The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

Device Description

The NeoMed NeoConnect™ Enteral Syringes are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied with a syringe tip cap. They are provided in varying sizes ranging from 0.5ml to 100ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with feeding tubes and extension sets that have ENFit male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (NeoMed NeoConnect™ Enteral Syringes with ENFit Connector). It does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML powered device, which typically involves metrics like sensitivity, specificity, AUC, or reader performance.

The document describes bench testing for the physical properties and safety of the syringe. These are acceptance criteria for a physical medical device, not an AI algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not applicable to the information provided in this regulatory submission.

However, I can extract the acceptance criteria and related "performance" from the document based on the provided bench testing section.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance/Compliance
Risk Management	EN ISO 14971:2012	Risk Analysis including design, user and process FMEA conducted.
Human Factors/Usability	Human Factors and Usability Validation	Design Validation performed. Human Factors Validation Study performed (for ENFit connector).
Biocompatibility	ISO 10993-5: Cytotoxicity	Testing conducted.
	ISO 10993-10: Irritation and sensitization	Testing conducted.
	ISO 10993-11: Acute Toxicity	Testing conducted.
Chemical Testing	Extractables and Leachables	Testing conducted.
Finished Device Verification	Critical Dimension verification	Verification conducted.
	Ink Adhesion	Testing conducted.
	Capacity Tolerance	Testing conducted.
	Graduated Scale	Testing conducted.
	Piston Fit in Barrel	Testing conducted.
	Air and Liquid Leakage Testing	Testing conducted.
Syringe Tip (ENFit connector)	Enteral Connector Misconnection Assessment	Assessment conducted.
	ENFit Connector Risk Management Report	Report (including misconnections FMEA) conducted.
	Dimensional verification	Verification conducted.
	Liquid Leakage Testing	Testing conducted.
	Stress Cracking	Testing conducted.
	Resistance to separation from axial load	Testing conducted.
	Resistance to separation from unscrewing	Testing conducted.
	Resistance to overriding	Testing conducted.
	Disconnection by unscrewing	Testing conducted.
Sterilization	Ethylene Oxide (EO), 10^-6^ SAL	Sterilization method is EO with 10^-6^ SAL.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The document refers to "Finished Device Verification Testing" and various specific tests but does not disclose the number of units tested.
Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective bench testing conducted by the manufacturer, NeoMed, Inc. The document implies the tests were performed as part of the device's design validation prior to market submission.

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

Not Applicable. This document describes testing for a physical medical device (syringe), not an AI/ML algorithm that requires expert-established ground truth for diagnostic or prognostic performance. The "ground truth" for these tests would be the measured physical properties or compliance with engineering standards.

4. Adjudication method for the test set:

Not Applicable. As above, this is not an AI/ML diagnostic or prognostic test. Adjudication methods like 2+1 or 3+1 are used for expert consensus in image interpretation or similar tasks, which are not relevant here.

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 for a physical medical device; no AI component is mentioned, and therefore, no MRMC study involving AI assistance would have been performed or reported here.

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

Not Applicable. There is no algorithm or software component described in this device submission.

7. The type of ground truth used:

Direct Measurement / Standard Compliance. The ground truth for this device's performance is established by direct physical measurements against defined engineering standards (e.g., critical dimensions, leakage rates, strength of connections, biocompatibility testing against ISO standards). This is typical for traditional hardware medical devices.

8. The sample size for the training set:

Not Applicable. This device does not have a "training set" as it is not an AI/ML product. The design and manufacturing processes are developed based on engineering principles and regulatory standards, not trained on data.

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

Not Applicable. As there is no training set, there is no ground truth for a training set.

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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

September 29, 2016

NeoMed, Inc. Melinda Harrison Smith, RAC, ASQ-CBA Director, Quality and Regulatory Affairs 100 Londonderry Court, Suite 112 Woodstock, GA 30188

K143344 Re:

Trade/Device Name: NeoMed NeoConnect™ Enteral Syringes with ENFit Connector Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PNR Dated: March 11, 2015 Received: March 13, 2015

Dear Melinda Harrison Smith,

This letter corrects our substantially equivalent letter of April 7, 2015.

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 for use bared in the 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 I he goneral ocharing 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.

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Page 2 - Melinda Harrison Smith, RAC, ASQ-CBA

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 (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" (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 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/Resourcesfor You/Industry/default.htm.

