K Number

Device Name

Enteral Feeding Syringes with Enfit Connectors

Manufacturer

Jiangsu Kangbao Medical Equipment Co., Ltd

Date Cleared

2018-11-09

(46 days)

Product Code

PNR

Regulation Number

876.5980

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161039

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and standard testing of a syringe, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow, which is a therapeutic intervention.

Diagnostic

Explanation: The device description states it is a "dispenser, a measuring device, and a fluid transfer device" used to "deliver fluids into the gastrointestinal system." It does not detect, monitor, or analyze medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (barrel, plunger, piston) and mentions sterilization and packaging, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is used to "deliver fluids into the gastrointestinal system of a patient." This is a direct interaction with the patient's body for therapeutic or supportive purposes.
IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details a syringe with a connector designed for enteral feeding, which is a method of delivering nutrition or medication directly into the stomach or small intestine. This is an in vivo application (within the living body).
Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.

The device described is a medical device used for patient care, specifically for enteral feeding, which is an in vivo procedure, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

PNR

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal system

Indicated Patient Age Range

all age groups

Intended User / Care Setting

users ranging from laypersons (under the supervision of a clinician) to clinicians in all age groups / clinical or home care settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161039

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

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

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)

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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

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

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	K161039
PNR
Regulation Number	21 CFR 876.5980	21 CFR 876.5980
Class	II	II
Indications for Use	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.	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 or home care
setting by users ranging from clinicians to
laypersons (under the supervision of a
clinician) in all age groups.
Configuration	Piston;
Plunger;
Barrel with ENFit connector	Piston;
Plunger;
Barrel with ENFit connector

Table 2 Substantially Equivalent Comparison

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 and
100ml	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.