(251 days)
No
The device description and testing summaries focus on the mechanical aspects of a blood collection set and its safety features, with no mention of AI or ML.
No
The device is described as a blood collection set used for venipuncture procedures, which is for diagnostic purposes (collecting blood) rather than for treating or preventing a disease or condition.
No
Explanation: The device is a blood collection set used for routine venipuncture procedures, not for diagnosing a medical condition. Its function is to collect blood safely, preventing needle-stick injuries.
No
The device description clearly outlines a physical medical device (needle, tubing, luer adapter, safety shield) used for blood collection, with no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "routine venipuncture procedures" and "blood collection." This describes the process of obtaining a biological sample (blood).
- Device Description: The device is a "winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter." This is a tool for collecting blood, not for performing a diagnostic test on the blood.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze the collected blood, detect specific substances, or provide any diagnostic information. Its function is solely to facilitate the safe collection of the sample.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood collection set is used in vivo (on the body) to obtain the specimen.
N/A
Intended Use / Indications 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.
Product codes
FMI, JKA
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.
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
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:
- 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:
- Physical Performance - Resistance to breakage Physical Performance - Stiffness
- Physical Performance - Resistance to corrosion
Conform to ISO 23908:
- Activated the sharps injury prevention feature in 500samples of each gauge size with zero failures.
Conform to 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. 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, 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
Conform to ISO 10993-7, Biological evaluation of medical devices. Ethylene oxide sterilization residuals.
- Ethylene oxide & Ethylene Chlorohydrin Residues Test
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
| RM 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:
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
4
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 | |
| 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. | The VACUETTE PREMIUM | |
| Safety Blood Collection Set 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. | ||
| 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 | |
| not less than 15N for 15s; | Withstand a static tensile force | |
| of not less than 15N for 15s; | ||
| Tubing | 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. | 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. | ||
| Materials | PVC | |
| HDPE | ||
| ABS | ||
| RUBBER | ||
| SUS 304 | ||
| PP | PVC | |
| HDPE | ||
| ABS | ||
| RUBBER | ||
| SUS 304 | ||
| PP | ||
| Sharps Injury Prevention | ||
| Features | ||
| force to attach connection | 100N | >100N |
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 |
| [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
6
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
7
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.