K Number
K160855
Device Name
U&U Enteral Syringe
Date Cleared
2016-11-22

(239 days)

Product Code
Regulation Number
876.5980
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

Not Found

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

No.
The device is a dispenser, measuring device, and fluid transfer device used to deliver fluids enterally, not to provide therapeutic treatment itself.

No

The device is a syringe used for fluid transfer and dispensing, not for diagnosis. Its intended use is to deliver fluids into the body, not to identify or monitor medical conditions.

No

The device description clearly outlines physical components (syringe barrel, plunger, gasket, tip cap) and the performance studies focus on physical characteristics and material biocompatibility, indicating a hardware-based medical device.

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 enterally." This describes a device used for administering substances directly into the gastrointestinal tract, which is a therapeutic or delivery function, not a diagnostic one.
  • Device Description: The description details a standard syringe designed for fluid transfer and measurement for enteral delivery. There is no mention of the device being used to examine specimens from the human body to provide information for diagnostic purposes.
  • Lack of Diagnostic Function: The document does not describe any function related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
  • Testing Standards: The testing standards mentioned (ISO7886-1 and ISO 80369-3) are related to the performance and safety of syringes and enteral connectors, not to the analytical performance of a diagnostic test.

In vitro diagnostics are devices used to perform tests on specimens taken from the human body outside of the body (in vitro) to provide information for diagnostic purposes. This syringe is used for delivering substances into the body, which is the opposite of an in vitro diagnostic function.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

PNR

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.

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

all age groups

Intended User / Care Setting

clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician)

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)

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

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.

K161039

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

§ 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.

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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

1

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

2

Food and Drug Administration

Indications for Use

510(k) Number (if known) K160855

Device Name

U&U ENFit Enteral Syringe

Indications for Use (Describe)

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.

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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3

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,China
RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN
HONG 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 To
100 ML) And NeoConnect Low Dose Tip Oral/Enteral Syringes With
ENFit Connector (0.5 ML To 6mL) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number: | K161039 |
| Company: | NeoMed, Inc. |

4. Devices 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.

4

22/11/16 Rev 1.01

5. Intended Use:

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.

6. Technological Characteristics:

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

Comparison Table

| Element of Comparison | Submission Device | Predicate Device
K161039 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | The device 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. |
| 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 sterilization
residuals, Part 10: Tests for
irritation anddelayed-type
hypersensitivity, Part 11: Tests for
systemic toxicity) | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR
Part 801 | Meet the requirements of 21 CFR
Part 801 |

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

5

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