Who is the manufacturer of RESUSCITAIRE WITH AUTOBREATH?

Draeger Medical Systems, Inc. filed the 510(k) submission for RESUSCITAIRE WITH AUTOBREATH (K120642).

What is the FDA product code for RESUSCITAIRE WITH AUTOBREATH?

FMT. It is classified under 21 CFR 880.5130 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for RESUSCITAIRE WITH AUTOBREATH?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RESUSCITAIRE WITH AUTOBREATH?

Resuscitaire® Radiant Warmer (K003335); MVP-10 Infant Ventilator (K89638); Neopuff Infant Resuscitator (K892885).

Who can help prepare an FDA 510(k) submission like RESUSCITAIRE WITH AUTOBREATH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RESUSCITAIRE WITH AUTOBREATH

K120642 · Draeger Medical Systems, Inc. · FMT · Nov 2, 2012 · General Hospital

Device Facts

Record ID	K120642
Device Name	RESUSCITAIRE WITH AUTOBREATH
Applicant	Draeger Medical Systems, Inc.
Product Code	FMT · General Hospital
Decision Date	Nov 2, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5130
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The Resuscitaire® Radiant Warmer is intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10kg. It is not intended for long term resuscitation or home use.

Device Story

Resuscitaire Radiant Warmer provides thermoregulation, skin temperature monitoring, and APGAR timing for newborns. Modified version includes AutoBreath feature for automated resuscitation. Device consists of bassinet, warmer, and controller module. AutoBreath feature uses pneumatically driven logic circuit to provide gas-powered, time-cycled respiratory support via face mask. Operates in labor and delivery settings; used by clinicians. Provides consistent I:E ratio and respiratory rate, reducing human variation compared to manual resuscitation. Benefits include standardized, automated respiratory support during critical neonatal care. Output includes thermal regulation and controlled gas delivery for resuscitation.

Clinical Evidence

Bench testing only. Performance testing, functional/operation testing, verification and validation, biocompatibility (ISO 10993), and risk analysis were conducted to demonstrate substantial equivalence. No clinical data presented.

Technological Characteristics

Infant radiant warmer with integrated pneumatically driven logic circuit for AutoBreath. Materials biocompatible per ISO 10993. Connectivity: None. Sterilization: Not applicable. Software: None (pneumatic logic). Conical connectors per ISO 5356-1.

Indications for Use

Indicated for thermoregulation, skin temperature monitoring, APGAR timing, and resuscitation of newly born infants up to 10kg. Not for long-term resuscitation or home use.

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® Radiant Warmer (K003335)
MVP-10 Infant Ventilator (K89638)
Neopuff Infant Resuscitator (K892885)

Submission Summary (Full Text)

