K Number
K191640
Device Name
TK Intravascular Administration Set
Date Cleared
2020-08-26

(434 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TK 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 Description
The TK 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 of spike, Spike, Micron filter, Air inlet, Drip chamber, Fluid filter, Tubing, Slide clamp, Pinch clamp, Flow regulator, Roller, Male luer lock, Stopcock (without needleless luer access valve), 4.0mm Connector, Y-site (access by needle), Rotating luer lock, Back check valve, Luer lock cap.
More Information

Not Found

No
The device description and performance studies focus on the physical components and standard non-clinical testing of a gravity-fed administration set, with no mention of AI or ML capabilities.

No.
The device administers fluids for therapeutic purposes but is not a therapeutic device itself, merely a delivery system.

No

The device is used to administer fluids, which is a therapeutic function, not a diagnostic one.

No

The device description explicitly lists numerous physical components (spike, tubing, filters, clamps, luer locks, etc.) and describes it as a gravity single-use device sterilized with Ethylene Oxide gas, indicating it is a hardware device. There is no mention of software as a component or function.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to administer fluids into a patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one.
  • Device Description: The components listed are all related to the physical process of delivering fluids intravenously. There are no components or functions described that would be used to analyze samples in vitro (outside the body) to diagnose a condition.
  • Lack of Diagnostic Function: The description focuses on the mechanics of fluid delivery, not on analyzing blood, urine, or other biological samples for diagnostic purposes.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

TK 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.

Product codes

FPA

Device Description

The TK 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 of spike, Spike, Micron filter, Air inlet, Drip chamber, Fluid filter, Tubing, Slide clamp, Pinch clamp, Flow regulator, Roller, Male luer lock, Stopcock (without needleless luer access valve), 4.0mm Connector, Y-site (access by needle), Rotating luer lock, Back check valve, Luer lock cap. The device is available in multiple configurations listed below.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vascular system

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non Clinical Performance Testing Included:
A. Biocompatibility Testing (ISO 10993-1:2018):

    1. Hemocompatibility (ISO 10993-4:2017)
    1. Cytotoxicity (ISO 10993-5:2017)
    1. Irritation (ISO 10993-10:2017)
    1. Sensitization (ISO 10993-10:2017)
    1. Acute Systemic Toxicity (ISO 10993-11:2017)
    1. Bacterial Endotoxins (ISO 10993-11:2017)
    1. Pyrogenicity (ISO 10993-11:2017)
    1. Subacute Systemic Toxicity (ISO 10993-11:2017)/ Subchronic Systemic Toxicity Study (ISO 10993-11:2017)

B. Other Non-clinical Test Conducted Using the Following Guidance and Standards:

  • FDA Guidance July 2018: Intravascular Administration Sets Premarket Notification Submissions [510(k)]
  • ISO 8536-4: 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1(2013)]
  • ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications
  • ISO 80369-20: 2015, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
  • ISO 11607-1: 2016, Packaging for terminally sterilized medical device -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607-2: 2016, Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
  • ISO 11135: 2014, Sterilization of health care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO10993-7: 2008, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
  • ISO10993-12: 2012, Biological evaluation of medical devices-Part 12: Sample preparation and reference materials
  • ASTM F1980- 2016, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • ASTM F1929- 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
  • ASTM F88- 2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
  • USP 788- Particulate matter for Injection

Key Results: The evaluation were performed using industry consensus standards and evaluated per the performance requirements of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151151

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around a symbol. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

August 26, 2020

Anhui Tiankang Medical Technology Co., Ltd. Bai Baodong RA Manager No.228 Weiyi Road, Economic Development Zone Tianchang, 239300 Anhui China

Re: K191640

Trade/Device Name: TK Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: July 28, 2020 Received: July 28, 2020

Dear Bai Baodong:

We have reviewed vour 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/cdrh/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

1

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

3

No.228 Weiyi Road ,Economic Development Zone ,Tianchang City, Anhui, China [TK Intravascular Administration Set]

510(K) Summary: K191640

Date prepared: 25.08.2020

1. Submitter Name and Address:

Owner Name:Anhui Tiankang Medical Technology Co., Ltd.
Address:No.228 Weiyi Road .Economic Development Zone
Tianchang City, Anhui, China
Contactor Name:Bai Baodong, RA Manager
TEL:+86-550-7309187
E-mail:tkquality@126.com

Manufacturer Nạme: Anhui Tiankang Medical Technology Co., Ltd

| Address: | No.228 Weiyi Road, Economic Development Zone
Tianchang City, Anhui, China |

----------------------------------------------------------------------------------------

US Agent:

US Agent:James H. Liao
Address:6775 Verde Ridge Rd., Rancho Palos Verdes, CA 90275
TEL:(310) 375-8169
Email:James@Sino2us.com

2. Submission Devices Information:

Trade/Proprietary Name: TK Intravascular Administration Set

Common Name: Intravascular administration set

4

No.228 Weiyi Road ,Economic Development Zone ,Tianchang City, Anhui, China [TK Intravascular Administration Set]

Regulation: 21CFR 880.5440 Regulation name: Set, Administration, Intravascular. Class: II Product Codes: FPA Submission Type: 510(K)

3. Predicate Device Information:

Trade Name: U&U Intravascular Administration Set 510(K) Number: K151151 Intravascular administration set Common Name: Regulation: 21CFR 880.5440 Regulation name: Set, Administration, Intravascular. Class: II Product Codes: FPA

4. Device Description:

TK Intravascular Administration Set

The TK 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 of spike, Spike, Micron filter, Air inlet, Drip chamber, Fluid filter, Tubing, Slide clamp, Pinch clamp, Flow regulator, Roller, Male luer lock, Stopcock (without needleless luer access valve), 4.0mm Connector, Y-site (access by needle), Rotating luer lock, Back check valve, Luer lock cap. The device is available in multiple configurations listed below.

