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 Oral/Enteral Syringe with ENFit connector is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The Oral/Enteral Syringe with ENFit connector consists of plunger, gasket/piston, barrel with ENFit connector, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The proposed syringe 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 three years.

AI/ML Overview

This document is a 510(k) premarket notification for an Oral/Enteral Syringe with ENFit connector, seeking substantial equivalence to a predicate device. As such, it does not describe a study to prove a device meets acceptance criteria in the way a clinical trial or performance study for a novel diagnostic algorithm might. Instead, it demonstrates substantial equivalence by showing that the device meets relevant performance standards and has similar technological characteristics to a predicate device.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable in the context of this 510(k) submission for a non-active medical device like a syringe.

However, I can extract the acceptance criteria where applicable (i.e., performance standards and biocompatibility) and report the device's performance against those standards as described in the document.

Acceptance Criteria and Device Performance (Oral/Enteral Syringe with ENFit connector)

Device Under Review: Oral/Enteral Syringe with ENFit connector (K222772)
Predicate Device: Oral/Enteral Syringe with ENFit connector (K211025)

1. Table of Acceptance Criteria and Reported Device Performance

Category / Test Type	Acceptance Criteria (Standard Reference)	Reported Device Performance / Conclusion
Biocompatibility	ISO 10993-1:2018 (Surface medical device-mucosal membrane, contact < 24 hours)	Biocompatibility was evaluated and "does not show any adverse effect." Specific tests:
In Vitro Cytotoxicity Test	ISO 10993-5:2009	No Cytotoxicity
Intracutaneous Reactivity Test	ISO 10993-10:2010	No Irritation
Skin Sensitization Test	ISO 10993-10:2010	No Sensitization
Sterilization	ISO 11135 (Sterilization of health care products — Ethylene oxide)	Sterilization method validated to ISO11135, routine control, and monitoring parameters determined. Device is EO Sterilized to SAL 10-6.
EO Residue	ISO 10993-7:2008	Complied
ECH Residue	ISO 10993-7:2008	Complied
Shelf Life	ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages)	Shelf life of three years determined based on stability studies, including accelerated aging test.
Package Integrity	ASTM F88/F88M-15 (Seal strength)	All packaging deemed acceptable for protection of product and sterility maintenance after environmental conditioning and simulated transportation.
	ASTM F1929-2015 (Blue Dye Penetration)	All packaging deemed acceptable for protection of product and sterility maintenance.
	ASTM F1886/F1886M-16 (Seal Integrity (Visual Inspection))	All packaging deemed acceptable for protection of product and sterility maintenance.
Product Performance	ASTM D638-22, ASTM D790-17 Procedure A (Mechanical properties of plastics)	Report of PP 5090T provided, implying compliance with these material property standards.
Dose Accuracy	ISO 7886-1:2017 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use)	Testing performed, implying compliance with dose accuracy requirements.
Enteral Connectors	ISO 80369-3:2016 (Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications)	Performance testing performed, implying compliance with enteral connector standards. The Gasket difference from the predicate was determined not to raise new safety/effectiveness issues as the device "passed the verification of ISO 80369-3, ISO 80369-20 and ISO 7886-1 standard tests, and the results meet the requirements."
General Connectors	ISO 80369-1:2018 (Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements)	Performance testing performed, implying compliance.
Common Test Methods	ISO 80369-20:2015 (Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods)	Performance testing performed, implying compliance.

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

Sample Size: Not explicitly stated for each test, but standard test methods were followed. The number of devices required for each standard (e.g., ISO 7886-1, ISO 80369-3) would dictate the sample sizes.
Data Provenance: The tests are non-clinical (bench testing, material testing, biocompatibility testing) performed on the manufactured device. The location of testing labs is not specified, but the applicant is based in China. The data is prospective for the purpose of this submission (i.e., new tests performed on the specific device for this 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 non-clinical device submission. "Ground truth" in the diagnostic/AI sense is not relevant. Performance is measured against established international and harmonized standards.

4. Adjudication method for the test set:

Not Applicable. This refers to clinical assessments or expert review, which is not part of this type of submission. Testing involves laboratory measurements against predefined criteria in 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:

Not Applicable. This is a non-clinical syringe, not an AI-enabled diagnostic device.

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

Not Applicable. This is a non-clinical syringe, not an AI-enabled diagnostic device.

