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 proposed device, Enteral Feeding Syringes with ENfit Connectors, is provided sterile, single use. It has 3 components: (1) barrel, (2) plunger, and (3) piston. The Enteral Feeding Syringes with ENfit Connectors is available in various size, including 1ml, 2.5ml, 5ml, 10ml, 20ml, 60ml and 100ml. In addition, it contains low dose enteral specific connectors. The Enteral Feeding Syringes with ENfit Connectors is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

AI/ML Overview

The provided text describes a 510(k) summary for Enteral Feeding Syringes with ENFit Connectors, which are medical devices, not AI/ML-driven software. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device are not applicable to this document. The document details the substantial equivalence of the proposed device to a predicate device based on non-clinical tests and conformance to established standards.

Here's an analysis of the provided information, focusing on the device's conformity to standards rather than AI-specific criteria.

Device: Enteral Feeding Syringes with ENFit Connectors

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria for this medical device are based on compliance with several ISO standards and specific performance tests. The device's reported performance demonstrates compliance with these standards.

Acceptance Criteria (Standard / Test)	Reported Device Performance
ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use	Complies with the standard
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications	Complies with the standard
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods	Complies with the standard
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity	No Cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	No Irritation to Skin, No significant evidence of sensitization
Dimension analysis	Complies with requirements
Dosing accuracy test	Complies with requirements
Connector incompatibility test	Complies with requirements
Sterilization Assurance Level (SAL)	10⁻⁶ (EO Sterilized)
Endotoxin Limit	20 EU per device

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

The document does not specify the exact sample sizes for each non-clinical test conducted. It states that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data is from in-house non-clinical testing performed by Jiangsu Kangbao Medical Equipment Co., Ltd.

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

This question is not applicable as the device is not an AI/ML system requiring expert-established ground truth for a test set. The validation relies on technical specifications and international standards, which are evaluated by engineers and quality control personnel.

4. Adjudication method for the test set

This question is not applicable as there is no mention of a human-based adjudication process for the non-clinical tests described. Compliance is determined by adherence to established measurement and testing protocols defined by the ISO standards.

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

This question is not applicable as the device is not an AI/ML system, and no human readership studies are referenced.

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

This question is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this physical device, the "ground truth" for non-clinical performance and safety is defined by the established international standards (ISO standards) and engineering specifications. For biocompatibility, this is determined by laboratory tests for cytotoxicity, irritation, and sensitization as per ISO 10993. For sterilization, it's about achieving a specific SAL.

8. The sample size for the training set

This question is not applicable as the device is not an AI/ML system and does not involve a training set.

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

This question is not applicable as the device is not an AI/ML system and does not involve a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2018

Jiangsu Kangbao Medical Equipment Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K182649

Trade/Device Name: Enteral Feeding Syringes with Enfit Connectors Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: September 19, 2018 Received: September 24, 2018

Dear Diana Hong:

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 mav, 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 avare 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.

{1}------------------------------------------------

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.html; 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,

Daniel G. Walter Jr -S 2018.11.09 16:55:01 -05'00'

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K182649

Device Name

Enteral Feeding Syringes with Enfit Connectors

Indications for Use (Describe)

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 agency 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."

{3}------------------------------------------------

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K182649

1. Date of Preparation: 11/06/2018
1. Sponsor Identification

Jiangsu Kangbao Medical Equipment Co., Ltd 78#, North Suzhong Road, Baoying, Yangzhou, 225800, China.

Establishment Registration Number: 3009742443

Contact Person: Qian Li Position: Marketing Manager Tel: +86-571-87987813 Email: ruffyhz(@aliyun.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net

{4}------------------------------------------------

K182649 Page 2 of 4

K182649

4. Identification of Proposed Device

Trade Name: Enteral Feeding Syringes with Enfit Connectors Model: 1ml, 2.5ml, 5ml, 10ml, 20ml, 60ml and 100ml Classification Name: Gastrointestinal tube and accessories Classification: II Product Code: PNR Regulation Number: 21 CFR 876.5980 Review Panel: Gastroenterology/Urology

Indications for Use:

Device Description

The proposed device, Enteral Feeding Syringes with ENfit Connectors, is provided sterile, single use. It has 3 components: (1) barrel, (2) plunger, and (3) piston.

The Enteral Feeding Syringes with ENfit Connectors is available in various size, including 1ml, 2.5ml, 5ml, 10ml, 20ml, 60ml and 100ml. In addition, it contains low dose enteral specific connectors.

The Enteral Feeding Syringes with ENfit Connectors is sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

1. Identification of Predicate Device
  Predicate Device

510(k) Number: K161039

Manufacturer: NeoMed, Inc.

Product Name: NeoConnector Oral/Enternal Feeding Syringes with ENFit Connector (12ml to 100ml) NeoConnector Low Dose Tip Oral/Enternal Feeding Syringes with ENFit Connector (0.5ml to 6ml)

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed

{5}------------------------------------------------

device complies with the following standards:

ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use;
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

In addition, the dimension analysis, dosing accuracy test and connector incompatibility test have been conducted to demonstrate the proposed device complies with these requirement.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device
Product Code	PNR	K161039PNR
Regulation Number	21 CFR 876.5980	21 CFR 876.5980
Class	II	II
Indications for Use	Enteral Feeding Syringe with ENFitConnector is indicated for use as adispenser, a measuring device, and afluid transfer device. It is used to deliverfluids into the gastrointestinal system ofa patient who is physically unable to eatand swallow. The enteral syringes areintended to be used in clinical or homecare settings by users ranging fromlaypersons (under the supervision of aclinician) to clinicians in all age groups.	The device is indicated for use as adispenser, a measuring device, and a fluidtransfer device. It is used to deliver fluidsinto the body orally or enterally. It isintended to be used in clinical or home caresetting by users ranging from clinicians tolaypersons (under the supervision of aclinician) in all age groups.
Configuration	Piston;Plunger;Barrel with ENFit connector	Piston;Plunger;Barrel with ENFit connector

Table 2 Substantially Equivalent Comparison

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

Single Use	Yes	Yes
Operation Mode	Manual Use	Manual Use
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801
Size	1ml, 2.5ml, 5ml, 10ml, 20ml, 60ml and100ml	0.5~100ml
Performance	Complies with:	Complies with:
	ISO 7886-1	ISO 7886-1
	ISO 80369-3	ISO 80369-3
Patient-contact component and material
Barrel	Polypropylene (PP)	Unknown
Plunger	Polypropylene (PP)	Unknown
Piston	Polyisoprene	Unknown
Color additive	Pigment	Unknown
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity
Skin Irritation	No Irritation to Skin	No Irritation to Skin
Sensitization	No significant evidence of sensitization	No significant evidence of sensitization
Sterilization
Method	EO Sterilized	EO Sterilized
SAL	10⁻⁶	10⁻⁶
Endotoxin Limit	20 EU per device	20 EU per device

The specifications of proposed device and predicate device are different, however, both of them comply with the same recognized standards. Therefore the differences on syringe size will not raise new problems on safety and effectiveness of the proposed device. In addition, the patient-contact components of the proposed device are same as those of the predicate device, although the patient-contacting materials of the predicated device are unknown, the proposed device and the predicated devices are biocompatible and conforms to ISO 10993 series standards. Therefore, the proposed device is claimed to be substantially equivalent to the predicate devices.

Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.

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.