The Pressure Connecting Tube is for use during angiography procedures as a connecting line for the injection of liquid, such as radiopaque dye, saline, or other diagnostic fluids.

Device Description

The Pressure Connecting Tube is a sterile, single use device which can withstand injection pressures to 350~1200psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors. This device is designed, like other legally marked devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The fluid such as radipoaque dye, saline, or other diagnostic fluid is then injected from the syringe, through the connecting tube, into the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe through the High Pressure Tube, into the catheter. According to the different pressure maintenance, the material of tube is PVC or PU, and the appearance is clear or braided.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Pressure Connecting Tube (K131770):

Key Takeaways Before Diving In:

This device is a tubing connector for angiographic procedures. It's a relatively low-risk device.
The study described is non-clinical testing, meaning it does not involve human subjects. It focuses on device performance and safety characteristics.
This submission relies heavily on substantial equivalence to a predicate device (K071196), meaning the manufacturer asserts that their device is as safe and effective as a previously cleared device.
There's no AI component in this device, so questions related to AI-specific metrics like human reader improvement with AI assistance, standalone AI performance, and AI-specific ground truth establishment are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the reference to international standards and manufacturer's internal standards. The "reported device performance" is a confirmation that the device met these standards.

Acceptance Criterion (Reference Standard/Requirement)	Reported Device Performance
Pressure Maintenance (Manufacturer's standard)	The product should fulfill the requirements of pressure maintenance as claimed (350psi, 600psi). The non-clinical testing verified that the proposed device is capable of the intended use, meaning it met these pressure requirements. (Specifically, types for 350psi and 600psi were tested).
Packaging:
* Seal strength	Verified (per ASTM F88)
* Integrity (Leaks)	Verified (per ASTM F1929)
* Vacuum leak	Verified (per ASTM D3078)
* Accelerated aging (Sterility Shelf Life)	Verified (per ASTM F1980-07)
* General packaging requirements	Verified (per ISO 11607-1)
Performance (Luer Taper Connections):
* General Requirements for Conical Fittings (Luer)	Verified (per ISO 594-1)
* Lock Fittings for Conical Fittings (Luer)	Verified (per ISO 594-2)
Sterilization:
* Process Development, Validation, Routine Control (EtO)	Verified (per ISO 11135-1)
* EO/ECH Residuals	Verified (per ISO 10993-7)
* Bacterial Endotoxin	Verified (per USP Chapter <85>)
* Sterility	Verified (per USP Chapter <71>)
Biocompatibility:
* Cytotoxicity	Verified (per ISO 10993-5)
* Sensitization	Verified (per ISO 10993-10)
* Irritation	Verified (per ISO 10993-10)
* Systemic Toxicity (Acute)	Verified (per ISO 10993-11)
* General Biocompatibility of materials (across all relevant)	All the biocompatibilities of materials meet the requirements of ISO 10993 standards (implying passes for all relevant parts of ISO 10993, not just those explicitly listed in the "Non-Clinical Testing Data" section but also potentially others like material characterization or hemocompatibility if applicable to the device contact. The "Summary of the Biocompatibility Testing" table is empty in the provided text, but the conclusion states it met ISO 10993 requirements).

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

Sample Size for Test Set: The document states that "The most complicated structure of each pressure type is selected to conduct the performance test." It does not specify an exact number of units/samples for each test. Typically, for such non-clinical tests, a statistically relevant number of samples (often 3-10, sometimes more depending on the test and risk) would be used to demonstrate consistency and robustness, but the exact number is not provided in this summary.
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. The manufacturer is based in China: Shenzhen ANT Hi-Tech Industrial Co., Ltd. The data is prospective in the sense that the tests were performed specifically for this submission to verify the device's performance against defined standards.

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

Not Applicable. This is a non-clinical device performance and safety study involving physical and chemical testing against engineering standards (e.g., pressure, leaks, biocompatibility, sterility). There is no "ground truth" established by human experts in the way it would be for a diagnostic imaging device. The "ground truth" is defined by the objective measurement results compared to the pass/fail criteria of the referenced international and manufacturer standards.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical physical and chemical testing, there is no expert adjudication process like 2+1 or 3+1. The results are objective measurements against predefined acceptance criteria from standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance

No. This device is a passive, non-AI medical device (a pressure connecting tube). MRMC studies, AI assistance, and related metrics are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a passive, non-AI medical device. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

Objective Measurements Against Industry Standards and Manufacturer Specifications: The "ground truth" for the non-clinical tests is based on the quantitative and qualitative results derived from testing the device according to established international standards (ISO, ASTM, USP) and the manufacturer's own internal standards for pressure maintenance. For example, pressure maintenance is a quantitative measurement, while sterility is determined by a pass/fail microbiological test as per USP <71>.

8. The Sample Size for the Training Set

Not Applicable. This is a non-AI medical device; therefore, there is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and material science, not learned from a dataset.

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

Not Applicable. As there is no AI component or training set, this question does not apply.

Summary

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K131770
FEB 26 2014

510(k) Summary

Date of Submission: Feb 25, 2014

Owner:

Name:	Shenzhen ANT Hi-Tech Industrial Co., Ltd
Address:	Jinhui Ave.18, Pingshan New District, Shenzhen, Guangdong, 518122, ChinaNo.46, Science and Technology Road, Yuquan Industrial Park,Fenggang Town, Dongguan City, 523690 P.R. China

Submission Contact Person:

Name:	Ms. Lynn. Fu
eMail:	lynn.fu@antmed.com lynn.fu@rendermed.com
Tel:	86-755-26903311 Fax: 86-755-26903355
Company:	Shenzhen ANT Hi-Tech Industrial Co., Ltd
Address:	Jinhui Ave.18, Pingshan New District, Shenzhen, Guangdong, 518122, China.

