(311 days)
The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.
The Tarry Medical Temperature Probes are intended to be used as replacement parts as various neonatal incubators including:
- Drager / Air Shields / Hill-Rom Isolette Incubators
- Drager / Air Shields / Hill-Rom Incubators
- GE / Ohmeda / Ohio IC and GC Care Plus
- GE / Ohmeda Panda Baby Warmers
- GE / Ohmeda Infant Warmer Systems
This 510(k) includes the following probes:
T-100 (skin temperature probe)
T-3000 (skin temperature probe)
T-20970 (skin temperature probe)
T-20980 (air temperature probe)
The temperature probes are for use with incubators and warmers in a hospital setting. The probes are reusable and reusable models. The probes were designed to meet OEM product specifications.
The temperature probes include thermistors and are used with disposable probe covers.
The provided text describes a 510(k) submission for Tarry Medical Temperature Probes. While it mentions performance data was collected, it does not provide specific acceptance criteria or detailed study results. The key information is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Subjected to biocompatibility, low level disinfection, accuracy, comparison, and electrical testing. No specific performance metrics or values are provided in the document. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be from testing conducted by Tarry Medical Products or a contracted entity for regulatory submission purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable as the device is a temperature probe, and ground truth for performance (e.g., accuracy) would typically be established against calibrated reference equipment, not expert consensus.
4. Adjudication Method for the Test Set:
- Not applicable for this type of device and testing.
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 is a medical device (temperature probe), not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a hardware device (temperature probe), not an algorithm. Performance testing would inherently be "standalone" in the sense that the device itself is being tested, though it is intended for use with human interaction in a clinical setting.
7. The Type of Ground Truth Used:
- For "accuracy, comparison, and electrical testing," the ground truth would likely be established using calibrated reference standards and laboratory equipment as per industry and regulatory guidelines for temperature measurement devices.
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of what is known from the document regarding performance:
- The Tarry Medical Temperature Probes underwent "biocompatibility, low level disinfection, accuracy, comparison, and electrical testing."
- The probes were "designed to meet OEM product specifications."
- The conclusion states that the devices are "as safe and effective as the predicate devices."
The document focuses on demonstrating substantial equivalence to predicate devices based on "material, technology, and performance" but does not elaborate on the specific performance metrics or the studies' results beyond general categories of testing.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).