The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) 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 60ml. 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 12ml, 35ml and 60ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 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 central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

AI/ML Overview

This document is a 510(k) Summary for the Oral/Enteral Syringe with ENFit connector (K211025). It does not contain information about a study proving the device meets acceptance criteria in the manner you describe for AI/imaging devices. Instead, it demonstrates substantial equivalence to a predicate device (K161039) through non-clinical testing.

Here's an analysis of the information provided in the context of your questions, explaining why certain sections are not applicable:

1. A table of acceptance criteria and the reported device performance

The document provides a list of standards the device complies with, which implicitly serve as acceptance criteria for different aspects of the device's performance. It also states that "dose accuracy testing is conducted to demonstrate the enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity." This is a key performance metric and a stated acceptance criterion.

Acceptance Criteria (Standards and Specific Performance)	Reported Device Performance
ISO 7886-1:2017 (Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use)	Complied
ISO 10993-5:2009 (Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity)	Complied (No Cytotoxicity)
ISO 10993-10:2010 (Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization)	Complied (No Irritation, No Sensitization)
ISO 10993-7:2008 (Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals)	Complied
ISO 14971:2007 (Medical Devices-Application of Risk Management to Medical Devices)	Complied
ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials)	Complied
ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)	Complied
ISO 80369-3:2016 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications)	Complied
ISO 80369-20:2015 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 20: Common Test Methods)	Complied
Dose accuracy: accurate to ±10% when filled with a minimum dose of 20% of overall syringe capacity	Demonstrated (See "Non-Clinical Test Conclusion")
Sterility Assurance Level (SAL)	10^-6

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non clinical tests were conducted," but does not specify the sample sizes for these tests for each standard or the dose accuracy testing. It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as these types of details are typically associated with clinical studies involving patient data, not non-clinical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. The "ground truth" concept, especially involving expert consensus and specific qualifications of medical professionals, is relevant for AI/imaging devices interpreting medical images or data. For this physical medical device (an enteral syringe), performance is assessed through objective engineering and biological tests against established international standards, not against expert human interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where multiple experts evaluate ambiguous cases. For non-clinical tests on a physical device, the results are typically objectively measured and do not require expert adjudication in this manner.

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. MRMC studies are specifically designed for assessing the performance of diagnostic devices, particularly AI-powered ones, and their impact on human reader performance. This submission is for a physical medical device (a syringe), not a diagnostic AI tool.

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

This question is not applicable. This refers to the standalone performance of an algorithm. The device here is a physical syringe, not an algorithm.

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

For this device, the "ground truth" is established by the requirements of the referenced international standards (e.g., ISO for sterility, biocompatibility, connector features, and ASTM for material properties) and specific performance specifications (e.g., dose accuracy ±10%). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for proving the performance of a syringe.

8. The sample size for the training set

This question is not applicable. This refers to the training data for an AI algorithm. This submission is for a physical medical device.

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

This question is not applicable. This refers to establishing ground truth for AI model training. This submission is for a physical medical device.

Summary

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June 30, 2021

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

Re: K211025

Trade/Device Name: Oral/Enteral Syringe with ENFit connector Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: April 2, 2021 Received: April 6, 2021

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.

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

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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 Shanil P. Haugen, Ph.D. Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211025

Device Name Oral/Enteral Syringe with ENFit connector

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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 Title 21, CFR Section 807.92.

The assigned 510(k) Number: K211025

1. Date of Preparation: 06/10/2021
1. Sponsor Identification

Ningbo Tianyi Medical Appliance Co., Ltd.

No.788, Mozhi North Road, Tourism Resort, Dongqian Lake, 315121 Ningbo, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: Not registered

Contact Person: Wenyu Zhang Position: Regulatory Affair Manager Tel: +86-574-55011007 Fax: +86-574-55011007 Email: vincent.zhang@tianyinb.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

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

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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Identification of Proposed Device 4.