Sincerely,

For Division

Douglas Silverstein -S 2016.09. -04'00'

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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Indications for Use

510(k) Number (if known) K143344

Device Name

NeoMed NeoConnect™ Enteral Syringes with ENFit Connector

Indications for Use (Describe)

The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92)

I. SUBMITTER	NeoMed, Inc.100 Londonderry CourtSuite 112Woodstock, GA 30188Tel: 770-516-2225Fax: 770-516-2448
Contact:	Melinda Harrison Smith, RAC, CBAmharrison@neomedinc.com
Date Prepared:	18 November 2014
EstablishmentRegistration Number:	3006520777

ll. DEVICE

Trade Name:	NeoConnect™ Enteral Syringes
Common Name:	Enteral Syringe
Classification Name:	Gastrointestinal tube and accessories (21 CFR § 876.5980)
Regulatory Class:	II
Product Code :	PIF

lll. PREDICATE DEVICE

NeoMed Oral / Enteral Syringe (0.5ml to 100ml) (K122373) This predicate had not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

Feature	PREDICATE DEVICE	SUBJECT DEVICE
Indications for Use /Intended UseStatement	The device is indicated for use asa dispenser, a measuring deviceand an oral fluid transfer device. Itis used to inject fluids into the bodyvia extension sets and feedingtubes in neonatal and smallpediatric patients.	The device is indicated for use as adispenser, a measuring device anda fluid transfer device. It is used todeliver fluids into the body viaextension sets and feeding tubes inneonatal and small pediatricpatients.
Patient Population /Environment of Use	Neonates and Small Pediatrics/Hospital, Disposable and for singlepatient use only	Neonates and Small Pediatrics/Hospital, Disposable and for singlepatient use only
Description of Device	An oral / enteral syringe consistingof a syringe barrel with integral tip(tapered), plunger, gasket, barrellubricant and supplied with asyringe tip cap.	An enteral syringe consisting of asyringe barrel with integral tip(ENFit), plunger, gasket, barrellubricant and supplied with asyringe tip cap.
Syringe Type	Oral / Enteral Syringe	Enteral Syringe
Principle of Operation	Piston Style Syringe	Piston Style Syringe
Syringe Tip Type	Tapered	ENFit(Dimensional compliance toAAMI/CN3:2014 (PS) Part 3 TableB.2 Female Enteral Small-BoreConnector).
Syringe Sizes(nominal volumes)	0.5ml to 100ml sizes	0.5ml to 100ml sizes
Syringe Barrel withintegral syringe tip andvolume graduations	Barrel - Polypropylene, class VIGraduation Ink - Orange	Barrel - Polypropylene, class VIGraduation Ink - Orange or Purple
Integral Syringe TipFlexural Modulus	9500 Kg/cm² (932 MPa)	9500 Kg/cm² (932 MPa)
Syringe Plunger	Inert Polypropylene, class VIWhite Colorant	Inert Polypropylene, class VIWhite Colorant
Syringe Gasket	Silicone, Class VI, Black Colorant	Silicone, class VI, Black Colorant
Syringe Tip Cap	Inert Polypropylene, class VIOrange Colorant	Inert Polypropylene, class VIOrange or Purple Colorant
Barrel Lubricant	Polydimethylsiloxane class VI	Polydimethylsiloxane class VI
Packaging Material	Tyvek or medical grade paper /film primary pouch, Double Flutepaper corrugate case box	Tyvek or medical grade paper / filmprimary pouch, Double Flute papercorrugate case box
Sterilization Method,SAL	Ethylene Oxide (EO), 10-6 SAL	Ethylene Oxide (EO), 10-6 SAL
Human Factors andUsability	Design Validation	Design ValidationDevice Master File #MAF2258
Risk Analysis	Device Risk Assessment includingDesign and User FMEA	Device Risk Assessment includingDesign and User FMEADevice Master File #MAF2258

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VII. PERFORMACE DATA (BENCH)

The following performance testing was conducted on the NeoConnect™ Enteral Syringe:

. Finished Device
O
Risk Analysis including design, user and process FMEA (Failure Modes and o Effects Analysis) in accordance with EN ISO 14971:2012
o Human Factors and Usability Validation
Biocompatibility o
- · ISO 10993-5: Cytotoxicity
- ISO 10993-10: Irritation and sensitization .
- . ISO 10993-11: Acute Toxicity
Chemical Testing o
- Extractables and Leachables .
- Finished Device Verification Testing
  - Critical Dimension verification .
  - . Ink Adhesion
  - =
    - Capacity Tolerance ●
    - Graduated Scale ●
    - Piston Fit in Barrel .
    - Air and Liquid Leakage Testing ●
Syringe Tip (ENFit connector) ●
- Enteral Connector Misconnection Assessment o
- ENFit Connector Risk Management Report (including misconnections FMEA) O
- Human Factors Validation Study o
- Dimensional verification O
- Liquid Leakage Testing O
- O Stress Cracking
- Resistance to separation from axial load O
- Resistance to separation form unscrewing O
- Resistance to overriding O
- Disconnection by unscrewing o

CONCLUSIONS VIII.

The NeoMed NeoConnect™ Enteral Syringes are substantially equivalent to the NeoMed Oral / Enteral Syringe (K122373).

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.