial use of similar and predicate devices, demonstrates that the Kentec Medical Enteral Feeding Extension Set (EFES) is as safe and effective as the legally marketed (predicate) devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned above three wavy lines, which may represent the nation's waters. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Kentec Medical, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

FEB 1 7 2012

Re: K120272

Trade/Device Name: Ameritus® Medical Enteral Feeding Extension Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 27, 2012 Received: January 30, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device w onave and 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 for abe said in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered processified 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 r ou may, arerelove, 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 adulteration. Thease noter of 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 your device is exassimou 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 that I Dr. Has made a cond regulations administered by other Federal agencies. You must of any I coordi statutes and regulements, including, but not limited to: registration and listing Comply with an the roll blog (21 CFR Part 801); medical device reporting (reporting of medical

{6}------------------------------------------------

device-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 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.

Sincerély vours,

Sincerely yours,

Benjamin K. Evanko

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

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Kentec Medical Enteral Feeding Extension Set PreMarket Notification [510(k)] Application

SECTION 4

INDICATION FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): _ K12 0272

Device Name: Ameritus® Medical Enteral Feeding Extension Set

Indication for Use:

The Ameritus® Enteral Feeding Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety naoogaatires which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.

Patient Population/ Environment of Use:

The Enteral Feeding Extension Set is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

The Enteral Feeding Extension Set is a sterile disposable for single patient use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/ OR

Over-The-Counter Use (Part 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)

Tom McWhirter

Division Sign-Off) ivision of Reproductive, Gastro-Renal, and Irological Devices K12027) 510(k) Number

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.