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K Number
K152808
Device Name
U&U Insulin Syringe with/without Safety Retractable Device
Manufacturer
U&U Medical Technology Co., Ltd
Date Cleared
2016-03-25

(179 days)

Product Code
MEG
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The U&U Insulin Syringe with Safety Retractable Device is a sterile, single use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The U&U Insulin Syringe is a sterile, single use, disposable, insulin syringe intended for injection of U-100 insulin into the body.
Device Description
The U&U Insulin Syringe with/without Safety Retractable Devices are similarl devices except one has a safety feature and the other is a standard insulin syringe. The U&U Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharps container. The subject devices are sterile, single use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body. The U&U Insulin Syringe with/without Safety Retractable Device will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )
More Information

K050131, K151949

Not Found

No
The device description and performance studies focus on mechanical and material properties of a physical syringe, with no mention of software, algorithms, or data processing.

No.
The device is an insulin syringe designed for the injection of U-100 insulin, which is a drug delivery device, not a therapeutic device itself. Its primary function is to deliver medication, not to provide therapy directly.

No

The device is an insulin syringe, intended for the injection of U-100 insulin into the body. This is a therapeutic action, not a diagnostic one.

No

The device is a physical syringe with a needle and plunger, designed for injecting insulin. The description focuses on its mechanical features, materials, and physical performance testing, not software functionality.

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

Here's why:

  • Intended Use: The intended use is for the "injection of U-100 insulin into the body". This is a direct administration of a substance into a living organism.
  • Device Description: The description details a syringe and needle designed for delivering medication.
  • Performance Studies: The performance studies focus on the physical characteristics and safety features of the syringe and needle, such as needle length, diameter, bond strength, leakage, and force required to operate the plunger. These are all related to the mechanical function of delivering a substance.
  • Biocompatibility: The biocompatibility testing is related to the device's interaction with the body's tissues and fluids when inserted, not for analyzing samples in vitro.

IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device is designed for delivering a substance into the body.

N/A

Intended Use / Indications for Use

The U&U Insulin Syringe with Safety Retractable Device is a sterile, single use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The U&U Insulin Syringe is a sterile, single use, disposable, insulin syringe intended for injection of U-100 insulin into the body.

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

MEG, FMF

Device Description

The U&U Insulin Syringe with/without Safety Retractable Devices are similarl devices except one has a safety feature and the other is a standard insulin syringe.

The U&U Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharps container.

The subject devices are sterile, single use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

The U&U Insulin Syringe with/without Safety Retractable Device will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )

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

Not Found

Intended User / Care Setting

Not Found

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.

• ISO 8537 Second edition 2007-10-01 Sterile single-use syringes, with or without needle, for insulin.

• ISO7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

· ISO7864:1993 Sterile hypodermic needles for single use

For the U&U Insulin Syringe with Safety Retractable Device Only: · ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices. ISO 23908 Sharps Injury Prevention Guidance document.

Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features:

The test items include following.

  • Insulin Syringe Physical Performance Needle length
  • Insulin Syringe Physical Performance Diameter
  • · Insulin Syringe Physical Performance Gauge
  • · Insulin Syringe Physical Performance Hub/needle bond strength
  • · Insulin Syringe Physical Performance Cover strength
  • Insulin Syringe Physical Performance Patency of Needle lumen
  • · Insulin Syringe Physical Performance Resistance to breakage
  • · Insulin Syringe Physical Performance Stiffness
  • Insulin Svringe Physical Performance Resistance to corrosion
  • · Insulin Syringe Physical Performance Maximum Dead Space
  • · Insulin Syringe Physical Performance Freedom from leakage at needle
  • Insulin Syringe Physical Performance Freedom Liquid and air leakage past piston
  • Insulin Syringe Physical Performance Force required to Operate plunger
  • · Sharps Injury Prevention Features Force to activate safety feature
  • Insulin Syringe Physical Performance Tolerance on graduated capacity (Dose accuracy)

Biocompatibility

Conforms to ISO10993

  • Part 1: Evaluation and testing.
  • Part 4: Selection of tests for interactions with blood,
  • 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.

K050131, K151949

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

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.

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

March 25, 2016

U&U Medical Technology Co., Ltd. Black Wang General Manager Dongzhou Village, Hengshanqiao Changzhou, Jiangsu 213119 CHINA

Re: K152808

Trade/Device Name: U&U Insulin Syringe with/without Safety Retractable Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: MEG and FMF Dated: February 18, 2016 Received: February 19, 2016

Dear Black Wang:

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.

1

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

Image /page/1/Picture/8 description: The image shows a signature of Tina Kiang. The signature is written in black ink on a white background. There is also a faint FDA logo in the background. The signature is followed by the letter S.

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152808

Device Name

U&U Insulin Syringe with/without Safety Retractable Device

Indications for Use (Describe)

The U&U Insulin Syringe with Safety Retractable Device is a sterile, single use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The U&U Insulin Syringe is a sterile, single use, disposable, insulin syringe intended for injection of U-100 insulin into the body.

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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K152808 510(K) Summary

Date Prepared: March 9, 2016

The assigned 510(k) Number: K152808

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

Contract Manufacturer Name: ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD.

Address:No 20 south renhe road tianchang, CHINA 239300
Web:www.tkmedical.com

US Agent:

Name:CARELIFE (USA) INC.
Address:1580 Boggs Rd, Suite 500/600 Duluth GA 30096
TEL:404-661-2228
Contact person :Ms. LI QIAN liqian@shanghaicarelife.com

2. Submission Devices Information:

Trade/Proprietary Name: U&U Insulin Syringe with/without Safety Retractable Device Common Name: Syringe, Antistick Piston Syringe Classification name: Piston Syringe. Class: 2 Panel: 80 Product codes: MEG and FMF Submission Type: 510(k) Traditional Regulation Number: 880.5860

3. Predicate Devices Information:

Trade Name:InsoSAFE BakSNAP Retractable Insulin Safety Syringe
510(K) Number:K050131
Company:M.K. Meditech Co., Ltd
Trade Name:Disposable Insulin Syringe
510(K) Number:K151949
Company:Jiangyin Caina Technology Co., Ltd.

