(80 days)
Not Found
No
The description focuses on basic thermal regulation and pressure reduction, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to aid in the maintenance of patient normal thermia and to prevent and treat hypothermia, which are therapeutic actions. It also aims to reduce pressure for patients, further contributing to a therapeutic function.
No.
The device is a patient warming system intended to maintain normal body temperature and aid in hypothermia prevention and pressure sore reduction. It does not provide information to diagnose a condition.
No
The device description explicitly states that the system includes a physical mattress with a heating element and a separate control unit, indicating it is a hardware-based device with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PRN ThermalCare patient warming system is a physical device that applies conductive heat to the patient's body externally to maintain their temperature. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for maintaining patient body temperature during the perioperative experience. This is a therapeutic/supportive function, not a diagnostic one.
The device falls under the category of medical devices used for patient care and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
By physicians in clinics and hospitals, the PRN ThermalCare Patient Warming System is intended to aid in maintaining the surgical patient's body temperature, before, during and after surgery. The heated pressure relieving surgical mattress is available in various lengths and is intended for use on operating tables, surgical and diagnostic surfaces in hospitals or surgical centers to prevent and treat hypothermia and to reduce the occurrence of pressure sores.
The PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 lbs./225k
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The PRN ThermalCare patient warming system, Model 3000 system includes a pressure reducing, thermal regulated mattress, which is placed beneath the patient, and a separate control unit. The mattress contains a carbon fiber heating element for which the control unit, when connected, supplies low voltage DC current, providing low level conductive heat (preset between 36°C and 40°C) to the patient.
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
Pediatric and Adult
Intended User / Care Setting
Physicians in clinics and hospitals, operating tables, surgical and diagnostic surfaces in hospitals or surgical centers.
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)
Testing of the safety of PRN ThermalCare Patient Warming System Model 3000 were reviewed and found in accordance with the requirements in UL 2601-1, CSA C22.2 No. 60601-1 and IEC 60601-2-35. The operational integrity testing conducted, demonstrated the device met the performance/effectiveness parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
7062794/
SECTION III
DEC - 7 2006
PREMARKET NOTIFICATION (510K) SUMMARY (Per 21 CFR 807.92)
Submitted by: American Healthcare Products, Inc. 3220 South Hanford Street Seattle, Wa. 98144 Phone: 800-833-1822 Fax: 206-721-8030
Contact Person: Kent D. Ellis Quality and Compliance Phone: 800-833-1822 Fax: 206-721-8030 mbmacellis@aol.com Date Prepared: January 2005
Device Name:
Trade Name:
Common Name: Classification Name: Product Code & Reg. No. PRN ThermalCare Patient Warming System: Model 3000 Hyperthermia System/Thermal Regulating System Thermal Regulating System DWJ, 21CFR 870.5900
Substantially Equivalent:
The PRN ThermalCare Patient Warming System Model 3000 is substantially equivalent to the following devices:
| Klimamed Thermal
Mat & Controller 95
&55 | The Bair Hugger®
Model 750
Temperature
Management System | Kimberly-Clark Patient
Warming System
Model 100 Control unit and
Energy Transfer Pads |
|------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| KO11859 | KO01149 | K033021 |
Description of the Device: The PRN ThermalCare patient warming system, Model 3000 system includes a pressure reducing, thermal regulated mattress, which is placed beneath the patient, and a separate control unit. The mattress contains a carbon fiber heating element for which the control unit, when connected, supplies low voltage DC current, providing low level conductive heat (preset between 36°C and 40°C) to the patient.
1
Section III: Premarket Summary- continued
Indication for Use: By physicians in clinics and hospitals, the PRN ThermalCare Patient Warming System is intended to aid in maintaining the surgical patient's body temperature, before, during and after surgery. The heated pressure relieving surgical mattress is available in various lengths and is intended for use on operating tables, surgical and diagnostic surfaces in hospitals or surgical centers to prevent and treat hypothermia and to reduce the occurrence of pressure sores.
Patient Population: Pediatric and Adult.
Environment of Use: Hospitals and surgical centers operating rooms
Contraindications: Do not use during surgical procedures that require patient hypothermia during operation. Consult with patient physician or anesthesiologist to determine if anti-hypothermia treatment is desired
Comparison to Predicated Devices: See attached comparison: Table 1 The differences between PRN ThermalCare 3000 and the predicated devices are minimal: These predicated devices are all cxternal, thermal regulating systems that consist of a device that is placed in contact with the patient and a microprocessor -based control unit that provides physician determined temperature control.
Testing Safety and Effectiveness: Testing of the safety of PRN ThermalCare Patient Warming System Model 3000 were reviewed and found in accordance with the requirements in UL 2601-1, CSA C22.2 No. 60601-1 and IEC 60601-2-35 . The operational integrity testing conducted, demonstrated the device met the performance/effectiveness parameters.
Conclusion: Based upon the testing and comparison we believe the PRN ThermalCare Model 3000 to be substantially equivalent to predicated devices and that there is no new safety or effectiveness issues.
2
| PRN ThermalCare
3000 Patient Warming
System | Klimamed
Thermal Mat &
Controller 95 &55 | The Bair
Hugger® Model
750
Temperature
Management
System | Kimberly-Clark
Patient Warming
System
Model 100 Control
unit and Energy
Transfer Pads | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 519(K) No. | | KO 11859 | K001149 | K033021 |
| Intended Use | Patient warming | Identical | Identical | Identical |
| Clinical areas
for Device Use | Hospital environment &
Surgical Centers | Identical | Identical | Identical |
| Patient
Population | Pediatric and adult | Identical | Identical | Identical |
| Device
Positioning | Control unit is placed on
hard surface, shelf, OR
pedestal, IV Pole
Pad is in external contact
with the Patient | Identical | Identical | Identical |
| Technology
Used | Conductive Heating
Carbon Fiber Heating | Similar:
Conductive Heating
Carbon Fiber | Different:
Convective
Heating
Forced air | Similar:
Conductive Heating
water |
| Over
temperature
detection | 2 completely
independent systems | Similar:
Independent
redundant safety
system | Similar:
Independent
electronic circuit.
Thermal cutoff
shuts heater off at
preset hi temp | Similar:
Temperature probe
connected to
control module.
Temp is controlled
by altering temp of
circulating water |
| Standards
Meet | UL 2601-1
IEC 60601-2-35
CSA 22.2 60601-1 | IEC 60601 &
60602 | UL 2601 & EN
60601 | IEC 601
EN60601
ISO 10993-1 |
| Alarms | Visual/Audible | identical | identical | identical |
| Control
circuitry | Microprocessor-based | identical | identical | identical |
Section III Table 1: Comparison to Predicated Devices
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
American Healthcare Products, Inc. c/o Mr. Kent D. Ellis Quality and Compliance 3220 South Hanford Street Seattle, WA 98144
DEC - 7 2006
Re: K062794
PRN ThermalCare Patient Warming System Model 3000 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: November 17, 2006 Received: November 20, 2006
Dear: Mr. Ellis:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. Kent D. Ellis
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION II
STATEMENT: INDICATION FOR USE
510 (k) Number K062794
Device Name: PRN ThermalCare Patient Warming System Model: PRN ThermalCare 3000
Indications for Use: The PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 1bs./225k
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use Over the Counter Use (Part 21 CFR 801 Subpart D) and/or (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K062794