(148 days)
For WAZMING BLANKETS/LINEN o R or Solutions SOLUTIONS MUST 136 . 197 EXTERNAL ાર્ટ હ ONLy ,
All Olympic Warmettes are essentially double walled, insulated cabinets with transparent doors. The Warmettes normally remain on continuously. The temperature is user selectable. The Model 10 uses a resistance element heater encapsuled in a high temperature r lie Model 10 uses a roclocanos element of the interior. Due to the small size, forced air circulation is not needed. The Models 30, 31 and 40 make use of a fan to force recirculating air past The Models 50, of and 10 make see above the main chamber) and then into the resistence heating bientified (roothe heaters via an air duct built into the left wall. The Models 31 and 40 differ from the Model 30 in two respects: · The selectable maximum temperature is higher. - · The delivery duct/plenum inside the right wall is more efficient, allowing the Models 31 and 40 to operate at the higher temperatures.
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Warmette" by Olympic Medical. It is a Class I device, a powered heating unit intended for warming blankets/linen or external solutions.
Based on the provided text, the device Warmette (Models 30, 31, and 40) meets acceptance criteria primarily through nonclinical testing, demonstrating substantial equivalence to a predicate device (Olympic Warmette Model 10). There is no mention of a study involving human readers or clinical trials for performance evaluation in the context of typical AI/diagnostic device acceptance criteria. The device is a heating cabinet, not an AI or diagnostic tool.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a formal table with pass/fail thresholds for specific performance metrics in the way one would see for a diagnostic device. Instead, it demonstrates performance by comparing its specifications to a predicate device and verifying certain safety functions. The key performance parameter is temperature range and accuracy.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Specifications) | Reported Device Performance (Models 30, 31, 40) |
|---|---|---|
| Adjustable Temperature Range | 75° - 150°F (Predicate device range) | Model 30: 80° - 135°F |
| Models 31, 40: 90° - 145°F¹ | ||
| Accuracy | ± 10°F (Predicate device accuracy) | ± 10°F |
| Safety (Overtemperature) | No exceedance of safe temperature limits | Overtemperature thermostat safety test performed successfully |
| Electrical Safety | Meets electrical safety standards | Current leakage, dielectric withstand, ground impedance tests performed successfully |
¹ Preliminary specifications, will not exceed the range of the predicate device (75° - 150°F)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a heating unit, not a diagnostic or AI-driven device with a "test set" in the context of patient data. The "tests" refer to engineering and safety verification.
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)
This information is not applicable. The "ground truth" for a heating unit involves physical measurements and engineering standards, not expert medical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for ambiguous diagnostic findings, which is not relevant to this device.
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
This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic tools. This device is a powered heating unit, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on engineering specifications, physical measurements, and compliance with recognized safety standards. For example, a thermometer would be used to verify the actual temperature of the unit and its contents, and electrical testing equipment would verify electrical safety parameters.
8. The sample size for the training set
This information is not applicable. The device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 0 2017
Mr. Joseph P. Stefanile Olympic Medical 5900 First Avenue South Seattle, Washington 98108
Re: K971117
Trade/Device Name: Warmette Regulation Number: 21 CFR 890.5950 Regulation Name: Powered heating unit Regulatory Class: Class I Product Code: LHC Dated: May 28, 1997 Received: May 30, 1997
Dear Mr. Joseph P. Stefanile,
This letter corrects our substantially equivalent letter of August 22, 1997.
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 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 Parts 801 and 809 ); medical device reporting (reporting of
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Page 2 - Mr. Joseph P. Stefanile
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 Parts 801 and 8091 ), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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との71117 510(k) Number (if known): WARMETTE OLYmpic Device Name:
Indications For Use:
For WAZMING BLANKETS/LINEN o R or Solutions SOLUTIONS MUST 136 . 197 EXTERNAL ાર્ટ હ ONLy ,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricca Caccinotti
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K971117
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
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Ka71117
ttachment C Page 1 of 4
AUG 22 14:47
Date: By:
SAFETY AND EFFECTIVENESS SUMMARY
*This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Contact Person: Joseph Stefanile
Olympic Medical 5900 First Ave. S. Seattle, WA 98108 206-767-3500
Common or usual name of device Trade or proprietary name Classification name (if known) Predicate device(s) to which substantial equivalence is being claimed
Warming Cabinet Olympic Warmette Model 30, 31, 40 80. Class II General Hospital
Olympic Warmette Model 10
Device Description
- Brief explanation of how the device functions. 1.
All Olympic Warmettes are essentially double walled, insulated cabinets with transparent doors.
