ENFit Oral/Enteral Syringe is indicated for use as a dispenser, a measuring device, and an oral/enteral 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 settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

Device Description

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 100ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 5ml, 6ml, 12ml, 20ml, 30ml, 35ml, 50ml, 60ml and 100ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 5ml and 6ml) incorporate a female low dosing ENFit connector. There are 2 types of the syringe: Side connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 10ml to 100ml; and central connector ENFit syringe range from 0.5ml to 100ml. The proposed syringe is sterile or non-sterile. Sterile device was 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 five years. The sterile syringes are provided with transparent barrel, and the non-sterile syringes are provided with transparent/ amber color barrel.

AI/ML Overview

This document describes the premarket notification (510(k)) for the ENFit Oral/Enteral Syringe manufactured by Jiangsu Caina Medical Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K161039).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized international standards for medical devices and specific tests. The reported device performance is indicated by the statement of compliance with these standards.

Acceptance Criteria (Standard / Test)	Reported Device Performance
ISO 80369-3:2016 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications)	Complied
ISO 7886-1:2017 (Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use)	Complied
ISO 80369-20:2015 (Small-Bore Connectors for Liquids And Gases in Healthcare Applications-Part 20: Common Test Methods)	Complied
ISO 10993-5:2009 (Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity)	Completed, did not show any adverse effect
ISO 10993-10:2010 (Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization)	Completed, did not show any adverse effect
ISO 10993-7:2008 (Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals)	Implied compliance (for EO sterilized devices)
ISO 14971:2007 (Medical Devices-Application of Risk Management to Medical Devices)	Implied compliance
ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials)	Implied compliance
ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)	Implied compliance
Sterility Assurance Level (SAL)	10^-6 (for sterile devices)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes used for each non-clinical test. The testing was conducted to verify compliance with international standards, which typically involve specific sample size requirements. The data provenance is from non-clinical tests conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd., based in China. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a submission for a physical medical device (syringe) and does not involve the use of AI, image analysis, or diagnostic interpretation requiring expert ground truth establishment in the traditional sense. The "ground truth" here is compliance with engineering and biological safety standards, which are evaluated by accredited laboratories and regulatory bodies, not by "experts" establishing a diagnostic truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study requiring adjudication of expert opinions. Device performance is determined by objective physical and chemical testing.

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

No MRMC study was done. This device is an ENFit Oral/Enteral Syringe, a physical device, and not an AI-powered diagnostic tool. Therefore, human readers or AI assistance are not relevant.

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

No standalone algorithm performance study was done. This is a physical device, not an algorithm.

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

For this device, the "ground truth" is defined by adherence to established international and national standards for medical devices, specifically:

Engineering and Performance Standards: ISO 80369-3, ISO 7886-1, ISO 80369-20, ASTM F88/F88M-15, ASTM F1929-15.
Biological Safety Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization), ISO 10993-7 (EO sterilization residuals).
Quality Management Standards: ISO 14971 (Risk Management).

Compliance with these standards, demonstrated through non-clinical laboratory testing, serves as the "ground truth" for the device's safety and effectiveness for its intended use.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

Summary

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August 6, 2019

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

Re: K190502

Trade/Device Name: ENFit Oral/Enteral Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: June 21, 2019 Received: July 2, 2019

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 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.

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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

Martha W. Betz, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190502

Device Name ENFit Oral/Enteral Syringe

Indications for Use (Describe)

ENFit Oral/Enteral Syringe is indicated for use as a dispenser, a measuring device, and an oral/enteral fluid transfer device. It is used to deliver fluids into the body or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary

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

The assigned 510(k) Number: K190502

1. Date of Preparation: 08/05/2019
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd.s No.23, Huanxi Rd. Zhutang Town, 214415 Jiangyin City, Jiangsu, China

Establishment Registration Number: 3005670221

Contact Person: Xinyan Ruan Position: QA Engineer Tel: +86-0510-8686 6666-8027 Fax: +86-0510-8686 6666-8009 Email: sherry.ruan@cainamed.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: +1-360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: ENFit Oral/Enteral Syringe Common Name: Enteral Feeding Syringe with ENFit Connector

Regulatory Information

Classification Name: Gastrointestinal tube and accessories Classification: II; Product Code: PNR Regulation Number: 21CFR 876.5980 Review Panel: Gastroenterology/Urology;

Indications for Use Statement:

Device Description:

There are 2 types of the syringe:

Side connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 10ml to 100ml; and central connector ENFit syringe range from 0.5ml to 100ml.

The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. The sterile syringes are provided with transparent barrel, and the non-sterile syringes are provided with transparent/ amber color barrel.

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5. Identification of Predicate Device

510(k) Number: K161039

Product Name: Oral/Enternal Feeding Syringes with ENFit Connector (12ml to 100ml) and 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 80369-3:2016 Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications

ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use;

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:

ISO 10993-7:2008, Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals

ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices;

ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;

ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Table 1 Comparison of Technology Characteristics

Item	Proposed Device	Predicate Device K161039
Product Code	PNR	PNR
Regulation Number	21CFR 876.5980	21CFR 876.5980
Indications for Use	ENFit Oral/Enteral Syringe is indicated	The device is indicated for use as a
	for use as a dispenser, a measuring	dispenser, a measuring device, and a fluid
	device, and an oral/enteral fluid	transfer device. It is used to deliver fluids
	transfer device. It is used to deliver	into the body orally or enterally. It is
	fluids into the body orally or enterally.	intended to be used in clinical or home care
	It is intended to be used in clinical or	setting by users ranging from clinicians to
	home care settings by users ranging	laypersons (under the supervision of a
	from clinicians to laypersons (under the supervision of a clinician) in all age groups.	clinician) in all age groups.
Configuration	Piston;	Piston;
	Plunger;	Plunger;
	Barrel with ENFit connector;	Barrel with ENFit connector;
	Tip cap	Tip cap
Material	Plunger: polypropylene (PP);	Unknown
	Barrel: polypropylene (PP);
	Piston: polyisoprene
Color	Plunger: purple	Plunger: white
	Barrel: transparent and amber color	Barrel: transparent and amber color
	Low does tip ENFit Syringe: 0.5ml,1ml, 3ml, 5ml and 6ml	Low dose tip ENFit syringe: 0.5ml~6ml;
Product Size	Standard ENFit syringe: 5ml, 6ml,10ml, 12ml, 20ml, 30ml, 35ml, 50ml,60ml and 100ml	Standard ENFit syringe: 12ml~100ml;
ProductPerformance	Complied with:ISO 80369-3;ISO 80369-20;ISO 7886-1;	Complied with:ISO 80369-3;ISO 80369-20;ISO 7886-1;
Operation Mode	For Manual Use Only	For Manual Use Only
Sterile	Sterile or non-sterile	Sterile or non-sterile
Sterile Method	EO Sterilized	EO Sterilized
SAL	10-6	10-6
Single Use	Single Use	Single Use

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The patient contact material for the predicate devices is unknown, and the plunger color is different between the proposed device and predicate device. However, the Cytotoxicity, Irritation, and Sensitization Testing on proposed device were completed according to ISO 10993, the results did not show any adverse effect. Therefore, this difference is not considered to effect substantially equivalency.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are 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.