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Respiguide outer guide catheter: The guide catheter is intended for use for intravascular introduction of interventional/diagnostic devices into peripheral vascular systems.

Respiguide inner (angiographic) catheter: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

Device Description

The Respiguide Delivery System is a single use catheter system consisting of a 7F slittable outer guide catheter and a 5F inner angiographic catheter. Both catheters consist of stainless steel wirebraid reinforced shafts, molded hubs, and flexible and tapered distal tips. The inner and outer catheter shafts contain the wire-braiding for torque performance. The tapered and flexible distal tips of the inner and outer catheters are designed to reduce the potential for vessel trauma. The outer guide catheter is offered with distal tips that are straight or have 90- or 120-degree angles. The inner angiographic catheter is offered with distal tips that are either straight or have a "KA2" shape (a gentle 60 degree shape). The shapes are designed to facilitate maneuvering of interventional/diagnostic devices into peripheral vascular systems.

AI/ML Overview

The provided 510(k) summary for the RespiGuide Delivery System (K130378) details acceptance criteria and the performance testing to meet them.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests without explicitly stating numerical acceptance criteria values in the summary. However, it indicates that the device met Respicardia, Inc. internal requirements for substantial equivalence. The "Reported Device Performance" column reflects whether the device successfully met these internal specifications based on the summary.

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Design Verification	Surface and cleanliness	Meet internal specifications for surface finish and cleanliness.	Met internal specifications.
	Dimensions	Meet specified dimensional tolerances.	Met internal specifications.
	Fit with 5F Impress Angiographic Catheter and SafeSheath Sealing Adaptor	Proper fit and compatibility with specified associated devices.	Met internal specifications; fit was smooth and worked well as a system (validated by physicians).
	Fluid Leakage	No fluid leakage under specified conditions.	Met internal specifications.
	Air Leakage	No air leakage under specified conditions.	Met internal specifications.
	Torque	Adequate torque transmission for maneuvering.	Met internal specifications; torque-ability was appropriate (validated by physicians).
	Bending	Withstand bending forces without damage or kinking.	Met internal specifications.
	Shaft Slit Force	Meet specifications for slitting function.	Met internal specifications.
	Hub Slit Force	Meet specifications for slitting function.	Met internal specifications.
	Kink Resistance	Resist kinking during normal use.	Met internal specifications.
	Force at Break	Withstand specified forces without breaking.	Met internal specifications.
	Corrosion Resistance	Resist corrosion under specified conditions.	Met internal specifications.
Design Validation (Human Factors Testing)	7F outer guide catheter shaft length	Appropriate length for intended use.	Deemed "appropriate" by physicians.
	7F outer guide catheter torque-ability	Ability to transmit torque and aim the tip as desired.	Deemed "appropriate" by physicians.
	7F outer guide catheter tip angle	Appropriate tip angle for intended use.	Deemed "appropriate" by physicians.
	7F outer guide catheter tip shape	Appropriate tip shape for intended use.	Deemed "appropriate" by physicians.
	7F outer guide catheter fit with 5F inner angiographic catheter	Smooth fit and system functionality.	Deemed "smooth and worked well as a system" by physicians.
	7F outer guide catheter slittability	Slittable with a catheter slitter.	Deemed "slittable" by physicians.
	5F inner angiographic catheter length	Appropriate length for intended use.	Deemed "appropriate" by physicians.
	5F inner angiographic catheter distal shape	Appropriate distal shape for intended use.	Deemed "appropriate" by physicians.
Shelf-Life	Packaging integrity	Maintain integrity after environmental, distribution, and accelerated aging conditioning.	Met specifications after specified conditioning.
	Device performance after aging	Device meets specifications after three (3) year accelerated aging.	Met specifications after three (3) year accelerated aging.
Sterilization	Sterility	Successfully sterilized using the same process as predicate devices and meet TIR 28 sterilization adoption.	Successfully sterilized using the same sterilization process as the predicate devices and met TIR 28 standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the specific number of units used for each bench test. However, it mentions "Design Validation Testing (Human Factors Testing)" was performed with "cadavers and glass models." The sample size for these models is not specified.
Data Provenance: All testing appears to be internal (Respicardia, Inc.) or performed by a contract testing facility (DDL, Inc. in Eden Prairie, MN, USA). Thus, the data provenance is United States, and the data is prospective (generated specifically for this regulatory submission through testing).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: The document states that "physicians were asked to use the Respiguide Delivery System and evaluate the performance of the following characteristics" during the Design Validation Testing. The specific number of physicians (experts) involved in this "qualitative analysis" is not specified.
Qualifications of Experts: The experts are referred to as "physicians." No further details regarding their specific specialty (e.g., interventional radiologists, cardiologists) or years of experience are provided in the summary.

4. Adjudication Method for the Test Set

The Design Validation Testing was a "qualitative analysis in which physicians were asked to use the Respiguide Delivery System and evaluate the performance." This implies a form of expert assessment. However, the document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies or aggregating individual physician opinions. It simply states they evaluated performance and the device "was appropriate" or "smooth and worked well."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical testing is being used to establish substantial equivalence." The entire performance evaluation relies on bench testing and human factors testing using cadavers and glass models. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a medical catheter system, not an AI algorithm. Its performance is inherent to its physical design and materials, and its use is always "human-in-the-loop."

7. Type of Ground Truth Used

For the bench testing, the "ground truth" was based on Respicardia Inc. internal specifications and engineering standards. For the Design Validation (Human Factors) testing, the "ground truth" was established through expert qualitative assessment by physicians using cadavers and glass models.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no training set for this type of device.

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