U&U Blood Collection Sets

K181508 · U&U Medical Technology Co, Ltd. · FMI · Feb 13, 2019 · General Hospital

Device Facts

• Record ID: K181508
• Device Name: U&U Blood Collection Sets
• Applicant: U&U Medical Technology Co, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Feb 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury.

Device Story

Single-use, sterile, winged blood collection needle; integrated safety shield; flexible tubing; female luer adapter. Used in clinical settings for routine venipuncture. Operator (clinician/phlebotomist) inserts needle into patient vein; blood flows through tubing into collection system. Post-collection, operator manually pulls tubing to retract needle into safety shield, locking it to prevent accidental needle-stick injury. Device provides physical barrier against sharps exposure; benefits patient and clinician by reducing risk of bloodborne pathogen transmission.

Clinical Evidence

Bench testing only. No clinical data. Testing included ISO 7864 (needle requirements), ISO 9626 (tubing physical performance), ISO 23908 (sharps protection, 500 samples, 0 failures), ISO 594-2 (luer leakage), ISO 11607-1 (packaging), and ISO 10993 (biocompatibility, cytotoxicity, hemolysis, irritation, sensitization, pyrogenicity, and EtO residuals).

Technological Characteristics

Materials: PVC, HDPE, ABS, Rubber, SUS 304 stainless steel, PP. Manual operation. Needle gauges: 19G to 27G. Sterilization: EtO gas. Connectivity: None. Standards: ISO 9626, ISO 23908, ISO 594-2, ISO 7864, ISO 10993.

Indications for Use

Indicated for routine venipuncture and blood collection in patients requiring blood sampling. Contraindications include known hypersensitivity to device materials.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• VACUETTE PREMIUM Safety Blood Collection Set (K102010)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

U&U Medical Technology Co.,Ltd Nick Wang Project Director Dongzhou Village, Hengshangiao Changzhou. China 213119 Jiangsu

Re: K181508

Trade/Device Name: U&U Blood Collection Sets Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, JKA Dated: January 8, 2019 Received: January 17, 2019

Dear Nick 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. 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/cdrl/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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sarah B. Mollo -S

for Tina Kiang, Ph.D. Acting 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) K181508

Device Name

U&U Blood Collection Sets

Indications for Use (Describe)

The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K181508

## K181508 510(K) Summary

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

#### 1.Submitter Name and Address:

| Name: | U&U Medical Technology Co., Ltd |
|---------------|---------------------------------------------------------------------------------------------------------------------------|
| Address: | Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China<br>RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China |
| Contact Name: | Xuebo Wang |
| TEL: | [phone] |
| E-mail: | [e-mail] |

US Agent:

| Name: | U&U Medical Inc. |
|-----------------|--------------------------------------------|
| Address: | 1580 Boggs Rd, Suite 500, Duluth, GA 30096 |
| TEL: | 404 426 1248 |
| Contact person: | Ms. LI QIAN [e-mail] |

Date Prepared: February 09, 2019

#### 2. Submission Devices Information:

| Trade/Proprietary Name: | U&U Blood Collection Sets |
|-------------------------|--------------------------------|
| Common Name: | Blood Collection Needle |
| Regulation Name: | Hypodermic single lumen needle |
| Class: | II |
| Product codes: | FMI, JKA |
| Regulation Number: | 21 CFR 880.5570 |

#### 3.Predicate Devices Information:

| Trade Name: | VACUETTE PREMIUM Safety Blood Collection Set |
|--------------------|----------------------------------------------|
| 510(K) Number: | K102010 |
| Regulation Number: | 21 CFR 880.5570 |
| Product codes: | FMI & JKA |

## 4. Devices Description:

The U&U Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system. It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is not made with Latex.

# 5.Indications for Use

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The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury.

# 6. Technological Characteristics:

The subject device has demonstrated substantial equivalence to the predicate device in device comparison technology, method of operation, intended use and through performance bench test results.

