(161 days)
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air-heated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.
Here's a breakdown of the requested information based on the provided 510(k) summary for the WarmAir® Model 135 Hyperthermia System:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list specific numerical acceptance criteria (e.g., a target temperature range with a tolerance) and corresponding reported performance metrics in a clear, quantitative table for objective performance. Instead, it describes various bench tests performed to validate the design against "company's specified design requirements" and to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance (as described) |
|---|---|
| Temperature Performance Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." The primary and secondary safety shutdown set points have changed from the prior model. |
| System Safety Limit Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." The new Model 135 uses a thermistor for primary temperature safety and a snap disc thermostat for secondary temperature safety. |
| Transportation Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." |
| Blanket Structural Integrity Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." |
| Safety Standards Adherence | Meets applicable requirements of IEC 60601-1 and IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes bench tests and adherence to standards, not a clinical study on patient data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as they relate to patient data or imagery are not applicable here. The testing was conducted on the device itself, likely in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was bench testing of a hardware device. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on medical images) does not apply.
4. Adjudication Method for the Test Set
Not applicable. This was bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a hardware device for temperature management, not an AI or diagnostic software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware device.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests would have been the engineering specifications and performance requirements defined by Cincinnati Sub-Zero, Inc. These are physical and measurable properties, not medical ground truth like pathology or expert consensus. For example, for "Temperature Performance Testing," the ground truth would be the expected temperature output and stability under various conditions, measured by calibrated instruments. For "System Safety Limit Testing," the ground truth would be the defined trip points for the safety mechanisms.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is a hardware device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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510(k) Summary
OCT 1 9 2010
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- COMPANY INFORMATION
Cincinnati Sub-Zero, Inc. 12011 Mosteller Road Cincinnati, Ohio 45241-1528 Telephone: (513) 772-8810 FAX: (513) 772-9119
- COMPANY INFORMATION
2. CONTACT INFORMATION
Steven J. Berke President and CEO Telephone: (513) 772-8810 ext 3212 FAX: (513) 772-9119 Email: sjberke@cszinc.com
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- DATE PREPARED: April 22, 2010
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- DEVICE TRADE NAME: WarmAir® Model 135 Hyperthermia System including blankets
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- COMMON NAME: Temperature management system
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- CLASSIFICATION NAME: System, Thermal Regulating
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- CLASSIFICATION REGULATION: 21 CFR 870.5900
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- CLASSIFICATION PRODUCT CODE: DWJ
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- PANEL: Cardiovascular
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- DEVICE CLASSIFICATION: Class II
11. IDENTIFICATION OF PREDICATES:
- a. K942599 and K942790 Cincinnati Sub-Zero WarmAir Hyperthermia system Model 133 and blankets
- b. K011907 SIMS Level 1 Snuggle Warm 4000/Equator 5000 Convective Warming System and blanket (now sold by Smiths Medical ASD)
- c. K040632 Smiths Medical ASD Sterile Cardiac Blanket component of Snuggle Warm 4000 Convective Warming System
- d. K960167 Bair Hugger Model 505 Total Temperature Management System
Response Page: J2-1
11
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DEVICE DESCRIPTION
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.
.
The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), recovery room, medical and surgical floors, emergency department, or any other department or hospital facility requiring patient temperature management.
DESCRIPTION OF THE DEVICE CHANGES
The predicate WarmAir System, Model 133 used a thermistor for the primary temperature safety and a bulb capillary type or thermostat for the secondary temperature safety. The new Model 135 uses a thermistor for the primary temperature safety and a snap disc thermostat for the secondary temperature safety. The specifications for the primary and secondary safety shut-down set points have changed from the prior model.
INTENDED USE
The WarmAir 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric, or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
BENCH TESTS PERFORMED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Bench testing was performed in order to validate the design according to the company's specified design requirements, and to demonstrate the new systems are substantially equivalent to the predicate devices.
The following bench tests were performed:
- Temperature Performance Testing .
- System Safety Limit Testing .
- Transportation Testing .
- Blanket Structural Integrity Testing .
In addition, the new systems meet the applicable requirements of the following standards:
- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
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- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements . for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
All necessary testing has been performed for the WarmAir 135 Hyperthermia system to assure substantial equivalence to the predicate devices.
SUBSTANTIAL EQUIVALENCE
The modified devices have the same intended use as the predicates and similar technological characteristics that do not raise new types of questions of safety and effectiveness and are therefore substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cincinnati Sub-Zero c/o Mr. Steven J. Berke President and CEO 12011 Mosteller Road Cincinnati, OH 45241-1528
OCT 1 9 2010
Re: K101148
WarmAir 135 Hyperthermia System and Blankets Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: September 28, 2010 Received: September 30, 2010
Dear Mr. Berke:
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. Iisting 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.
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Page 2 - Mr. Steven J. Berke
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
B. Zaleski, MD
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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Indications for Use
QCT 1 9 2010
510(k) Number (if known): 110 1148
Device Name: Warm Air® Model 135 and Blankets
Indications for Use:
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air-heated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K101148 |
Submission Page: 14
§ 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).