(118 days)
No
The summary describes a radiant warmer with optional features like resuscitation and weighing. There is no mention of AI or ML in the intended use, device description, or performance studies. The "AutoBreath®" function is described as pneumatically-driven, not AI/ML controlled.
Yes
The device is indicated for "thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants," which are treatments or interventions for a disease or condition.
No
The device is primarily intended for thermoregulation, skin temperature regulation, weighing, and resuscitation of neonates and infants. While it provides measurements like skin temperature and weight, these are for monitoring and guiding therapeutic interventions (warmth, resuscitation), rather than for diagnosing a disease or condition. Its functions are supportive and therapeutic, not diagnostic.
No
The device description clearly details a physical medical device (radiant warmer, resuscitation module, scale, etc.) with hardware components, not solely software.
Based on the provided text, the Babyroo TN300 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Babyroo TN300 Function: The Babyroo TN300 is a medical device that provides external support and therapy to neonates and infants. Its functions include thermoregulation, skin temperature regulation, weighing, and resuscitation. These are all direct interventions and measurements on the patient's body, not analysis of specimens taken from the body.
- Intended Use: The intended use clearly describes providing heat, regulating skin temperature, weighing, and resuscitation for neonates and infants. None of these involve in vitro testing.
- Device Description: The description focuses on the physical components and functionalities related to providing warmth, respiratory support, and weighing. There is no mention of analyzing biological samples.
Therefore, the Babyroo TN300 falls under the category of a therapeutic and monitoring medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) of neonates and infants. The device is designed for use with patients with a body weight up to 10 kg (22 lb).
The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.
Product codes (comma separated list FDA assigned to the subject device)
FMT
Device Description
The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.
The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.
Infant warming is facilitated via three (3) available thermoregulation modes:
- Manual mode
- · Skin temperature mode
- Kangaroo mode
In manual mode, the warmer power is set manually by the clinician. Supply of heat from the radiant warmer at power settings above 30% are limited by the device to predefined time intervals.
In skin temperature mode, the temperature is regulated by means of a temperature setting determined by the clinician and skin temperature sensors applied to the infant patient.
In kangaroo mode, warming is provided by the infant's body heat. The infant's temperature must be monitored continuously during kangaroo mode.
The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatic powered, can be connected to central gas supplies or gas cylinders and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:
- · Resuscitation module with gas mixer and AutoBreath®.
- · Resuscitation module with gas mixer.
- Resuscitation with O2 only.
The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control.
The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.
The Babyroo TN300 device has an expected service life of 10 years. The expected service life is an attribute related to the conformity requirements of international standard: IEC 60601-1 and is defined as the time period during which the device is expected to remain suitable for its intended use and in which all risk control measures need to remain effective. Maintenance, inspection, and service intervals required to ensure the proper functioning of the device within its expected service life are defined in the instructions for use.
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
neonates and infants
Intended User / Care Setting
clinicians / labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer.
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)
Non-clinical Performance Testing:
The subject Babyroo TN300 was tested in accordance with applicable standards, quidance, and internal design requirements, including performance testing, functional/operation testing, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components. The results of the non-clinical performance testing support substantial equivalence.
The performance test data were provided to support substantial equivalence included:
- IEC 60601-1:2005/A1:2012/ COR1:2014: Medical Electrical Equipment, Part ● 1: General Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromaqnetic disturbances - Requirements and tests
- . IEC 60601-1-6: 2010/A1:2013: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 62366-1:2015 COR 1 2016: Medical devices - Part 1: Application of usability engineering to medical devices
- . Human Factors Testing: With reference to February, 2016, Guidance for Industry and Food and Drug Administration Staff: Applving Human Factors and Usability Engineering to Medical Devices
- IEC 62304:2006/A1:2015: Medical device software Software life cycle ● processes
- Software Documentation: With reference to November, 2021, Draft Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Device Software Functions
- . Software Documentation: According to September, 2019, Guidance for Industry and Food and Drug Administration Staff: Off-The-Shelf Software Use in Medical Devices
- . Software Documentation: With reference to April, 2022, Draft Guidance for Industry and Food and Drug Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- . IEC 60601-2-21:2009/A1:2016: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
- IEC 80601-2-35:2009/A1:2016: Medical electrical equipment Part 2-35: ● Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
- . IEC 10651-5:2006: Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
- . ISO 10079-3:2014: Medical suction equipment -- Part 3: Suction equipment powered from a vacuum or pressure gas source
- ISO 10993-1:2018: Biological evaluation of medical devices -- Part 1: ● Evaluation and testing within a risk management process
- ISO 18562-1:2017-03: Biocompatibility evaluation of breathing gas . pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 17664:2017: Sterilization of medical devices Information to be . provided by the manufacturer for the processing of resterilizable medical devices
Clinical Performance Testing:
No human clinical data are included in support of substantial equivalence.