#### Comparison Table

| Element of Comparison | Submission Device | Predicate Device |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K181508 | K102010 |
| Indication for Use | The U&U Blood Collection Sets<br>is used in routine venipuncture<br>procedures. It is used for blood<br>collection. The safety shield is<br>activated to cover the needle<br>immediately following blood<br>collection thus preventing<br>accidental needle-stick injury. | The VACUETTE PREMIUM<br>Safety Blood Collection Set is<br>used in routine venipuncture<br>procedures. It is used for<br>blood collection. The safety<br>shield is activated to cover the<br>needle immediately following<br>blood collection thus<br>preventing accidental needle-<br>stick injury. |
| Regulation Number | 880.5570 | 880.5570 |
| Product codes | FMI & JKA | FMI & JKA |
| Principle of Operation | Manual | Manual |
| Needle gauges | 19G to 27G | 21G to 25G |
| Leakage | No Leakage | No Leakage |
| Tensile strength | Withstand a static tensile force of<br>not less than 15N for 15s; | Withstand a static tensile force<br>of not less than 15N for 15s; |
| Tubing | The tubing shall be transparent<br>or sufficiently translucent so that<br>the interface of air and water<br>during the passage of air bubbles<br>can be observed with normal or<br>corrected vision. | The tubing shall be<br>transparent or sufficiently<br>translucent so that the<br>interface of air and water<br>during the passage of air<br>bubbles can be observed with<br>normal or corrected vision. |
| Materials | PVC<br>HDPE<br>ABS<br>RUBBER<br>SUS 304<br>PP | PVC<br>HDPE<br>ABS<br>RUBBER<br>SUS 304<br>PP |
| Sharps Injury Prevention<br>Features | | |
| force to attach connection | < 15N | < 15N |
| force to<br>activate<br>number of<br>activations to | < 15N<br>Tested 500, Failure 0 | < 15N<br>Tested 100, Failure 0 |
| failure | >100N | >100N |

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K181508

| 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 |
| [U&U Blood Collection Set] |

| force to deactivate | ≥100N | ≥100N |
|--------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Sterilization Method | EtO Gas | EtO Gas |
| Method to retract needle | Pull back on tubing until needle is locked within the Safety Shield | Pull back on tubing until needle is locked within the Safety Shield |
| Performances | Conforms to ISO 9626, 23908, 594-2, ISO7864 | Conforms to ISO 9626, 23908, 594-2, ISO7864 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Shelf life | 5 Years | 3 Years |
| Labeling | Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 |

## 7. Summary Non-Clinical Test:

The non-clinical testing consisted of evaluation studies of the U&U Blood Collection Set to verify its ability to meet its intended use requirements. This testing also included testing to the relevant product standards. When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results. The data obtained from bench testing, sterilization testing, and biocompatibility testing showed that the device is substantially equivalent to the predicated device.

#### Conform to ISO 7864

ISO 7864: Sterile hypodermic needles for single use -- Requirements and test methods.

- Surface Finish and Cleanliness Needle Freedom from Defects Bond Between Hub and Needle Tube Needle Tolerance on Length Needle Patency of Lumen Lubricant Reducing (oxidizable) matter Metal ions Titration acidity or alkalinity Residue on evaporation UV absorption of extract solution Pyrogenicity
## Conform to ISO 9626

ISO 9626: Stainless steel needle tubing for medical devices.

Physical Performance - Resistance to breakage Physical Performance - Stiffness

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Physical Performance - Resistance to corrosion

#### Conform to ISO 23908

Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.

Activated the sharps injury prevention feature in 500samples of each gauge size with zero failures.

Conform to ISO 594-2

ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.

Leakage with Positive and Negative Pressure

Conform to ISO 11607-1

ISO 11607-1. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging.

Seal Strength Visual Inspection Dye Penetration Bubble Emission

Conform to ISO 10993-1

ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Acute Systemic Toxicity Bacterial endotoxins(Gel-clot techniques) Cyotoxicity Haemolysis Irritation Skin Sensitization Test for Pyrogenicity

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# Conform to ISO 10993-7

ISO 10993-7, Biological evaluation of medical devices. Ethylene oxide sterilization residuals.

Ethylene oxide & Ethylene Chlorohydrin Residues Test

# 8. Conclusion:

The subject device has demonstrated substantial equivalence to the predicate device in device comparison technology, method of operation, intended use and through performance bench test results.