(289 days)
The ChillBuster® Model 8001 Portable Electric Blanket System has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.
The ChillBuster® Model 8001 Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Battery, Cabling, AC Adapter, and Carrying Bag. The Blanket features a waterproof nylon outer layer, an inner layer of soft polar fleece, and a unique pattern of special thermal wire and a wire-adjacent thermistor. The Control Module contains an electronic circuit board, a User Interface Panel, Interconnect Wiring, and a Molded Chassis with a compartment for the Battery. The System uses a sealed lead acid, rechargeable Battery. Cabling includes a standard Blanket Interconnect Cable and an optional cable for connection to a vehicle cigarette lighter socket. All Systems include a standard AC-to-DC Adapter. The Carrying Bag conveys no impact on system safety.
The provided text does not contain acceptance criteria or study details for a medical device in the context of the requested information (AI/algorithm performance, ground truth, expert review, MRMC studies, etc.).
Instead, the document is a 510(k) summary for a "ChillBuster® Model 8001 Portable Electric Blanket System," which is a physical medical device, not a software algorithm or AI-based system.
Therefore, I cannot extract the information required to populate the table or answer the specific questions about AI/algorithm performance. The non-clinical performance data section describes tests conducted on the physical electric blanket, focusing on safety standards (IEC, UL), general operation, warming performance, and comparison to a predicate device in terms of heat output and distribution.
To directly address your request given the provided input:
1. Table of acceptance criteria and reported device performance:
The document does not explicitly state "acceptance criteria" for an algorithm. It describes safety standards and functional verification for a physical electric blanket, and "product specifications" were met.
| Acceptance Criteria (Not applicable for AI/Algorithm) | Reported Device Performance (Physical device - ChillBuster Model 8001) |
|---|---|
| NA | Met IEC 601-1 (1998; Amd. 1: 1991; Amd. 2; 1995) Safety Standard |
| NA | Met UL 2601-1 Safety Standard |
| NA | Met IEC 601-1-2 EMC Standard |
| NA | Generated distributed, low-level active heat throughout intended operating range |
| NA | Demonstrated progressive lengthening of functional blanket heat delivery as temperature setting varied from highest to lowest |
| NA | Met all product specifications under simulated in-use test conditions |
| NA | Compared favorably to predicate device (Life-Air 1000) in heat production and distribution (Model 8001 showed more even heat distribution while predicate had higher max output) |
| NA | Informal tests by >50 subjects reported rapid rise to moderate, comfortable temperature, then constant |
| NA | No adverse equipment or performance encountered in informal testing |
| NA | Maintained function after 10 machine wash/dry cycles without degradation of temperature rise time or heat delivery |
2. Sample size used for the test set and the data provenance: Not applicable for an AI/Algorithm test set. For the physical device, informal tests involved ">50 individuals" (independent subjects). The formal tests were conducted by Northwest EMC, Inc., an independent commercial firm. The data provenance is primarily from independent testing by Northwest EMC, Inc. and informal testing by ThermoGear™ in the US (Tigard, OR).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/algorithm is not discussed. For the physical device, compliance with standards and functional performance was assessed by an independent testing firm and informal user feedback.
4. Adjudication method for the test set: Not applicable.
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 document describes a physical electric blanket, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable for an AI/algorithm. For the physical device, "ground truth" was based on adherence to recognized safety and EMC standards (IEC 601-1, UL 2601-1, IEC 601-1-2) and the observed functional characteristics during testing (e.g., heat generation, battery life, washing performance).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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MAR - 1 2000
APPENDIX III
510(k) Summary (Reference: Section G, Main Text)
The following material presents the 510(k) Summary for the ChillBuster® Model 8001 Portable Electric Blanket
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K 991684
TM ThermoGear, Inc.
