Babyroo TN300

K230278 · Draeger Medical Systems, Inc. · FMT · May 30, 2023 · General Hospital

Device Facts

• Record ID: K230278
• Device Name: Babyroo TN300
• Applicant: Draeger Medical Systems, Inc.
• Product Code: FMT · General Hospital
• Decision Date: May 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 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.

Device Story

Babyroo TN300 is an open care radiant warmer for neonates/infants (up to 10 kg) in NICUs, labor/delivery, ORs, or during intra-hospital transfer. Device provides thermoregulation via radiant warmer and optional heating plate/gel mattress. Three modes: Manual (clinician-set power), Skin Temperature (sensor-regulated), and Kangaroo (monitored body heat). Optional pneumatic resuscitation module provides emergency respiratory support/suction, including AutoBreath functionality for automated respiratory rate/PEEP control. Clinicians operate device via control interface; output includes temperature display, weight, and respiratory parameters. Device aids clinical decision-making by maintaining infant thermal stability and providing emergency respiratory intervention. Benefits include controlled warming and integrated resuscitation capabilities.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical performance testing, including functional/operational testing, biocompatibility, human factors, risk analysis, and verification of risk control measures per consensus standards (IEC 60601 series, ISO 10993, etc.).

Technological Characteristics

Open care radiant warmer; controller-based; fixed/adjustable trolley. Features: radiant heater, optional heating plate, pneumatic resuscitation module, integrated scale. Connectivity: Nurse call, USB (data import/export), RJ45 service port. Standards: IEC 60601-1, IEC 60601-2-21, IEC 80601-2-35, ISO 10993-1, ISO 18562-1. Software lifecycle per IEC 62304.

Indications for Use

Indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants up to 10 kg (22 lb). Contraindicated for patients >10 kg.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Resuscitaire® with AutoBreath® (K120642)

Reference Devices

• Babyleo TN500 (K182859)

Submission Summary (Full Text)

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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

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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 [phone] 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

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### 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)

| <span style="font-size:10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(k) Summary K230278

| 1. Submitter: | Draeger Medical Systems, Inc.<br>3135 Quarry Road<br>Telford, PA 18951 | | |
|---------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | Contact Person: | Karl Nittinger<br>Manager, Regulatory Affairs<br>E-Mail: [e-mail]<br>Telephone: [phone] | |
| | Date prepared: | 30 May 2023 | |
| 2. | Device: | Trade Name:<br>Common Name:<br>Classification Name:<br>Regulation Number:<br>Product Code:<br>Class: | Babyroo TN300<br>Infant Radiant Warmer<br>Infant Radiant Warmer<br>21 CFR §880.5130<br>FMT<br>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<br>AutoBreath® | K120642 | Draeger Medical Systems,<br>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<br>Performance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential<br>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<br>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 –<br>Collateral Standard: General requirements, tests and guidance for alarm systems in<br>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<br>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<br>performance of heating devices using blankets, pads and mattresses and intended for heating in<br>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<br>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<br>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<br>resterilizable medical devices |

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#### 7. Substantial Equivalence Comparison and Discussion

