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.

AI/ML Overview

The provided document is a 510(k) summary for the "TK Intravascular Administration Set". This document primarily focuses on establishing substantial equivalence to a predicate device (U&U Intravascular Administration Set, K151151) rather than detailing a specific clinical study with acceptance criteria and reported device performance directly.

The document lists "Non Clinical Performance Testing" and references various ISO standards and FDA guidance documents. These standards likely define the acceptance criteria for physical, chemical, and biological properties of the device. However, the document does not explicitly list a table of acceptance criteria alongside reported device performance for these non-clinical tests. It states that evaluations were performed using industry consensus standards and evaluated per the performance requirements of the device, and that the results for pyrogenicity and sterility were in line with requirements.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary, as it is a premarket notification for a Class II medical device focused on substantial equivalence to a predicate, not a detailed clinical study report.

However, I can extract the information that is present and indicate where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table with explicit acceptance criteria and corresponding reported performance results for a device study. Instead, it outlines the non-clinical tests performed to demonstrate substantial equivalence to the predicate device, relying on compliance with recognized standards.

Implicit Acceptance Criteria (based on referenced standards) and Partial Reported Performance:

Feature/Test	Acceptance Criteria (Implicitly from Standards)	Reported Device Performance (Partial)
Pyrogenicity	<0.5 EU (likely based on ISO 10993-11)	<0.5 EU (Same as predicate)
Sterility	No microbial growth observed (based on USP<71>)	In line with USP<71> requirements: No microbial growth was observed. (Same as predicate)
Biocompatibility	Compliance with ISO 10993-1, -4, -5, -10, -11	Tested per these standards, but specific results/acceptance criteria for each sub-test are not detailed in this summary.
Packaging Integrity	Compliance with ISO 11607-1, 11607-2, ASTM F1980, F1929, F88	Tested per these standards, but specific results/acceptance criteria for each sub-test are not detailed in this summary.
EO Residuals	Compliance with ISO 10993-7	Tested per this standard, but specific results/acceptance criteria are not detailed in this summary.
Particulate Matter	Compliance with USP 788	Tested per this standard, but specific results/acceptance criteria are not detailed in this summary.
Functional Performance	Compliance with ISO 8536-4, ISO 80369-7, ISO 80369-20 (e.g., flow rate, connection integrity)	Tested per these standards, but specific results/acceptance criteria are not detailed in this summary. The summary states "evaluation were performed using industry consensus standards and evaluated per the performance requirements of the device."
Shelf Life	Demonstrated stability over 3 years (based on ASTM testing)	3 years (Evaluated per ASTM testing)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified for any of the non-clinical tests.
Data Provenance: The tests are non-clinical (laboratory/bench testing) of the device components and entire product in China, performed by the manufacturer, Anhui Tiankang Medical Technology Co., Ltd.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as this is a 510(k) summary for a Class II medical device, focusing on non-clinical performance and substantial equivalence. There is no mention of a "test set" requiring expert-established ground truth in a clinical context. The "ground truth" for the non-clinical tests would be the established scientific/engineering principles and performance requirements outlined in the referenced ISO standards.

4. Adjudication Method for the Test Set

Not applicable. As described above, there is no clinical "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI systems where human readers interpret patient cases. The "TK Intravascular Administration Set" is a physical medical device (infusion set), and a clinical study with human readers would not be relevant in this context.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone (algorithm only) performance study was not done. This device is a physical medical administration set, not an algorithm or AI-powered system that would have a "standalone" or "human-in-the-loop" performance.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluations described (biocompatibility, sterility, pyrogenicity, etc.) is based on recognized international standards (e.g., ISO, ASTM, USP) and FDA guidance documents. These standards define the acceptable limits and methodologies for testing.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The product design and manufacturing processes are likely informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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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

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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

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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 ZoneTianchang 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 ZoneTianchang City, Anhui, China
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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

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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

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.

Ref	Description
-----	-------------

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

Number
TKIV-F05	Intravascular Administration Set
TKIV-F09	Intravascular Administration Set
TKIV-F10	Intravascular Administration Set
TKIV-F11	Intravascular Administration Set
TKIV-F12	Intravascular Administration Set
TKIV-F13	Intravascular Administration Set
TKIV-F14	Intravascular Administration Set
TKIV-F15	Intravascular 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.

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

Element of Comparison	SUBJECT DEVICEK191640	PREDICATE DEVICEK151151	Comment
Indications for Use	The TK IntravascularAdministration Set is adevice used to administerfluids from a container to apatient's vascular systemthrough a needle or catheterinserted into a vein.	The U&U IntravascularAdministration Set is adevice used to administerfluids from a container to apatient's vascular systemthrough a needle or catheterinserted into a vein.	Same
Mode of Fluid Delivery	Gravity	Gravity	Same
Y-site	Septum	Luer access valve	Different - seediscussion above
Tubing	The tubing shall betransparent or sufficientlytranslucent so that theinterface of air and waterduring the passage of airbubbles can be observedwith normal or correctedvision.	The tubing shall betransparent or sufficientlytranslucent so that theinterface of air and waterduring the passage of airbubbles can be observedwith normal or correctedvision.	Same

Intravascular Administration Set Comparison Table

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

Materials
Tubing	PVC	PVC
Drip chamber	PVC	PVC
Spike	ABS	ABS
Protective cap of spike	LDPE	LDPE
Micron filter	PTFE	PTFE
Air inlet	PVC	PVC
Fluid filter	ABS	ABS	Different - seediscussion above
Slide clamp	ABS	ABS
Pinch clamp	POM	POM	Biocompatibilitytesting per ISO10993-1
Flow regulator	ABS	ABS
Roller Clamp	ABS	ABS
Male luer lock	MABS	MABS
Stopcock	MAKROLON	ABS HDPE
4.0mm Connector	MABS	MABS
Y-site	MABS	MABS
Rotating luer lock	MABS	MABS
Back check valve	MABS	MABS
Luer lock cap	HDPE	HDPE
Pyrogenicity	<0.5 EU	<0.5 EU	Same

	Method: by EO	Method: by EO
	Sterility inspection is	Sterility inspection is
Sterility	based on the methods	based on the methods	Same
	stipulated in USP<71>,	stipulated in USP<71>,
	and the results are in line	and the results are in line
	with requirements of	with requirements of
	USP<71>: No microbialgrowth was observed.	USP<71>: No microbialgrowth was observed.
Shelf life	3 years	Unknown	Evaluated perASTM testing
Labeling	Meet the requirements of21 CFR Part 801	Meet the requirements of21 CFR Part 801	Same

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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)]

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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.

Regulation Number and Section

§ 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.