18005 Lower Boones Ferry Rd Tigard, OR 97224 (503) 624-1415 (Fax) 624-2784
510(k) Summary
Submitter Information
ThermoGear™, Inc. (address and phone/fax numbers per letterhead) Wayne Fields, Ph.D. Contact Person: Summary Preparation Date: May 1, 1999
Device Information
Trade or Proprietary Name: Device Common or Usual Name: Hypothermic Therapy System CDRH Product Nomenclature: Classification:
ChillBuster® Model 8001 Portable Electric Blanket Thermal Regulation System (21 CFR 870.5900) 74 DWJ
Predicate Device
ThermoGear™ has designated the Life-Air 1000® Hypothermic Therapy System, manufactured by Progressive Dynamics Inc. of Marshall. MI (616-781-4241), as the predicate device for the ChillBuster® Model 8001 Portable Electric Blanket System.
Device Description
The ChillBuster® Model 8001 Portable Electric Blanket System is made up of six major components:
- . Blanket. This main functional element of the System features a waterproof nylon outer layer, and an inner layer of soft polar fleece. Lying between the latter two layers and attached to the internal aspect of the polar fleece is a unique pattern of special thermal wire and, at one point in the wire array, a wire-adjacent thermistor. The Blanket is machine washable;
- . Control Module. Four key subunits form this component: 1) one electronic circuit board (ECB) where all control and operating electronics reside; 2) one User Interface Panel, providing information, controls and cable connectors; 3) Interconnect Wiring; and 4) a Molded Chassis that forms the base for the other components, along with a recessed compartment for the system Battery;
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- Battery. The Model 8001 employs a sealed lead acid, rechargeable Battery. The . Control Module will accept two different Battery configurations, of 7 Amp-Hour and 4 Amp-Hour capacity, respectively. The purchaser specifies the desired Battery capacity at the time of purchase:
- . Cabling. A single Blanket Interconnect Cable is standard, extending from the Control Module to a mating connector at one Blanket corner. One optional cable is also available, allowing connection of the Model 8001 System to a vehicle cigarette lighter socket, permitting the alternative of obtaining external System power for direct System operation and simultaneous System battery recharging;
- . AC Adapter. All Model 8001 Systems include a standard AC-to-DC Adapter properly matched to the voltage, current and interconnect requirements of other System components: and
- Carrying Bag. ChillBuster® Model 8001 Systems include a custom Carrying Bag. . The Carrying Bag conveys no impact on system safety.
Intended Use
The ChillBuster® Model 8001 Portable Electric Blanket has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.
Non-Clinical Performance Data
A. Formal Studies Conducted Independent of ThermoGear™
The studies reported in this subsection were conducted by the product Safety group at Northwest EMC, Inc., an independent commercial firm accredited to test and certify equipment on behalf of numerous agencies worldwide, including TUV Rheinland. The 8001 system passed all tests.
Standards. The Model 8001 System has been tested to the following standards:
General Medical Safety: IEC 601-1:1998; Amd. 1: 1991; Amd. 2; 1995 UL 2601-1
EMC: IEC 601-1-2
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Verification of 8001 Operation.
The Model 8001 was set up and operated according to the Operating Manual. In Verification Test #1, the Model 8001 was found to generate distributed, low-level active heat throughout the intended operating range of user intensity settings. In Verification Test #2, the Model 8001 demonstrated a progressive lengthening of functional blanket heat delivery sessions (a direct function of battery life) as the operator-set temperature setting was varied from highest to lowest setting. Northwest EMC deemed that the Model 8001 successfully met all product specifications under simulated in-use test conditions.
Comparison to Predicate Device.
The Model 8001 was set up and operated according to the Operating Manual under two configurations, using internal and external 12 VAC battery power, respectively. The predicate device was operated according to its Operating Manual, powered from 120 VAC. All tests were conducted at the highest available temperature settings. In Comparison Test #1, all three test runs demonstrated distributed, low-level active heat production, the predicate showing higher average heat output (note that its highest setting of 110F exceeds the comparable figure of 105F for the 8001), while both Model 8001 configurations demonstrated more even heat distribution than the predicate. In Comparison Test #2, the same basic setups were used to compare operation of both Model 8001 configurations and the predicate at different ambient temperatures. All three systems revealed distributed, low-level active heat production as before, although the predicate showed little extra heat production over either of the Model 8001s, while heat distribution uniformity in this test series was of similar character for all three systems.
