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 orally or enterally. It is intended to be used in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups.

Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile):

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 orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

Device Description

NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 12 mL to 60 mL nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

NeoMed Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip that has the additional low dose tip design feature, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 1 mL to 6 mL nominal capacity. The integral syringe tip is a female ENFit connector with the additional low dose tip design feature which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

Reusable Standard ENFit Syringes (12 mL to 60 mL) and reusable Low Dose Tip ENFit Svringes (1 mL to 6 mL) are supplied non-sterile and are intended for single patient use. They are provided in varying colors and sizes ranging from 1 mL to 60 mL nominal capacity.

AI/ML Overview

The provided text describes a medical device, NeoMed Oral/Enteral Syringes with ENFit® connector, and its substantial equivalence to a predicate device. However, the document does not contain information typically found in studies that prove a device meets acceptance criteria for an AI/ML product. The questions raised in the prompt are more relevant to AI/ML device performance evaluation than to the type of medical device described (syringes).

Therefore, I cannot provide a direct answer to the acceptance criteria and study details for an AI/ML device based on the given input, as the input focuses on a physical medical device (syringes) and its substantial equivalence determination.

The document does list "PERFORMANCE DATA (BENCH)" for the syringes, which includes various tests to ensure the physical device's functionality, safety, and compliance with standards. These are benchmarks for the syringes, not for an AI/ML algorithm.

If the prompt were intended for a different type of medical device where AI/ML is involved, the information required would typically be found in clinical study reports, performance evaluation sections, or specific FDA guidance documents for AI/ML-based medical devices.

Summary of what can be extracted from the provided text regarding device performance (for the syringes, not an AI/ML device):

The device is NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL).

The document details various performance tests (bench) conducted to demonstrate the device's substantial equivalence to a predicate device (K161039). These tests assess the physical and functional attributes of the syringes.

Here's a breakdown of the performance data provided for the syringes:

Finished Device Testing:
- Risk Analysis (design, use, and process FMEA in accordance with ISO 14971:2007)
- Human Factors and Usability Validation
- Biocompatibility (ISO 10993-5: Cytotoxicity, ISO 10993-10: Irritation and sensitization, ISO 10993-11: Acute Toxicity)
- Chemical Testing (Extractables and Leachables)
- Reusability (Cleaning Instructions Validation, Use Cycle Parameters Study)
- Finished Device Verification Testing (Critical Dimension verification, Ink Adhesion, ISO 7886)
- Capacity Tolerance
- Graduated Scale
- Piston Fit in Barrel
- Air and Liquid Leakage Testing
- Direct Oral Administration Dosing Accuracy Testing
Syringe Tip (ISO 80369-3 (ENFit) connector) Testing:
- Enteral Connector Misconnection Assessment
- Human Factors Validation Study (Standard ENFit)
- Dimensional verification to ISO 80369-3
- Liquid leakage testing
- Resistance to stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
Syringe Tip (ISO 80369-3 (ENFit) connector with Low Dose Tip Design Feature) Testing:
- Low Dose Tip Misconnection Risk Management Report
- Usability Study for Low Dose Syringe Tip Design Feature
- Low Dose Tip Oral/Enteral Syringe Design Dosing Accuracy Testing
- Dimensional verification to ISO 80369-3
- Liquid leakage testing
- Resistance to stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing

Regarding the specific questions in the prompt (relevant to an AI/ML device, not these syringes):

A table of acceptance criteria and the reported device performance: This information is not provided in a format relevant to AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The performance data listed are for the physical properties and functionality of syringes.
Sample size used for the test set and the data provenance: Not applicable to this type of device. The "test set" here refers to the samples of syringes subjected to various bench tests, not a dataset for an AI/ML model.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for AI/ML refers to expert labels or pathology results. For these syringes, "ground truth" would be engineering specifications and international standards.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for assessing human performance with/without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used: For these syringes, the "ground truth" for the tests would be established by engineering specifications, validated test methods, and adherence to international standards like ISO 14971, ISO 10993, ISO 7886, and ISO 80369-3.
The sample size for the training set: Not applicable; this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a lighter blue font.

