(345 days)
No
The summary describes a thermal regulating system with feedback of patient's temperature, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to alter the body temperature of adult patients by delivering cooled or warmed intravenous solutions, making it a therapeutic device.
No
This device is designed to alter a patient's body temperature by cooling or warming intravenous solutions. While it includes a temperature probe for feedback, its primary function is therapeutic (temperature regulation), not diagnostic (identifying a disease or condition). The temperature probe is used for monitoring to facilitate the therapeutic function, not for independent diagnostic assessment.
No
The device description explicitly states it is a "System" that includes accessories like a power cord, tubing set, and temperature probe, and mentions patient-contacting hardware parts. The performance studies also detail testing of hardware components like infusion accuracy and temperature sensing accuracy.
Based on the provided information, the Seiratherm GmbH tempedy 5000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients." This describes a therapeutic intervention directly applied to the patient's body, not a test performed on samples taken from the body.
- Device Description: The description focuses on the system's function in cooling or warming intravenous fluids and regulating patient temperature. It explicitly states it does not deliver drugs or colloids, and is only for crystalloids. This aligns with a fluid management and temperature regulation device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on the device's ability to accurately deliver fluids at specific temperatures and flow rates, as well as safety aspects related to infusion and electrical safety. These are typical performance metrics for a fluid management device, not an IVD.
- Predicate Devices: The predicate devices listed (Artic Blast Intravenous Fluid Chiller, Ranger Rapid Flow Blood/Fluid Warning System, RapidBlue System) are all devices used for warming or cooling fluids for patient administration, further supporting that this device falls into that category, not IVD.
In summary, the Seiratherm tempedy 5000 is a device used for managing patient body temperature through the administration of temperature-controlled intravenous fluids. This is a therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
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.
Product codes
NCX, LGZ
Device Description
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
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
- Infusion Essential Function and Safety Testing (Third Party Testing to EN 60601-2-24: 2012-10):
- Study Type: Safety and infusion accuracy tests performed by Third Party.
- Key Results: Pass on all clauses.
- Spillage testing (IEC 60529 - IPX2 Clause 201.11.6.3 and 5):
- Study Type: Test per IEC 60529.
- Key Results: Pass.
- Unintended bolus testing (Clause 201.12.4.4.104):
- Study Type: For Min/max occlusion pressure, time to occlusion alarm (acceptance criterion
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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.
4
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
5
-
- 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.
6
| Characteris
tic | Seiratherm GmbH
tempedy | Medivance,
Inc. Arctic
Blast
Intravenous
Fluid Chiller | Arizant
Healthcare Inc.
Ranger Rapid
Flow
blood/fluid
warming
system.
Now owned by
3M. | INNERCOOL therapies
Inc. RapidBlue System |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicable
510(k)s | NA | K080899 | K082217 | K080908
K033623 |
| Common/Us
ual Name
Classificatio
n Name | Thermal Regulating
System
Blood/Fluid
Warmer
System,
hypothermia,
intravenous cooling | Thermal
regulating
system
System,
hypothermia,
intravenous
cooling | Blood/Fluid
Warmer with
Pressure Infusor | Thermal regulating system
System, hypothermia,
intravenous cooling |
| Panel | General and Plastic
Surgery | General and
Plastic Surgery | General Hospital | General and Plastic Surgery |
| Product
Code
Regulation
Number | NCX / LGZ
21 CFR 870.5900 /
Unclassified | NCX
21 CFR
