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 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.

AI/ML Overview

The provided document is a 510(k) summary for the U&U Blood Collection Sets, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. As such, the "acceptance criteria" and "device performance" are typically defined by demonstrating conformance to recognized standards and through direct comparison with the predicate device, rather than explicit numerical thresholds for diagnostic performance metrics like sensitivity or specificity.

Here's an analysis of the provided information, structured as requested:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Defined by Conformance to Standards & Predicate Comparison)	Reported Device Performance (U&U Blood Collection Sets)
Indication for 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. (Equivalent to Predicate)
Regulation Number	880.5570 (Conforms)
Product Codes	FMI & JKA (Conforms)
Principle of Operation	Manual (Equivalent to Predicate)
Needle Gauges	19G to 27G (Predicate: 21G to 25G. The subject device offers a wider range, but still meets safety and performance requirements as demonstrated by testing.)
Leakage (ISO 594-2)	No Leakage (Conforms, Equivalent to Predicate)
Tensile Strength	Withstand a static tensile force of not less than 15N for 15s; (Conforms, Equivalent to Predicate)
Tubing Transparency	The tubing shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision. (Conforms, Equivalent to Predicate)
Materials	PVC, HDPE, ABS, RUBBER, SUS 304, PP (Equivalent to Predicate)
Force to Attach Connection (Sharps Injury Prevention Features)	< 15N (Conforms, Equivalent to Predicate)
Force to Activate (Sharps Injury Prevention Features)	< 15N (Conforms, Equivalent to Predicate)
Number of Activations to Failure (Sharps Injury Prevention Features for Subject Device)	Tested 500, Failure 0 (Predicate: Tested 100, Failure 0. The subject device demonstrated superior performance in terms of number of activations tested without failure, exceeding the predicate's tested number. Note: ISO 23908 specifies "500 samples of each gauge size with zero failures" for activation, directly addressed by this test).
Force to Deactivate (Sharps Injury Prevention Features)	≥100N (Conforms, Equivalent to Predicate)
Sterilization Method	EtO Gas (Equivalent to Predicate)
Method to Retract Needle	Pull back on tubing until needle is locked within the Safety Shield (Equivalent to Predicate)
Biocompatibility (ISO 10993)	Conforms to ISO10993 (Acute Systemic Toxicity, Bacterial endotoxins, Cytotoxicity, Haemolysis, Irritation, Skin Sensitization, Pyrogenicity)
Ethylene Oxide Residues (ISO 10993-7)	Ethylene oxide & Ethylene Chlorohydrin Residues Test (Conforms)
Shelf Life	5 Years (Predicate: 3 Years. The subject device has a longer shelf life, demonstrating superior or equivalent performance in this aspect.)
Labeling	Meet the requirements of 21 CFR Part 801 (Conforms)
Conforms to ISO 7864	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 (Conforms)
Conforms to ISO 9626	Physical Performance - Resistance to breakage, Physical Performance - Stiffness, Physical Performance - Resistance to corrosion (Conforms)
Conforms to ISO 23908 (Sharps Protection)	Activated the sharps injury prevention feature in 500 samples of each gauge size with zero failures. (Conforms)
Conforms to ISO 11607-1 (Packaging)	Seal Strength, Visual Inspection, Dye Penetration, Bubble Emission (Conforms)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing rather than clinical validation with a "test set" in the context of diagnostic algorithms. For the non-clinical tests:

Sharps Injury Prevention Feature Activation (ISO 23908): "500 samples of each gauge size with zero failures."
- For the predicate comparison: "Tested 500, Failure 0" for the subject device and "Tested 100, Failure 0" for the predicate device in the "number of activations to failure" row. This implies a test size of 500 samples for the subject device.
Data Provenance: The studies were non-clinical bench tests performed by the manufacturer, U&U Medical Technology Co., Ltd. (China). The data is from laboratory testing of the devices themselves, not human patient data, and is effectively prospective for the purpose of demonstrating device performance against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this submission. The device is a physical blood collection set, not a diagnostic algorithm that requires expert-established ground truth from medical images or patient data. Its performance is evaluated against engineering standards and a predicate device through physical and material tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no "test set" requiring human adjudication as would be found in AI/ML performance studies. The tests are bench tests with objective measurements against specified criteria.

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. The device is a physical medical instrument (blood collection set), not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or needed.

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

This is not applicable. The device is a physical blood collection set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is primarily established by:

International Standards: Conformance to recognized ISO standards (e.g., ISO 7864, ISO 9626, ISO 23908, ISO 594-2, ISO 11607-1, ISO 10993, ISO 10993-7). These standards define objective, measurable physical, chemical, and biological properties expected of such devices.
Predicate Device Performance: Direct comparison with the performance characteristics of the legally marketed predicate device (VACUETTE PREMIUM Safety Blood Collection Set, K102010). The predicate's established safety and effectiveness serve as a benchmark.

8. The sample size for the training set

This is not applicable. The device is a physical blood collection set, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device submission.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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,ChinaRM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China
Contact Name:	Xuebo Wang
TEL:	+86-13564751751
E-mail:	nick.wang@uu-med.net

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 li@UU-Medicalus.com

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:

5.Indications for Use

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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 Setsis used in routine venipunctureprocedures. It is used for bloodcollection. The safety shield isactivated to cover the needleimmediately following bloodcollection thus preventingaccidental needle-stick injury.	The VACUETTE PREMIUMSafety Blood Collection Set isused in routine venipunctureprocedures. It is used forblood collection. The safetyshield is activated to cover theneedle immediately followingblood collection thuspreventing accidental needle-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 ofnot less than 15N for 15s;	Withstand a static tensile forceof not less than 15N for 15s;
Tubing	The tubing shall be transparentor sufficiently translucent so thatthe interface of air and waterduring the passage of air bubblescan be observed with normal orcorrected vision.	The tubing shall betransparent or sufficientlytranslucent so that theinterface of air and waterduring the passage of airbubbles can be observed withnormal or corrected vision.
Materials	PVCHDPEABSRUBBERSUS 304PP	PVCHDPEABSRUBBERSUS 304PP
Sharps Injury PreventionFeatures
force to attach connection	< 15N	< 15N
force toactivatenumber ofactivations to	< 15NTested 500, Failure 0	< 15NTested 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.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).