April 30, 2019

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

Re: K183540

Trade/Device Name: Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: March 25, 2019 Received: March 27, 2019

Dear Melinda Harrison Smith:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183540

Device Name Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL)

Indications for Use (Describe)

Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile):

Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile):

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 orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

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

| Prescription Use (Part 21 CFR 801 Subpart D) { Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

"An aqency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

SC Publishing Services (301) 443-6740 EF

NeoMed, Inc. Traditional 510(k)

December 18, 2018

Traditional 510(k) NeoMed Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)

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

l. SUBMITTER NeoMed, Inc. 100 Londonderry Court Suite 112 Woodstock, GA 30188 Tel: 770-516-2225 Fax: 770-516-2448
- Contact: Melinda Smith, MS, RAC, CBA msmith@neomedinc.com

Date Prepared: 18 December 2018

Establishment 3006520777 Registration Number:

II. DEVICE

Trade Name:	Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL)and Low Dose Tip Oral/Enteral Syringes with ENFit® connector(1 mL to 6 mL)
Common Name:	Enteral Syringe with Enteral Specific connector
Classification Name:	Gastrointestinal tube and accessories (21 CFR § 876.5980)
Regulatory Class:	II
Product Code :	PNR

PREDICATE DEVICE III.

Oral/Enteral Syringes with ENFit™ connector (12 mL to 100 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit™ connector (0.5 mL to 6 mL) (K161039)

Predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

NeoMed, Inc. Traditional 510(k)

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colors and sizes ranging from 1 mL to 6 mL nominal capacity. The integral syringe tip is a female ENFit connector with the additional low dose tip design feature which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

V. INDICATIONS FOR USE

Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile): 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 orally or enterally. It is intended to be used in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups.

Reusable Oral/Enteral Syringes with ENFit connector (provided non-sterile):

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 orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), and Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) have identical designs, principles of operation, materials, patient populations and use environments (however, no longer under the supervision of a clinician) as well as similar indications for use as the predicate devices cleared per K161039.

VII. PERFORMACE DATA (BENCH)

The following performance testing was conducted on the Oral/Enteral Syringes with ENFit connector and Low Dose Tip Oral/Enteral Syringes with ENFit connector:

. Finished Device
- Risk Analysis including design, use and process FMEA (Failure Modes and O Effects Analysis) in accordance with ISO 14971:2007
- Human Factors and Usability Validation o
- Biocompatibility o
  - · ISO 10993-5: Cytotoxicity
  - ISO 10993-10: Irritation and sensitization .
  - ISO 10993-11: Acute Toxicity
- Chemical Testing o
  - Extractables and Leachables ■
- Reusability o
  - Cleaning Instructions Validation ■
  - Use Cycle Parameters Study
- Finished Device Verification Testing o
  - Critical Dimension verification 트
  - Ink Adhesion
  - ISO 7886

NeoMed, Inc. Traditional 510(k)

December 18, 2018

Traditional 510(k) NeoMed Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)

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K183540 Page 3 of 3

Capacity Tolerance ●
. Graduated Scale
Piston Fit in Barrel ●
. Air and Liquid Leakage Testing
Direct Oral Administration Dosing Accuracy Testing
Syringe Tip (ISO 80369-3 (ENFit) connector) ●
- Enteral Connector Misconnection Assessment O
- o Human Factors Validation Study (Standard ENFit)
- Dimensional verification to ISO 80369-3 O
- Liquid leakage testing O
- Resistance to stress cracking o
- Resistance to separation from axial load o
- Resistance to separation from unscrewing O
- Resistance to overriding O
- Disconnection by unscrewing o
Syringe Tip (ISO 80369-3 (ENFit) connector with Low Dose Tip Design Feature) ●
- Low Dose Tip Misconnection Risk Management Report O
- Usability Study for Low Dose Syringe Tip Design Feature o
- Low Dose Tip Oral/Enteral Syringe Design Dosing Accuracy Testing O
- Dimensional verification to ISO 80369-3 O
- Liquid leakage testing O
- Resistance to stress cracking O
- Resistance to separation from axial load O
- Resistance to separation from unscrewing o
- Resistance to overriding o
- Disconnection by unscrewing O

VIII. CONCLUSIONS

NeoMed's Oral/Enteral Syringes with ENFit® connector (12 mL to 60mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL) are substantially equivalent to NeoMed's Oral/Enteral Syringes with ENFit™ connector (12 mL to 100mL) and Low Dose Tip Oral/Enteral Syringes with ENFit™ connector (1 mL to 6 mL) cleared per K161039.

NeoMed, Inc. Traditional 510(k)

Traditional 510(k) NeoMed Oral/Enteral Svringes with ENFit connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)

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.