(222 days)
The Temperature Probe is indicated for use during open-heart surgery to monitor myocardial temperature.
The Chase Temperature Probe consist of a 15mm stainless steel needle connected to 8 ft. of cable with a dual prong plug.
The Chase Temperature Probe consist of a 15mm, .032 O.D. stainless steel needle. The needle is attached to a cable support and eight feet of insulated twin lead cable. The rable ends in a dual prong connector plug.
The device is the Chase Temperature Probe, indicated for use during open-heart surgery to monitor myocardial temperature.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics | Non-differentiable compared to the predicate device (Webster Labs Temperature Probe, K813271) due to similar fit, form, and function. |
| Material Composition | Identical to the predicate device. |
| Sterilization | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶. |
| Package Integrity | Tyvek/Polymylar passed burst test per ASTM F 1 40-88. |
| Shipping & Distribution Testing | Passed National Safe Transit Ass. vibration and drop tests. |
| Accelerated Aging | Two-year shelf life established. |
Study Details
The provided document describes the substantial equivalence of the Chase Temperature Probe to a predicate device, rather than a standalone clinical study with specific performance metrics against defined acceptance criteria in the traditional sense. The "study" here is a comparative one against a predicate device.
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Sample size used for the test set and the data provenance: Not applicable. The "testing" primarily involved comparing functional characteristics, materials, and performing engineering tests (sterilization, package integrity, shipping, aging) on the device itself. No patient data or test set in the context of clinical performance data is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in a clinical sense with expert consensus is not described for this type of device and submission.
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Adjudication method for the test set: Not applicable.
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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 temperature probe, not an AI-powered diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical instrument, not an algorithm.
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The type of ground truth used: For functional characteristics, the "ground truth" was established by comparison to the predicate device's fit, form, and function. For sterilization, packaging, shipping, and aging, the ground truth was based on adherence to established standards and validation methods (e.g., SAL 10⁻⁶, ASTM F 1 40-88).
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The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.