(8 days)
The ChillBuster® Model 8002 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. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.
This device, as now cleared, permits use with either a sterile or a non-sterile blanket cover, as necessary, upon the determination by a health care practitioner. Most intended use does not involve surgery. Also, even during surgery, only those interventions where the blanket cover would threaten a sterile operating field actually require a sterile blanket cover to achieve intended function. The present design modification involves no change to intended use, indications for use, technological basis, device design, or substantial equivalence. And both the ChiliBuster® Predicate and Modified devices require use of a blanket cover with every therapy session. For ThermoGear's ChillBuster® product, the only Predicate/Modified device difference lies in labeling that addresses when to use a sterile versus non-sterile blanket cover. While the Predicate 8002 requires use of a sterile blanket cover for every therapy, the Modified 8002 "requires the decision to use a sterile or a non-sterile blanket the woulded by a medical practitioner, familiar with the patient's condition and circumstance."
This 510(k) summary (K083135) describes a modification to the ChillBuster® Model 8002 Portable Electric Blanket, specifically regarding the labeling for when to use sterile versus non-sterile blanket covers. It is not a study demonstrating device performance against specific acceptance criteria. Instead, it is a statement affirming that the modified device is substantially equivalent to its predicate device and that the change is a labeling update, not a change requiring new performance data.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this submission explicitly states no performance data was required for this particular change.
Here's why each point is not applicable based on the provided document:
1. A table of acceptance criteria and the reported device performance
Not Applicable. The document explicitly states: "Clearance of the subject of this submittal, requirements of when to use a sterile or non-sterile blanket cover, does not require performance data. The two cover types are the same in every way, save the state of sterility." Since no performance data was collected or required, there are no acceptance criteria or reported device performance for this specific modification.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. No performance testing was conducted for this specific labeling modification, so there is no test set or associated data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. As no performance testing was performed, there was no need for experts to establish ground truth for a test set. The change is related to the decision of a medical practitioner (implied expert in clinical practice) regarding sterility, not a diagnostic or therapeutic performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No performance testing was performed, so no adjudication method was used for a test set.
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 device is a portable electric blanket, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a hardware device (electric blanket) and not an algorithm. Standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No performance testing was performed, so no ground truth was established for the purpose of evaluating the modified device's performance. The "ground truth" for the submission is the regulatory and clinical understanding that practitioners can determine when a sterile vs. non-sterile cover is needed.
8. The sample size for the training set
Not Applicable. This device uses a predicate device model; it doesn't involve machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, there is no ground truth to establish for it.
In summary, the provided document describes a regulatory submission for a labeling change to a medical device, not a study evaluating its performance against specific technical criteria. The core argument is that the change itself (allowing practitioner discretion for blanket cover sterility) does not impact safety or effectiveness and therefore does not require new performance data.
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1083135
4
OCT 3 1 2008
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of a Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
Submitter Information
ThermoGear™ Inc. (contact: Wayne Fields, PhD) 16337 SW Bryant Rd (PO Box 1545) Lake Oswego, OR 97035 (FAX): 503.697.1907 (Phone): 503.697.1900;
Date Summary Prepared: June 27, 2008
Device Information
ChillBuster® Model 8002 Portable Electric Blanket, with CDRH formal identity:
Device Group: Medical Specialty: Product Code: Device Class: Regulation No:
System, Thermal Regulating Cardiovascular DWJ 2 870.5900
Predicate Devices
#K071918 ChillBuster® Model 8002 Portable Electric Blanket; ThermoGear Inc; #K072513 DM-EMG Hypothermic Therapy System; Medvation LLC.
Device Description
This device, as now cleared, permits use with either a sterile or a non-sterile blanket cover, as necessary, upon the determination by a health care practitioner. Most intended use does not involve surgery. Also, even during surgery, only those interventions where the blanket cover would threaten a sterile operating field actually require a sterile blanket cover to achieve intended function.
The present design modification involves no change to intended use, indications for use, technological basis, device design, or substantial equivalence. And both the ChiliBuster® Predicate and Modified devices require use of a blanket cover with every therapy session. For ThermoGear's ChillBuster® product, the only Predicate/Modified device difference lies in labeling that addresses when to use a sterile versus non-sterile blanket cover.
ThermoGear Inc.
Confidential & Proprietary
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While the Predicate 8002 requires use of a sterile blanket cover for every therapy, the Modified 8002 "requires the decision to use a sterile or a non-sterile blanket the woulded by a medical practitioner, familiar with the patient's condition and circumstance." This improves practicality, while not sacrificing device safety and effectiveness.
Intended Use
There is no difference in intended use of the Modified versus Predicate devices.
The ChillBuster® Model 8002 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.
For both the Modified and Predicate devices, use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.
Technological Characteristics
The elements of the ChillBuster® system that comprise the current subject, sterile and non-sterile blanket covers, are exactly the same in both the Modified and Predicate devices. The only difference is in labeling related to when to use sterile covers compared to non-sterile ones. The latter is treated in prior discussion.
Non-Clinical Performance Data
Clearance of the subject of this submittal, requirements of when to use a sterile or non-sterile blanket cover, does not require performance data. The two cover types are the same in every way, save the state of sterility. Practitioners can be expected to know the functional properties of sterile versus non-sterile single-use products. The present design change merely replaces an overly restrictive requirement for sterile cover use with one that is practical in the real world.
Conclusion
The ChillBuster® Modified 8002 is substantially equivalent to the ChillBuster® Predicate 8002 at all levels of system design. The subject here is an upgrade of labeling, to render required use of a sterile blanket cover only when the attending practitioner judges such protection is needed. This provides better clarity to assure safer and more effective use.
Confidential & Proprietary
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2008
Microtek Medical, Inc. c/o Mr. Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road Newton, CT 06470
Rc: K083135
ChillBuster Portable Electric Blanket, Model 8002 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: October 2, 2008 Received: October 23, 2008
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device w only reveal 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 for use stated in the encreated)76 the enactment date of the Medical Device Amendments, or to continer of they 20, 2018 10:11 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, manes of the Act include requirements for annual registration, listing of general connects provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device 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. Tamas Borsai
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 rcquirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice rcquirements 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 Scction 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K08 313 5 510(k) Number (if known):
ChillBuster® Model 8002 Portable Electric Blanket Device Name:
Indications for Use: The ChillBuster® Model 8002 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. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.
| Prescription Use | X | AND/OR | Over-The-Counter Use | _ |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (Part 21 CFR 801 Subpart D) |
(Division/Sign-Off)
Division of Cardiovascular Devices
| ThermoGear Inc. | 510(k) Number | K083135 | Confidential & Proprietary |
|---|---|---|---|
| ----------------- | --------------- | --------- | ---------------------------- |
§ 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).