(245 days)
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.
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.
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).