The Monoject™ Enteral Feeding Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

Device Description

The Monoject™ Enteral Feeding Syringe with ENFit Connector is a disposable enteral feeding syringe provided in sizes of 1mL and 3mL. The device specific for low dose applications incorporates a female ENFit Syringe tip with an internal tip lumen for connection to an enteral access device with male ENFit connector.

AI/ML Overview

This document is a 510(k) premarket notification for the Monoject™ Enteral Feeding Syringe with ENFit Connector. As such, it details the non-clinical testing performed to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study proving the device meets specific performance criteria against a ground truth.

Therefore, many of the requested sections related to clinical studies, expert-established ground truth, and human reader performance will not be applicable or available from this document.

Here's an analysis of the provided information based on your request:

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a non-clinical evaluation for a medical device (enteral feeding syringe), the "acceptance criteria" are based on the requirements of recognized industry standards. The "device performance" is reported as conformity to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Defined in AAMI /CN3 (PS):2014)	Test Method (Defined in ISO 80369-20)	Reported Device Performance
Fluid Leakage (Clause 6.2)	Annex C	Conforms to requirements
Stress Cracking (Clause 6.3)	Annex E	Conforms to requirements
Resistance to separation from axial load (Clause 6.4)	Annex F	Conforms to requirements
Resistance to separation from unscrewing (Clause 6.5)	Annex G	Conforms to requirements
Resistance to overriding (Clause 6.6)	Annex H	Conforms to requirements
Disconnection by unscrewing (Clause 6.7)	Annex I	Conforms to requirements
Dimensional analysis for low dose ENFit connector	- (AAMI /CN3 (PS):2014 Table B.2)	Conforms to criteria
Dosing Accuracy of low dose tip ENFit connector	-	Verified
Biocompatibility	-	Demonstrated biological safety
Stability	-	Properties maintained after accelerated aging (supports labeling)
ISO 7886-1 Sterile Hypodermic Syringes (Part 1)	-	Conforms to requirements

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

Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of syringes tested for fluid leakage). It generally states that "Testing performed on the Monoject™ Enteral Feeding Syringes with low dose tip ENFit Connectors included the items listed below..."
Data Provenance: The tests are non-clinical (laboratory/bench testing) performed by the manufacturer, Covidien, based in Mansfield, MA, USA. The data is thus internally generated non-clinical test data. It is neither retrospective nor prospective in the clinical sense.

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

Not applicable. For non-clinical device testing verifying compliance with standards, "experts" in the sense of clinical specialists establishing a "ground truth" are not relevant. The "ground truth" is defined by the technical specifications and requirements of the referenced ISO and AAMI standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions. Device performance is assessed directly against the objective criteria of the specified standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes a 510(k) submission for an enteral feeding syringe, which is a physical medical device. It does not involve AI, image analysis, or human readers, so an MRMC comparative effectiveness study is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software device or an algorithm.

7. Type of Ground Truth Used

The "ground truth" for these tests is the set of objective, measurable requirements specified in the following international and industry standards:

AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications.
ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
ISO 7886-1, Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use.
Biocompatibility standards (not explicitly listed, but implied by "Biocompatibility testing has demonstrated the biological safety").

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable, as there is no training set. The relevant "ground truth" for non-clinical performance evaluation is established by international and industry consensus standards.

Summary

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

June 17, 2016

Covidien Sona Manickam Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048

Re: K161045

Trade/Device Name: Monoject™ Enteral Feeding Syringe with ENFit Connector Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: April 11, 2016 Received: April 13, 2016

Dear Sona Manickam:

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.

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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 (reporting of medical 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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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1.0 Indications for Use Statement

Indications for Use

510(k) Number (if known): K161045

Device Name:

Monoject™ Enteral Feeding Syringe with ENFit Connector

Prescription Use X (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

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2.0 510(k) Summary

Monoject™ Enteral Feeding Syringe with ENFit Connector

In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:

Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: June 15, 2016

a. Contact Person

Sona Manickam Sr. Regulatory Affairs Specialist Covidien Telephone: (508) 261-8147 Fax: (508) 261-8461

b. Name of Medical Device
Common Name: Enteral Syringes with Enteral Specific Connectors

U.S. FDA Classification Product Code: PNR

U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980

Proprietary / Trade Name: Monoject™ Enteral Feeding Syringe with ENFit Connector

c. Identification of Legally Marketed Device(s)

K142128 - Kangaroo™ Enteral Feeding Syringe with ENFit Connector K152857 - NeoMed NeoConnect™ Enteral Syringes with ENFit Connector and compatible NeoSecure™ Tip Caps

d. Device Brief Description

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e. Indications for Use

Product Comparison Summary f.

The proposed and predicate enteral feeding syringes are intended for patients who require enteral nutrition due to illness or injury which prevents normal chewing and swallowing. These products are enteral syringes that have the same intended use, the same function, and the same general characteristics except for the modification of the ENFit connector in compliance with AAMI /CN3 (PS):2014 to include an internal lumen tip to ensure dosing accuracy in low dose applications.

g. Nonclinical testing

Biocompatibility testing has demonstrated the biological safety of the proposed devices which may indirectly contact the patients
. Stability testing evaluated the properties of the enteral feeding syringes after accelerated aging in support of the labeling.
Testing performed on low dose Enteral Syringe design demonstrates the proposed devices conform to the requirements of ISO 7886-1 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
Dimensional analysis of the low dose ENFit connector was conducted for critical dimensions, in accordance with AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The analysis demonstrates the proposed devices conform to the criteria in Table B.2 of AAMI /CN3 (PS):2014.
. Testing performed on the Monoject™ Enteral Feeding Syringes with low dose tip ENFit Connectors included the items listed below, in accordance with AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications -Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications -Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80369-20.

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Individual Test Definedin AAMI /CN3(PS):2014	RequirementDefined in AAMI/CN3 (PS):2014	Test MethodDefined in ISO80369-20
Fluid Leakage	Clause 6.2	Annex C
Stress Cracking	Clause 6.3	Annex E
Resistance to separationfrom axial load	Clause 6.4	Annex F
Resistance to separationfrom unscrewing	Clause 6.5	Annex G
Resistance to overriding	Clause 6.6	Annex H
Disconnection byunscrewing	Clause 6.7	Annex I

Verification of low dose Enteral Syringe design to demonstrate the dosing Accuracy of ● the low dose tip ENFit connector
The risk associated with the misconnection of the ENFit low dose tip connector has been assessed.
Low Dose Tip ENFit Syringe Tip Usability Testing. ●

h. Clinical testing

Clinical evaluations were not relied upon for evidence of safety and effectiveness, or for a determination of substantial equivalence.

i. Conclusions

The information provided within this pre-market notification demonstrates that the Monoject™ Enteral Feeding Syringe with ENFit Connector has no difference that would affect the safety or effectiveness of the devices as compared to the predicate devices and is substantially equivalent.

End of Summary

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.