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 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.

AI/ML Overview

The document provided describes a 510(k) submission for the ASC Maxi-Torque Plus Softtip Angiographic Catheters (ASCMPSACs), asserting their substantial equivalence to a predicate device. The information focuses on safety and performance testing for a medical device rather than an AI/ML diagnostic tool. Therefore, many of the requested categories related to AI/ML study design (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable to this submission.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ASCMPSACs are based on compliance with specific international standards and successful bench testing demonstrating equivalence to the predicate device. The performance is reported through a comparison of technological characteristics and successful completion of various physical and material tests.

Feature / Test Category	Acceptance Criteria (Implied)	Reported Device Performance and Compliance
Technological Characteristics	Substantial equivalence to predicate device in terms of: - Manufacturer - Sterile packaging - Sterilization method - Pyrogenicity - Shelf Life - Intended use - Hub with female luer taper - Radiopacifier materials (shaft, stem, soft tip) - Catheter, available sizes (French) - Catheter, available lengths (cm) - Maximum Guide Wire O.D. (inches) - Hub material - Reinforcement braid material - Shaft material - Stem material - Soft tip material - Stem to soft tip attachment method - Stem to shaft attachment method - Specifications printed on hub/strain relief - Maximum pressure - Strain relief	The detailed table provided compares each technological characteristic of the ASCMPSAC to the Predicate Device (Cordis Super Torque (Infiniti™)). The ASCMPSAC is shown to be largely identical or highly similar across all these features, with minor differences only in some radiopacifier materials (stem: Bismuth Oxychloride for ASCMPSAC vs Barium Sulfate for predicate) and specifications printed on the hub/strain relief (Catheter length, outside diameter, and inside diameter for ASCMPSAC vs Catheter length, diameter, and maximum guide wire size for predicate). These differences are implicitly considered not to affect substantial equivalence.
Material Biocompatibility	Pass testing required by ISO-10993 for all direct and indirect blood contact materials.	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.
Physical Performance (Bench Testing)	Equivalent performance to predicate device in: - Jacket tensile strength - Stem tensile strength - Flow rate - Dynamic burst strength - Static burst strength	Extensive bench testing was conducted on both the ASCMPSAC and the predicate device. Testing included jacket tensile strength, stem tensile strength, flow rate, dynamic burst strength, and static burst strength. The results demonstrated substantial equivalence, supporting the claim that the device performs as well as or better than the predicate device.
Compliance with Standards	Compliance with: - ISO 10555-1:1995(E) (Sterile, single-use intravascular catheters) - 21 CFR, § 821.100 (Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol residue limits) - ANSI/AAMI/ISO 10993-7:1995 (Ethylene oxide sterilization residuals) - ISO-10993-1 (Biological Evaluation of Medical Devices)	The ASCMPSACs comply with all listed standards, practices, and guidances.
Manufacturing Practices	Manufactured per specifications using good manufacturing practices to ensure safety and effectiveness.	The ASCMPSACs will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.

Non-Applicable Sections for this Device Submission:

Since this document describes a traditional medical device (angiographic catheter) and its substantial equivalence claims, rather than an AI/ML-driven diagnostic or treatment device, the following categories are not relevant and thus no information is provided in the source text:

Sample size used for the test set and the data provenance: Not an AI/ML study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML study.
Adjudication method for the test set: Not an AI/ML study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI/ML study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML study.
The type of ground truth used: For mechanical device testing, the "ground truth" is typically defined by engineering specifications, material properties, and physical test results, not expert consensus or pathology in the diagnostic sense.
The sample size for the training set: Not an AI/ML study.
How the ground truth for the training set was established: Not an AI/ML study.

Summary

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11 N 13 1997

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

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Image /page/0/Figure/3 description: The image shows a document titled "Summary of Safety and Effectiveness for ASC Maxi-Torque Plus Softtip Angiographic Catheters." It indicates that the document was submitted by Adam Spence Corporation, located at 1746 Route 34, Wall, NJ 07719. The phone number is (908) 681-7070, and the facsimile number is (908) 222-5928.

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

Image /page/0/Figure/8 description: The image shows a diagram of a medical instrument. The instrument has several parts, including a hub, strain relief, shaft, stem, and soft tip. The shaft is long and thin, and the stem is curved. The soft tip is located at the end of the stem.

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.

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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 madeof Mylar® and Tyvek®	On a card, inserted into a pouch madeof 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 delivercontrast medium to selected sites in thevascular system.	Cordis catheters are designed to deliverradiopaque contrast media to selectedsites in the vascular system.
Hub with female luertaper	Yes	Yes
Radiopacifier, shaft	Barium Sulfate	Barium Sulfate
Radiopacifier, stem	Bismuth Oxychloride	Barium Sulfate
Radiopacifier, soft tip	Bismuth Subcarbonate	Bismuth Subcarbonate
Catheter, availablesizes (French)	5, 6, and 7	5, 6, and 7
Catheter, availablelengths (cm)	65, 80, 100, 110, and 125	65, 80, 100, 110, and 125
Maximum GuideWire O.D. (inches)	0.038	0.038
Hub material	Nylon	Nylon
Reinforcement braidmaterial	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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Feature	ASCMPSAC	Predicate Device
Stem to soft tip at-tachment method	Heat fuse	Heat fuse
Stem to shaft attach-ment method	Heat fuse	Heat fuse
Specifications printedon hub or strain relief	Catheter length, outside diameter, andinside diameter	Catheter length, diameter, and maxi-mum guide wire size
Maximum pressure	1200 PSI	1200 PSI
Strain relief	Yes	Yes

Table Continued

Summary of Performance Data

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

Sterile, single-use intravascular catheters: International Standards Organi-● zation 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 sterili-. zation 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.

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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.

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).