(80 days)
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
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.
The provided document is a 510(k) premarket notification for the PRN ThermalCare Patient Warming System Model 3000. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a clinical trial for a diagnostic AI device would.
However, I can extract the information related to safety and effectiveness testing as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the "acceptance criteria" are implicitly defined by compliance with recognized safety standards and acceptable operational integrity, as demonstrated by internal testing. The device's "performance" is stated as meeting these parameters.
| Acceptance Criteria (Implicit from Compliance) | Reported Device Performance |
|---|---|
| UL 2601-1 Safety Standard Compliance | Met requirements |
| CSA C22.2 No. 60601-1 Safety Standard Compliance | Met requirements |
| IEC 60601-2-35 Safety Standard Compliance | Met requirements |
| Operational Integrity Parameters | Met performance parameters |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of an analytical study with a specific number of instances. The testing described is related to device safety and operational integrity/performance, not a comparative efficacy study with human or AI readers. Therefore, information on sample size and data provenance (country, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The concept of "ground truth" and "experts" to establish it is typically relevant for diagnostic or AI-driven devices where human assessment is the reference. For this patient warming system, which is a therapeutic device, these elements are not applicable. The "ground truth" for safety and performance is based on adherence to engineering and medical device standards.
4. Adjudication Method
Since there is no "test set" or diagnostic assessment involving human experts, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is designed for diagnostic tools, particularly those involving image interpretation by multiple human readers, often with or without AI assistance. This type of study is not applicable to a patient warming system.
6. Standalone Performance Study
The document mentions "operational integrity testing," which demonstrates the device's standalone performance in meeting specified parameters. However, it does not provide quantitative results or a detailed study design typically associated with standalone performance reports for AI algorithms. It states: "The operational integrity testing conducted, demonstrated the device met the performance/effectiveness parameters."
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established by compliance with recognized electrical and medical device safety standards (UL 2601-1, CSA C22.2 No. 60601-1, IEC 60601-2-35) and demonstrated operational integrity against pre-defined performance parameters through internal testing. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. Sample Size for the Training Set
The concept of a "training set" with a specific sample size is relevant for machine learning or AI models. This device is a hardware-based patient warming system, not an AI or software algorithm in the sense that would require a training set. Therefore, information on a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for the type of device described, how its "ground truth" was established is not applicable.
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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 ThermalMat & Controller 95&55 | The Bair Hugger®Model 750TemperatureManagement System | Kimberly-Clark PatientWarming SystemModel 100 Control unit andEnergy 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.
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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.
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| PRN ThermalCare3000 Patient WarmingSystem | KlimamedThermal Mat &Controller 95 &55 | The BairHugger® Model750TemperatureManagementSystem | Kimberly-ClarkPatient WarmingSystemModel 100 Controlunit and EnergyTransfer Pads | |
|---|---|---|---|---|
| 519(K) No. | KO 11859 | K001149 | K033021 | |
| Intended Use | Patient warming | Identical | Identical | Identical |
| Clinical areasfor Device Use | Hospital environment &Surgical Centers | Identical | Identical | Identical |
| PatientPopulation | Pediatric and adult | Identical | Identical | Identical |
| DevicePositioning | Control unit is placed onhard surface, shelf, ORpedestal, IV PolePad is in external contactwith the Patient | Identical | Identical | Identical |
| TechnologyUsed | Conductive HeatingCarbon Fiber Heating | Similar:Conductive HeatingCarbon Fiber | Different:ConvectiveHeatingForced air | Similar:Conductive Heatingwater |
| Overtemperaturedetection | 2 completelyindependent systems | Similar:Independentredundant safetysystem | Similar:Independentelectronic circuit.Thermal cutoffshuts heater off atpreset hi temp | Similar:Temperature probeconnected tocontrol module.Temp is controlledby altering temp ofcirculating water |
| StandardsMeet | UL 2601-1IEC 60601-2-35CSA 22.2 60601-1 | IEC 60601 &60602 | UL 2601 & EN60601 | IEC 601EN60601ISO 10993-1 |
| Alarms | Visual/Audible | identical | identical | identical |
| Controlcircuitry | Microprocessor-based | identical | identical | identical |
Section III Table 1: Comparison to Predicated Devices
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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.
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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
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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
§ 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).