The U&U ENFit Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body 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 U&U ENFit Enteral Syringes are standard piston style syringes consisting of a syringe barrel, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 1 mL to 60 mL nominal capacity. The integral syringe tip is a female connector which is compatible only with enteral access devices having male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (U&U ENFit Enteral Syringe). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical trial or a comprehensive performance study for an AI/diagnostic device would.

Based on the information given, here's an analysis of the "acceptance criteria" and "study" as they pertain to this type of regulatory submission:

For a Medical Device like a Syringe:

The "acceptance criteria" are generally derived from recognized international standards and ensure the device performs as intended and is safe for its stated use. The "study" refers to the non-clinical tests performed to demonstrate compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several tests derived from ISO standards, implying that meeting these standards constitutes the acceptance criteria. The performance is reported as "Conforms" to these standards.

Acceptance Criteria (Stated as "Test Items")	Reported Device Performance
Physical Performance
Diameter	Conforms
Maximum Dead Space	Conforms
Freedom Liquid and air leakage past piston	Conforms
Force required to Operate plunger	Conforms
Tolerance on graduated capacity (Dose accuracy)	Conforms
Syringe Tip (ISO 80369-3 female connector)
Fluid Leakage by pressure decay	Conforms
Fluid Leakage by falling drop positive pressure decay	Conforms
Stress Cracking	Conforms
Resistance to separation from axial load	Conforms
Resistance to separation from unscrewing	Conforms
Resistance to overriding	Conforms
Low Dose Tip Misconnection Analysis	Conforms
Low Dose Dimension Analysis	Conforms
Biocompatibility
ISO10993 Part 1: Evaluation and testing	Conforms
ISO10993 Part 5: Tests for in vitro cytotoxicity	Conforms
ISO10993 Part 7: Ethylene oxide sterilization residuals	Conforms
ISO10993 Part 10: Tests for irritation and delayed-type hypersensitivity	Conforms
ISO10993 Part 11: Tests for systemic toxicity	Conforms

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

The document does not explicitly state the sample sizes (e.g., number of syringes) used for each specific non-clinical test. It is typical for these types of tests to use a statistically relevant number of samples, but the exact numbers are not provided in this summary.

Data Provenance: The tests were performed on the "subject device" (U&U ENFit Enteral Syringe) by the manufacturer or accredited testing facilities. The country of origin for the device is China (both U&U Medical Technology Co., Ltd and U&U (HONGKONG) Medical Technology Co., Limited). The data would be considered prospective in the sense that the tests were conducted specifically for this regulatory submission.

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

This type of information is generally not applicable for non-clinical performance and biocompatibility testing of a medical device like a syringe. The "ground truth" is established by the predefined parameters and methodologies outlined in the international standards (e.g., ISO 7886-1, ISO 80369-3, ISO 10993 series). The "experts" would be the personnel at the testing lab carrying out these standardized tests, who are qualified to perform and interpret results according to the standards, rather than clinical experts establishing a medical ground truth.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for evaluating diagnostic devices where expert consensus is needed to establish a "true" diagnosis or condition. For syringe performance, the results are objectively measured against the criteria defined by the ISO 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

This is not applicable. An MRMC study is relevant for evaluating diagnostic tools, particularly those involving human interpretation (e.g., radiologists reading images) where AI might assist. This submission is for a physical medical device (syringe) and does not involve AI or human "readers" in that context.

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

This is not applicable. This question pertains to AI/algorithm performance. The U&U ENFit Enteral Syringe is a physical, non-AI medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics of the syringe is the objective, measurable criteria defined by the international standards (ISO 7886-1, ISO 80369-3, ISO 10993 series). These standards prescribe specific test methods and acceptable ranges for various physical and material properties (e.g., force to operate, leakage, dimensional tolerances, cytotoxicity).

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product, not an algorithm, so there is no training set in this context.

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

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 3, 2017

U&U Medical Technology Co., Ltd Black Wang GM Dongzhou Village, Hengshangiao Changzhou, Jiangsu 213119 China

Re: K160855 Trade/Device Name: U&U ENFit Enteral Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tubes and Accessories Regulatory Class: II Product Code: PNR Dated (Date on orig SE ltr): October 18, 2016 Received (Date on orig SE ltr): October 20, 2016

Dear Black Wang:

This letter corrects our substantially equivalent letter of November 22, 2016

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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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

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Food and Drug Administration

Indications for Use

510(k) Number (if known) K160855

Device Name

U&U ENFit Enteral Syringe

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) Submission

U&U Medical Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medical Technology Co., Limited RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [ENFit Enteral Syringe]

Rev 1.01 22/11/16

Section 005 510(K) Summary

This summary of 510(k) information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.

