(259 days)
The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.
The Pintler Patient Warming System a thermal regulating operating room pad, and a power control unit mounted to a standard IV pole. The operating room pad utilizes a low voltage resistant heating element , DC power and warms patients with conductive warming technology.
This document focuses on the Pintler Patient Warming System, a thermal regulating operating room pad. The provided text is a 510(k) summary, which describes the device and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided in the input, specifically focusing on what is stated and what is not explicitly stated as per your request:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., target temperature range, heating rates, safety thresholds with specific values). Instead, it makes a general statement about meeting performance/effectiveness/safety parameters.
| Acceptance Criteria (Explicitly stated) | Reported Device Performance (Explicitly stated) | Notes |
|---|---|---|
| Safety parameters met | Testing conducted, demonstrated the device met the performance/effectiveness/safety parameters. | The document states "Bench testing for safety of the Pintler Patient Warming System has been completed. Testing was conducted, demonstrated the device met the performance/effectiveness/safety parameters." This is a high-level statement without specific measurable criteria or detailed performance results. |
| Effectiveness parameters met | Testing conducted, demonstrated the device met the performance/effectiveness/safety parameters. | Similar to safety, a general claim without specific metrics. The "Indication for use" defines the intended function: "aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients." The study implies it achieved this, but no numerical data is given. |
| EN60601-1-2 Compliance | Both devices are required to be compliant to EN60601-1-2. (Implied compliance for the Pintler Device) | The document states that both devices (Pintler and predicate) are required to be compliant with EN60601-1-2. While it doesn't explicitly say "Pintler is compliant," completion of "bench testing for safety" for a medical device strongly implies compliance with relevant standards like EN60601-1-2 for safety. |
| Substantial Equivalence | Found to be substantially equivalent to the predicated device. | The primary conclusion of the 510(k) process is substantial equivalence. The document states: "Testing and comparison of the Pintler Patient Warming System found the product to be substantially equivalent to the predicated device and there are no new safety or effectiveness issues introduced." |
2. Sample Size for Test Set and Data Provenance
The document explicitly states "Bench testing for safety of the Pintler Patient Warming System has been completed."
- Sample Size: Not specified.
- Data Provenance: Not specified. This "bench testing" would typically involve testing the device in a laboratory setting, not on human subjects.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. As this is bench testing of a physical medical device (patient warmer) and not for an AI/imaging device requiring expert interpretation of data like images, there's no mention of experts establishing ground truth in the way it would be for a diagnostic AI.
4. Adjudication Method for Test Set
- Not Applicable. Since no experts are involved in establishing ground truth for the type of bench testing described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned as this device is a patient warmer, not an AI/imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This question is also typically relevant for AI/software devices. The Pintler Patient Warming System is a physical device, and its performance would be assessed directly, not as a standalone algorithm.
7. Type of Ground Truth Used
- Engineering/Performance Standards & Benchmarks: The ground truth for this device's performance would be established by objective measurements against engineering specifications, safety standards (like EN60601-1-2), and comparison to the predicate device's known performance characteristics. The document implies that the "performance/effectiveness/safety parameters" served as the basis for evaluation.
8. Sample Size for the Training Set
- Not Applicable. The concept of a "training set" is relevant for AI or machine learning models. This is a physical, electrically powered medical device for patient warming, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
In summary, the provided text details a 510(k) submission for a patient warming system. The "study" mentioned is "bench testing," which confirmed the device met general safety, effectiveness, and performance parameters, leading to its determination as substantially equivalent to a predicate device. The detailed statistical and expert-driven information requested for AI/diagnostic devices is not relevant or present in this context.
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K113705
AUG 3 1 2012
Section III
Premarket Notification (510 (k)) Summary (Per·21 CFR 807.92)
Date:
March 14, 2012
Submitted by:
Pintler Medical 3220 South Hanford Street Seattle, WA. 98144 (206 660 9020)
Contact Person:
Maribeth Macintyre-Ellis President Phone: 206 660 9020 maribeth@Pintlermedical.com
Device Name
| Trade Name: | |
|---|---|
| Common Name: | |
| Classification Name: | |
| Product Code & Reg. No. |
Pintler Patient Warmer System Thermal Maintenance System Thermal Regulating System DWJ, 21 CFR870.5900
Substantially Equivalent: The Pintler Patient Warming System is substantially equivalent to the following devices:
PRN ThermalCare 3000 Control Unit and Power Also known as PerfecTemp K062794
Description of the Device: The Pintler Patient Warming System a thermal regulating operating room pad, and a power control unit mounted to a standard IV pole. The operating room pad utilizes a low voltage resistant heating element , DC power and warms patients with conductive warming technology.
Indication for use: The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.
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Place the unit OFF in all procedures where hypothermic treatment or Contraindications: administration is prescribed or facility procedure. Patient care procedures prescribing hypothermic treatment can or may exhibit an adverse event, i. e. skin damage, skin tissue burns or other types of skin tissue damage from heat.
Patient Population: Pediatric (5 kilo) and Adult (capability of the table to bear weight)
Environment of Use: Hospitals, surgery center and/or other sites designated for surgical · procedures
Comparison of Predicated Devices:
The differences between the Pintler Patient Warmer and the predicated device is minimal. Both devices are conductive warmers. Both devices use a resistant warming technology. Both devices require a IV mounted or separate power input. Both devices use a microprocessor for operational functionality and safety. Both devices are required to be compliant to EN60601-1-2.
Testing Safety and Effectiveness: Bench testing for safety of the Pintler Patient Warming System has been completed. Testing was conducted, demonstrated the device met the performance/effectiveness/safety parameters.
Conclusion: Testing and comparison of the Pintler Patient Warming System found the product to be substantially equivalent to the predicated device and there are no new safety or effectiveness issues introduced.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 3 1 2012
Pintler Medical c/o Ms. Paula Wilkerson Senior Staff Engineer, Senior Reviewer Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087
K113705 Re:
Pintler Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: August 22, 2012 Received: August 23, 2012
Dear Ms. Wilkerson:
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. 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
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Page 2 - Ms. Paula Wilkerson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
M. A. Alleman
Co 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
K 113705 510 (k) Number
Device Name: Pintler Patient Warming System
Patient Population: Pediatric to Adult
Environment of use: Hospitals, Surgery Centers, and other surgical sites
Indication of Use: The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.
Prescription Use X Part 21 CFR 801 Subpart D and /or Over the counter use 21CFR 801 Subpart C
(PLEASE SO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)
C.Y. Killian
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
儿115705 510(k) Number_
6
§ 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).