7. The type of ground truth used:

Not Applicable. For this type of device, performance is evaluated against objective, measurable criteria defined in international scientific and engineering standards (e.g., ISO, ASTM). There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of a diagnostic product.

8. The sample size for the training set:

Not Applicable. This is a non-AI device submission; there is no "training set."

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

Not Applicable. This is a non-AI device submission; there is no "training set" or ground truth for it.

Summary of Study (Based on Submitted Information):

The "study" in this context is a collection of non-clinical performance evaluations and testing conducted to demonstrate that the Anhui Tiankang Medical Technology Co., Ltd. Oral/Enteral Syringe with ENFit connector is substantially equivalent to its predicate device. This involves:

Biocompatibility Testing: Evaluating the device's materials for cytotoxicity, irritation, and sensitization according to ISO 10993 series. The device reported "No Cytotoxicity; No Irritation; No Sensitization."
Sterilization Validation: Confirming the Ethylene Oxide (EO) sterilization process meets ISO 11135 standards and an SAL of 10-6, along with EO and ECH residue testing per ISO 10993-7. The device was found to comply.
Shelf Life Determination: Performing accelerated aging tests according to ASTM F1980-16 to support a 3-year shelf life.
Package Integrity Testing: Conducting tests like seal strength (ASTM F88/F88M-15), blue dye penetration (ASTM F1929-2015), and visual inspection (ASTM F1886/F1886M-16) to ensure packaging maintains sterility. All packaging was deemed acceptable.
Product Performance Testing: Evaluating the syringe against specific functional standards:
- Dose accuracy according to ISO 7886-1:2017.
- Enteral connector compatibility and performance according to ISO 80369-3:2016.
- General connector requirements and common test methods from ISO 80369-1:2018 and ISO 80369-20:2015.
- Material properties referenced by ASTM D638-22 and ASTM D790-17.

The submission concludes that the non-clinical testing demonstrates the device's safety, effectiveness, and performance are comparable to the legally marketed predicate device, thereby establishing substantial equivalence. No clinical studies were included or deemed necessary for this type of device.

Summary

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August 17, 2023

Anhui Tiankang Medical Technology Co., Ltd. Zhang Yong Management No. 228, Weiyi Road, Economic Development Zone Tianchang, Anhui 239300 China

Re: K222772

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: July 10, 2023 Received: July 17, 2023

Dear Zhang Yong:

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. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Sivakami Venkatachalam -S

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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Indications for Use

510(k) Number (if known) K222772

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)

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510(k) summary

l Submitter

Device submitter: Anhui Tiankang Medical Technology Co., Ltd. No.228, Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China.

Contact person: Name: Zhang yong Title: Management representative Phone: +86-13705505106 Fax: +86-550-7309158 E-mail: zy@tkmedical.com

II Device

Trade Name of Device: Oral/Enteral Syringe with ENFit connector Common Name: Enteral Syringes With Enteral Specific Connectors Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product code: PNR Review Panel: Gastroenterology/Urology

III Predicate Device 1

Trade name:	Oral/Enteral Syringe with ENFit connector
Regulation name:	Gastrointestinal tube and accessories
Classification:	Class II
Product Code:	PNR
Premarket Notification:	K211025
Manufacturer:	Ningbo Tianyi Medical Appliance Co., Ltd.

IV Device description

The proposed syringe 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 three years.

V Indications for use

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VI Comparison of technological characteristics with the predicate devices

The Oral/Enteral Syringe with ENFit connector has the same intended use, technology, design and biocompatibility is either identical or substantially equivalent to existing legally marketed predicate devices. The comparison between the subject device and the predicate devices are listed in below tables:

