U & U Intravascular Administration Set

K151151 · U&U Medical Technology Co, Ltd. · FPA · Sep 24, 2015 · General Hospital

Device Facts

• Record ID: K151151
• Device Name: U & U Intravascular Administration Set
• Applicant: U&U Medical Technology Co, Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The U&U Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Device Story

Gravity-fed single-use intravascular administration set; delivers fluids from container to patient vein via needle or catheter. Components include protective cap, spike, drip chamber, back check valve, pinch/slide clamps, stopcock, micron filter, and needleless Y-site. Used in clinical settings by healthcare professionals. Device ensures fluid delivery; prevents leakage; maintains flow rates; provides particulate filtration. Benefits patient by enabling controlled intravenous fluid administration.

Clinical Evidence

Bench testing only. No clinical data. Testing verified compliance with ISO 8536-4 (Infusion sets for single use, gravity feed), including particulate contamination, leakage, flow rate, tensile strength, air-inlet performance, and filter retention. Biocompatibility testing confirmed conformance to ISO 10993.

Technological Characteristics

Gravity-fed administration set. Materials: PVC (tubing), ABS (spike, back check valve, roller clamp, male luer lock), ABS/HDPE (stopcock). Sterilization: Ethylene Oxide gas. Complies with ISO 8536-4 and ISO 10993. No software or electronic components.

Indications for Use

Indicated for patients requiring administration of fluids from a container to the vascular system via a needle or catheter inserted into a vein.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Zyno Medical Administration Set (K120685)

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

September 24, 2015

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

Re: K151151

Trade/Device Name: U & U Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 23, 2015 Received: June 26, 2015

Dear Mr. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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, Tina Kiang -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)

## K151151

Device Name

U&U Intravascular Administration Set

Indications for Use (Describe)

The U&U Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

| 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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22/09/15 Rev 0.03

## Section 005 510(K) Summary

Date Prepared: 22. 09.2015

### 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 6612228 |
| Contact person : | Ms. LI QIAN [e-mail] |

### 2. Submission Devices Information:

Trade/Proprietary Name: U&U Intravascular Administration Set Common Name: Intravascular administration set Classification name: set, administration, intravascular. Class: 2. Panel: General Hospital Product codes: FPA Submission Type: 510(k) Regulation Number: 880.5440

## 3. Predicate Devices Information:

| Trade Name: | Zyno Medical Administration Set |
|----------------|---------------------------------|
| 510(K) Number: | K120685 |

### 4. Devices Description:

The U&U Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components:

Protective cap, Spike, Drip chamber, Back check valve, Pinch clamp, Slide clamp, Stopcock, Micron filter, Needleless Y-site, Male luer lock, Luer lock cap.

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### 5. Intended Use:

The U&U Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

### 6. Technological Characteristics:

U&U Intravascular Administration Set is constructed of high grade extruded Polyvinyl Chloride (PVC). The primary components of U&U Intravascular Administration Set are manufactured to identical or similar specifications of the predicated devices listed above. The intended use, basic design, function and materials used are identical or similar to the predicate devices. The technical characteristic is substantially equivalent to the predicate devices.

| Element of Comparison | Submission Device | Predicate Device<br>K120685 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The U&U Intravascular<br>Administration Set is a device<br>used to administer fluids from a<br>container to a patient's vascular<br>system through a needle or<br>catheter inserted into a vein. | The Zyno Intravascular<br>Administration Set is a<br>device used to administer<br>fluids from a container to a<br>patient's vascular system<br>through a needle or catheter<br>inserted into a vein. |
| Principle of Operation | Normal | Normal |
| Particulate contamination | Contamination index<90 | Contamination index<90 |
| Leakage | No Leakage | No Leakage |
| Flow rate | 1m, 10min>1000ml | 1m, 10min>1000ml |
| 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; |
| Closure-piercing device | The closure-piercing device<br>shall be capable of piercing<br>and penetrating the closure<br>without premiering. No coring<br>should occur during this<br>procedure. | The closure-piercing device<br>shall be capable of piercing<br>and penetrating the closure<br>without premiering. No coring<br>should occur during this<br>procedure. |
| Air-inlet device | Air penetration rate≥90% | Air penetration rate≥90% |
| 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 | | |
| Tubing | PVC | PVC |
| Spike | ABS | ABS |
| Back check valve | ABS | ABS |
| Roller clamp | ABS | ABS |
| Stopcock | ABS HDPE | ABS HDPE |
| Male luer lock | ABS | ABS |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR<br>Part 801 | Meet the requirements of 21<br>CFR Part 801 |

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### 7. Summary Non-Clinical Test:

The non-clinical testing consisted of evaluation studies of the U&U Intravascular Administration 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 predicate device.

The test results demonstrated that the proposed device complies with the following standards: ISO 8536-4, Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed

| Elements | Submission Device |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The U&U Intravascular Administration Set is a<br>device used to administer fluids from a container to<br>a patient's vascular system through a needle or<br>catheter inserted into a vein. |
| Principle of Operation | Normal |
| Particulate contamination | Contamination index<90 |
| Leakage | No Leakage |
| Flow rate | 1m, 10min>1000ml |
| Tensile strength | Withstand a static tensile force of not less than 15N<br>for 15s; |
| Closure-piercing device | The closure-piercing device shall be capable of<br>piercing and penetrating the closure. No coring<br>should occur during this procedure. |
| Air-inlet device | Air penetration rate≥90% |
| Tubing | The tubing shall be transparent or sufficiently<br>translucent so that the interface of air and water<br>during the passage of air bubbles can be observed<br>with normal or corrected vision. |
| Materials | |
| Tubing | PVC |
| Spike | ABS |
| Back check valve | ABS |
| Roller clamp | ABS |
| Stopcock | ABS HDPE |
| Male luer lock | ABS |
| Fluid filter | The retention of latex particles on the filter shall be<br>not less than 80% |
| Dimensions of the drip<br>chamber | There shall be a distance of not less than 30mm<br>between the drip tube and fluid filter |
| Pyrogenicity | <0.5 EU |
| Biocompatibility | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR Part 801 |

### 8. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent.