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The Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The Safe-Cross Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guidewires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. The Safe-Cross Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The effective length of the Safe-Cross Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guidewires.

The Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE". "Non-Pyrogenic" and is intended for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "ILT Safe-Cross® Deflecting Catheter." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive performance studies against pre-defined acceptance criteria for efficacy or diagnostic performance. Instead, the "acceptance criteria" here refer to the functional performance requirements of the device and its biocompatibility, which are typically met through bench testing and standard biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" in a quantitative, tabular format as one might find for a diagnostic or AI-based device's performance. Instead, it discusses the device's functional characteristics and how its performance was evaluated against these.

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Biocompatibility	Device materials must be biocompatible (to ensure safety when in contact with body tissues). (Implicit)	"Biocompatibility test results indicate that the device materials are biocompatible."
Functional Performance	Device must satisfy functional performance requirements for its intended use (e.g., ability to facilitate guidewire access and exchange, suitable for delivering saline/contrast). (Implicit)	"Performance test results indicate that the device satisfies functional performance requirements when used as indicated."
Specific dimensions are provided as characteristics, implying they meet design specifications:

Effective length: 135-140 cm
Shaft nominal O.D.: 2.5 F (0.033")
Max O.D. of deflecting segment: 3.5 F (0.045") at 10 atm
I.D. at tip: 0.016"
Accommodates 0.014" guidewires |
| Sterility | Device must be sterile. (Implicit) | "The packaged units are sterilized with ethylene oxide gas. The device is provided 'STERILE'." |
| Pyrogenicity | Device must be non-pyrogenic. (Implicit) | "'Non-Pyrogenic'" |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "bench studies" and "biocompatibility testing." These types of studies typically involve a set number of manufactured devices tested against engineering specifications and biological safety standards. However, the exact sample sizes for these tests are not specified in the provided text. The data provenance is also not specified, though it would originate from the manufacturer's testing facilities. These were likely prospective tests performed on newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is a medical catheter, not a diagnostic device relying on expert interpretation of data or images to establish ground truth for performance. The "ground truth" for this device's performance would be objective measurements against engineering specifications and standard biocompatibility assay results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation of medical data where there's a need to resolve discrepancies between multiple readers.

5. 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

An MRMC study was not done. This device is a physical catheter, not an AI or imaging-based diagnostic system. Therefore, there's no concept of human readers or AI assistance in its direct use or evaluation in the context of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical catheter, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on:

Engineering Specifications: Measurements of physical dimensions, flexibility, pushability, torqueability, and other mechanical properties against pre-defined design criteria.
Standard Biocompatibility Test Results: Objective results from assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) performed according to international standards (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the conventional sense.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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K Number

K031692

Device Name

SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1

Manufacturer

INTRALUMINAL THERAPEUTICS, INC.

Date Cleared

2003-08-22

(81 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K010531

Intended Use

The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The Safe-Cross® Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The effective length of the Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross® Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guide wires.

The Safe-Cross® Deflecting Catheter is packaged in a Tyvek® covered custom PETG trav that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.

AI/ML Overview

This document is a 510(k) summary for a medical device called the Safe-Cross® Deflecting Catheter. It focuses on establishing substantial equivalence to a predicate device, not on AI/ML-driven performance or standalone algorithm efficacy. Therefore, much of the requested information regarding AI device evaluation is not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Device Performance)	Reported Device Performance (Safe-Cross® Deflecting Catheter)
Biocompatibility	Meets established biocompatibility standards for intravascular devices.	"Biocompatibility test results indicate that the device materials are biocompatible."
Functional Performance	Satisfies functional requirements (e.g., guide wire access, exchange, delivery of solutions).	"Performance test results indicate that the device satisfies functional performance requirements when used as indicated."
Material/Design Similarity	Similar basic materials, design, construction to predicate.	"The Safe-Cross® Deflecting Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device."
Physical Dimensions	Effective length, OD, ID comparable to predicate/clinically acceptable.	"The effective length of the Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip...is a nominal 0.016" and...accommodate commercially available 0.014" guide wires."
Sterility	Sterilized and non-pyrogenic.	"The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic"."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a "test set" in the context of AI/ML evaluation. The document refers to "Biocompatibility testing and bench studies," but the number of devices or iterations tested is not provided.
Data Provenance: Not applicable in the context of AI/ML data provenance (e.g., country of origin for images). These are bench tests and biocompatibility studies.