Device feature	Subject Device	Predicate Device K211025	Comment
Product	Oral/Enteral Syringe withENFit connector	Oral/Enteral Syringe withENFit connector	/
Product code	PNR	PNR	Same
RegulationNumber	21CFR 876.5980	21CFR 876.5980	Same
Indications for use	The device is intended foruse as a dispenser, ameasuring device and anoral fluid transfer device. Itis intended to be used todeliver fluids into the bodyorally or enterally. It isintended to be used inclinical or home caresettings by operatorsranging from qualifiedmedical practitioners tolaypersons (under thesupervision of a qualifiedmedical practitioners) in allage groups.	The device is intended foruse as a dispenser, ameasuring device and an oralfluid transfer device. It isintended to be used to deliverfluids into the body orally orenterally. It is intended to beused in clinical or home caresettings by operators rangingfrom qualified medicalpractitioners to laypersons(under the supervision of aqualified medicalpractitioners) in all agegroups.	Same
	Configuration	Piston/Gasket;Plunger;	Piston;Plunger	DifferenceComment 1
	Device feature	Subject Device	Predicate Device K211025	Comment
		Barrel with ENFit connector;	Barrel with ENFit connector;
		Tip cap	Tip cap
	Single Use	Single Use	Single Use	Same
	Product Size(nominalvolumes)	TKESNC001, TKESNC002,TKESNC003, TKESNC004:0.5ml, 1ml, 2.5ml, 3ml, 5ml,6ml, 10ml, 12ml, 20ml,30ml, 35ml, 60ml.	Low dose tip ENFit syringe:0.5ml, 1ml, 3ml, 6ml;	Difference
		TKESNC005: 0.5ml, 1ml,2.5ml, 3ml, 5ml, 6ml, 10ml,12ml, 20ml, 30ml,35ml, 60ml.	Standard ENFit syringe:12ml, 20ml, 35ml, 60ml;	Comment 2
	ProductPerformance	Complied with:ISO 80369-3ISO 80369-20ISO 7886-1	Complied with:ISO 80369-3ISO 80369-20ISO 7886-1	Same
	Materials	Barrel: Polypropylene (PP),Polypropylene (PP) andAmber Pigment;Plunger: Polypropylene (PP) and White Pigment,Polypropylene (PP) and Purple Pigment;Gasket: S1Si;Piston: Polyisoprene RubberTip Cap: PP and Purple Pigment, PP and Orange Pigment, PP and White Pigment;	Barrel: Polypropylene (PP)Plunger: Polypropylene (PP) and white pigmentPiston: Silicone rubberTip Cap: Polypropylene (PP) and Orange pigment orpolypropylene (PP) and purple pigment	DifferenceComment 3
	Biocompatibility	No Cytotoxicity;No Irritation;No Sensitization;	No Cytotoxicity;No Irritation;No Sensitization;	Same
	Sterile	Sterile	Sterile or non-sterile	Same
Sterile Method	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	Same

Table 6-1 Substantial Equivalence Discussion- Oral/Enteral Syringe with ENFit connector

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Difference comment 1

The Gasket of the subject device is not covered by the predicate device, but the Oral/Enteral Syringe with ENFit connector of the structure has passed the verification of ISO 80369-3, ISO 80369-20 and ISO 7886-1 standard tests, and the results meet the

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requirements. Therefore, this difference does not raise new safety and effectiveness issues for the device.

Difference comment 2

The product size for subject device is different from predicate device. The subject device includes 12 sizes, 0.5ml, 1ml, 2.5ml/3ml, 10ml/12ml, 20ml, 30ml, 30ml, 35ml, 60ml all of which are covered by predicative device. but after the test of product performance, the safety and effectiveness of the product have been verified. 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.

Difference comment 3

subject device is different from predicate device in material, but the main material of the device is PP. 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.

VII Performance data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the Oral/Enteral Syringe with ENFit connector was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface medical device-mucosal membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended:

In Vitro Cytotoxicity Test	ISO 10993-5: 2009
Intracutaneous Reactivity Test	ISO 10993-10: 2010
Skin Sensitization Test	ISO 10993-10: 2010

Sterilization and shelf life testing

The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters.

The testing is performed according to the following standards:

ISO 10993-7:2008 EO residue

ECH residue ISO 10993-7:2008

The shelf life of three years is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16.

Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed

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acceptable for protection of product and sterility maintenance.

The testing is performed according to the following standards:

Seal strength	ASTM F88/F88M-15
Blue Dye Penetration	ASTM F 1929-2015
Seal Integrity (Visual Inspection)	ASTM F 1886/ F 1886M-16

Performance testing

Testing Name		standards	No.
report of PP 5090T		ASTM D638-22, ASTM D790-17	SHMR221101124301
		Procedure A
dose	accuracy	ISO7886-1	1888-0009
testing
Performance report		ISO 80369-3:2016	QDHL2210015086MD

Performance testing is performed according to the following standards:

ISO 7886-1:2017: Sterile hypodermic syringes for single use Part 1: Syringes for > manual use
A ISO 80369-1:2018: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
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

VIII Clinical Test Conclusion

No clinical study is included in this submission.

IX Conclusion

The Oral/Enteral Syringe with ENFit connector is substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.

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.