| | Predicate Device | Proposed Device | Comment |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Resuscitaire® with AutoBreath<br>(K120642) | Babyroo TN300 | |
| Regulation | 880.5130 | 880.5130 | Same - The proposed device and |
| Product Code | FMT | FMT | the predicate device (K120642) are<br>Class II devices regulated under |
| Classification | II | II | 880.5130 (product code: FMT). |
| Indications for Use | The Resuscitaire® Radiant Warmer<br>is intended for thermoregulation,<br>skin temperature monitoring,<br>APGAR timing and resuscitation of<br>newly born infants up to 10 kg. It is<br>not for long term resuscitation or<br>home use. | The Babyroo TN300 is an open<br>care radiant warmer that provides a<br>controlled source of heat and<br>regulation of skin temperature for<br>neonates and infants. The optional<br>integrated resuscitation module<br>provides emergency respiratory<br>support administered by clinicians<br>and includes the functionality of<br>suction. Additionally, the device<br>provides weighing (optional) of<br>neonates and infants. The device is<br>designed for use with patients with<br>a body weight up to 10 kg (22 lb).<br>The device is indicated for<br>thermoregulation, skin temperature<br>regulation, weighing (optional), and<br>resuscitation (optional) of neonates<br>and infants. | Same - The proposed device and<br>the predicate device are both<br>primarily intended for use for the<br>thermoregulation of infant patients<br>with the inclusion of resuscitation<br>(optional in both cases). The weigh<br>limitation (10 kg) for the proposed<br>device, is identical to the primary<br>predicate device (K120642) and is<br>established in the proposed device<br>contraindications. While not stated<br>in the cleared indications, weighing<br>functionality in the predicate device<br>(K120642) and APGAR timing in th<br>proposed device are present. |
| Contraindications | The Resuscitaire Radiant Warmer<br>is not intended for home use or<br>long-term resuscitation. | The device is contraindicated for<br>patients with a body weight above 10<br>kg (22 lb). The device is not intended<br>for use outside of the specified<br>environments of<br>use. | |
| | Predicate Device | Proposed Device | Comment |
| | Resuscitaire® with AutoBreath<br>(K120642) | Babyroo TN300 | |
| Environment of Use | For use in any location within a health<br>care facility where labor and delivery<br>may occur. | For use in labor and delivery units,<br>neonatal intensive care units,<br>operating rooms, and during intra-<br>hospital transfer where some of the<br>functions described in the intended<br>use description are not available. | Same - The intended environments<br>of use for the predicate device<br>(K120642) is inclusive of those for<br>the proposed device. |
| Fundamental principle of<br>operation | Controller-based, open care radiant<br>warmer that facilitates<br>thermoregulation and emergency<br>resuscitation of infants. | Controller-based, open care radiant<br>warmer that facilitates<br>thermoregulation and emergency<br>resuscitation of infants. | Same - The fundamental principle of<br>operation of the proposed device is<br>the same as that of the primary<br>predicate device (K120642). |
| Irradiance | 30% power - 10 mW/cm² | 30% power - 10 mW/cm²<br>60% power - 18 mW/cm²<br>100% power - 32 mW/cm² | Same – The proposed device<br>features the same irradiance at 30%<br>power as the predicate device<br>(K120642). |
| Pre-warm Procedure | Power<br>Duration<br>1. 100%<br>3 min.<br>2. 60%<br>12 min.<br>3. 30%<br>*Until clinician sets a value. | Power<br>Duration<br>Display<br>1. 100%<br>3 min.<br>"Pre"<br>2. 60%<br>11.5 min.<br>"Pre"<br>3. 30%<br>*<br>"30"<br>*Until clinician sets a value. | Same - The proposed device<br>incorporates the same power<br>sequence during pre-warm as the<br>predicate device (K120642). |
| Warming Therapy Modes | - Skin temperature mode<br>- Manual mode | - Skin temperature mode<br>- Manual mode<br>- Kangaroo mode | Different - The warming therapy<br>modes offered in the predicate device<br>(K120642) include skin temperature<br>mode and manual mode. Kangaroo<br>mode is not present in the predicate<br>device (K120642). However, the<br>underlying questions of safety and<br>effectiveness are not affected as both<br>device have warming features and the<br>verification of requirements relating to<br>Kangaroo mode in the proposed<br>Babyroo TN300 device is included in<br>support of substantial equivalence. |
| Skin Temperature Mode | Temperature control by set value<br>for the skin temperature. | Temperature control by set value for<br>the skin temperature. | Same - The skin temperature<br>mode in the proposed device is |
| | The temperature can be set in<br>steps of 0.1 °C (0.1 °F). | The temperature can be set in steps<br>of 0.1 °C (0.1 °F). | identical to that of the predicate<br>device (K120642). |
| | Temperature Range Settings:<br>34°C to 37°C (93.2°F to 98.6°F) | Temperature Range Settings:<br>34°C to 37°C (93.2°F to 98.6°F) | |
| | Extended range: 37.1°C to 38°C<br>(98.7°F to 100.4°F) | Extended range: 37.1°C to 38°C<br>(98.7°F to 100.4°F) | |
| | Predicate Device | Proposed Device | Comment |
| | Resuscitaire® with AutoBreath<br>(K120642) | Babyroo TN300 | |
