K Number

Device Name

Oral/Enteral Syringe with ENFit connector

Manufacturer

Anhui Tiankang Medical Technology Co., Ltd.

Date Cleared

2023-08-17

(337 days)

Product Code

PNR

Regulation Number

876.5980

Intended Use

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.

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

K211025

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization of a syringe, with no mention of AI or ML.

Therapeutic

No
The device is described as a dispenser, measuring device, and oral fluid transfer device for delivering fluids. It does not perform a therapeutic function itself.

Diagnostic

Reason: The device is described as a dispenser, a measuring device, and an oral fluid transfer device, intended to deliver fluids into the body orally or enterally. It is not designed to detect, diagnose, or monitor a disease or condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical syringe made of components like a plunger, gasket/piston, and barrel, and undergoes physical testing like biocompatibility and sterilization.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "deliver fluids into the body orally or enterally." This describes a device used for administering substances to the body, not for testing samples from the body to diagnose or monitor a condition.
Device Description: The description details a syringe for fluid delivery, not a device for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The performance studies focus on physical properties, sterilization, and biocompatibility, which are typical for devices used for administration, not diagnosis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for delivering fluids.

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

in all age groups.

Intended User / Care Setting

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)

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)

Biocompatibility testing:

In Vitro Cytotoxicity Test (ISO 10993-5: 2009)
Intracutaneous Reactivity Test (ISO 10993-10: 2010)
Skin Sensitization Test (ISO 10993-10: 2010)
Results: No Cytotoxicity; No Irritation; No Sensitization.

Sterilization and shelf life testing:

Validation to ISO11135 for sterilization method.
EO residue testing (ISO 10993-7:2008)
ECH residue testing (ISO 10993-7:2008)
Ageing test according to ASTM F1980-16 for three-year shelf life determination.
Package integrity testing after environmental conditioning and simulated transportation.
Seal strength (ASTM F88/F88M-15)
Blue Dye Penetration (ASTM F 1929-2015)
Seal Integrity (Visual Inspection) (ASTM F 1886/ F 1886M-16)
Results: All packaging deemed acceptable for protection of product and sterility maintenance.

Performance testing:

report of PP 5090T (ASTM D638-22, ASTM D790-17 Procedure A)
dose accuracy testing (ISO7886-1)
Performance report (ISO 80369-3:2016)
ISO 7886-1:2017: Sterile hypodermic syringes for single use Part 1: Syringes for manual use
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
Results: The device demonstrates that it is as safe, as effective and performs as well as the legally marketed device.

Clinical Test Conclusion:
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.

K211025

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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

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

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

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

V Indications for use

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 with
ENFit connector	Oral/Enteral Syringe with
ENFit connector	/
Product code	PNR	PNR	Same
Regulation
Number	21CFR 876.5980	21CFR 876.5980	Same
Indications for use	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.	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.	Same
	Configuration	Piston/Gasket;
Plunger;	Piston;
Plunger	Difference
Comment 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
(nominal
volumes)	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
	Product
Performance	Complied with:
ISO 80369-3
ISO 80369-20
ISO 7886-1	Complied with:
ISO 80369-3
ISO 80369-20
ISO 7886-1	Same
	Materials	Barrel: Polypropylene (PP),
Polypropylene (PP) and
Amber Pigment;
Plunger: Polypropylene (PP) and White Pigment,
Polypropylene (PP) and Purple Pigment;
Gasket: S1Si;
Piston: Polyisoprene Rubber
Tip Cap: PP and Purple Pigment, PP and Orange Pigment, PP and White Pigment;	Barrel: Polypropylene (PP)
Plunger: Polypropylene (PP) and white pigment
Piston: Silicone rubber
Tip Cap: Polypropylene (PP) and Orange pigment or
polypropylene (PP) and purple pigment	Difference
Comment 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

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

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 ( 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.