U&U Insulin Syringe with/without Safety Retractable Device

K152808 · U&U Medical Technology Co, Ltd. · MEG · Mar 25, 2016 · General Hospital

Device Facts

• Record ID: K152808
• Device Name: U&U Insulin Syringe with/without Safety Retractable Device
• Applicant: U&U Medical Technology Co, Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Mar 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Manual piston syringe for U-100 insulin injection; available with or without integrated manual retractable safety mechanism. Safety version allows needle retraction into barrel after injection to prevent sharps injuries; plunger is snapped off to render device unusable. Used in clinical or home settings by patients or healthcare providers. Provides clear visualization of injection site. Benefits include accurate insulin delivery and reduced risk of accidental needle sticks and syringe reuse.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated against ISO 8537, ISO 7886-1, ISO 7864, ISO 9626, and ISO 23908. Biocompatibility testing performed per ISO 10993 (parts 1, 4, 5, 7, 10, 11).

Technological Characteristics

Materials: Polypropylene (PP) barrel/plunger/hub/sheath, TPE piston, stainless steel needle. Lubricant: Silicone oil. Sizes: 0.3cc/ml to 1cc/ml; 27G to 31G needles. Principle: Manual piston syringe with optional manual retractable safety mechanism. Sterilization: Ethylene oxide. Standards: ISO 8537, ISO 7886-1, ISO 7864, ISO 9626, ISO 23908, ISO 10993.

Indications for Use

Indicated for patients requiring subcutaneous injection of U-100 insulin. Intended for single-use, manual administration.

Regulatory Classification

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.

Predicate Devices

• InsoSAFE BakSNAP Retractable Insulin Safety Syringe (K050131)
• Disposable Insulin Syringe (K151949)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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<br>RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN<br>HONG KONG |
| Contactor Name: | Xuebo Wang |
| TEL: | [phone] |
| E-mail: | [e-mail] |

## 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 [e-mail] |

# 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

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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<br>Number | Model<br>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<br>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<br>K050131 | Predicate Device<br>K151949 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The U&U Insulin Syringe<br>with Safety Retractable<br>Device a sterile, single use,<br>disposable and non-<br>reusable, manual retractable<br>safety insulin syringe<br>intended for injection of U-<br>100 insulin into the body,<br>while reducing the risk of<br>sharps injuries and the<br>potential for insulin syringe<br>reuse.<br><br>The U&U insulin syringe is a<br>sterile, single use,<br>disposable and non-<br>reusable, insulin syringe<br>intended for injection of U-<br>100 insulin into the body. | The InsoSAFE BakSNAP<br>Retractable Insulin Safety<br>Syringe a sterile, single-<br>use, disposable and non-<br>reusable, manual<br>retractable safety insulin<br>syringe intended for<br>injection of insulin into<br>the body, while reducing<br>the risk of sharps injuries<br>and the potential for<br>insulin syringe reuse. | The disposable insulin syringe<br>is intended for medical<br>purposes for the manual<br>aspiration of insulin, and<br>for the injection of insulin into<br>parts of the body below the<br>surface skin. |
| Principle of Operation | Normal | Normal | Normal |

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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<br>0.5cc/ml Needle 27G to 31G<br>1cc/ml Needle 27G to 31G<br><br>U&U Insulin Syringe with Safety Retractable Device:<br>1cc/ml only needle 27G to 31G | Various Sizes | 0.3ml<br>0.5ml<br>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<br>Plunger<br>Piston<br>Needle Hub<br>Needle<br>Needle Sheath | PP<br>PP<br>TPE<br>PP<br>Stainless Steel<br>PP | PP<br>PP<br>Silicone<br>PP<br>Stainless Steel<br>PP | PP<br>PP<br>Polysoprene<br>PP<br>Stainless Steel<br>PE |
| Needle Gauge and Length | Various Sizes | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil | Polydimethylsiloxane |
| U&U Insulin Syringe with<br>Safety Retractable Device:<br>Sharps Injury Prevention<br>Features | Manual Retractable<br>Conforms to ISO 23908 | Manual Retractable<br>Conforms to ISO 23908 | N.A |
| Performances | Conforms to ISO7864<br>ISO8537 | Conforms to ISO7864<br>ISO8537 | Conforms to ISO7864 ISO8537 |
| Biocompatibility | Conforms to ISO10993 (Part<br>1: Evaluation and testing,<br>Part 4: Selection of tests for<br>interactions with blood, Part<br>5: Tests for in vitro<br>cytotoxicity, Part 7: Ethylene<br>oxide sterilization residuals,<br>Part 10: Tests for irritation<br>anddelayed-type<br>hypersensitivity, Part 11:<br>Tests for systemic toxicity) | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21<br>CFR Part 801 | Meet the requirements of<br>21 CFR Part 801 | Meet the requirements of 21<br>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:

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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.