{0}------------------------------------------------ K12064'2 510(k) Summary acc. to 807.92 Drager Medical Systems, Inc. NOV 2 2012 3135 Quarry Road Telford, PA 18969 Establishment Registration Number: 2510954 Contact Person: Gale Winarsky Manager, Regulatory Affairs Phone: 215-660-2239 215-721-5424 Fax: Date summary was prepared: 2012-10-04 Device Name: Trade Name: Resuscitaire Radiant Warmer Classification Name: Regulation Number: Product Code: Class: Manufacturer Name and Address: Infant Radiant Warmer 21 CRF 880.5130 -FMT ll Legally Marketed Device Identification: Substantial equivalence is claimed to the Resuscitaire® Radiant Warmer K003335, Neopuff Infant Resuscitator K892885, and MVP-10 Infant Ventilator (MVP10) K89638. ## Device Description: The modified Resuscitaire Radiant Warmer is for newbom infants and consists of a bassinet, warmer and a controller module which provides heat control, monitoring of the skin temperature and an APGAR timer. It also includes optional manual and automated resuscitation with suction and oxygen delivery and a patient gas supply breathing circuit. ### Intended Use: The Resuscitaire Radiant Warmer is intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10kg. It is not intended for long term resuscitation or home use. {1}------------------------------------------------ Comparison of Technological Characteristics with Predicate Devices: · . " | Specification | Predicate | Predicate | Predicate | Device Under Review | Comments | |------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Resuscitaire® Radiant Warmer | MVP- 10K1Ventilator (MVP10) Predicate for AutoBreath Feature Only | Neopuff In- fant Resusci- tator Predicate for AutoBreath Feature Only | Resuscitaire® Radiant Warmer | | | Manufacturer | Hill-Rom Air Shields | Bio-Med Devices Inc. | Fisher & Paykel | Draeger Medical Systems, Inc. | | | 510(k) Number | K003335 | K896381 | K892885 | | | | Regulation Number | 880.5130 | 868.5895 | 868.5925 | 880.5130 | | | Product Code | FMT | CBK | BTL | FMT | | | Classification | II | II | II | II | | | Intended Use | Intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newborn in- fants in the labor and delivery room. | Intended for respiratory support of neo- natal and pedi- atric patients both in hospital and during transport. Pri- marily for use in applications requiring tidal volume up to 660 ml. May be used with a wide range of I:E ratios in- cluding inverse ratios. | Intended for resuscitation of infants in labor & deliv- ery, postnatal wards, ORs, transport, special care baby units, and NICUs | Thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newborn in- fants. It is not intended for home use or long-term resuscitation | The Intended Use has been modi- fied to clarify the use of the device with or without the AutoBreath option. | | Indications for Use | Thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newborn in- fants. | Not Found on FDA Site | Not Found on FDA Site | Thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10 kg. It is not in- tended for long- term resuscitation or home use. | The Indications have been modi- fied to clarify the use of the device with or without the AutoBreath option. | | Target Population/Patient Population | Newborn infants | Newborn and Pediatrics | Newborns and Pediatrics | Newly born in- fants up to 10 kg. | The 10 kg is in reference to the weight the Re- suscitaire Radiant Warmer bed is made to hold. | | Environment of Use | Labor and deliv- ery room in a Healthcare Facil- ity | | | Labor and deliv- ery setting in a Healthcare Facil- ity | | | AutoBreath™ Infant Resuscita- tor Feature (AB) | | | | | | | Specification | Predicate | Predicate | Predicate | Device Under Review | Comments | | Device Name | Resuscitaire® Radiant Warmer | MVP- 10K1Ventilator (MVP10) Predicate for AutoBreath Feature Only | Neopuff In- fant Resusci- tator Predicate for AutoBreath Feature Only | Resuscitaire® Radiant Warmer | | | Operating Principle | N/A | Gas powered, continuous flow, time cy- cled BPM, pneumatically driven logic circuit | Gas powered, continuous flow, manu- ally cycled BPM | Same as Predicate MVP-10 | | | I:E Ratio | N/A | 1:8 to 3:1 (adjustable) | Manually estimated | Fixed internally at 1:2 nominal (1:1.6 to 1:2.2) (non adjustable) | The fixed I:E ratio of the AB falls within the normal range for neona- tal