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510(k) Data Aggregation
(105 days)
The pressure isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device may be used in procedures lasting up to 6 hours in duration.
The Terumo Pressure Isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device is geometrically similar to the IBC Isolator device, which is the predicate device for purposes of this application. Furthermore, the operating principles and product technology of the two devices are identical. The Terumo Pressure Isolator has a housing that is made of rigid polyvinylchloride and includes a flexible polyvinylchloride diaphragm inside the housing chamber.
This response is based on the provided text, which refers to a 510(k) submission for a medical device called the "Terumo Pressure Isolator." The document focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance in the same way a new, novel device might.
Here's an analysis based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format. Instead, it describes performance through comparative studies, aiming to show "functional equivalence" or "no difference" compared to the predicate device.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tubing Connection Strength | Functionally equivalent to the predicate device (IBC Isolator). | "No difference" in strength of connection between circuit tubing and the device, both with and without solvent bonding, compared to the predicate device. |
| Pressure Transduction Accuracy | Capable of accurately and consistently transferring circuit pressures to gauges, functionally equivalent to the predicate device. | Noted to be "functionally equivalent to the predicate device" in accurately and consistently transferring circuit pressures to gauges at a distal point in the pressure monitoring circuit. |
| Mechanical Integrity (Leak Test) | No evidence of breach under negative and positive pressures, equivalent to the predicate device. | "The Terumo device and the predicate device were found to be equivalent" in the leak test, where both negative and positive pressures were applied, and devices were examined for evidence of breach. |
| Sterility Assurance Level (SAL) | SAL of 10⁻⁴. | "Sterilization conditions for the Terumo Pressure Isolator are validated to provide a Sterility Assurance Level (SAL) of 10⁻⁴." |
| Ethylene Oxide Residues | Not to exceed stated or implied maximum residue limits. | "Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution." |
| Biocompatibility | Meet recommendations in FDA General Program Memorandum #G95-1 (ISO 10993). | Blood contacting materials were "found to be biocompatible" as recommended in FDA General Program Memorandum #G95-1 (ISO 10993 - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing; External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the tests (tubing connection, pressure transduction, mechanical integrity). It also does not specify the country of origin of the data or whether the studies were prospective or retrospective.
3. 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)
This section is not applicable to the type of device and testing described. The "ground truth" for this device's performance would be objective measurements from laboratory testing (e.g., pressure readings, force measurements, leak detection), not expert opinion or interpretation of data in the way radiologists or pathologists might establish ground truth for an imaging AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the type of testing performed. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert interpretation are resolved, which is not relevant for the objective physical performance tests described for the Terumo Pressure Isolator.
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
There was no MRMC comparative effectiveness study done, as this is neither an imaging device nor an AI device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the Terumo Pressure Isolator is a physical medical device, not an algorithm or AI. The testing described focuses on the physical performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests described (tubing strength, pressure transduction, mechanical integrity) would be objective, quantifiable measurements from the physical tests themselves. For example:
- Tubing connection strength: Force required to disconnect or break the connection.
- Pressure transduction: Output pressure readings vs. input pressure, indicating accuracy.
- Mechanical integrity: Observation of leaks (or lack thereof) under specified pressure conditions.
- Sterility: Laboratory testing results confirming SAL.
- Biocompatibility: Results from standardized biological tests.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a device of this type.
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