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510(k) Data Aggregation
(345 days)
The Seiratherm GmbH tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients.
The Seiratherm tempedy System is an adjunct to normalizing the body temperature of adults. It is intended to be used in situations when the patient is hypothermic and requires warming or when the patient is hyperthermic and requires cooling.
- It is an intravenous fluid cooling system
- It is an intravenous fluid warming system
- It is a thermal regulating system with feedback of patient's temperature
The tempedy System does not deliver drugs. It is not a drug infusion device.
The tempedy System does not deliver colloids (blood products, plasma, lipids, etc.) It is only for delivery of crystalloids (normal saline, Ringers, etc.).
The tempedy System includes the following accessories: Power cord, Tubg Set, and Temperature Probe. A list of accessories is on Page 50 of the Instructions for Use Manual.
Patient contacting parts: The sterile "Tubing Set T0" is a patient contacting part of the system. The Tubing Set TO is a single use part in the tempedy System.
The GE Healthcare, K051873, M1024231 GP Temperature Probe, Adult YS1 400 compatible temperature probe is also a patient contacting part of the system. It is a manufacturer sterilized, single use part.
This document outlines the acceptance criteria and study proving the Seiratherm GmbH tempedy 5000 system meets these criteria.
The Seiratherm GmbH tempedy 5000 is a thermal regulating system intended to deliver cooled or warmed sterile intravenous solutions to alter the body temperature of adult patients. It was found substantially equivalent to predicate devices in terms of technology, function, and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion (a.c.) | Reported Device Performance |
|---|---|---|
| Spillage testing (IEC 60529 - IPX2 Clause 201.11.6.3 and 5) | IPX2 compliant | Pass |
| Unintended bolus testing (Clause 201.12.4.4.104) | Time to occlusion alarm < 2.5 s; measurement of surplus bolus < 5 ml | Time to occlusion alarm < 2.5s; No measurable unintended bolus. Pass. |
| Reverse delivery testing (Clause 201.12.4.4.105) | No instance of reverse flow | No instance of reverse flow. Pass. |
| Fitting of tubing, alarms (Clause 201.15.101 and 102) | 100% function for alarm at incorrect positioning of tubing, bubble detection, traction to patient | Pass |
| Use errors / alarms (Clause 201.15.103) | 2 actions required before flow after alarm or a start up | Pass |
| Infusion Accuracy - Bolus Accuracy (Clause 201.12.1.106) | < 6% deviation for delivered boluses | All boluses (n=25) were delivered with acceptance criterion of <6%. Pass |
| Infusion Accuracy - Flow Accuracy (Clause 201.12.1.107) | < 6% deviation for all flow rates | All Flow Rates within acceptance criterion of <6%. Pass |
| Temperature Sensing Accuracy (DIN EN ISO 80601-2-56) | Tprobe = Tdisplay = Tservice connection (+/- 0.2°C) | Pass |
| Performance Cooling (038_20160725_performance cooling) | Appropriate responses to cooling when in Temperature Management Mode | Appropriate responses to cooling. |
| Performance Warming (039_20160727_performance warming) | Appropriate responses to warming when in Temperature Management Mode | Appropriate responses to warming. |
| Hemocompatibility (ISO 10993-4 Hemolysis) | Test material does not release substances in hemolytic concentrations during 24h contact of 4.5 cm2 surface area to 1ml of physiological fluid | Tubing set does not cause hemolysis. |
| Cytotoxicity, L929-Proliferation (ISO 10993-5, -12) | Test material does not release substances in cytotoxic concentrations during 24h contact of 4.5 cm2 surface area to 1ml physiological fluid | Tubing set is not cytotoxic. |
| Chemical analysis, characterization of organic leachables / extractables (ISO 10993-12, -18) | Extractable substances are not released in toxicologically relevant concentrations during clinical application | The extractable substances are not released in toxicologically relevant concentrations during clinical application. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state a comprehensive sample size for the test set across all performance tests. Here are the details provided:
- Infusion Accuracy - Bolus Accuracy: n=25 boluses.
- Other tests: For most other tests, the sample size is not explicitly stated but implied to be sufficient for a "Pass" result according to the specific standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It mentions "Third Party Testing to EN 60601-2-24:2012-10" and adherence to ISO standards, suggesting testing was conducted in a controlled environment.
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 information is not provided in the document. The tests described are primarily bench performance and biocompatibility tests conducted according to defined engineering and medical device standards. There is no indication of expert assessment used to establish ground truth in the context of diagnostic interpretation or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests performed are objective performance and safety tests against predetermined technical standards, not subjective assessments requiring expert adjudication.
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. The "tempedy 5000 system" is a thermal regulating device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device for thermal regulation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the testing described is based on established engineering standards and regulatory requirements for medical devices (e.g., EN 60601-2-24, IEC 60529, ISO 80601-2-56, ISO 10993 series). The device's performance is measured against objective, quantifiable parameters defined by these standards.
8. The sample size for the training set
Not applicable. This device is not an AI/Machine Learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As this device is not an AI/Machine Learning algorithm, there is no training set or ground truth in that context.
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