(85 days)
No
The device description focuses on standard medical device components for temperature regulation and does not mention any AI/ML terms or functionalities.
No
The primary function of the device as described is to maintain body temperature, which is a supportive function rather than a direct therapeutic intervention for a specific disease or condition. While maintaining body temperature is crucial for infant care, the device itself doesn't treat, cure, or mitigate a disease.
No
Explanation: The device, an "Infant Radiant Warmer," is designed to maintain an infant's body temperature, not to diagnose medical conditions. Its features involve temperature control and support, not diagnostic analysis.
No
The device description clearly outlines multiple hardware components including an infrared heating element, bassinet, mattress, trays, storage, casters, and optional scale and hilo feature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain an infant's body temperature using radiant heat. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a device that provides heat and monitoring of body temperature. It does not mention any analysis of biological samples (blood, urine, tissue, etc.) which is characteristic of IVDs.
- Lack of IVD Keywords: There are no mentions of terms typically associated with IVDs such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analysis," etc.
The device is a medical device used for patient care, specifically temperature regulation in infants, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Stabilet- Infant Radiant Warmer maintains the infant's body temperature at a level determined by the caregiver through the use of an infrared radiant heating element and is designed to be used in those areas of the healthcare facility that provide neonatal and infant care.
Federal law restricts this device to sale by or on the order of a licensed health care practitioner and its use is restricted to health care facilities.
Product codes
Not Found
Device Description
The Hill-Rom Stabilet- is a device consisting of an infrared heating element positioned over an infant to maintain the infant's body temperature by means of radiant heat. Available features include a warming/lighting module which provides heat through two stainless steel heater tubes, manual or servo heat control with a temperature monitoring sensor and temperature alarms, procedural Apgar timer, bassinet with mattress and spring loaded fold down sides, trendelenburg/reverse trendelenburg, x-ray cassette tray, retractable Mayo tray, slide through storage drawer, resuscitation equipment, storage bin and casters with front locking brakes, optional scale and hilo feature.
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
neonatal and infant
Intended User / Care Setting
licensed health care practitioner, health care facilities
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
0
APR -3 1997
510(k) Summary
January 6, 1996
Applicant:
Hill-Rom, Inc. 1069 St. Route 46 East Batesville, IN 47006 Reg. No: 1824206
Contact Person:
James G. Carpenter Ph: (812)934-1671 Fx: (812)934-1675
Device trade/proprietary name:
" Stabilet-"
Device common/usual/classification name:
Infant Radiant Warmer
Classification:
General Hospital and Personal Use Device, 21 CFR 880.5130 , Infant Radiant Warmer, 80FMT, Class III
Predicate (Current) Device:
Hill-Rom " Stabilet-" Infant Radiant Warmer, K942948
Device Description
The Hill-Rom Stabilet- is a device consisting of an infrared heating element positioned over an infant to maintain the infant's body temperature by means of radiant heat. Available features include a warming/lighting module which provides heat through two stainless steel heater tubes, manual or servo heat control with a temperature monitoring sensor and temperature alarms, procedural Apgar timer, bassinet with mattress and spring loaded fold down sides, trendelenburg/reverse trendelenburg, x-ray cassette tray, retractable Mayo
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1
tray, slide through storage drawer, resuscitation equipment, storage bin and casters with front locking brakes, optional scale and hilo feature.
Intended Use:
The Stabilet- Infant Radiant Warmer maintains the infant's body temperature at a level determined by the caregiver through the use of an infrared radiant heating element and is designed to be used in those areas of the healthcare facility that provide neonatal and infant care.
Federal law restricts this device to sale by or on the order of a licensed health care practitioner and its use is restricted to health care facilities.
Design and construction:
Both the new and predicate warmers utilize the same materials and methods of construction. The warmers are fabricated from steel, aluminum, and plastic. The submitted warmer's most highly stressed areas utilize only steel and aluminum. Plastics are used in less stressed areas. Steel and aluminum warmer components are welded or assembled with commercially available fasteners. Plastics used in less stressed areas are assembled with fasteners.
The subject warmer and predicate warmer in this submission are substantially equivalent. There is some variation in the available features of the warmers, but the variations do not significantly affect the safety or efficacy of the warmers.
This submission is a result of the introduction of several improvement modifications Hill-Rom has introduced to the existing product. The principal changes are:
Modification of the heater lamp housing
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Bare quartz element changed to a stainless steel element. ●
The new element eliminates tube breakage as a hazard to the patient or caregiver. The electrical contacts have been changed from a spring compression socket arrangement to an insulated wire with a screw. This provides a positive locking electrical connection to the power supply. -
One heating element to two.
2
- Heating element length increased from 12" to 16"
- Change parabolic reflector from pebbled to smooth to optimize . irradiance pattern with new dual heating elements
Two 375W elements centered over the bassinet replace the single 760W element in the predicate warmer. In conjunction with the increased length and the changes to the parabolic reflector, the irradiance pattern is more evenly distributed and the time required to warm the infant to the caregiver- selected skin temperature is reduced.
Height adjustability for the 1500C and 2000D.
This is a customer preference feature and does not impact the safety of the device to the user or patient. The heater lamp housing to bassinet surface relationship is maintained.
Quartz Halogen task light replaces the florescent task light.
The light is balanced to 3200°K. This more closely approximates natural ambient light and eliminates the color bias imparted by florescent lighting.
Accessories
Resusitation and Suction modules are offered as options on all current and previous models and the 1250C and 1500C Stabiler. This does not represent an increased risk to the user or patient as these options are already standard features on the Predicate 2000C.
A scale option (Premarket Notification K926174) is also available on the P1500C and P2000D models.