4. Devices Description:

The U&U Insulin Syringe with/without Safety Retractable Devices are similarl devices except one has a safety feature and the other is a standard insulin syringe.

The U&U Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of

4

the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharps container.

The subject devices are sterile, single use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

The U&U Insulin Syringe with/without Safety Retractable Device will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )

| Ref
Number | Model
Number | Description | Size |
|---------------|-----------------|---------------------------------------------------|----------------------------|
| UUIS001 | UUIS | Insulin Syringe | 0.3cc/ml Needle 27G to 31G |
| UUIS002 | UUIS | Insulin Syringe | 0.5cc/ml Needle 27G to 31G |
| UUIS003 | UUIS | Insulin Syringe | 1cc/ml Needle 27G to 31G |
| UUSIS001 | UUSIS | Insulin Syringe with Safety
Retractable Device | 1cc/ml Needle 27G to 31G |

5. Intended Use:

The U&U Insulin Syringe with Safety Retractable Device a sterile, single use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The U&U insulin syringe is a sterile, single use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

6. Technological Characteristics:

Through comparisons between the submitted devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices.

Comparison Table

| Element of Comparison | Submission Device | Predicate Device
K050131 | Predicate Device
K151949 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The U&U Insulin Syringe
with Safety Retractable
Device a sterile, single use,
disposable and non-
reusable, manual retractable
safety insulin syringe
intended for injection of U-
100 insulin into the body,
while reducing the risk of
sharps injuries and the
potential for insulin syringe
reuse.

The U&U insulin syringe is a
sterile, single use,
disposable and non-
reusable, insulin syringe
intended for injection of U-
100 insulin into the body. | The InsoSAFE BakSNAP
Retractable Insulin Safety
Syringe a sterile, single-
use, disposable and non-
reusable, manual
retractable safety insulin
syringe intended for
injection of insulin into
the body, while reducing
the risk of sharps injuries
and the potential for
insulin syringe reuse. | The disposable insulin syringe
is intended for medical
purposes for the manual
aspiration of insulin, and
for the injection of insulin into
parts of the body below the
surface skin. |
| Principle of Operation | Normal | Normal | Normal |

5

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 [Insulin Syringe]

| Syringe Capacity | 0.3cc/ml Needle 27G to 31G
0.5cc/ml Needle 27G to 31G
1cc/ml Needle 27G to 31G

U&U Insulin Syringe with Safety Retractable Device:
1cc/ml only needle 27G to 31G | Various Sizes | 0.3ml
0.5ml
1ml |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------|
| Nozzle Type | N.A | N.A | N.A |
| Lubricant for Barrel | Silicone Oil | Silicone Oil | Polydimethylsiloxane |
| Barrel Transparency | Transparent and Clear | Transparent and Clear | Transparent and Clear |
| Gradations Legibility | Legible | Legible | Legible |
| Materials | | | |
| Barrel
Plunger
Piston
Needle Hub
Needle
Needle Sheath | PP
PP
TPE
PP
Stainless Steel
PP | PP
PP
Silicone
PP
Stainless Steel
PP | PP
PP
Polysoprene
PP
Stainless Steel
PE |
| Needle Gauge and Length | Various Sizes | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil | Polydimethylsiloxane |
| U&U Insulin Syringe with
Safety Retractable Device:
Sharps Injury Prevention
Features | Manual Retractable
Conforms to ISO 23908 | Manual Retractable
Conforms to ISO 23908 | N.A |
| Performances | Conforms to ISO7864
ISO8537 | Conforms to ISO7864
ISO8537 | Conforms to ISO7864 ISO8537 |
| Biocompatibility | Conforms to ISO10993 (Part
1: Evaluation and testing,
Part 4: Selection of tests for
interactions with blood, 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 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21
CFR Part 801 | 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.

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

• ISO 8537 Second edition 2007-10-01 Sterile single-use syringes, with or without needle, for insulin.

• ISO7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

· ISO7864:1993 Sterile hypodermic needles for single use

For the U&U Insulin Syringe with Safety Retractable Device Only: · ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices. ISO 23908 Sharps Injury Prevention

Guidance document.

Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features:

6

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 [Insulin Syringe]

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m071663.htm

The test items include following.

  • Insulin Syringe Physical Performance Needle length
  • Insulin Syringe Physical Performance Diameter
  • · Insulin Syringe Physical Performance Gauge
  • · Insulin Syringe Physical Performance Hub/needle bond strength
  • · Insulin Syringe Physical Performance Cover strength
  • Insulin Syringe Physical Performance Patency of Needle lumen
  • · Insulin Syringe Physical Performance Resistance to breakage
  • · Insulin Syringe Physical Performance Stiffness
  • Insulin Svringe Physical Performance Resistance to corrosion
  • · Insulin Syringe Physical Performance Maximum Dead Space
  • · Insulin Syringe Physical Performance Freedom from leakage at needle
  • Insulin Syringe Physical Performance Freedom Liquid and air leakage past piston
  • Insulin Syringe Physical Performance Force required to Operate plunger
  • · Sharps Injury Prevention Features Force to activate safety feature
  • Insulin Syringe Physical Performance Tolerance on graduated capacity (Dose accuracy)

Biocompatibility

Conforms to ISO10993

  • Part 1: Evaluation and testing.
  • Part 4: Selection of tests for interactions with blood,
  • 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 devices are substantially equivalent.