(86 days)
Not Found
No
The description details a standard warming cabinet with basic temperature regulation and safety features, with no mention of AI or ML.
No
This device is designed to warm and store blankets, linens, and fluids; it does not directly treat or diagnose a medical condition.
No
Explanation: The device is designed to store and warm blankets, hospital linens, and medical fluids. Its function is purely for warming and storage, not for diagnosing any medical condition or
disease. It does not analyze patient data, receive biological samples, or provide any diagnostic output. Its purpose is to prepare items for patient use and does not involve any diagnostic or evaluative processes.
No
The device description clearly outlines physical hardware components such as stainless steel cabinets, heating elements, fans, thermostats, and temperature sensors. It is a physical warming cabinet, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to store and warm blankets, hospital linens, and fluids (irrigation and/or injection). This is a physical warming and storage function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details the physical components and heating mechanism of a warming cabinet. There is no mention of reagents, assays, or any process for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic interpretation of results
- Use in the diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly designed for warming and storing items used in a healthcare setting, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (Irrigation and/or Injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.
Product codes (comma separated list FDA assigned to the subject device)
LGZ
Device Description
The Natus Warmette® Cabinets are made of stainless steel and are well insulated to reduce heat loss and noise. Cabinet doors are double glazed with safety glass. A pull out shelf inside the top of the cabinet contains the heating element, fan, thermostat and temperature sensor. The electronics are located on the outside top of the cabinet and the power cable is connected at the back of the electronic cabinet. Wheeled shelves and baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning or repositioning. The Natus Warmette® Blanket Cabinet is factory-set to 130ºF (54ºC) with a temperature range of 95º - 176ºF (35º -80°C). For the Natus Warmette® Dual Cabinet, the blanket and linen compartment is factory-set to 130°F (54°C) with a temperature range of 95° - 1769F (35° - 80°C); while the fluid compartment is factory-set to 110°F (43°C) with a temperature range of 970 - 122°F (36° - 50°C). The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment, and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items. The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through the outlets. The temperature is regulated by the temperature regulator T1 to the set temperature. Thermostat T2 functions as over temperature protection and will take over the temperature control in case the air temperature exceeds set maximum temperature by 90F (5°C). At the same time the red lamp on the front panel will be lit to indicate that there is a malfunction. Inside the heating element itself, there is an additional over temperature protection that is self-resetting. It will be activated in case the fan stops or goes too slow.
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)
Tests conducted on the cabinets consist of verification of the functional controls and calibration, electrical safety, and a physical inspection of each cabinet. Each cabinet must meet the specified test requirements per a formal, written test procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K112702 Imperial Surgical Blanket and Solution Warming Cabinets
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Manufacturer's Name:
Natus Nicolet Ireland Limited IDA Business Park Gort, County Galway Ireland
Manager, Quality Assurance Natus Nicolet Ireland Limited
Official Correspondent:
Telephone Number: Fax Number:
Summary Date:
July 8, 2013
Michael Galvin
IDA Business Park
+353-(0)91-647451
+353-(0)91-630050
Gort, County Galway
Trade Names:
July 3, 2018
Ireland
Natus Warmette® Blanket Cabinet Natus Warmette® Dual Cabinet
Common or Usual Name: Warming Cabinets
Classification Name And Number:
Predicate Device:
Unclassified, Product Code: LGZ
K112702 Imperial Surgical Blanket and Solution Warming Cabinets
Device Description:
The Natus Warmette® Cabinets are made of stainless steel and are well insulated to reduce heat loss and noise. Cabinet doors are double glazed with safety glass.
A pull out shelf inside the top of the cabinet contains the heating element, fan, thermostat and temperature sensor. The electronics are located on the outside top of the cabinet and the power cable is connected at the back of the electronic cabinet.
Wheeled shelves and baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning or repositioning.
OCT 0 3 2013
1
The Natus Warmette® Blanket Cabinet is factory-set to 130ºF (54ºC) with a temperature range of 95º - 176ºF (35º -80°C). For the Natus Warmette® Dual Cabinet, the blanket and linen compartment is factory-set to 130°F (54°C) with a temperature range of 95° - 1769F (35° - 80°C); while the fluid compartment is factory-set to 110°F (43°C) with a temperature range of 970 - 122°F (36° - 50°C).
The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment, and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.
The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through the outlets. The temperature is regulated by the temperature regulator T1 to the set temperature.
Thermostat T2 functions as over temperature protection and will take over the temperature control in case the air temperature exceeds set maximum temperature by 90F (5°C). At the same time the red lamp on the front panel will be lit to indicate that there is a malfunction. Inside the heating element itself, there is an additional over temperature protection that is self-resetting. It will be activated in case the fan stops or goes too slow.
Tests conducted on the cabinets consist of verification of the functional controls and calibration, electrical safety, and a physical inspection of each cabinet. Each cabinet must meet the specified test requirements per a formal, written test procedure.
The Natus Nicolet Warmette® Blanket and Dual Cabinets are equivalent to the devices cleared under K112702, as is presented in the following table.