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.
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.
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
§ 880.5130 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
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May 30, 2023
Draeger Medical Systems, Inc. Karl Nittinger Manager, Regulatory Affairs 3135 Quarry Road Telford, Pennsylvania 18969
Re: K230278
Trade/Device Name: Babyroo TN300 Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT Dated: April 28, 2023 Received: April 28, 2023
Dear Karl Nittinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230278
Device Name Babyroo TN300
Indications for Use (Describe)
The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).
The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "Dräger" in a bold, blue font. The "ä" in Dräger has two dots above it. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology products.
510(k) Summary K230278
| 1. Submitter: | Draeger Medical Systems, Inc.
3135 Quarry Road
Telford, PA 18951 | | |
|---------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | Contact Person: | Karl Nittinger
Manager, Regulatory Affairs
E-Mail: karl.nittinger@draeger.com
Telephone: (267) 272-1913 | |
| | Date prepared: | 30 May 2023 | |
| 2. | Device: | Trade Name:
Common Name:
Classification Name:
Regulation Number:
Product Code:
Class: | Babyroo TN300
Infant Radiant Warmer
Infant Radiant Warmer
21 CFR §880.5130
FMT
II |
3. Predicate Devices
The predicate device that has been identified relating to the substantial equivalence of the Babyroo TN300 device are:
Predicate Devices:
| Predicate Device | 510(k) | Manufacturer |
|---|---|---|
| Resuscitaire® with | ||
| AutoBreath® | K120642 | Draeger Medical Systems, |
| Inc. |
The following reference device is utilized in support of substantial equivalence.
| Reference Device | 510(k) | Manufacturer |
|---|---|---|
| Babyleo TN500 | K182859 | Drägerwerk AG & Co. KGaA |
4. Device Description
The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.
The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.
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Infant warming is facilitated via three (3) available thermoregulation modes:
- Manual mode
- · Skin temperature mode
- Kangaroo mode
In manual mode, the warmer power is set manually by the clinician. Supply of heat from the radiant warmer at power settings above 30% are limited by the device to predefined time intervals.
In skin temperature mode, the temperature is regulated by means of a temperature setting determined by the clinician and skin temperature sensors applied to the infant patient.
In kangaroo mode, warming is provided by the infant's body heat. The infant's temperature must be monitored continuously during kangaroo mode.
The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatic powered, can be connected to central gas supplies or gas cylinders and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:
- · Resuscitation module with gas mixer and AutoBreath®.
- · Resuscitation module with gas mixer.
- Resuscitation with O2 only.
The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control.
The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.
The Babyroo TN300 device has an expected service life of 10 years. The expected service life is an attribute related to the conformity requirements of international standard: IEC 60601-1 and is defined as the time period during which the device is expected to remain suitable for its intended use and in which all risk control measures need to remain effective. Maintenance, inspection, and service intervals required to ensure the proper functioning of the device within its expected service life are defined in the instructions for use.
5. Indications for Use
The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) of neonates and infants. The device is designed for use with patients with a body weight up to 10 kg (22 lb).
The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.
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List of Consensus Standards 6.
| Standard Number and Version | Title |
|---|---|
| IEC 60601-1:2005/A1:2012/COR1:2014 | Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential |
| Performance | |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential |
| performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
| IEC 60601-1-6: 2010/A1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential |
| performance - Collateral standard: Usability | |
| IEC 62366-1:2015 COR 1 2016 | Medical devices - Part 1: Application of usability engineering to medical devices |
| IEC 60601-1-8:2006/A1:2012 | Medical Electrical Equipment, Part 1-8: General Requirements for Basic Safety and Essential Performance – |
| Collateral Standard: General requirements, tests and guidance for alarm systems in | |
| medical electrical equipment and medical electrical systems | |
| IEC 62304:2006/A1:2015 | Medical device software - Software life cycle processes |
| IEC 60601-2-21:2009/A1:2016 | Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential |
| performance of infant radiant warmers | |
| IEC 80601-2-35:2009/A1:2016 | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential |
| performance of heating devices using blankets, pads and mattresses and intended for heating in | |
| medical use | |
| ISO 10079-3:2014 | Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure gas source |
| IEC 10651-5:2006 | Lung ventilators for medical use - Particular requirements for basic safety and essential |
| performance - Part 5: Gas-powered emergency resuscitators | |
| ISO 18562-1:2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and |
