(154 days)
The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Multifunction Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.
The Hot Dog Multifunction Controller consists of a temperature control unit that monitors and controls the temperature of patient warming blankets and mattresses.
The provided text describes a medical device, the "Hot Dog Multifunction Controller," and its premarket 510(k) summary for FDA clearance. However, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or the details of such a study as requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).
The non-clinical data section states:
"Bench testing was performed to demonstrate that the proposed controller is substantially equivalent to the predicate devices. Temperature characteristics and safety systems were compared and found to be comparable."
"The controller is designed to meet the following performance standards:
- IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance, edition: 2
- IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 2.1
- IEC 60601-1-4:2000, Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1."
The clinical data section simply states: "Not required."
Therefore, based solely on the provided text, I can only provide the following, which aligns with the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 (General Safety & Essential Performance) | Bench testing demonstrated substantial equivalence to predicate devices; temperature characteristics and safety systems were comparable. Designed to meet this standard. |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Designed to meet this standard. |
| IEC 60601-1-4 (Programmable Electrical Medical Systems) | Designed to meet this standard. |
| Substantial Equivalence to Predicate Devices (K052392, K092807) | Bench testing found the proposed controller to be substantially equivalent in technological characteristics, safety, and indications for use. |
| Temperature characteristics comparable to predicate devices | Bench testing showed comparable temperature characteristics. |
| Safety systems comparable to predicate devices | Bench testing showed comparable safety systems. |
2. Sample size used for the test set and the data provenance:
Not explicitly stated in the provided text. The document only mentions "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical or expert-reviewed ground truth study is described. The performance assessment relied on technical bench testing against predicate devices and adherence to international standards.
4. Adjudication method for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The document states "Clinical Data: Not required," indicating that studies involving human readers or clinical outcomes were not part of this 510(k) submission for the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a "Multifunction Controller" for a "Thermal Regulating System," not an algorithm in the typical sense of AI/image analysis. Its performance was assessed via "bench testing" focusing on its technical functions (temperature control, safety systems) against established standards and predicate devices.
7. The type of ground truth used:
For the technical performance, the "ground truth" was established by adherence to international performance standards (IEC 60601-1 series) and comparison to the characteristics of legally marketed predicate devices.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Section 5 Premarket 510k Summary
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| SubmitterInformation: | Augustine Biomedical & Design, LLC6581 City West ParkwayEden Prairie, MN 55344952.465.3500. |
|---|---|
| Contact: | James D. Ecklein, Director RA/QAJUN - 3 2010 |
| DatePrepared: | November 20, 2009 |
| Trade Name | Hot Dog Multifunction ControllerModel Number: WC52 |
| Product Code | DWJ (21 CFR Part 870.5900) |
| CommonName | Thermal Regulating System |
| PredicateDevice | Hot Dog Patient Warming System K052392Hot Dog Patient Warming Mattress System K092807 |
| DeviceDescription | The Hot Dog Multifunction Controller consists of a temperature controlunit that monitors and controls the temperature of patient warmingblankets and mattresses. |
| Intended Use | The Hot Dog Patient Warming System is intended to prevent or treathypothermia and to provide warmth to patients. The Hot Dog PatientWarming System should be used in circumstances in which patients maynot maintain a state of normothermia.The System is intended primarily for use in hospitals and surgical centersincluding without limitation operating, recovery and emergency rooms andon medical/surgical floors. |
| TechnologicalCharacteristics | A comparison between the new and predicate devices shows that thetechnological characteristics and indications for use are equivalent. Theproducts have similar designs, materials, components and dimensions. |
| Non ClinicalData | Bench testing was performed to demonstrate that the proposed controller issubstantially equivalent to the predicate devices. Temperaturecharacteristics and safety systems were compared and found to becomparable. |
| The controller is designed to meet the following performance standards: | |
| IEC 60601-1 Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And Essential Performance, edition: 2IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral standard: ElectromagneticCompatibility - Requirements and Tests, edition: 2.1IEC 60601-1-4:2000, Medical electrical equipment - Part 1: Generalrequirements for safety - 4 - Collateral standard: Programmable electricalmedical systems, edition 1.1. | |
| Clinical Data | Not required |
| Conclusion | The Hot Dog Multifunction Controller was found to be equivalent to thepredicate device in technological characteristics, safety and indications foruse. |
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Section 5 Premarket 510k Summary
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مستعمار سرع
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Regulatory Technology Services LLC c/o Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313
JUN - 3 2010
Re: K094056
Augustine Biomedical + Design LLC Hotdog Multi-Functional Controller Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: II Product Code: DWJ Dated: May 17, 2010 Received: May 18, 2010
Dear Mr. Job:
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 Foord, Or ug, 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 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. Mark Job
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/CDRH/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,
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 4 Indications For Use Statement
Indications for Use
510(k) Number (if known): Unknown
Device Name: Hot Dog Multifunction Controller
Indications for Use:
The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Multifunction Controller should be used in circumstances in which patients may not maintain a state of normothermia.
The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division $1gn-Off) Division of Cardiovascular Devices 510(k) Number_K694056
11/09/09
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§ 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).