PRESSURE CONNECTING TUBE

K131770 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · DQO · Feb 26, 2014 · Cardiovascular

Device Facts

• Record ID: K131770
• Device Name: PRESSURE CONNECTING TUBE
• Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

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 Story

Pressure Connecting Tube is a sterile, single-use device designed to connect a fluid source (e.g., angiographic syringe) to a catheter. It facilitates the delivery of radiopaque dye, saline, or other diagnostic fluids during angiography procedures. The device is compatible with power injectors and can withstand injection pressures ranging from 350 to 1200 psi. It is constructed from PVC or PU, available in clear or braided configurations, and may include luer connectors and protection caps. The device is intended for use by healthcare professionals in clinical settings. By providing a secure, high-pressure-rated conduit, it enables the controlled administration of contrast media, aiding in diagnostic imaging and clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Testing included packaging integrity (ASTM F88, F1929, D3078, F1980-07), luer fitting performance (ISO 594-1, ISO 594-2), pressure maintenance, sterilization validation (ISO 11135-1), EO/ECH residuals (ISO 10993-7), bacterial endotoxins (USP <85>), sterility (USP <71>), and biocompatibility (ISO 10993-5, -10, -11).

Technological Characteristics

Materials: PVC or PU. Design: Flexible, clear or braided tube with optional luer lock/connector and protection cap. Pressure rating: 350-1200 psi. Sterilization: Ethylene Oxide (EtO). Connectivity: Mechanical luer interface. Standards: ISO 594-1/2 (fittings), ISO 11607-1 (packaging), ISO 10993 (biocompatibility).

Indications for Use

Indicated for use during angiography procedures as a connecting line for the injection of radiopaque dye, saline, or other diagnostic fluids in patients undergoing such procedures.

Regulatory Classification

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.

Predicate Devices

• Disposable High Pressure Injection Lines with and with out rotating adapters Coeur, Inc (K071196)

Submission Summary (Full Text)

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K131770
FEB 26 2014

## 510(k) Summary

Date of Submission: Feb 25, 2014

### Owner:

r

| Name: | Shenzhen ANT Hi-Tech Industrial Co., Ltd |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Jinhui Ave.18, Pingshan New District, Shenzhen, Guangdong, 518122, China<br>No.46, Science and Technology Road, Yuquan Industrial Park,<br>Fenggang Town, Dongguan City, 523690 P.R. China |

### Submission Contact Person:

| Name: | Ms. Lynn. Fu |
|----------|---------------------------------------------------------------------------|
| eMail: | [e-mail] [e-mail] |
| Tel: | 86-755-26903311 Fax: [phone] |
| 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 use<br>during angiography procedures as a<br>connecting line for the injection of liquid,<br>such as radiopaque dye, saline, or other<br>diagnostic fluids. | The legally market device is for use<br>during coronary angiography<br>procedure as a connecting line for the<br>injection of radiopaque dye, saline, or<br>other diagnostic fluids. |
| Material | Plastic polymers | same |
| Flexible | YES | same |
| Connector<br>Tube | Multiple lengths of braided or unbraided<br>Clear or tinted | same |
| Components | With or without luer connector, luer lock<br>connector.<br>Protection cap. | Combinations of male and female luers<br>(including rotating male luers), with<br>and 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:<br>Requirements for materials, sterile barrier systems and packaging systems |
| | Seal strength<br>ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials Integrity<br>ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical<br>Packaging by Dye Penetration Vacuum leak<br>ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by<br>Bubble Emission Accelerated aging<br>ASTM F1980-07 Standard Guide For Accelerated Aging Of Sterile Barrier<br>Systems For Medical Devices. (Sterility) |
| Performance | ISO 594-1 Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And<br>Certain Other Medical Equipment - Part 1: General Requirements. |
| | ISO 594-2 Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And<br>Certain Other Medical Equipment - Part 2: Lock Fittings. |
| | Pressure Maintenance: Manufacturer's standard. The product should fulfill the<br>requirements of pressure maintenance as claimed. |
| Sterilization | ISO 11135-1 Sterilization Of Health Care Products - Ethylene Oxide - Part 1:<br>Requirements For Development, Validation And Routine Control Of A Sterilization<br>Process For Medical Devices. |
| | EO/ECH Residuals<br>ISO 10993-7 Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide<br>Sterilization Residuals. Bacterial Endotoxin<br>USP Chapter<85> Bacterial Endotoxins Test. Sterility<br>USP Chapter<71> Sterility Tests. |
| Items | Reference Standards |
| Cytotoxicity | ISO 10993-5 Biological Evaluation Of Medical Devices -- Part 5: Tests For<br>In Vitro Cytotoxicity |
| Sensitization | ISO 10993-10 Biological Evaluation Of Medical Devices - Part 10: Tests For<br>Irritation And Skin Sensitization. |
| Irritation | |
| System toxicity (acute) | ISO 10993-11 Biological Evaluation Of Medical Devices Part 11: Tests For<br>Systemic 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 [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" (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 [phone] or [phone] 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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