Intended Use:
Technological Characteristics:
Nonclinical Tests:
Substantial Equivalence:
Page 2 of 5
2
Comparison Table:
| | Imperial Surgical Blanket and Solution
Warming Cabinets | Natus Warmette® Blanket and
Dual Cabinets |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate 510(k)
number | K112702 | New device |
| Intended Use | Designed to store and warm blankets, hospital linens, irrigation fluids and/or injection fluids with the recommended warning temperatures and storage time guidelines provided by the manufacturers of such products. | Same |
| Heating System | Convection Electric heating element with circulating fan | The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through outlets. The temperature is regulated by the temperature regulator T1 to the set temperature. |
| Unit Configuration | Single / dual | Same |
| Cabinet Dimensions
(H x W x D) in inches | 7000 & 8000 Series options:
34 x 29 x 20
34 x 29 x 26
74 x 29 x 22
74 x 29 x 28
9000 Series:
15 x 23 x 19 | Warmette® Blanket and Dual
Cabinets:
With adjustable feet (standard):
71.25 - 73.25 x 26 x 25 With wheel kit (optional):
72.5 x 26 x 25 |
| Model | Wall or Counter | Wall |
| Interior and Exterior
Surfaces | Stainless Steel interior and exterior on table top and full size models. Counter top model made with baked on power coated steel outer shell with Stainless Steel interior. | Made of high quality stainless steel. Polyurethane foam insulation for minimal heat leakage and optimal sound insulation. |
| Installation | Free standing | User manual specifies that cabinet is to be secured to the wall using the built in brackets at the top of the cabinet. |
| Door | Stainless steel or double pane glass set in stainless steel frame on table top and full size models.
Counter top model has Plexiglas mounted on to anodized aluminum door frame. | The door has double glazed safety glass. |
| | Imperial Surgical Blanket and Solution
Warming Cabinets | Natus Warmette® Blanket and
Dual Cabinets |
| | | |
| Predicate 510(k)
number | K112702 | New device |
| Door Lock | No | Magnetic handle |
| Cabinet Storage
Capacity | Dual compartment and full size cabinets
equipped with 3 stainless steel perforated
shelves.
Table top model equipped with 1
stainless steel perforated shelf. | Cabinets are equipped with rails
for shelves or baskets. The
Natus Warmette® Blanket
Cabinet can accommodate 4
shelves. The Natus Warmette®
Dual Cabinet (Blanket and Fluid)
can accommodate 2 shelves in
the blanket compartment and 2
shelves and 1 basket in the fluid
compartment. |
| Cabinet Volume | Single compartment shallow depth design
capacity 14.6 cu ft
Table top model capacity 7.5 cu ft
Dual compartment capacity 18.1 cu ft
overall (4.3 cu ft upper - 13.8 cu ft lower)
Table top shallow design capacity 5.2 cu ft
Counter top version has capacity of 2.0
cu ft (approx.). | For Natus Warmette® Blanket
Cabinet:
Volume = 14.66 cu ft
Inside dimensions =
55 x 22 x 21 in (H x W x D)
For Natus Warmette® Dual
Cabinet:
Each compartment (Blanket or
Fluid):
Volume = 5.65 cu ft
Inside dimensions =
23 x 22 x 21 in (H x W x D) |
| Voltage Requirements | 120V AC 60Hz | 120V, 60Hz or 230V, 50Hz |
| Software | N/A | N/A |
| Controls | Electronic temperature controller with
LED display. Illuminated power switch /
breaker (red). Amber neon indicator for
Element on. Red neon indicator for
trouble. | Electronic temperature controller
with LED display. The ON/OFF
switch isolates the cabinet
electronics from mains power. A
red over-temperature lamp will
be lit to indicate a malfunction. |
| Temperature Selection
Range | Factory set:
For Blankets: 86°F to 160°F (30° to 71°C)
For Irrigation Fluids: 86°F to 150°F (30° to
66°C)
For Injection Fluids: 86°F to 104°F (30° to
40°C)
Must be specified at time of ordering. | Factory set:
For Natus Warmette® Blanket
Cabinet:
130°F (54°C); range 95° to 176°F
(35° to 80°C)
For Natus Warmette® Dual
Cabinet:
● Blanket compartment: 130°F
(54°C); range 95° to 176°F
(35° to 80°C)
● Fluid compartment: 110°F
(43°C); range 97° to 122°C
(36° to 50°C) |
| | Imperial Surgical Blanket and Solution
Warming Cabinets | Natus Warmette® Blanket and
Dual Cabinets |
| Predicate 510(k)
number | K112702 | New device |
| Temperature resetting | Settings are factory set and locked. The
device can be unlocked in the field and
user can change settings if they wish to. | The user site's technician can
change the factory preset
temperature setting to meet the
site's specific requirements.
Temperature can be blocked at a
fixed value. |
| Over-Temperature Alarm
Point | Visual alarm if chamber exceeds 6°C
above set temperature. Internal sensor
shuts off heating elements when over
temperature occurs. | A capillary thermostat ensures
independent over temperature
prevention.
A bimetal thermostat is
integrated in the heating element.
Additionally, the red over-
temperature lamp will be lit to
indicate a malfunction. |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, representing care and protection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002
October 3, 2013
Natus Nicolet Ireland Limited C/O Mr. Michael Galvin Manager, Quality Assurance IDA Business Park Gort, Country Galway IRELAND
Re: K132110
Trade/Device Name: Natus Warmette® Blanket and Dual Cabinets Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LGZ Dated: July 8, 2013 Received: July 9, 2013
Dear Mr. Galvin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revioused jour we 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 enorsers) to 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.
6
Page 2 - Mr. Galvin
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 Part 801); medical device reporting (reporting of 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Natus Warmette® Blanket and Dual Cabinets
Indications for Use:
The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (Irrigation and/or Injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ਮ (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/7/Picture/10 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is composed of the letters "FDA" in a stylized font. The letters are made up of small squares and rectangles, giving the logo a pixelated appearance.
Richard C. Chapman 2013.10.03 15:56:47 -04'00'
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