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 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 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.

AI/ML Overview

The description you've provided is for a 510(k) premarket notification for a medical device called "ASC High Pressure Braided Tubing" (HPBT), aiming to demonstrate substantial equivalence to a predicate device. This type of regulatory submission typically focuses on functional and safety performance rather than clinical efficacy studies often found with novel devices.

Given this context, the document doesn't describe a clinical study in the way a diagnostic AI device's performance would be evaluated. Instead, it describes bench testing to ensure the device meets engineering specifications and safety standards. Therefore, many of your requested points (sample size of test set, data provenance, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable in this context.

Here's how to interpret and answer your questions based on the provided document:

Acceptance Criteria and Reported Device Performance

The document describes several performance characteristics and standards the HPBT must meet. The "reported device performance" is integrated into the descriptions of compliance with these standards and the bench testing results, which aim to demonstrate equivalence or superiority to the predicate device.

Acceptance Criteria / Standard	Reported Device Performance
Material Properties:
Luer material: Polycarbonate	HPBT uses Polycarbonate, same as predicate.
Reinforcement braid material: Nylon	HPBT uses Nylon braid (predicate is non-braided). This is a difference, but supported by performance data.
Tubing material: Polyurethane	HPBT uses Polyurethane (predicate uses Vinyl). This is a difference, but supported by performance data.
Functional Performance:
Rated pressure (PSI)	HPBT has a rated pressure of 1200 PSI (predicate is 1100 PSI). Meets (exceeds) acceptance criteria.
Component tensile strength	Bench testing demonstrates compliance.
Static burst strength	Bench testing demonstrates compliance.
Luer compatibility	Bench testing demonstrates compliance, including compliance with ISO 594-1:1986 (E) and 594-2:1991 (E) standards for luer taper and lock fittings.
Sterilization & Biocompatibility:
Sterile packaging	Mylar® and Tyvek® heat seal pouch, same as predicate.
Sterilization method: Ethylene Oxide Gas	Ethylene Oxide Gas, same as predicate. Complies with ANSI/AAMI/ISO 11135-1994.
Pyrogenicity: Non-pyrogenic	Non-pyrogenic, same as predicate.
Biological Evaluation of Medical Devices (ISO-10993-1)	All direct and indirect blood contact materials pass required testing per ISO-10993-1.
Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol Residue	Complies with 21 CFR, § 821.100 (Proposed Rule, June 23, 1978) and ANSI/AAMI/ISO 10993-7:1995.
Other:
Shelf life: 3 years	HPBT has a 3-year shelf life (predicate not specified in labeling).
Available with rotating or non-rotating male luer lock connectors	HPBT offers rotating or non-rotating (predicate non-rotating only).
Available working lengths (inches)	HPBT offers 10, 16, 20, 30, and 48 inches (predicate 10 and 20 inches).

Study Details (as applicable to a 510(k) bench testing submission)

Sample size used for the test set and the data provenance:
The document states "extensive bench testing of both devices" was performed. It does not specify the exact sample sizes (number of units tested) for individual tests like tensile strength, burst strength, or luer compatibility.
Data Provenance: The testing was conducted internally by Adam Spence Corporation, implying the data is from in-house lab testing, not clinical data from a specific country. This is a prospective set of tests designed specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable in the context of this type of submission. "Ground truth" established by human experts is relevant for diagnostic AI devices where human interpretation is the benchmark. For this device (HPBT), ground truth is established by engineering specifications, validated test methods (e.g., ISO standards), and physical measurements. No human experts were used to establish a "ground truth" for the performance characteristics of the tubing itself.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. Adjudication methods are used in studies involving human interpretation or clinical endpoints. For bench testing, results are objective measurements against predefined criteria/standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This question is not applicable. MRMC studies are specific to evaluating diagnostic systems, especially those involving human interpretation (e.g., radiologists reading images with or without AI assistance). This document describes a medical device (tubing) for fluid delivery, not a diagnostic AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This device is not an algorithm or an AI system. Its performance is entirely mechanical/physical.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench testing, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO for luer fittings, AAMI for sterilization), and physical measurement thresholds. For example, the "ground truth" for rated pressure is 1200 PSI, which is a design specification and a quantifiable test outcome. The "ground truth" for biocompatibility is compliance with ISO-10993-1.
The sample size for the training set:
This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The device is manufactured based on design specifications and then tested against those specifications and relevant standards.
How the ground truth for the training set was established:
This question is not applicable as there is no training set.

Summary

{0}------------------------------------------------

K964331

ા રે વિવ 11 11

Summary of Safety and Effectivenessfor
ASC High Pressure Braided Tubingsubmitted by
Adam Spence Corporation
1746 Route 34
Wall, NJ 07719
Phone: (908) 681-7070
Facsimile: (908) 222-5928

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

Image /page/0/Figure/9 description: The image shows a technical drawing of a tubing system. The system consists of a "Rotating Male Luer" on the left, connected to a "Fixed Female Luer" on the right, with "Polyurethane Braided Tubing" in between. The drawing provides a detailed view of the connection and the tubing material.

Typical HPBT

{1}------------------------------------------------

Image /page/1/Figure/2 description: The image shows three sets of technical drawings of mechanical parts. Each set includes a cross-sectional view from the side and a top-down view. The drawings appear to be detailed schematics, possibly for manufacturing or engineering purposes, with precise lines and concentric circles indicating cylindrical shapes and internal structures.

Cross-sectional Views

Intended Use

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 rotat-ing or non-rotatingmale luer lock con-nectors	Yes	Non-Rotating Only
Available workinglengths (inches)	10, 16, 20, 30, and 48	10 and 20

{2}------------------------------------------------

Feature	HPBT	Predicate Device
Intended use	ASC High Pressure Braided Tubes areaccessory devices to angiographiccatheters intended to provide an extended luminal connection between anangiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium toselected sites in the vascular system.	USCI® Catheter Connectors are designed to provide an extension from anangiographic catheter to a standard automatic contrast media (dye) injector.
Nominal Inside Diameter (Inches)	0.071	0.105
Nominal OutsideDiameter	0.142	0.208
Luer material	Polycarbonate	Polycarbonate
Reinforcement braidmaterial	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 sterili-. zation 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 ●

{3}------------------------------------------------

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 mects 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.

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).