(148 days)
Olympic Warmette Model 10
Not Found
No
The device description and performance studies focus on basic heating and temperature control mechanisms, with no mention of AI or ML.
No.
The device is a blanket and solution warmer intended for external use, not for direct therapeutic application to a patient.
No
The device description indicates it is an insulated cabinet designed to warm blankets/linen and solutions. Its function is to provide warmth, not to diagnose a medical condition.
No
The device description clearly details physical components like insulated cabinets, doors, heating elements, and fans, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "WARMING BLANKETS/LINEN or Solutions SOLUTIONS MUST 136 . 197 EXTERNAL ાર્ટ હ ONLy". This describes a device used to warm materials, not to perform diagnostic tests on biological samples.
- Device Description: The description details a warming cabinet with heating elements and air circulation. This aligns with a device for warming materials, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly intended for warming external materials, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
For WAZMING BLANKETS/LINEN o R or Solutions SOLUTIONS MUST 136 . 197 EXTERNAL
Product codes
LHC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive verification testing performed including: Temperature tests of all interior and exterior surfaces. Temperature tests of blankets/linen and solutions placed inside the Warmette. Current leakage and dielectric withstand test. Ground impedance. Overtemperature thermostat safety test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Olympic Warmette Model 10
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
3
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.
4
-
- 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 30
Models 31,40 | 80° - 135°F
90° - 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
5
- The technological characteristics of the device compared to the predicate product. 7.
COMPARISON CHART - DEVICE CHARACTERISTICS COMPARED TO PREDICATE PRODUCTS
| Model | Predicate Device
10 | 30 | 31 | 40 |
|---------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Olympic Medical | |
| Indicators | · Power On
· Heater On
· Oven Set Temp |