RESUSCITAIRE WITH AUTOBREATH by Draeger Medical Systems, Inc.

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 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Resuscitaire Radiant Warmer." This type of document is for premarket notification of a device claiming substantial equivalence to a legally marketed predicate device, not typically for evaluating AI/algorithm performance. Therefore, much of the requested information, specifically regarding AI algorithm performance, ground truth, sample sizes for training/test sets, expert adjudication methods, and MRMC studies, is not applicable to this type of traditional medical device submission.

The "study" described in this document is a comparison of technological characteristics with predicate devices and non-clinical testing to demonstrate safety and effectiveness for a modified device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table with corresponding device performance metrics in the typical format for AI/algorithm performance studies. Instead, it compares specifications and performance characteristics of the device under review (Resuscitaire Radiant Warmer with AutoBreath feature) against three predicate devices. The "reported device performance" is implied by demonstrating substantial equivalence across these characteristics.

Based on the "Comparison of Technological Characteristics with Predicate Devices" table, here's an attempt to structure relevant points into the requested format, focusing on the added AutoBreath™ Infant Resuscitator Feature (AB) as it represents the primary modification and subject of comparative analysis. It's important to note that the "acceptance criteria" here are essentially the characteristics of the predicate devices or established medical norms.

Acceptance Criteria (Based on Predicate Devices/Medical Norms)	Reported Device Performance (Resuscitaire Radiant Warmer with AutoBreath-AB)	Comments from Document
I:E Ratio: Within normal range for neonatal ventilation (e.g., 1:1 to 1:3). Predicate MVP-10: 1:8 to 3:1 (adjustable). Predicate Neopuff: 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 neonatal ventilation as published in the Assisted Ventilation of the Neonate 4th Edition copyright 2003, (1:1 to 1:3). Additionally the 2010 AHA Guidelines for neonatal resuscitation recommend breath rates of 40 -60 BPM. All three devices can provide I:E ratios within the recommended range. The Neopuff is manually estimated and controlled 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."
Adjustable PEEP: Minimum 3-4 cmH2O for newborns, flow rate 5-8 LPM for low birth weight, 6-10 LPM for term infants. Predicate MVP-10: Variable up to 18 ± 3 cm H2O. Predicate Neopuff: 1-25 cm H2O/mbar across different LPMs.	@ 5 LPM minimum PEEP < 2 cm H2O. @ 10 LPM minimum PEEP ≤ 4 cm H2O. @ 15 LPM maximum PEEP > 14 cm H2O.	"Although not identical, the PEEP ranges are similar. Based on the application of use the differences 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: Predicate MVP-10: 0 to 120 BPM. Predicate Neopuff: User dependent.	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 eliminate the human variation associated with manually controlled rates (RW82 & Neopuff). The MVP10 has a larger respiratory rate range, is due to the patient population of the MVP10 which includes pediatrics. The RW82 w/ AB is only intended for the resuscitation of newborns in L&D environments."
Adjustable Airway Pressure Relief (PIP): Predicate MVP-10: 10 + 5 to 80 + 10 cm H2O. Predicate Neopuff: 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 environments."
Fixed Max Pressure (P Lim min): Predicate MVP-10: Variable up to 70 ± 10 cm H2O. Predicate Neopuff: 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 related to the environment in which resuscitation is provided... Like the Neopuff, the RW82 w/ AB also provides manually adjustable PEEP & PIP. It differs in that it provides a lower fixed max. pressure because the intended use is limited to the L&D."
Fixed Min Pressure (P Lim min): Predicate RW82: 0 cmH2O. Predicate MVP-10: 0 cmH2O. Predicate Neopuff: 0 cm H2O ± 2.	Same as predicate RW82 (0 cmH2O).	None specified beyond "Same as predicate RW82". This indicates it meets or is equivalent to the predicate.
Logic Circuit (Pneumatic Control): Predicate MVP-10: Approx 4 LPM at 50 BPM. Predicate Neopuff: None.	5 LPM (for pneumatic control for AutoBreath).	"Like the MVP-10 the RW82 w/ AB is a pneumatically controlled device. Both circuits control the time intervals between exhalation and inspiration and the pressure in the patient circuit."
Dead Space: Predicate MVP-10: 0.5 ml max. Predicate Neopuff: 6 ml.	3.4 ml.	"Dead space will vary based on the make up/mfg. of the patient breathing circuit."
Body Weight Range: Predicate MVP-10: Applications requiring TV up 660 ml. Predicate Neopuff: Up to 10 kg.	Same as Neopuff (up to 10 kg).	This indicates it meets or is equivalent to the predicate.
Patient Interface: Predicate MVP-10: Endotracheal Tube. Predicate Neopuff: Face Mask or Endotracheal Tube.	Face Mask.	None.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. This device is a hardware product with added functionality, not an AI/algorithm. The "testing" referred to is engineering verification and validation, as well as comparison of specifications to predicate devices.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/algorithm being evaluated for diagnostic or prognostic accuracy against a ground truth established by experts. The "ground truth" for this device's performance is its physical and functional specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The AutoBreath feature is an integrated pneumatic control system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of an AI/algorithm's "ground truth." For this device, the "ground truth" for its performance evaluation (non-clinical testing) refers to established engineering standards, guidance documents (e.g., ISO, AAMI/ANSI), and the performance characteristics of its predicate devices, as well as physiological recommendations for neonatal resuscitation (e.g., AHA Guidelines for neonatal resuscitation).

