(83 days)
The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.
The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Jostra Vent Catheter:
The provided 510(k) summary for the Jostra Vent Catheter (K022022) focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific quantitative acceptance criteria or detailing a comprehensive study with the elements typically found in AI/ML device submissions.
Therefore, the requested information elements related to AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) are not applicable to this traditional medical device submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device Performance) | Reported Device Performance (Jostra Vent Catheter) |
|---|---|---|
| Biocompatibility | Equivalent biocompatibility to predicate devices. | Biocompatibility testing performed and deemed equivalent. |
| Kink Stability | Equivalent kink stability to predicate devices. | Kink stability testing performed on smallest and largest models; deemed equivalent. |
| Leak Testing | Equivalent leak integrity to predicate devices. | Leak testing performed on smallest and largest models; deemed equivalent. |
| Tensile Strength | Equivalent tensile strength to predicate devices. | Tensile strength testing performed on smallest and largest models; deemed equivalent. |
| Effects on Cellular Components | No adverse effects on cellular components beyond that of predicate devices. | In-vitro testing performed to determine effects on cellular components; deemed equivalent. |
| Design Dimensions (French size) | Within acceptable range for intended use; comparable to predicate devices. | Range from 8 to 18 French. (Predicate devices: Medtronic DLP 10-20 Fr, Edwards Lifesciences 20 Fr). Differences did not affect safety/effectiveness. |
| Design Dimensions (Length) | Within acceptable range for intended use; comparable to predicate devices. | Range from 23 to 40 cm. (Predicate devices: Medtronic DLP 33 & 41 cm, Edwards Lifesciences 36.8 cm). Differences did not affect safety/effectiveness. |
| Intended Use | Same intended use as predicate devices. | Used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less. (Same as predicates). |
| Materials | Similar materials to predicate devices. | Made of polyvinyl chloride. (Implicitly similar to predicates). |
| Principles of Operation | Same principles of operation as predicate devices. | (Implicitly same as predicates). |
Note: The acceptance criteria are implicitly derived from the performance and characteristics of the legally marketed predicate devices. The study's goal was to demonstrate "substantial equivalence" of the Jostra Vent Catheters to these predicates, meaning its performance, safety, and effectiveness are comparable.
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "Performance testing of the smallest and largest models" and "in-vitro testing." It does not specify the exact number of units tested for each parameter (kink stability, leak, tensile strength) or the specific number of in-vitro samples.
- Data Provenance: Not specified. Given it's a submission by a German company (Jostra AG) to the US FDA, the testing likely occurred at the manufacturer's facilities or a contract lab, but the country of origin of the data itself is not detailed. The testing is non-clinical/bench testing, not patient data, so "retrospective or prospective" is not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a mechanical medical device (catheter), not an AI/ML diagnostic tool. There is no concept of "ground truth" established by experts for its performance tests (kink stability, leak, tensile strength). These are objective engineering measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not an AI/ML diagnostic or image-based device requiring expert adjudication. The tests performed are objective, measurable physical properties.
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
- Not Applicable. This device is a component used in surgery; it does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Objective Measurement. For the performance tests (kink stability, leak, tensile strength), the "ground truth" or reference is based on established engineering standards and the performance of the predicate devices, measured objectively. For biocompatibility, it refers to standard biological response evaluations.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set or ground truth for such.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).