(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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
Seiratherm GmbH Mike Johnson, M.D. Philosopher's River LLC PO Box 106 Willow Creek, MT 59760
Re: K152946
Trade/Device Name: tempedy 5000 system Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX, LGZ Dated: August 5, 2016 Received: August 16, 2016
Dear Dr. Mike Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Seiratherm GmbH tempedy 5000
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 06-30-2016 [21 CFR 807.92(a)(1)].
Applicant Name and Address [21 CFR 807.92(a)(1)] A.
Seiratherm GmbH
Beethoven Street. 10
91074 Herzogenaurach
Bavaria
Tel: +49 89 80 91 31 420
Fax: +49 89 80 91 31 421
B. Contact Information
Philosopher's River llc
P O Box 106
Willow Creek, MT 59760
Tel: 406-209-3039
Fax: 406 2093039
Contact person: Mike Johnson M.D.
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C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: tempedy 5000 system Device Common Name: Thermal regulating system Classification Name: System, Hypothermia, Intravenous, Cooling 21 CFR 870.5900 Product Code: NCX Device Classification: Class II
D. Predicate Devices [21 CFR 807.92(a)(3)]
The tempedy system uses similar technology and physical output characteristics as the following predicate devices:
- K080899 Artic Blast Intravenous Fluid Chiller (similar infusion of cold iv ● fluid to cool patient) from Medivance Inc. NCX Thermal regulating system
- K082217 Ranger Rapid Flow Blood/Fluid Warning System (similar infusion ● of warm iv fluid to warm the patient) from Arizant Healthcare Inc. LGZ Unclassified
- K080908 RapidBlue System (similar patient temperature control of cooling ● or warming of the patient) from INNERCOOL Therapies Inc. NCX Thermal regulating system
E. Device Description [21 CFR 807.92(a)(4)]
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
The tempedy allows the operator to control temperature (4° to 42°) and flow rate of a crystalloid iv solution. This function has as its predicate, the Medivance Inc. Artic Blast Fluid Chiller. A salient difference is that the tempedy allows precise control of the flow rate and the predicate relies on gravity.
- It is an intravenous fluid cooling system
-
- It is an intravenous fluid warming system
The tempedy when it warms the crystalloid iv solution, functions similarly to its predicate, the Arizant Healthcare Inc. Ranger Rapid Flow System. However, the tempedy precisely controls flow whereas the predicate uses pressure of 300 mmHg to cause flow without monitoring flow rate.
- It is an intravenous fluid warming system
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-
- It is a thermal regulating system with feedback of patient's temperature
The tempedy may be used in conjunction with a patient temperature sensor. The flow rate for a preset temperature of iv fluid may be feedback controlled toward a target temperature setpoint. When used in this temperature feedback mode, the tempedy is similar to a third predicate, the INNERCOOL Therapies, Inc. RapidBlue System. A difference is that the RapidBlue System uses a closed loop circulation and heat exchanger to cool/warm the patient. Because of this catheter, the RapidBlue must have a central line access. The tempedy may be used with a peripheral or central catheter access. Both systems use a YSI 400 compatible temperature probe.
- 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.
F. Principle of Operation: The tempedy System has two insulated compartments ("thermal chambers") for storing iv crystalloid solutions at operator specified temperature. The 1 liter iv bags hand on a rack in each compartment. Each compartment has a Peltier device and a fan, which act as a heat pump to the ambient environment. This allows the usre to specify the temperature of each of the compartments individually. One compartment is designated "Cool" and other "Warm" by the operator. By independently controlling the flow rate of iv solution from each compartment and mixing the tow flows, a specified output temperature is obtained. This output temperature may be changed rapidly by changing the relative flow rates if the desired temperature is between the selected "Warm" and "Cool" compartments.
G. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]
The predicate devices used to argue substantial equivalence are the K080899 Medivance, Inc. Arctic Blast Intravenous Fluid Chiller, K082217 Arizant Healthcare Inc. Ranger Rapid Flow blood/fluid warming system, and INNERCOOL therapies Inc. RapidBlue System. Below is a comparison table.
