(147 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called the "U&U Intravascular Administration Set." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Zyno Medical Administration Set" (K120685). The information provided focuses on the non-clinical testing performed.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document provides a table comparing the technological characteristics of the submission device (U&U Intravascular Administration Set) and the predicate device (Zyno Medical Administration Set). It also includes a summary of non-clinical test results for the submission device, which effectively acts as a table of acceptance criteria and reported performance.
| Acceptance Criteria (from Predicate Device/ISO 8536-4) | Reported Device Performance (U&U Intravascular Administration Set) |
|---|---|
| Intended Use: The Zyno 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 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. |
| 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 not less than 15N for 15s; | Withstand a static tensile force of not less than 15N for 15s; |
| Closure-piercing device: The closure-piercing device shall be capable of piercing and penetrating the closure without premiering. No coring should occur during this procedure. | The closure-piercing device shall be capable of piercing and penetrating the closure. No coring should occur during this procedure. |
| Air-inlet device: Air penetration rate ≥ 90% | Air penetration rate ≥ 90% |
| 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: | |
| 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 Part 801 | Meet the requirements of 21 CFR Part 801 |
| Fluid filter: The retention of latex particles on the filter shall be not less than 80% (from Section 7) | The retention of latex particles on the filter shall be not less than 80% |
| Dimensions of the drip chamber: There shall be a distance of not less than 30mm between the drip tube and fluid filter (from Section 7) | There shall be a distance of not less than 30mm between the drip tube and fluid filter |
| Pyrogenicity: <0.5 EU (from Section 7) | <0.5 EU |
2. Sample size used for the test set and the data provenance:
The document states, "When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results." However, the specific sample sizes used for each test (e.g., for particulate contamination, leakage, flow rate, tensile strength) are not detailed in this document.
The data provenance is from non-clinical bench testing performed by U&U Medical Technology Co., Ltd. and its contract manufacturer. The document doesn't specify the country of origin of the raw data, but the submitting company is based in China, and the contract manufacturer is also in China. The data is prospective as it involves tests conducted on the newly manufactured U&U Intravascular Administration Set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as this study is not evaluating a diagnostic algorithm or a clinical scenario requiring expert interpretation to establish "ground truth." The "ground truth" here is objective physical and chemical properties measured against established engineering standards and specifications.
4. Adjudication method for the test set:
This is not applicable for the same reason as point 3. The testing involves objective measurements rather than subjective assessments requiring adjudication.
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. This document is for a physical medical device (intravascular administration set), not an AI-powered diagnostic tool, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as there is no algorithm or AI component in this medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by objective engineering standards and specifications, specifically those outlined in ISO 8536-4 (Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed), as well as general expectations for such devices (e.g., "No Leakage," "Normal" principle of operation). The predicate device's characteristics also serve as a benchmark for substantial equivalence.
8. The sample size for the training set:
This is not applicable as this is a physical medical device and does not involve machine learning algorithms requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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,ChinaRM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLNHONG KONG |
| Contactor Name: | Xuebo Wang |
| TEL: | +86-13564751751 |
| E-mail: | Blackwang@tkmedical.com |
| 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 liqian@shanghaicarelife.com |
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 DeviceK120685 |
|---|---|---|
| Intended Use | The U&U IntravascularAdministration Set is a deviceused to administer fluids from acontainer to a patient's vascularsystem through a needle orcatheter inserted into a vein. | The Zyno IntravascularAdministration Set is adevice used to administerfluids from a container to apatient's vascular systemthrough a needle or catheterinserted 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 ofnot less than 15N for 15s; | Withstand a static tensile forceof not less than 15N for 15s; |
| Closure-piercing device | The closure-piercing deviceshall be capable of piercingand penetrating the closurewithout premiering. No coringshould occur during thisprocedure. | The closure-piercing deviceshall be capable of piercingand penetrating the closurewithout premiering. No coringshould occur during thisprocedure. |
| Air-inlet device | Air penetration rate≥90% | Air penetration rate≥90% |
| 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 | ||
| 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 CFRPart 801 | Meet the requirements of 21CFR 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 adevice used to administer fluids from a container toa patient's vascular system through a needle orcatheter 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 15Nfor 15s; |
| Closure-piercing device | The closure-piercing device shall be capable ofpiercing and penetrating the closure. No coringshould occur during this procedure. |
| Air-inlet device | Air penetration rate≥90% |
| Tubing | The tubing shall be transparent or sufficientlytranslucent so that the interface of air and waterduring the passage of air bubbles can be observedwith 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 benot less than 80% |
| Dimensions of the dripchamber | There shall be a distance of not less than 30mmbetween 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.
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.