WARMETTE

K971117 · Olympic Medical Corp. · LHC · Aug 22, 1997 · Physical Medicine

Device Facts

• Record ID: K971117
• Device Name: WARMETTE
• Applicant: Olympic Medical Corp.
• Product Code: LHC · Physical Medicine
• Decision Date: Aug 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5950
• Device Class: Class 1

Intended Use

For warming of blankets/linen or solutions solutions must be in external use only.

Device Story

Olympic Warmette (Models 30, 31, 40) is a double-walled, insulated cabinet with transparent doors used for warming blankets, linens, or external-use solutions. Device operates continuously with user-selectable temperature controls. Models 30, 31, and 40 utilize a fan-forced air circulation system; air is heated by resistance elements above the main chamber and recirculated via an internal wall duct. Models 31 and 40 feature higher temperature ranges and more efficient plenum designs compared to Model 30. Used in clinical settings; operated by healthcare staff. Output is a temperature-controlled environment for medical supplies; benefits include patient comfort and maintenance of solution temperature for external application.

Clinical Evidence

Bench testing only. Testing included temperature verification of interior/exterior surfaces and contents (blankets/solutions), current leakage, dielectric withstand, ground impedance, and overtemperature thermostat safety tests.

Technological Characteristics

Double-walled insulated cabinet; resistance heating elements; fan-forced air circulation (Models 30, 31, 40); thermostatic temperature controls; 120V/60Hz power; hospital-grade power cord. Design standards: CSA/NRTL-C, UL-544. Temperature range: 80°-145°F (model dependent). Accuracy: ± 10°F.

Indications for Use

Indicated for warming blankets, linens, or solutions for external use only.

Regulatory Classification

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.

Predicate Devices

• Olympic Warmette Model 10

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002

JAN 10 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 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] 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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510(k) Number (if known): K 971117

Device Name: OLYMPIC WARMENTTE

Indications For Use:

For warming of blankets/linen or solutions solutions must be in external use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K 971117

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)

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Attachment C
Page 1 of 4
AUG 22 1997
Date: _______________
By: _______________

# SAFETY AND EFFECTIVENESS SUMMARY

*This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.*

Olympic Medical
5900 First Ave. S.
Seattle, WA 98108
206-767-3500

Contact Person: Joseph Stefanile

Common or usual name of device: Warming Cabinet
Trade or proprietary name: Olympic Warmette Model 30, 31, 40
Classification name (if known): 80, Class II General Hospital
Predicate device(s) to which substantial equivalence is being claimed: Olympic Warmette Model 10

## Device Description

1. Brief explanation of how the device functions.

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 silicone or kapton material bonded to the underside 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 resistance heating elements (located above the main chamber) and then into the main chamber. Air is returned to the 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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Attachment C
Page 2 of 4

2. 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)

3. Significant physical and performance characteristics of the device. (Ex. device design and physical properties.

| Temp Range | Model 30 | 80° - 135°F |
| --- | --- | --- |
| | Models 31,40 | 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

4. 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.

5. Does the indication statement (4) differ from those of the predicate device?

Check one:
☐ Differs (complete section 6)
☑ Does not differ (skip to section 7)

6. 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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Attachment C
Page 3 of 4

7. The technological characteristics of the device compared to the predicate product.

## COMPARISON CHART - DEVICE CHARACTERISTICS COMPARED TO PREDICATE PRODUCTS

| Model | Predicate Device 10 | 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 Conductor
18 AWG
Hospital Grade
Connector | <--- | <--- | <--- |
| Adjustable Temperature Range | 75° - 150°F | 80° - 135°F | 90° - 145°F¹ | <--- |
| External Dimensions | 16"H x 20"W x 15"D | 84¼"H x 26"W x 21"D | <--- | <--- |
| Capacity, Cu. Ft. | 1.2 | 13.5 | <--- | <--- |
| Accuracy | ± 10°F | <--- | <--- | <--- |
| Controls | • Power Switch
• Set Temp Control | <--- | <--- | <--- |
| Indicators | • Power On
• Heater On
• Oven Set Temp | <--- | <--- | <--- |
| Design Standards | CSA/NRTL-C
UL-544 | <--- | <--- | <--- |
| Heater Type | Radiant Element (encapsulated) | Radiant Element (forced air system) | <--- | <--- |

¹ Preliminary specification shown—will not exceed the range of the Predicate Device 75° - 150°F

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Attachment C
Page 4 of 4

8. A brief description of nonclinical tests and their results.

Extensive verification testing performed including:

1. Temperature tests of all interior and exterior surfaces.
2. Temperature tests of blankets/linen and solutions placed inside the Warmette.
3. Current leakage and dielectric withstand test.
4. Ground impedance.
5. Overtemperature thermostat safety test.

9. 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 equivalent to the predicate device, in all critical parameters (temperature, accuracy, etc.).

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