| testing within a risk management Process | |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 17664:2017 | Sterilization of medical devices – Information to be provided by the manufacturer for the processing of |
| resterilizable medical devices |
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7. Substantial Equivalence Comparison and Discussion
| Predicate Device | Proposed Device | Comment | |
|---|---|---|---|
| Resuscitaire® with AutoBreath | |||
| (K120642) | Babyroo TN300 | ||
| Regulation | 880.5130 | 880.5130 | Same - The proposed device and |
| Product Code | FMT | FMT | the predicate device (K120642) are |
| Class II devices regulated under | |||
| Classification | II | II | 880.5130 (product code: FMT). |
| Indications for Use | The Resuscitaire® Radiant Warmer | ||
| is intended for thermoregulation, | |||
| skin temperature monitoring, | |||
| APGAR timing and resuscitation of | |||
| newly born infants up to 10 kg. It is | |||
| not for long term resuscitation or | |||
| home use. | The Babyroo TN300 is an open | ||
| care radiant warmer that provides a | |||
| controlled source of heat and | |||
| regulation of skin temperature for | |||
| neonates and infants. The optional | |||
| integrated resuscitation module | |||
| provides emergency respiratory | |||
| support administered by clinicians | |||
| and includes the functionality of | |||
| suction. Additionally, the device | |||
| provides weighing (optional) of | |||
| neonates and infants. The device is | |||
| designed for use with patients with | |||
| a body weight up to 10 kg (22 lb). | |||
| The device is indicated for | |||
| thermoregulation, skin temperature | |||
| regulation, weighing (optional), and | |||
| resuscitation (optional) of neonates | |||
| and infants. | Same - The proposed device and | ||
| the predicate device are both | |||
| primarily intended for use for the | |||
| thermoregulation of infant patients | |||
| with the inclusion of resuscitation | |||
| (optional in both cases). The weigh | |||
| limitation (10 kg) for the proposed | |||
| device, is identical to the primary | |||
| predicate device (K120642) and is | |||
| established in the proposed device | |||
| contraindications. While not stated | |||
| in the cleared indications, weighing | |||
| functionality in the predicate device | |||
| (K120642) and APGAR timing in th | |||
| proposed device are present. | |||
| Contraindications | The Resuscitaire Radiant Warmer | ||
| is not intended for home use or | |||
| long-term resuscitation. | The device is contraindicated for | ||
| patients with a body weight above 10 | |||
| kg (22 lb). The device is not intended | |||
| for use outside of the specified | |||
| environments of | |||
| use. | |||
| Predicate Device | Proposed Device | Comment | |
| Resuscitaire® with AutoBreath | |||
| (K120642) | Babyroo TN300 | ||
| Environment of Use | For use in any location within a health | ||
| care facility where labor and delivery | |||
| may occur. | For use in labor and delivery units, | ||
| neonatal intensive care units, | |||
| operating rooms, and during intra- | |||
| hospital transfer where some of the | |||
| functions described in the intended | |||
| use description are not available. | Same - The intended environments | ||
| of use for the predicate device | |||
| (K120642) is inclusive of those for | |||
| the proposed device. | |||
| Fundamental principle of | |||
| operation | Controller-based, open care radiant | ||
| warmer that facilitates | |||
| thermoregulation and emergency | |||
| resuscitation of infants. | Controller-based, open care radiant | ||
| warmer that facilitates | |||
| thermoregulation and emergency | |||
| resuscitation of infants. | Same - The fundamental principle of | ||
| operation of the proposed device is | |||
| the same as that of the primary | |||
| predicate device (K120642). | |||
| Irradiance | 30% power - 10 mW/cm² | 30% power - 10 mW/cm² | |
| 60% power - 18 mW/cm² | |||
| 100% power - 32 mW/cm² | Same – The proposed device | ||
| features the same irradiance at 30% | |||
| power as the predicate device | |||
| (K120642). | |||
| Pre-warm Procedure | Power | ||
| Duration |
- 100%
3 min. - 60%
12 min. - 30%
*Until clinician sets a value. | Power
Duration
Display - 100%
3 min.
"Pre" - 60%
11.5 min.
"Pre" - 30%
"30"
*Until clinician sets a value. | Same - The proposed device
incorporates the same power
sequence during pre-warm as the
predicate device (K120642). |
| Warming Therapy Modes | - Skin temperature mode
- Manual mode | - Skin temperature mode
- Manual mode
- Kangaroo mode | Different - The warming therapy
modes offered in the predicate device
(K120642) include skin temperature
mode and manual mode. Kangaroo
mode is not present in the predicate
device (K120642). However, the
underlying questions of safety and
effectiveness are not affected as both
device have warming features and the
verification of requirements relating to
Kangaroo mode in the proposed
Babyroo TN300 device is included in
support of substantial equivalence. |
| Skin Temperature Mode | Temperature control by set value
for the skin temperature. | Temperature control by set value for
the skin temperature. | Same - The skin temperature
mode in the proposed device is |
| | The temperature can be set in
steps of 0.1 °C (0.1 °F). | The temperature can be set in steps
of 0.1 °C (0.1 °F). | identical to that of the predicate
device (K120642). |
| | Temperature Range Settings:
34°C to 37°C (93.2°F to 98.6°F) | Temperature Range Settings:
34°C to 37°C (93.2°F to 98.6°F) | |
| | Extended range: 37.1°C to 38°C
(98.7°F to 100.4°F) | Extended range: 37.1°C to 38°C
(98.7°F to 100.4°F) | |
| | Predicate Device | Proposed Device | Comment |
| | Resuscitaire® with AutoBreath
(K120642) | Babyroo TN300 | |
| Manual warming mode | Radiant warmer power is set
manually.