ventilation as published in the. Assisted Ventila- tion of the Neo- nate 4th Edition copyright 2003, (1:1 to 1:3). Addi- tionally the 2010 AHA Guidelines for neonatal re- suscitation rec- ommend breath rates of 40 -60 BPM. All three devices can provide I:E ratios within the recommended range The Neopuff is manually esti- mated and con- trolled by the user therefore both the I:E ratio and BPM will vary. The preset I:E ratio of the RW82 w/ AB eliminates human variation by guaranteeing a consistent I:E ratio. The MVP-10 incorporates a | | Specification | Predicate | Predicate | Predicate | Device Under Review | Comments | | Device Name | Resuscitaire® Radiant Warmer | MVP- 10K1Ventilator (MVP10) Predicate for AutoBreath Feature Only | Neopuff In- fant Resusci- tator Predicate for AutoBreath Feature Only | Resuscitaire® Radiant Warmer | | | Adjustable PEEP | N/A | Variable up to $18 ± 3$ cm H2O at a flow of 6 l/min | @ 5 LPM 1-5 cm H20/mbar @ 8 LPM 1-9 cm H20/mbar @ 10 LPM 2- 15 cm H20/mbar @ 15 LPM 3- 25 cm H20/mbar | @ 5 LPM minimum PEEP <2 cm H2O @ 10 LPM minimum PEEP ≤ 4 cm H2O @15 LPM maximum PEEP > 14 cm H2O | ratios including inversion ratios for use outside L&D and with larger patients. The RW82 w/AB is only used for clinician adminis- tered short term resuscitation in L&D settings. Although not identical, the PEEP ranges are similar. Based on the application of use the differ- ences are not significant. For newborns the recommendations are: minimum PEEP from 3 to 4 cmH2O, and flow rate 5 to 8 LPM for low birth weight infants and flow rate 6 to 10 LPM for term infants | | Adjustable Respiratory Rate Range | Achieved via bag and mask resusci- tation, user de- pendant | Variable from 0 to 120 BPM | Achieved via t-piece breathing circuit, user dependant | 18 to 60 BPM ± 10% of setting | Both the RW82 w/ AB and the MVP10 allow the user to set the respiratory rate. The advantage of a set respiratory rate is to elimi- nate the human variation associ- ated with manu- ally controlled rates (RW82 & Neopuff). The MVP10 has a larger respira- tory rate range. | | | Predicate | | | | | | evice Name | Resuscitaired | 10K1Ventilato MVP10) Predicate fo AutoBreath Feature Only | Neopuff In- fant Resusci- aror Predicate for AutoBreath Feature Only | Radiant Warmer | | | | | | | | is due to the pa- tient population of the MVP10 which includes pediat- rics. The RW82 w/ AB is only intended for the resuscitation of newborns in L&D environments. | | Adjustable Airway Pressure Relief (range of working pressure) (PIP) | None | 10 cm H20 + 5 to 80 cm H2O + 10 | 2 to 80 cm H2O | 0 to 50 cmH2O + 5 cm H2O (0 to 4.9 kPa + 0.5 kPa) | The MVP10 and the Neopuff have a larger range based on patient populations for ventilation, while RW82 w/ AB is only intended for the resuscitation of newborns in L&D environ- ments. | | Fixed Max Pres- sure (P Lim min) | 160 cm H2O (15.7 kPa ) ± 10% | Variable up to 70 cm H2O ± 10 | Variable up to 80 cm H2O | 50 cm H2O + 10% (5.0 kPa + 10%) | The differences between the fixed max pressures of the MVP-10, Neopuff & Auto- Breath are re- lated to the envi- ronment in which resuscitation is provided. | | | | | | | The Neopuff uses a T-piece circuit with manually adjustable PEEP & PIP with higher fixed max. pres- sure for use in the NICU. | | | | | | | Like the Neopuff, the RW82 w/ AB also provides manually adjust- able PEEP & PIP. It differs in that it provides a lower fixed max. pres- sure because the | | Specification | Predicate | Predicate | Predicate | Device Under Review | Comments | | Device Name | Resuscitaire® Radiant Warmer | MVP- 10K1Ventilator (MVP10) Predicate for AutoBreath Feature Only | Neopuff In- fant Resusci- tator Predicate for AutoBreath Feature Only | Resuscitaire® Radiant Warmer | | | Fixed Min Pressure (P Lim min) | 0 cmH2O | 0 cmH2O | 0 cm H2O ±2 | Same as predicate RW82 | intended use is limited to the L&D. The RW82 is not a predicate for this function. | | Logic Circuit | None | Approx 4 LPM at 50 BPM | None | 5 LPM | Like the MVP-10 the RW82 w/ AB is a pneumatically controlled device. Both circuits con- trol the time inter- vals between exhalation and inspiration and the pressure in the patient circuit. | | Dead Space | N/A | 0.5 ml max | 6 ml | 3.4 ml | Dead space will vary based on the make up/mfg. of the patient breathing circuit. | | Body Weight Range | N/A | Applications