K160855

Date Prepared: 11. 22 .2016

1. Submitter Name and Address:

Owner Name:	U&U Medical Technology Co., Ltd
Address:	Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,ChinaRM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLNHONG KONG
Contactor Name:	Xuebo Wang
TEL:	+86-13564751751
E-mail:	Blackwang@tkmedical.com

US Agent:

Name:	CARELIFE (USA) INC.
Address:	1580 Boggs Rd, Suite 500/600 Duluth GA 30096
TEL:	404 6612228
Contact person :	Ms. LI QIAN liqian@shanghaicarelife.com

2. Submission Devices Information:

Trade/Proprietary Name: U&U ENFit Enteral Svringe Common Name: Gastrointestinal tube and accessories Classification name: ENFit Enteral Syringes With Enteral Specific Connectors Class: 2. Review Panel: Gastroenterology/Urology. Product codes: PNR Submission Type: 510(k) Regulation Number: 21 CFR § 876.5980

3. Predicate Devices Information:

Trade Name:	NeoConnect Oral/Enteral Syringes With ENFit Connector (12 ML To100 ML) And NeoConnect Low Dose Tip Oral/Enteral Syringes WithENFit Connector (0.5 ML To 6mL)
510(K) Number:	K161039
Company:	NeoMed, Inc.

4. Devices Description:

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22/11/16 Rev 1.01

5. Intended Use:

6. Technological Characteristics:

Through comparisons between the submitted devices with the predicate devices as follows tables.

Comparison Table

Element of Comparison	Submission Device	Predicate DeviceK161039
Intended Use	The U&U ENFit Enteral Syringeis indicated for use as adispenser, a measuring deviceand a fluid transfer device. It isused to deliver fluids into the bodyenterally. It is intended to beused in clinical or home caresettings by users ranging fromclinicians to laypersons (under thesupervision of a clinician) in allage groups.	The device is indicated for use asa dispenser, a measuring deviceand a fluid transfer device. It isused to deliver fluidsinto the body enterally. It isintended to be used in clinical orhome care settings by usersranging from clinicians tolaypersons (under the supervisionof a clinician) in all age groups.
Principle of Operation	Normal	Normal
Syringe Capacity	1cc/ml to 60cc/ml	0.5cc/ml to 100cc/ml
Nozzle Type	ISO 80369-3	ISO 80369-3
Lubricant for Barrel	Silicone Oil	Silicone Oil
Barrel Transparency	Transparent and Clear	Transparent and Clear
Gradations Legibility	Legible	Legible
Materials
Barrel	PP	PP
Plunger	PP	PP
Piston	Silicone or Rubber	Silicone
Performances	Conforms to ISO7886 ISO80369-3	Conforms to ISO7886 ISO80369-3
Biocompatibility	Conforms to ISO10993 (Part 1:Evaluation and testing, Part 5:Tests for in vitro cytotoxicity, Part 7:Ethylene oxide sterilizationresiduals, Part 10: Tests forirritation anddelayed-typehypersensitivity, Part 11: Tests forsystemic toxicity)	Conforms to ISO10993
Labeling	Meet the requirements of 21 CFRPart 801	Meet the requirements of 21 CFRPart 801

7. Non-Clinical Tests performed on the subject device.

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Rev 1.01 22/11/16

The proposed devices were tested per the following standards, to evaluate its performance.

· ISO7886-1 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
ISO 80369-3 Small-bore connectors for liquids and gases in healthcare applications -- Part
3: Connectors for enteral applications

The test items include following

· Physical Performance Diameter
· Physical Performance Maximum Dead Space
Physical Performance Freedom Liquid and air leakage past piston
· Physical Performance Force required to Operate plunger
Physical Performance Tolerance on graduated capacity (Dose accuracy)
· Syringe Tip (ISO 80369-3 female connector)

Fluid Leakage by pressure decay Fluid Leakage by falling drop positive pressure decay Stress Cracking Resistance to separation from axial load Resistance to separation from unscrewing Resistance to overriding Disconnection by unscrewing Low Dose Tip Misconnection Analysis Report Low Dose Dimension Analysis Report

Biocompatibility

Conforms to ISO10993 Part 1: Evaluation and testing, Part 5: Tests for in vitro cytotoxicity, Part 7: Ethylene oxide sterilization residuals, Part 10: Tests for irritation and delayed- type hypersensitivity, Part 11: Tests for systemic toxicity

8. Conclusion:

The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent.

END

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.