After the user sets the radiant
warmer power, a timer starts:
– After 10 minutes the "Check
patient" alarm is displayed.
– After 15 minutes, the radiant
warmer is switched off. | Radiant warmer power is set manually.
If the user sets the radiant warmer
power above 30 %, a timer starts and
the following alarms are displayed after
predefined time intervals:
– After 14 minutes the "Check patient's
condition" alarm is displayed.
– After 15 minutes, the radiant warmer
is switched off and the "Warmer off,
check patient's condition alarm" is
displayed. | Same - The manual warming mode
specification in the predicate device (K120642)
is inclusive of that of the proposed device. |
| Kangaroo warming mode | N/A | The patient is warmed by the parent's
body heat instead of the device. Once
kangaroo mode has been activated, the
device is maintained in manual mode
with 30 % of the radiant warmer power.
During kangarooing, the patient's
temperature is monitored continuously. | Different - The proposed device incorporates
kangaroo warming mode, which is not present
in the predicate device (K120642). While the
predicate device (K120642) does not
incorporate Kangaroo mode, the underlying
questions of safety and effectiveness are not
affected as both devices have warming
features and the verification of requirements
relating to Kangaroo mode in the proposed
Babyroo TN300 device is included in support
of substantial equivalence. |
| Skin temperature
measuring range | 18°C to 43°C (64.4° F to 109.4° F) | 13°C to 43°C (55.4° F to 109.4° F) | Different - The skin temperature
measurement range of the proposed device
is inclusive of that of the predicate device
(K120642). |
| Skin Temperature
Measurement Accuracy | Display Accuracy: ± 0.2°C | Overall Accuracy: ± 0.3° C (0.54° F) | Different - The skin temperature
measurement display accuracy of the
proposed device is slightly different than the
predicate device (K120642) Verification
testing included in support of substantial
equivalence demonstrates that underlying
questions of safety and effectiveness are
not affected . |
| Skin Temperature
Display | 0.1° | 0.1° | Same - The skin temperature display
resolution of the proposed device is the
same as that of the predicate device
(K120642). |
| | Predicate Device | Proposed Device | Comment |
| | Resuscitaire® with AutoBreath
(K120642) | Babyroo TN300 | |
| Primary patient outlet
adjustable airway pressure
limit | 0 cmH2O to 50 cmH2O | 0 cmH2O to 40 cmH2O | Different -The maximum airway pressure of
the proposed device does not exceed that of
the predicate device (K120642). Typical airway
pressures are administered at 30 to 40 cm H2O may be
required for patients without spontaneous
ventilation. As recommended by the American
Academy of Pediatrics (AAP)1 |
| Primary patient outlet fixed
airway pressure limit | 50 cmH2O ± 10% | 50 cmH2O ± 10% | Same - The proposed device's primary patient
outlet fixed airway pressure limit is identical to
that of the predicate device (K120642). |
| Primary Patient Outlet Flow
Control Range | 0 L/min. to 15 L/min. | 0 L/min. to 15 L/min. | Same - The proposed device's primary patient
outlet Flow Control Range is identical to that of
the predicate device (K120642). |
| Auxiliary Supply Pressure
Limit | 160 cmH2O ± 10% | 75 cmH2O ± 10% | Different -The maximum auxiliary supply
pressure limit of the proposed device does
not exceed the predicate device (K120642).
Typical airway pressures are administered at
14 cmH2O (at 15 L/min) | 14 cmH2O (at 15 L/min) | Same - The proposed device's adjustable PEEP
characteristics for its AutoBreath® functionality is
identical to that of the predicate device
(K120642). |
| Suction Circuit Adjustable
Suction Pressure | 0 kPa to 20 kPa (0 mmHg to 150
mmHg) | 0 kPa to 20 kPa (0 mmHg to 150
mmHg) | Same - The proposed device provides the same
suction pressure range as the predicate device
(K120642). |
| Suction Circuit Maximum
Flow Rate |