The Warmettes normally remain on continuously. The temperature is user selectable.
The Model 10 uses a resistance element heater encapsuled in a high temperature r lie Model 10 uses a roclocanos element of the interior. Due to the small size, forced air circulation is not needed.
The Models 30, 31 and 40 make use of a fan to force recirculating air past The Models 50, of and 10 make see above the main chamber) and then into the resistence heating bientified (roothe heaters via an air duct built into the left wall. The Models 31 and 40 differ from the Model 30 in two respects:
· The selectable maximum temperature is higher.
- · The delivery duct/plenum inside the right wall is more efficient, allowing the Models 31 and 40 to operate at the higher temperatures.
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-
- Basic scientific concepts that form the basis for the device.
- · Resistance heating elements
- · Thermostatic temperature controls
- · Fluid flow (air speed, plenum back pressures, exit air velocity)
-
- Significant physical and performance characteristics of the device. (Ex. device design and physical properties.
| Temp Range | Model 30Models 31,40 | 80° - 135°F90° - 145°F¹ |
|---|---|---|
| Dimensions | 84¼"H x 26"W x 21"D | |
| Internal Capacity | 13.5 cu. ft. | |
| Accuracy | ± 10°F |
1 Preliminary specifications-will not exceed the range of the predicate device 75° - 150°F
- র্ব Intended Use of the device
The Olympic Warmette is intended to be used for warming of blankets/linen or solutions.
The solutions must be for external use only. The Warmette is not intended to be used for solutions with low boiling points or solutions containing flammable solvents or vehicles.
-
- Does the indication statement (4) differ from those of the predicate device?
| Check one: | Differs (complete section 6) | |
|---|---|---|
| X | Does not differ (skip to section 7) |
- ે. Explanation of why the differences are not critical to the intended use of the device and why the differences do not affect the safety or effectiveness of the device.
N/A
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- The technological characteristics of the device compared to the predicate product. 7.
COMPARISON CHART - DEVICE CHARACTERISTICS COMPARED TO PREDICATE PRODUCTS
| Model | Predicate Device10 | 30 | 31 | 40 |
|---|---|---|---|---|
| Manufacturer | Olympic Medical | <----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | - | <--- |
| Electrical Power | 120V, 60 Hz, 1.5 amps | 120V, 60 Hz, 8.0 amps | 120 V, 60 Hz, 14 amps | ---- |
| Heater Wattage | 150 W | 900 W | 1500 W | 1500 W |
| Power Cord | 3 Conductor18 AWGHospital GradeConnector | <---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ﻤﺴﺎﺝ |
| AdiustableTemperature Range | 75° - 150°F | 80° - 135°F | 90° - 145°F' | --- |
| External Dimensions | 16"H x 20"W x 15"D | 84%"H x 26"W x 21"D | ﺎ ﺳﮯ ﮐﮩﺎ ﮨﮯ ﮐﮧ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﮐﺎ ﺍﯾﮏ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺍﯾﮏ ﮐﺎ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﮐﺎ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺳﮯ ﺍﯾﮏ ﮐﮯ ﺳﺎﺗﮫ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﺍ | - |
| Capacity, Cu. Ft. | 1.2 | 13.5 | ﺴﻪ ﻣﻦ ﻣ | ﻤﻌﻪ ﻟﻪ |
| Accuracy | ± 10°F | <---- | ---- | <--- |
| Controls | · Power Switch· Set Temp Control | <----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | <============================================================================================================================================================================= | ﺴ > |
| Indicators | · Power On· Heater On· Oven Set Temp | <--- | <----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | <-- |
| Design Standards | CSANRTL-CUL-544 | <--- | <--- | ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ |
| Heater Type | Radiant Element(encapsulated) | Radiant Element (forcedair system) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
1 Preliminary specification shown-will not exceed the range of the Predicate Device 75° - 150°F
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-
- A brief description of nonclinical tests and their results.
Extensive verification testing performed including:
- A brief description of nonclinical tests and their results.
-
Temperature tests of all interior and exterior surfaces. 1.
-
- Temperature tests of blankets/linen and solutions placed inside the Warmette.
-
- Current leakage and dielectric withstand test.
-
- Ground impedance.
દ્યું
- ട്. Overtemperature thermostat safety test.
-
- Conclusions drawn from nonclinical and clinical tests that demonstrate the device is safe, effective, and performs as well as or better than the legally marketed device.
The nonclinical testing verifies the device meets its specifications and technological characteristics (as described in chart, Question 7). The performance is equiralent to the predicate device, in all critical parameters (temperature, accuracy, etc.),
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.