Proposed Device:

Trade name:	Pressure Connecting Tube
Common name:	High pressure tube, High Pressure Line, Pressure Connecting Line
Classification name:	Diagnostic intravascular catheter (21CFR, 870.1200, Product Code DQO)

Classification :

Class: Il Product Code: DQO Regulation Number: 870.1200

Predicate Device:

K 071196
Disposable High Pressure Injection Lines with and with out rotating adapters Coeur, Inc

Intended Use: '

The Pressure Connecting Tube is indicated for use during angiography procedures as a connecting line for the injection of liquid, such as radiopaque dye, saline, or other diagnostic fluids.

Device Description:

The Pressure Connecting Tube is a sterile, single use device which can withstand injection

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pressures to 350~1200psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors.

This device is designed, like other legally marked devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The fluid such as radipoaque dye, saline, or other diagnostic fluid is then injected from the syringe, through the connecting tube, into the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe through the High Pressure Tube, into the catheter.

According to the different pressure maintenance, the material of tube is PVC or PU, and the appearance is clear or braided.

Technological Characteristics

The design and technological characteristics of the Pressure Connecting Tube is substantially equivalent to the predicate devices except the following:

The predicate device pressure rating is 500 to 1200psi while the proposed device can withstand injection pressure form 350 to 1200psi.

The difference does not have a significant impact on the safety or effectiveness of the device.

Characteristic	Proposed device	Legally market device (K071196)
Intended Use	This Pressure Connecting Tube is for useduring angiography procedures as aconnecting line for the injection of liquid,such as radiopaque dye, saline, or otherdiagnostic fluids.	The legally market device is for useduring coronary angiographyprocedure as a connecting line for theinjection of radiopaque dye, saline, orother diagnostic fluids.
Material	Plastic polymers	same
Flexible	YES	same
ConnectorTube	Multiple lengths of braided or unbraidedClear or tinted	same
Components	With or without luer connector, luer lockconnector.Protection cap.	Combinations of male and female luers(including rotating male luers), withand without dust caps(protection cap.
Packaging	Sealed Tyvek-lidded package.	same
Sterility	EtO	same
Disposable	YES	same
Pressure	350 to 1200psi	500 to 1200psi

Summary of Technological Characteristic compared to legally market device:

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Non-Clinical Testing Data:

The proposed device including three pressure sustaining types: 350psi, 600psi. The most complicated structure of each pressure type is selected to conduct the performance test. The results of the testing verified that the proposed device is capable of the intended use. The specific test items are listed below:

Summary of the non-Clinical Testing

Items	Reference Standards
Packaging	ISO 11607-1 Packaging for terminally sterilized medical devices -Part 1:Requirements for materials, sterile barrier systems and packaging systems
	Seal strengthASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials IntegrityASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous MedicalPackaging by Dye Penetration Vacuum leakASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging byBubble Emission Accelerated agingASTM F1980-07 Standard Guide For Accelerated Aging Of Sterile BarrierSystems For Medical Devices. (Sterility)
Performance	ISO 594-1 Conical Fittings With A 6% (Luer) Taper For Syringes, Needles AndCertain Other Medical Equipment - Part 1: General Requirements.
	ISO 594-2 Conical Fittings With A 6% (Luer) Taper For Syringes, Needles AndCertain Other Medical Equipment - Part 2: Lock Fittings.
	Pressure Maintenance: Manufacturer's standard. The product should fulfill therequirements of pressure maintenance as claimed.
Sterilization	ISO 11135-1 Sterilization Of Health Care Products - Ethylene Oxide - Part 1:Requirements For Development, Validation And Routine Control Of A SterilizationProcess For Medical Devices.
	EO/ECH ResidualsISO 10993-7 Biological Evaluation Of Medical Devices - Part 7: Ethylene OxideSterilization Residuals. Bacterial EndotoxinUSP Chapter<85> Bacterial Endotoxins Test. SterilityUSP Chapter<71> Sterility Tests.
Items	Reference Standards
Cytotoxicity	ISO 10993-5 Biological Evaluation Of Medical Devices -- Part 5: Tests ForIn Vitro Cytotoxicity
Sensitization	ISO 10993-10 Biological Evaluation Of Medical Devices - Part 10: Tests ForIrritation And Skin Sensitization.
Irritation
System toxicity (acute)	ISO 10993-11 Biological Evaluation Of Medical Devices Part 11: Tests ForSystemic Toxicity

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Biocompatibility of materials:

All the biocompatibilities of materials meet the requirements of ISO 10993 as listed below:

Summary of the Biocompatibility Testing

Clinical Tests: NA.

Conclusion:

The predicate device has the same classification, intended use, technology designing and sterile specification. The differences between the proposed device and the predicated device will not affect the safety and efficiency.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.

February 26, 2014

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen ANT Hi-Tech Industrial Co., Ltd c/o Ms. Lynn Fu Jinhui Ave. 18 Pingshan New District Shenzhen. Guangdong. 518122 China

Re: K131770

Trade/Device Name: Pressure Connecting Tube Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: January 5, 2014 Received: January 17, 2014

Dear Ms. Fu:

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.

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

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Page 2 - Ms. Lynn Fu

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.. . . . . .

Indication for Use

510(k) Number:

Device Name: Pressure Connecting Tube

Indications for Use:

The Pressure Connecting Tube is for use during angiography procedures as a connecting line for the injection of liquid, such as radiopaque dye, saline, or other diagnostic fluids.

Prescription Use J (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Stillman

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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).