MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER

K963092 · Adam Spencer Corp. · DQO · Jan 13, 1997 · Cardiovascular

Device Facts

• Record ID: K963092
• Device Name: MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER
• 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 Maxi-Torque Plus Softip Angiographic Catheters are designed to deliver contrast medium to selected sites in the vascular system.

Device Story

The ASC Maxi-Torque Plus Softip Angiographic Catheter is a sterile, single-use, disposable device designed for vascular access. It consists of a hub with a luer connector, a shaft, a stem, and a soft distal tip. The shaft features a 2-layer coaxial nylon extrusion reinforced with 300 series stainless steel braid wire to provide torque control and strength. The device accommodates guidewires up to 0.038 inches in diameter. It is used by clinicians to deliver radiopaque contrast media to specific vascular sites. The device is operated manually by the clinician during angiographic procedures. Performance is verified through bench testing, including tensile strength, flow rate, and burst strength assessments.

Clinical Evidence

Bench testing only. Testing included jacket tensile strength, stem tensile strength, flow rate, dynamic burst strength, and static burst strength. Compliance with ISO 10555-1 (intravascular catheters) and ISO 10993 (biological evaluation) was demonstrated. No clinical data provided.

Technological Characteristics

Materials: Nylon (hub, shaft, stem, soft tip), 300 series stainless steel (braid). Radiopacifiers: Barium Sulfate (shaft), Bismuth Oxychloride (stem), Bismuth Subcarbonate (tip). Dimensions: 5-7 French, 65-125 cm lengths. Max guidewire: 0.038 inches. Max pressure: 1200 PSI. Sterilization: Ethylene Oxide. Standards: ISO 10555-1, ISO 10993.

Indications for Use

Indicated for delivery of contrast medium to selected sites in 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

• Cordis Infiniti™
• Cordis TorquePlus™

Submission Summary (Full Text)

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JAN 13 1997

510(k), ASC Maxi-Torque Plus Softip Angiographic Catheters (ASCMPSACs)

Page 39 of 42

K963092

# Summary of Safety and Effectiveness for ASC Maxi-Torque Plus Softip Angiographic Catheters submitted by Adam Spence Corporation
1746 Route 34
Wall, NJ 07719
Phone: [phone]
Facsimile: [phone]

## Identification of a Legally Marketed Predicate Device

The ASC French Maxi-Torque Plus Softip Angiographic Catheters (ASCMPSACs) are substantially equivalent to catheters that are manufactured and marketed by the Cordis Corporation under the Infiniti™ and TorquePlus™ trademarks.

## Device Description

The ASCMPSACs are classified as Class II in 21 CFR §870.1200. The ASCMPSACs are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The ASCMPSACs consist of five components: catheter hub with luer connector, catheter shaft, catheter stem, soft distal tip, and catheter shaft braid wire. The catheter is shown below.


The catheter shaft has three sub-components: extrusion base coat, reinforcement braid wire, and extrusion top coat. The braiding is intended to provide torque control and strength.

All versions of the catheter are designed to accommodate a maximum guidewire diameter of 0.038 inches. The strain relief is imprinted with three descriptive dimensions: the French size of the catheter, minimum inside diameter, and the catheter working length.

(AS) Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719

August 7, 1996

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510(k), ASC Maxi-Torque Plus Softip Angiographic Catheters (ASCMPSACs)
Page 40 of 42

# Intended for Use

ASC Maxi-Torque Plus Softip Angiographic Catheters are designed to deliver contrast medium to selected sites in the vascular system.

# Summary of Technological Characteristics

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

| Feature | ASCMPSAC | Predicate Device |
| --- | --- | --- |
| Manufacturer | Adam Spence Corporation | Cordis Super Torque (Infiniti™) |
| Sterile packaging | On a card, inserted into a pouch made of Mylar® and Tyvek® | On a card, inserted into a pouch made of Mylar® and Tyvek® |
| Sterilization method | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Shelf Life | 3 years | 3 years |
| Intended use | ASCMPSACs are designed to deliver contrast medium to selected sites in the vascular system. | Cordis catheters are designed to deliver radiopaque contrast media to selected sites in the vascular system. |
| Hub with female luer taper | Yes | Yes |
| Radiopacifier, shaft | Barium Sulfate | Barium Sulfate |
| Radiopacifier, stem | Bismuth Oxychloride | Barium Sulfate |
| Radiopacifier, soft tip | Bismuth Subcarbonate | Bismuth Subcarbonate |
| Catheter, available sizes (French) | 5, 6, and 7 | 5, 6, and 7 |
| Catheter, available lengths (cm) | 65, 80, 100, 110, and 125 | 65, 80, 100, 110, and 125 |
| Maximum Guide Wire O.D. (inches) | 0.038 | 0.038 |
| Hub material | Nylon | Nylon |
| Reinforcement braid material | 300 Series Stainless Steel | 300 Series Stainless Steel |
| Shaft material | 2 layer coaxial nylon extrusion | 2 layer coaxial nylon extrusion |
| Stem material | Nylon | Nylon |
| Soft tip material | Nylon | Nylon |

Table Continued on Next Page

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Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719
August 7, 1996

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510(k), ASC Maxi-Torque Plus Softip Angiographic Catheters (ASCMPSACs)
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Table Continued

| Feature | ASCMPSAC | Predicate Device |
| --- | --- | --- |
| Stem to soft tip attachment method | Heat fuse | Heat fuse |
| Stem to shaft attachment method | Heat fuse | Heat fuse |
| Specifications printed on hub or strain relief | Catheter length, outside diameter, and inside diameter | Catheter length, diameter, and maximum guide wire size |
| Maximum pressure | 1200 PSI | 1200 PSI |
| Strain relief | Yes | Yes |

## Summary of Performance Data

The ASCMPSACs comply with the following standards, practices, and guidances:

- Sterile, single-use intravascular catheters: International Standards Organization Reference Number 10555-1:1995(E) (1995)
- 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
- Biological Evaluation of Medical Devices, ISO-10993-1

The ASCMPSACs are substantially equivalent to catheters which are legally marketed by the Cordis Corporation under the Infiniti™ and TorquePlus™ trademarks. This has been demonstrated by extensive bench testing of both devices. Testing includes jacket tensile strength, stem tensile strength, flow rate, dynamic burst strength and static burst strength. Furthermore, the devices have the same technological characteristics as the Cordis Infiniti™ and TorquePlus™ Angiographic Catheters.

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

The ASCMPSACs will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.

Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719
August 7, 1996

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510(k), ASC Maxi-Torque Plus Softip Angiographic Catheters (ASCMPSACs)
Page 42 of 42

Since the ASCMPSAC meets the requirements of the stated standards and embody 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 ASCMPSACs will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

(as) Adam Spence Corporation · 1746 Route 34 · Wall, NJ 07719
August 7, 1996