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| Characteristic | Seiratherm GmbHtempedy | Medivance,Inc. ArcticBlastIntravenousFluid Chiller | ArizantHealthcare Inc.Ranger RapidFlowblood/fluidwarmingsystem.Now owned by3M. | INNERCOOL therapiesInc. RapidBlue System |
|---|---|---|---|---|
| Applicable510(k)s | NA | K080899 | K082217 | K080908K033623 |
| Common/Usual NameClassification Name | Thermal RegulatingSystemBlood/FluidWarmerSystem,hypothermia,intravenous cooling | ThermalregulatingsystemSystem,hypothermia,intravenouscooling | Blood/FluidWarmer withPressure Infusor | Thermal regulating systemSystem, hypothermia,intravenous cooling |
| Panel | General and PlasticSurgery | General andPlastic Surgery | General Hospital | General and Plastic Surgery |
| ProductCodeRegulationNumber | NCX / LGZ21 CFR 870.5900 /Unclassified | NCX21 CFR870.5900 | LGZUnclassified | NCX / LGZ21 CFR 870.5900 |
| Indicationsfor UseStatement | The SeirathermGmbH tempedy isintended to delivercooled sterilesolutions andwarmed sterilesolutions to adultpatients. | The Artic BlastIntravenousFluid Chiller isintended to coolsterile solutionsduringintravenousadministrationwhere clinicallyindicated forreduction ofpatienttemperature. | The Ranger RapidFlow Blood/FluidWarming Systemis intended todeliver warmblood, bloodproducts, andliquids to adult andpediatric patients. | The RapidBlue System is athermal regulating systemintended to induce, maintain,and reverse mildhypothermia in neurosurgicalpatients in surgery and inrecovery/intensive care, toachieve and/or maintainnormothermia in cardiacsurgery patients in surgeryand in recovery/intensivecare, and for the use in feverreduction, as an adjunct toother antipyretic therapy, inpatients with cerebralinfarction and intracerebralhemorrhage who requiredaccess to the central venouscirculation and who areintubated and sedated. |
| Classificatio | Class II | Class II | Class II | Class II |
| n | ||||
| InfusionPump | Flow rate control1-250 ml/min | Gravity infusion | Pressure of 300mmHgflow rates up to30,000 mL perhour | Flow rate control of closedloop system. |
| SafetyFeatures | Air bubbledetection, pressure& temperaturesensors | NA | Air bubbledetectionFluid leveldetection | Air trap, temperature sensors |
| CoolingMechanism | Two chamberheating and coolingchambers withcontrolled mixing | Heat exchangerassembly andadsorptioncooling module | NA | Refrigeration and hatingelements with heatexchanger. |
| HeatingMechanism | Two chamberheating and coolingchambers withcontrolled mixing | NA | Warming plates | Refrigeration and hatingelements with heatexchanger. |
| TemperatureRange | 4°C - 42°C | 4°C - 6°C | 42°C | 4°C - 42°C |
| Feedback ofPatientTemperature | Yes | No | No | Yes |
| PatientTemperatureSensor | Off the shelftemperature probessuch as YSI-400esophageal, bladderor rectal probes | NA | NA | Off the shelf temperatureprobes such as YSI-400esophageal probes or probeintegrated into the centralvenous catheter. |
| OperatorControls andDisplays | Graphical UserInterface(TouchscreenMonitor) | NA | Display oftemperature andwarming unitstatus. | Graphical User Interface(Touchscreen Monitor) |
| Alarms | Audible and visualalarms. | None | Audible and visualunder and overtemperature.Alarms activate at25°C, 45.5°C, and46°C | Audible and visual alarms. |
| Closed-LoopCirculationvs. Infusion | Infusion | Infusion | Infusion | Closed-loop fluid circulationwith heat exchange at distalend of endovascular catheter. |
| InfusionFluid | Crystalloid Fluids | CrystalloidFluids | Crystalloid orBlood ProductsFluids | No infusion |
| FluidContactingPathway | Disposable steriletubing set | Disposablesterile tubing set | Disposable steriletubing set | Disposable sterile tubing set |
| SterilizationMethod | 100% EO | 100% EO | 100% EO,reference IsomedixSoft Cycle | 100% EO |
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| DisposablePackaging | Box and pouch.Packaging validated. | Box and pouch. | Box and pouch.Made ofpolyethylene andtyvek header.Packagingvalidated | Box and pouch. |
|---|---|---|---|---|
| EquivalencedeterminedbyPerformance/ ClinicalTrial | Performance | Performance | Performance | Performance |
H. Indications for Use [21 CFR 807.92(a)(5)]
The Seiratherm tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients.
