(190 days)
The Chase Left Vent Safety Valve is intended to be used during open heart surgery and placed in a vent line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.
The Left Vent Safety Valve is a three function assembly that is positioned in the vent line and includes a check valve which permits flow only away from the heart. A second vent valve is located downstream of the check valve to prevent buildup of drain line pressure. A third inwardly directed umbrella valve limits line vacuum intensity.
This looks like a pre-market notification for a medical device (K96439). The provided text describes the device, its intended use, and claims substantial equivalence to a predicate device (C.R. Bard overpressure safety valve, K820297). However, the document does not report any specific clinical study or performance data that would typically be used to establish acceptance criteria for device performance in the way a diagnostic algorithm or a complex interventional device might.
Instead, the "acceptance criteria" and "study" described here are related to functional testing and material equivalence, largely relying on the predicate device's established safety and effectiveness.
Here's an analysis of the provided information in the context of your request:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are primarily based on functional tests and demonstrating equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Leak Test | No leaks at 10 psi air | Passed: "No leaks at 10 psi air on Chase device at 4℃ and 40°C" |
| Package Integrity | Tyvek/Polymylar burst test per ASTM F1140-88 | Passed: "Tyvek/Polymylar passed burst test per ASTM F1140-88" |
| Shipping & Distribution Testing | Vibration and drop tests per National Safe Transit Ass. | Passed: "Per National Safe Transit Ass. vibration and drop tests" |
| Accelerated Aging | "Two year shelf life" | Implied Passed: The statement "Two year shelf life" suggests the device meets this, likely through accelerated aging correlation. |
| Functional Characteristics | Non-differentiable from predicate device | Achieved: "All functional characteristics of the Chase Left Vent Safety Valve are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition." |
| Materials | Identical to predicate device | Achieved: "All materials are identical to the predicate device." |
| Sterilization | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10-6 | Achieved: "Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10-6" |
Study Details and Other Information
Given the nature of this 510(k) submission and the simplicity of the device (a mechanical safety valve), many of the detailed study parameters you've requested (like sample sizes for test sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable or not provided in this document. This is common for devices demonstrating substantial equivalence through bench testing and material comparisons.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a "test set" in the context of clinical or diagnostic studies. For the functional tests (leak, package integrity, shipping), a sufficient number of units would have been tested to demonstrate compliance, but specific numbers are not provided. The data provenance is likely internal testing by the manufacturer (CHASE MEDICAL INC., Richardson, TX). The tests are prospective in nature, as they involve testing the manufactured device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a mechanical valve, not a diagnostic algorithm. "Ground truth" in this context refers to the physical properties and functional performance of the device, established through engineering testing and validated methods rather than expert interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human interpretation or adjudication in the sense of comparing readings is involved. The tests (leak, burst, vibration) yield objective pass/fail results based on predefined engineering specifications.
- 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 is a mechanical device, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
- 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 and validated test methods. For example, "no leaks at 10 psi" is a physical specification, not an expert opinion or clinical outcome. The equivalence to the predicate device, K820297, also serves as a "ground truth" benchmark for its overall safety and effectiveness profile.
- The sample size for the training set
- Not Applicable. There is no "training set" as this is not an algorithm using machine learning.
- How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm.
In summary: The provided document is a 510(k) summary for a relatively simple mechanical medical device. The "acceptance criteria" and "study" refer to engineering-based functional integrity and performance tests, along with a strong reliance on demonstrating substantial equivalence to a previously cleared predicate device. It does not involve complex clinical trials, expert interpretation studies, or AI-driven performance evaluations.
§ 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).