RefDescription
------------------

5

No.228 Weiyi Road ,Economic Development Zone ,Tianchang City, Anhui, China [TK Intravascular Administration Set]

Number
TKIV-F05Intravascular Administration Set
TKIV-F09Intravascular Administration Set
TKIV-F10Intravascular Administration Set
TKIV-F11Intravascular Administration Set
TKIV-F12Intravascular Administration Set
TKIV-F13Intravascular Administration Set
TKIV-F14Intravascular Administration Set
TKIV-F15Intravascular Administration Set

5. Indications for use:

TK 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. Comparison of technological characteristics with the predicate:

TK Intravascular Administration Set is constructed of high grade extruded Polyvinyl Chloride (PVC). The primary components of TK Intravascular Administration Set are manufactured to identical or similar specifications of the predicate device listed above. The intended use, basic design, function and materials used are identical or similar to the predicate device. The differences between the subject device and the predicate device are the y-site in the subject device is a septum while the predicate utilized a needless luer access valve and the material for the stopcock is made of Makrolon for the subject device while the predicate is made of ABS HDPE. These differences in technology do not affect the safety and effectiveness of the subject device because the evaluation were performed using industry consensus standards and evaluated per the performance requirements of the device. Therefore, the different technological characteristics do not raise new questions of safety and effectiveness and is substantially equivalent to the predicate device.

6

No.228 Weiyi Road ,Economic Development Zone ,Tianchang City, Anhui, China [TK Intravascular Administration Set]

| Element of Comparison | SUBJECT DEVICE
K191640 | PREDICATE DEVICE
K151151 | Comment |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Indications for Use | The TK 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. | Same |
| Mode of Fluid Delivery | Gravity | Gravity | Same |
| Y-site | Septum | Luer access valve | Different - see
discussion above |
| 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. | Same |

Intravascular Administration Set Comparison Table

7

No.228 Weiyi Road ,Economic Development Zone ,Tianchang City, Anhui, China [TK Intravascular Administration Set]

Materials
TubingPVCPVC
Drip chamberPVCPVC
SpikeABSABS
Protective cap of spikeLDPELDPE
Micron filterPTFEPTFE
Air inletPVCPVC
Fluid filterABSABSDifferent - see
discussion above
Slide clampABSABS
Pinch clampPOMPOMBiocompatibility
testing per ISO
10993-1
Flow regulatorABSABS
Roller ClampABSABS
Male luer lockMABSMABS
StopcockMAKROLONABS HDPE
4.0mm ConnectorMABSMABS
Y-siteMABSMABS
Rotating luer lockMABSMABS
Back check valveMABSMABS
Luer lock capHDPEHDPE
Pyrogenicity,stipulated in USP,
and the results are in lineand the results are in line
with requirements ofwith requirements of
USP: No microbial
growth was observed.USP: No microbial
growth was observed.
Shelf life3 yearsUnknownEvaluated per
ASTM testing
LabelingMeet the requirements of
21 CFR Part 801Meet the requirements of
21 CFR Part 801Same

8

No.228 Weiyi Road ,Economic Development Zone ,Tianchang City, Anhui, China [TK Intravascular Administration Set]

7. Non Clinical Performance Testing

  • A. Biocompatibility Testing (ISO 10993-1:2018):
    1. Hemocompatibility (ISO 10993-4:2017)
    1. Cytotoxicity (ISO 10993-5:2017)
    1. Irritation (ISO 10993-10:2017)
    1. Sensitization (ISO 10993-10:2017)
    1. Acute Systemic Toxicity (ISO 10993-11:2017)
    1. Bacterial Endotoxins (ISO 10993-11:2017)
    1. Pyrogenicity (ISO 10993-11:2017)
    1. Subacute Systemic Toxicity (ISO 10993-11:2017)/ Subchronic Systemic Toxicity Study (ISO 10993-11:2017)
  • B. Other Non-clinical Test Conducted Using the Following Guidance and Standards:
    • FDA Guidance July 2018: Intravascular Administration Sets Premarket Notification Submissions [510(k)]
    • ISO 8536-4: 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1(2013)]

9

510(k) Submission

No.228 Weiyi Road ,Economic Development Zone ,Tianchang City, Anhui, China [TK Intravascular Administration Set]

  • ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications
  • ISO 80369-20: 2015, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
  • ISO 11607-1: 2016, Packaging for terminally sterilized medical device -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607-2: 2016, Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
  • ISO 11135: 2014, Sterilization of health care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
  • . ISO10993-7: 2008, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
  • ISO10993-12: 2012, Biological evaluation of medical devices-Part 12: Sample preparation and reference materials
  • ASTM F1980- 2016, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • ASTM F1929- 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
  • ASTM F88- 2015, Standard Test Method for Seal Strength of Flexible Barrier Materials ●
  • USP 788- Particulate matter for Injection

8. Conclusions:

The Indications for Use, technological characteristics, and performance testing demonstrate that the subject device is substantially equivalent as the predicate device.