requiring TV up 660 mls. | Up to 10 kg | Same as Neopuff | | | Patient Interface | N/A | Endotracheal Tube | Face Mask or Endotracheal Tube | Face Mask | | | Infant Resuscitator Feature | | | | | | | Patient Gas Supply Airway Pressure Limit, Operator Adjustable | 0 to 50 cm H2O (0 to 4.9 kPa) ± 10% of max set- ting | N/A | N/A | Same as predicate RW82 | | | Patient Outlet Flow Control Range | 0 to 15 LPM ± 3% of full scale or ± 10% of setting, whichever is greater | N/A | N/A | Same as predicate RW82 | | | Fixed Airway Pres- sure Limit, Preset | 60 cm H2O (4.9 kPa) ± 20 % of setting | N/A | N/A | Same as predicate RW82 | | | Auxiliary Supply Pressure Limit | 160 cm H2O (15.7 kPa) ± 10% of setting | N/A | N/A | Same as predicate RW82 | | | Specification | Predicate | Predicate | Predicate | Device Under Review | Comments | | Device Name | Resuscitaire® Radiant Warmer | MVP- 10K1Ventilator (MVP10) Predicate for AutoBreath Feature Only | Neopuff In- fant Resusci- tator Predicate for AutoBreath Feature Only | Resuscitaire® Radiant Warmer | | | Auxiliary Flow Control Range | 0 to 15 LPM ± 3% of full scale or ± 10 % of setting whichever is greater | N/A | N/A | Same as predicate RW82 | | : ・ : {2}------------------------------------------------ ・ -・ : Page 3 of 8 · · : {3}------------------------------------------------ · . . . . . . Page 4 of 8 {4}------------------------------------------------ 1 : Page 5 of 8 · · {5}------------------------------------------------ 1. September 2017 {6}------------------------------------------------ ### Discussion of Non-clinical Studies: The modification of the RW82 to include AutoBreath was tested in accordance with applicable standards, guidance and internal design control procedures including performance testing, functional/operation testing, verification and validation, biocompatibility, risk analysis and verification of risk control measures and was determined to be as safe and effective for its intended use as the predicates. Testing performed indicate that the modifications as described in this submission have not altered the fundamental application of the device in its intended environment. ### Biocompatibility: Testing was performed to ISO 10993. The results show the relevant components to be biocompatible. ### Sterilization: Not applicable Standards and Guidance: Performance Standards: None International Standards: ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets ISO 10651-5:2006 -- Lung ventilators for medical use -- Particular requirements for basic safety and essential performance - Part 5 AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices - Part 5, Tests for in vitro Cytotoxicity AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices - Part 10, Tests for irritation and delayed hypersensitivity AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices - Part 12, Sample preparation and reference materials ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets Page 7 of 8 {7}------------------------------------------------ **Dräger** Guidance: Draft Emergency Resuscitator Guidance, April 1993 Draft Reviewer Guidance for Ventilators, July 1995 Conclusion Drawn from Non-Clinical Studies: The results of the non-clinical testing, and comparison to the predicate devices show that the modified Resuscitaire Radiant Warmer meets the performance requirements of the standards and guidance mentioned above and is substantially equivalent to the predicate devices. {8}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Dräger Medical Systems, Incorporated Ms. Gale Winarsky Manager, Regulatory Affairs 3135 Quarry Road Telford, Pennsylvania 18969 November 2, 2012 Re: K120642 Trade/Device Name: Resuscitaire Radiant Warmer Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: October 5, 2012 Received: October 9, 2012 Dear Ms. Winarsky: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {9}------------------------------------------------ ## Page 2 - Ms. Winarsky 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 go'to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Sm…

RESUSCITAIRE WITH AUTOBREATH

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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RESUSCITAIRE WITH AUTOBREATH

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

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