I. Nonclinical Tests [21 CFR 807.92(b)(1)]
| Test | Test Method | Results | |
|---|---|---|---|
| Summary | |||
| Infusion Essential Function and SafetyTestingThird Party Testing to EN 60601-2-24:2012-10 | Safety and infusionaccuracy testsperformed by ThirdParty. Subsets of thistesting is described | Pass on all clauses. | |
| Spillage testing | below. AcceptanceCriterion = "a.c."Test per IEC 60529. | Pass | |
| IEC 60529 - IPX2Clause 201.11.6.3 and 5 | IPX2 | ||
| Unintended bolus testingClause 201.12.4.4.104 | For Min/max occlusionpressure, time toocclusion alarm (a.c. <2.5 s), measurement ofsurplus bolus (a.c.<5ms) | Time to occlusion alarm <2.5s. No measureableunintended bolus. Pass. | |
| Reverse delivery testingClause 201.12.4.4.105 | Visual inspection | No instance of reverseflow. Pass. | |
| Fitting of tubing, alarmsClause 201.15.101 and 102 | Alarm at incorrectpositioning of tubing,bubble detection,traction to patient. (a.c.100% function) | Pass | |
| Use errors / alarmsClause 201.15.103 | 2 actions requiredbefore flow after alarmor a start up | Pass | |
| Infusion Accuracy - Bolus AccuracyClause 201.12.1.106 | Minimum and maximal boluseswere delivered and measured byweight. | All boluses (n=25) weredelivered with acceptancecriterion of <6%. Pass | |
| Infusion Accuracy - Flow AccuracyClause 201.12.1.107 | Start Up Diagrams and TrumpetDiagramsFlow Pump 1Pump 23500400040004000 | All Flow Rates withinacceptance criterion of<6%. Pass |
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| 7500 | 7500 ml/h | ||
|---|---|---|---|
| Temperature Sensing AccuracyDIN EN ISO 80601-2-56 | TemperatureManagement Mode | Tprobe=Tdisplay=Tservice connection (+/- 0.2°C).Pass | |
| 038_20160725_performance cooling | Cooling infusion inTemperatureManagement Mode | Appropriateresponses tocooling. | |
| 039_20160727_performance warming | Warming infusion inTemperatureManagement Mode | Appropriateresponses towarming |
Performance tests: The EN 60601-2-24 guided bench testing of the tempedy. The ISO 80601-2-56 guided testing of the GE Healthcare, K051873, M1024231 GP Temperature Probe, Adult YSI 400 compatible temperature sensor.
Safety tests: The tempedy was tested to the 60601-1 and 60601-1-2 consensus standards. Third party testing reports were submitted.
| Test | Results | Conclusions |
|---|---|---|
| iso 10993-1 Biologicalevaluation of medicaldevices – Part 1:Evaluation and testing | ||
| Hemocompatibilityiso 10993-4 Hemolysis | Test material does notrelease substances inhemolytic conentrationsduring 24 h contact of 4.5cm2 surface area to 1 mlof physiological fluid. | Tubing set does not causehemolysis. |
| Cytotoxicity, L929-Proliferationiso 10993-5, -12 | Test material does notrelease substances incytotoxic concentrationsduring 24 h contact of 4.5cm2 surface area to 1 mlphysiological fluid. | Tubing set is not cytotoxic. |
| Chemical analysis,characterization of organicleachables / extractablesiso 10993-12, -18 | Extraction tests on thetest materials wereperformed with organicand aqueous solutions at37°C. | The extractable substances are notreleased in toxicologically relevantconcentrations during clinicalapplication. |
Biocompatibility tests (Tubing Set T0): See table below:
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J. Conclusion [21 CFR 807.92(b)(3)]
The Seiratherm GmbH tempedy 5000 was found to be substantially equivalent to the predicate devices, in terms of technology, function and intended use. The indications for use are similar to the previously cleared devices INNERCOOL Therapies Inc. RapidBlue System (K080908), Arizant Healthcare Inc. Ranger Rapid Flow (K082217), and Medivance, Inc. Arctic Blast (K080899). We believe that there are no new questions of safety or efficacy raised by the introduction of the tempedy 5000 System.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).