B. Informal Studies Conducted by ThermoGearTM
The following items represent informal tests or observations that corroborate the formal test results cited above:
- Warming Performance. Complete 8001 systems were informally tested by a large number of independent subjects (estimated to exceed 50 individuals) in the course of late-term ThermoGear™ product development and design. Every subject reported 8001 system behavior to be the rapid rise of blanket temperature to a moderate, comfortable level, which thereafter remained essentially constant for the duration of sampling,
- Adverse System Performance. No adverse conditions of the equipment or its performance were encountered in the informal 'Warming Performance' testing cited above,
- Machine Washing Performance. The 8001 System was functionally tested after subjecting the system Blanket to ten consecutive cycles of machine washing (cold water; gentle agitation; home detergent; no bleach) and machine drying (low temperature; gentle cycle). No degradation of blanket temperature rise time or routine operating heat delivery was apparent to manual palpation over the full area of the blanket. There was also no compromise to the blanket, functionally or otherwise, apparent to visual inspection;
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Conclusions Drawn from Non-Clinical Tests
In conclusion, across all formal tests conducted by Northwest EMC and the informal ThermoGear™ tests reported above, the 8001 system performed according to specification, compared favorably to the Predicate device, and no new issues of safety or effectiveness were found to arise in the 8001 System compared to the Predicate device.
Comparison of Technological Characteristics (8001 vs Predicate Device)
| FEATURES | MODEL 8001 SYSTEM | LIFE-AIRE 1000 SYSTEM |
|---|---|---|
| Indications for Use | counteract hypothermia | counteract hypothermia |
| Function | low-level distributed heat topatient | low-level distributed heat topatient |
| Heat Delivery Mechanism | conduction | convection |
| Heat Source | thermal wire in blanket | heater in blanket input manifold |
| Electrical Requirements | 12 VDC @ 3.2 Amp | 120 VAC, 60 HZ, @ 7 Amp |
| Heating Element Power | about 40 W | about 700 W |
| Max Heat Presented to Patient | 105F | 110F |
| User Heat Output Control | uncalibr'd continuous, ~20W-40W | discrete steps,80F/90F/100F/110F |
| Thermal Temperature Cutoff | 105F @ blanket wire surface | 120F @ blanket inlet manifold |
| Alarms | none | 1 audio; 1 visual |
| Circuit Protection | fused positive battery lead | power supply circuit breaker |
| Internal Diagnostics | none | auto or manual self-test sequence |
| Safety Agency Approvals | TUV Rheinland | UL544; CSA |
| EMC Compatibility Testing | IEC 601-1-2 | unavailable to ThermoGear™ |
| Cross-Contamination Protection | sterile, single-use blanket cover | sterile, single-use blanket |
| Blanket Material(s) | oxford nylon & nylon acrylic | unavailable to ThermoGear™ |
| Control Unit Construction | flame-retardant polycarbonate | 16 ga. steel; baked enamel finish |
| Blanket Cleaning | machine washable & dryable | disposed after single use |
| System Weight | 8 lbs | 35 lbs |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2000
Dr. R. Wayne Fields Senior VP ThermoGear™ Inc. 180015 Lower Boones Ferry Road Tigard, OR 97224
K991684 /S2 Re: Chillbuster Portable Electric Blanket System, Model 8001 Regulatory Class: II (two) Product Code: DWJ February 18, 2000 Dated: Received: February 22, 2000
Dear Dr. Fields:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Dr. R. Wayne Fields
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Cezmi Can Kınıkli
Celia M. Witten, Ph.D., M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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S10(k) NUMBER (IF KNOWN): K991684 DEVICE NAME: Model 800) Portable Electric Blueket System INDICATIONS FOR USE:
The ChillBuster® Model 8001 Portable Electric Blanket System has been developed to reduce the effects of hypothermia encountered during the transma of a surgicul procedure or other medical crisis which could result in the enset of a hypothermic condition.
Sette Xa Campiree
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over - The - Counter - Use (Optional Format 1-2-9
§ 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).