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 a variety of sizes from 6mL to 60mL. The device incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically an enteral feeding syringe. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI algorithm or an acceptance criteria study related to an AI device's performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria because the document is not about an AI device.

However, I can extract the acceptance criteria and test results for the physical characteristics of the Monoject™ Enteral Feeding Syringe with ENFit Connector, as detailed in the "Nonclinical testing" section.

Here's the information adapted to the prompt's structure for the physical device, recognizing this is not an AI study:

1. Table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (Requirement Defined in AAMI /CN3 (PS):2014)	Reported Device Performance
Fluid Leakage	Clause 6.2	Conforms to the requirements of AAMI /CN3 (PS):2014
Stress Cracking	Clause 6.3	Conforms to the requirements of AAMI /CN3 (PS):2014
Resistance to separation from axial load	Clause 6.4	Conforms to the requirements of AAMI /CN3 (PS):2014
Resistance to separation from unscrewing	Clause 6.5	Conforms to the requirements of AAMI /CN3 (PS):2014
Resistance to overriding	Clause 6.6	Conforms to the requirements of AAMI /CN3 (PS):2014
Disconnection by unscrewing	Clause 6.7	Conforms to the requirements of AAMI /CN3 (PS):2014
Dimensional Analysis	Criteria in Table B.2 of AAMI /CN3 (PS):2014	Conforms to the criteria in Table B.2 of AAMI /CN3 (PS):2014
Biocompatibility	Not explicitly stated, implied by "demonstrated the biological safety"	Demonstrated the biological safety
Stability	Not explicitly stated, implied by "evaluated the properties... after accelerated aging"	Evaluated properties after accelerated aging in support of labeling

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of syringes tested for fluid leakage). It mentions "accelerated aging" for stability testing, implying lab-based, prospective testing conducted by the manufacturer, Covidien, based in Mansfield, MA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI device or a study requiring expert human interpretation for ground truth establishment. The ground truth for physical tests is based on objective measurements against international standards (ISO 80369 series and AAMI /CN3 (PS):2014).

4. Adjudication method for the test set

Not applicable. The tests are objective physical measurements against predefined criteria.

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

Not applicable. This is not an AI device or a study involving human readers.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

For the physical tests, the ground truth is based on objective measurements against established international and industry standards. For example, fluid leakage is "true" if the device meets Clause 6.2 of AAMI /CN3 (PS):2014.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

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

Not applicable.

Summary regarding the device:

The Monoject™ Enteral Feeding Syringe with ENFit Connector underwent non-clinical testing to demonstrate its substantial equivalence to predicate devices and conformity to relevant standards (ISO 80369-3, ISO 80369-20, and AAMI /CN3 (PS):2014). The testing covered aspects like fluid leakage, stress cracking, resistance to separation, resistance to overriding, disconnection by unscrewing, dimensional analysis, biocompatibility, and stability. All tested parameters met the specified criteria in the relevant standards. Clinical testing was not deemed necessary for the demonstration of safety and effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

May 12, 2016

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

Re: K160419

Trade/Device Name: Monoject™ Enteral Feeding Syringe with ENFit Connector Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tubes and Accessories Regulatory Class: II Product Code: PNR Dated: February 12, 2016 Received: February 16, 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 vours.

Herbert P. Lerner -S

for 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

K160419 510(k) Number (if known):

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: May 5, 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.

The design and materials of the proposed devices are identical to the predicate Kangaroo™ Enteral Feeding Syringe with ENFit Connector (K142128). The only difference between the cleared K142128 predicate and the proposed device is the expansion of the cleared indication to include enteral delivery of fluids in addition to the already cleared indication of delivery of enteral nutrition.

g. Nonclinical testing

o 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.
o Dimensional analysis was conducted for critical dimensions of the Monoject Enteral Feeding Syringes with ENFit connector and the accessories, in accordance with ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The testing 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 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 AAMI /CN3 (PS):2014.

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Individual Test Definedin ISO 80369-3	Requirement Definedin AAMI /CN3(PS):2014	Test Method Definedin ISO 80369-20
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

The risk associated the misconnection of the ENFit connector has been assessed at length and captured in the following documents..
- o PG Lock Misconnection Data with FMEA 2014-01-9
- o 3595-0501-04 Enteral Connector Misconnection Assessment
- o Enteral Connection Risk Management Report Rev 2.0
- o PG Lock Misconnection Risk Assessment Report 041513
Usability and human factors testing was conducted as part of the design of the ENFit ● connector.

h. Clinical testing

Clinical evaluations were not relied upon for evidence of safety of 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 device and provide reasonable assurance of the safety and effectiveness of the device to demonstrate substantial equivalency.

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.