| Manual warming mode | Radiant warmer power is set<br>manually.<br>After the user sets the radiant<br>warmer power, a timer starts:<br>– After 10 minutes the "Check<br>patient" alarm is displayed.<br>– After 15 minutes, the radiant<br>warmer is switched off. | Radiant warmer power is set manually.<br>If the user sets the radiant warmer<br>power above 30 %, a timer starts and<br>the following alarms are displayed after<br>predefined time intervals:<br>– After 14 minutes the "Check patient's<br>condition" alarm is displayed.<br>– After 15 minutes, the radiant warmer<br>is switched off and the "Warmer off,<br>check patient's condition alarm" is<br>displayed. | Same - The manual warming mode<br>specification in the predicate device (K120642)<br>is inclusive of that of the proposed device. |
| Kangaroo warming mode | N/A | The patient is warmed by the parent's<br>body heat instead of the device. Once<br>kangaroo mode has been activated, the<br>device is maintained in manual mode<br>with 30 % of the radiant warmer power.<br>During kangarooing, the patient's<br>temperature is monitored continuously. | Different - The proposed device incorporates<br>kangaroo warming mode, which is not present<br>in the predicate device (K120642). While the<br>predicate device (K120642) does not<br>incorporate Kangaroo mode, the underlying<br>questions of safety and effectiveness are not<br>affected as both devices have warming<br>features and the verification of requirements<br>relating to Kangaroo mode in the proposed<br>Babyroo TN300 device is included in support<br>of substantial equivalence. |
| Skin temperature<br>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<br>measurement range of the proposed device<br>is inclusive of that of the predicate device<br>(K120642). |
| Skin Temperature<br>Measurement Accuracy | Display Accuracy: ± 0.2°C | Overall Accuracy: ± 0.3° C (0.54° F) | Different - The skin temperature<br>measurement display accuracy of the<br>proposed device is slightly different than the<br>predicate device (K120642) Verification<br>testing included in support of substantial<br>equivalence demonstrates that underlying<br>questions of safety and effectiveness are<br>not affected . |
| Skin Temperature<br>Display | 0.1° | 0.1° | Same - The skin temperature display<br>resolution of the proposed device is the<br>same as that of the predicate device<br>(K120642). |
| | Predicate Device | Proposed Device | Comment |
| | Resuscitaire® with AutoBreath<br>(K120642) | Babyroo TN300 | |
| Primary patient outlet<br>adjustable airway pressure<br>limit | 0 cmH2O to 50 cmH2O | 0 cmH2O to 40 cmH2O | Different -The maximum airway pressure of<br>the proposed device does not exceed that of<br>the predicate device (K120642). Typical airway<br>pressures are administered at < 30 cm H2O. In<br>some cases, >30 to 40 cm H2O may be<br>required for patients without spontaneous<br>ventilation. As recommended by the American<br>Academy of Pediatrics (AAP)1 |
| Primary patient outlet fixed<br>airway pressure limit | 50 cmH2O ± 10% | 50 cmH2O ± 10% | Same - The proposed device's primary patient<br>outlet fixed airway pressure limit is identical to<br>that of the predicate device (K120642). |
| Primary Patient Outlet Flow<br>Control Range | 0 L/min. to 15 L/min. | 0 L/min. to 15 L/min. | Same - The proposed device's primary patient<br>outlet Flow Control Range is identical to that of<br>the predicate device (K120642). |
| Auxiliary Supply Pressure<br>Limit | 160 cmH2O ± 10% | 75 cmH2O ± 10% | Different -The maximum auxiliary supply<br>pressure limit of the proposed device does<br>not exceed the predicate device (K120642).<br>Typical airway pressures are administered at<br>< 30 cm H₂O. In some cases. ≥30 to 40 cm<br>H2O may be required for patients without<br>spontaneous ventilation. As recommended by<br>the American Academy of Pediatrics (AAP)1 |
| Blender Module Adjustable<br>O2 Concentration | 21 % to 100 % | 21 % to 100 % | Same - The proposed device's adjustable<br>O2 concentration range identical to that of<br>the predicate device (K120642). |
| Operating principle | Gas powered, continuous flow,<br>time cycled breaths per minute,<br>pneumatically driven logic circuit. | Gas powered, continuous flow,<br>time cycled breaths per minute,<br>pneumatically driven logic circuit | Same - The proposed device's optional<br>AutoBreath® functionality is identical to that<br>of the predicate device (K120642). |
| I:E Ratio | Non-adjustable. Fixed internally<br>at 1:2 nominal (1:1.6 to 1:2.4) | Non-adjustable. Fixed internally at<br>1:2 nominal (1:1.6 to 1:2.4) | Same - The proposed device's I:E ratio for<br>its AutoBreath® functionality is identical to<br>that of the predicate device (K120642). |
| | Predicate Device | Proposed Device | Comment |
| | Resuscitaire® with AutoBreath<br>(K120642) | Babyroo TN300 | |
| Adjustable PEEP | < 2 cmH2O (at 5 L/min)<br>≤ 4 cmH2O (at 10 L/min)<br>> 14 cmH2O (at 15 L/min) | < 2 cmH2O (at 5 L/min)<br>≤ 4 cmH2O (at 10 L/min)<br>> 14 cmH2O (at 15 L/min) | Same - The proposed device's adjustable PEEP<br>characteristics for its AutoBreath® functionality is<br>identical to that of the predicate device<br>(K120642). |
| Suction Circuit Adjustable<br>Suction Pressure | 0 kPa to 20 kPa (0 mmHg to 150<br>mmHg) | 0 kPa to 20 kPa (0 mmHg to 150<br>mmHg) | Same - The proposed device provides the same<br>suction pressure range as the predicate device<br>(K120642). |
| Suction Circuit Maximum<br>Flow Rate | < 20 L/min. | < 20 L/min. | Same - The proposed device provides the same<br>suction maximum flow rate as the predicate<br>device (K120642).…