Trade Name: Oral/Enteral Syringe with ENFit connector Common Name: Enteral Syringe with Enteral Specific connector

Regulatory Information

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

Indication for Use:

Device Description

There are 2 types of the syringe:

Side connector ENFit syringe and central connector ENFit syringe. The sizes of the central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml.

The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

న. 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)

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Non-Clinical Test Conclusion 6.

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 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;
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.

In addition, dose accuracy testing is conducted to demonstrate the enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity.

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

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8. Summary of Technology Characteristics

Item	Proposed Device	Predicate Device K161039	Remark
Product Name	Oral/Enteral Syringe with ENFitconnector	Oral/Enternal Feeding Syringes withENFit Connector (12ml to 100ml)and Low Dose Tip Oral/EnternalFeeding Syringes with ENFitConnector (0.5ml to 6ml)	/
Product Code	PNR	PNR	Same
RegulationNumber	21CFR 876.5980	21CFR 876.5980	Same
Indications forUse	The device is intended for use as adispenser, a measuring device and anoral fluid transfer device. It isintended to be used to deliver fluidsinto the body orally or enterally. It isintended to be used in clinical orhome care settings by operatorsranging from qualified medicalpractitioners to laypersons (under thesupervision of a qualified medicalpractitioners) in all age groups	The device is indicated for use as adispenser, a measuring device, and afluid transfer device. It is used todeliver fluids into the body orally orenterally. It is intended to be used inclinical or home care setting by usersranging from clinicians to laypersons(under the supervision of a clinician)in all age groups.	Same
Configuration	Piston;Plunger;Barrel with ENFit connector;Tip cap	Piston;Plunger;Barrel with ENFit connector;Tip cap	Same
Single Use	Single Use	Single Use	Same
Product Size(nominalvolumes)	Low dose tip ENFit syringe: 0.5ml,1ml, 3ml, 6ml;Standard ENFit syringe: 12ml, 20ml,35ml, 60ml;	Low dose tip ENFit syringe:0.5ml~~6ml;Standard ENFit syringe:12ml~~100ml;	Different
ProductPerformance	Complied with:ISO 80369-3ISO 80369-20ISO 7886-1	Complied with:ISO 80369-3ISO 80369-20ISO 7886-1	Same
Material
Barrel	Polypropylene (PP)	Unknown	Different

		Table 1 Comparison of Technology Characteristics
--	--	--------------------------------------------------

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Plunger	Polypropylene (PP) and white pigment
Piston	Silicone rubber
Tip Cap	Polypropylene (PP) and Orange pigment
	Or polypropylene (PP) and purple pigment
Biocompatibility
Cytotoxicity	No Cytotoxicity	Conform with ISO 10993	Similar
Skin Irritation	No Irritation
Sensitization	No Sensitization
Sterile	Sterile or non-sterile	Sterile or non-sterile	SE
Sterile Method	EO Sterilized	EO Sterilized	SE
SAL	10-6	10-6	SE

Different - Product Size

The product size for proposed device is different from predicate device. The proposed device includes 8 sizes, 0.5 ml, 1ml, 3ml, 6ml, 20ml, 35ml, 60ml, all of which are covered by predicative device. In addition, this difference is just in infusion capacity and dose not effect indication for use, and the physician can select by per patient's condition. Therefore, this difference does not raise new safety and effectiveness issues for the device.

Different- Material

The material for the predicate devices is unknown. However, the biocompatibility test has been performed on proposed device according to ISO 10993, the result does not show any adverse effect which can demonstrate the safety of proposed device. Therefore, this difference does not raise new safety and effectiveness issues for the device.

Similar- Biocompatibility

The biocompatibility of proposed device and predicate device is similar. Both of them comply with standard ISO 10993, the result does not show any adverse effect which can demonstrate the safety of proposed device. Therefore, this difference does not raise new safety and effectiveness issues for the device.

9. Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, the Oral/Enteral Syringe with ENFit Connector is as safe, as effective, and performs as well

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as or better than the legally marketed predicative device cleared under K161039.

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.