870.5900 | LGZ
Unclassified | NCX / LGZ
21 CFR 870.5900 |
| Indications
for Use
Statement | The Seiratherm
GmbH tempedy is
intended to deliver
cooled sterile
solutions and
warmed sterile
solutions to adult
patients. | The Artic Blast
Intravenous
Fluid Chiller is
intended to cool
sterile solutions
during
intravenous
administration
where clinically
indicated for
reduction of
patient
temperature. | The Ranger Rapid
Flow Blood/Fluid
Warming System
is intended to
deliver warm
blood, blood
products, and
liquids to adult and
pediatric patients. | The RapidBlue System is a
thermal regulating system
intended to induce, maintain,
and reverse mild
hypothermia in neurosurgical
patients in surgery and in
recovery/intensive care, to
achieve and/or maintain
normothermia in cardiac
surgery patients in surgery
and in recovery/intensive
care, and for the use in fever
reduction, as an adjunct to
other antipyretic therapy, in
patients with cerebral
infarction and intracerebral
hemorrhage who required
access to the central venous
circulation and who are
intubated and sedated. |
| Classificatio | Class II | Class II | Class II | Class II |
| n | | | | |
| Infusion
Pump | Flow rate control
1-250 ml/min | Gravity infusion | Pressure of 300
mmHg
flow rates up to
30,000 mL per
hour | Flow rate control of closed
loop system. |
| Safety
Features | Air bubble
detection, pressure
& temperature
sensors | NA | Air bubble
detection
Fluid level
detection | Air trap, temperature sensors |
| Cooling
Mechanism | Two chamber
heating and cooling
chambers with
controlled mixing | Heat exchanger
assembly and
adsorption
cooling module | NA | Refrigeration and hating
elements with heat
exchanger. |
| Heating
Mechanism | Two chamber
heating and cooling
chambers with
controlled mixing | NA | Warming plates | Refrigeration and hating
elements with heat
exchanger. |
| Temperature
Range | 4°C - 42°C | 4°C - 6°C | 42°C | 4°C - 42°C |
| Feedback of
Patient
Temperature | Yes | No | No | Yes |
| Patient
Temperature
Sensor | Off the shelf
temperature probes
such as YSI-400
esophageal, bladder
or rectal probes | NA | NA | Off the shelf temperature
probes such as YSI-400
esophageal probes or probe
integrated into the central
venous catheter. |
| Operator
Controls and
Displays | Graphical User
Interface
(Touchscreen
Monitor) | NA | Display of
temperature and
warming unit
status. | Graphical User Interface
(Touchscreen Monitor) |
| Alarms | Audible and visual
alarms. | None | Audible and visual
under and over
temperature.
Alarms activate at
25°C, 45.5°C, and
46°C | Audible and visual alarms. |
| Closed-Loop
Circulation
vs. Infusion | Infusion | Infusion | Infusion | Closed-loop fluid circulation
with heat exchange at distal
end of endovascular catheter. |
| Infusion
Fluid | Crystalloid Fluids | Crystalloid
Fluids | Crystalloid or
Blood Products
Fluids | No infusion |
| Fluid
Contacting
Pathway | Disposable sterile
tubing set | Disposable
sterile tubing set | Disposable sterile
tubing set | Disposable sterile tubing set |
| Sterilization
Method | 100% EO | 100% EO | 100% EO,
reference Isomedix
Soft Cycle | 100% EO |
7
8
| Disposable
Packaging | Box and pouch.
Packaging validated. | Box and pouch. | Box and pouch.
Made of
polyethylene and
tyvek header.
Packaging
validated | Box and pouch. |
|-----------------------------------------------------------------------|----------------------------------------|----------------|------------------------------------------------------------------------------------------|----------------|
| Equivalence
determined
by
Performance
/ Clinical
Trial | 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 Safety | |||
| Testing | |||
| Third Party Testing to EN 60601-2-24: | |||
| 2012-10 | Safety and infusion | ||
| accuracy tests | |||
| performed by Third | |||
| Party. Subsets of this | |||
| testing is described | Pass on all clauses. | ||
| Spillage testing | below. Acceptance | ||
| Criterion = "a.c." | |||
| Test per IEC 60529. | Pass | ||
| IEC 60529 - IPX2 | |||
| Clause 201.11.6.3 and 5 | IPX2 | ||
| Unintended bolus testing | |||
| Clause 201.12.4.4.104 | For Min/max occlusion | ||
| pressure, time to | |||
| occlusion alarm (a.c. |