ASC HIGH PRESSURE BRAIDED TUBES

K964331 · Adam Spencer Corp. · DQO · Jan 13, 1997 · Cardiovascular

Device Facts

• Record ID: K964331
• Device Name: ASC HIGH PRESSURE BRAIDED TUBES
• Applicant: Adam Spencer Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system.

Device Story

Sterile, single-use, disposable braided polymeric tubing; terminated with male, male rotating, or female luer connectors. Tubing construction: extrusion base coat, nylon reinforcement braid, extrusion top coat. Used in clinical settings as an extension between angiographic injectors and catheters to deliver contrast media. Provides higher rated pressure (1200 PSI) compared to non-braided predicates. Bench testing confirms tensile strength, static burst strength, and luer compatibility.

Clinical Evidence

Bench testing only. Testing included component tensile strength, static burst strength, and luer compatibility. Materials passed ISO-10993-1 biological evaluation.

Technological Characteristics

Materials: Polyurethane tubing, nylon reinforcement braid, polycarbonate luer connectors. Sterilization: Ethylene Oxide (ANSI/AAMI/ISO 11135-1994). Standards: ISO 594-1:1986 (Luer taper), ISO 594-2:1991 (Luer lock), ISO-10993-1 (Biocompatibility). Rated pressure: 1200 PSI. Form factor: Braided tubing with various lengths (10-48 inches).

Indications for Use

Indicated for use as an accessory to angiographic catheters to provide an extended luminal connection between an angiographic injector and an angiographic catheter for delivery of radiopaque contrast medium to the vascular system.

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

• High Pressure Catheter Connector (USCI® Bard Corporation)

Submission Summary (Full Text)

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510(k), ASC High Pressure Braided Tubing
K964331
Page 24 of 27
JAN 13 1997

# Summary of Safety and Effectiveness for ASC High Pressure Braided Tubing
*submitted by*
**Adam Spence Corporation**
1746 Route 34
Wall, NJ 07719
Phone: [phone]
Facsimile: [phone]

## Identification of a Legally Marketed Predicate Device

The Adam Spence Corporation High Pressure Braided Tubing (HPBT) is substantially equivalent to the High Pressure Catheter Connector that is manufactured and marketed by the USCI® Bard Corporation.

## Device Description

The HPBT are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The HPBT consists of braided polymeric tubing terminated at both ends with luer connectors. The luer connector may be one of three types: male, male rotating, or female. A typical HPBT is shown below. Cross-sectional views of the three luer connectors are shown on the next page. The tubing has three sub-components: extrusion base coat, reinforcement nylon braid, and extrusion top coat.


Typical HPBT

© Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719
October 28, 1996

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510(k), ASC High Pressure Braided Tubing
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Cross-sectional Views

## Intended Use

ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system.

## Summary of Technological Characteristics

The table below compares the technological characteristics of the HPBT to the predicate device.

| Feature | HPBT | Predicate Device |
| --- | --- | --- |
| Manufacturer | Adam Spence Corporation | USCI® Bard Corporation |
| Sterile packaging | Mylar® and Tyvek® heat seal pouch | Mylar® and Tyvek® heat seal pouch |
| Sterilization method | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Shelf life | 3 years | Not shown in labeling |
| Available with rotating or non-rotating male luer lock connectors | Yes | Non-Rotating Only |
| Available working lengths (inches) | 10, 16, 20, 30, and 48 | 10 and 20 |

Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719
October 28, 1996

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510(k), ASC High Pressure Braided Tubing
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| Feature | HPBT | Predicate Device |
| --- | --- | --- |
| Intended use | ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system. | USCI® Catheter Connectors are designed to provide an extension from an angiographic catheter to a standard automatic contrast media (dye) injector. |
| Nominal Inside Diameter (Inches) | 0.071 | 0.105 |
| Nominal Outside Diameter | 0.142 | 0.208 |
| Luer material | Polycarbonate | Polycarbonate |
| Reinforcement braid material | Nylon | Non-braided |
| Tubing material | Polyurethane | Vinyl |
| Rated pressure (PSI) | 1200 | 1100 |

## Summary of Performance Data

The HPBT complies with the following standards, practices, and guidances:

- Medical Devices—Validation and Routine Control of Ethylene Oxide Sterilization, ANSI/AAMI/ISO 11135-1994, Approved March 24, 1994 by the American National Standards Institute, Inc.
- Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol, Proposed Maximum Residue Limits and Maximum Levels of Exposure, 21 CFR, § 821.100, Proposed Rule, June 23, 1978
- Biological Evaluation of Medical Devices—Part 7: Ethylene oxide sterilization residuals, American National Standard, ANSI/AAMI/ISO 10993-7:1995
- Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — General Requirements: International Standards Organization Reference Number 594-1:1986 (E)
- Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — lock fittings: International Standards Organization Reference Number 594-2:1991 (E)
- Biological Evaluation of Medical Devices, ISO-10993-1

Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719
October 28, 1996

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510(k), ASC High Pressure Braided Tubing
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The HPBT is substantially equivalent to High Pressure Catheter Connector which is legally marketed by the USCI® Bard Corporation. This has been demonstrated by extensive bench testing of both devices. Testing includes component tensile strength, static burst strength, and luer compatibility. Furthermore, the device has similar technological characteristics to High Pressure Catheter Connector which is legally manufactured by the USCI® Bard Corporation.

All direct and indirect blood contact materials used to fabricate the HPBT pass the testing required by ISO-10993-1. These materials are currently used in many disposable medical devices.

Since the HPBT meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The HPBT will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719
October 28, 1996