8. The sample size for the training set

Not applicable. There is no training set for this type of device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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:

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.

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Comparison of Technological Characteristics with Predicate Devices:

. "

Specification	Predicate	Predicate	Predicate	DeviceUnderReview	Comments
Device Name	Resuscitaire®Radiant Warmer	MVP-10K1Ventilator(MVP10)Predicate forAutoBreathFeature Only	Neopuff In-fant Resusci-tatorPredicate forAutoBreathFeature Only	Resuscitaire®Radiant Warmer
Manufacturer	Hill-Rom AirShields	Bio-MedDevices Inc.	Fisher &Paykel	Draeger MedicalSystems, 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 forthermoregulation,skin temperaturemonitoring,APGAR timingand resuscitationof newborn in-fants in the laborand deliveryroom.	Intended forrespiratorysupport of neo-natal and pedi-atric patientsboth in hospitaland duringtransport. Pri-marily for usein applicationsrequiring tidalvolume up to660 ml. Maybe used with awide range ofI:E ratios in-cluding inverseratios.	Intended forresuscitationof infants inlabor & deliv-ery, postnatalwards, ORs,transport,special carebaby units,and NICUs	Thermoregulation,skin temperaturemonitoring,APGAR timingand resuscitationof newborn in-fants. It is notintended for homeuse or long-termresuscitation	The Intended Usehas been modi-fied to clarify theuse of the devicewith or withoutthe AutoBreathoption.
Indications for Use	Thermoregulation,skin temperaturemonitoring,APGAR timingand resuscitationof newborn in-fants.	Not Found onFDA Site	Not Found onFDA Site	Thermoregulation,skin temperaturemonitoring,APGAR timingand resuscitationof newly borninfants up to 10kg. It is not in-tended for long-term resuscitationor home use.	The Indicationshave been modi-fied to clarify theuse of the devicewith or withoutthe AutoBreathoption.
TargetPopulation/PatientPopulation	Newborn infants	Newborn andPediatrics	NewbornsandPediatrics	Newly born in-fants up to 10 kg.	The 10 kg is inreference to theweight the Re-suscitaire RadiantWarmer bed ismade to hold.
Environment ofUse	Labor and deliv-ery room in aHealthcare Facil-ity			Labor and deliv-ery setting in aHealthcare 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 forAutoBreathFeature Only	Neopuff In-fant Resusci-tatorPredicate forAutoBreathFeature Only	Resuscitaire®Radiant Warmer
Operating Principle	N/A	Gas powered,continuousflow, time cy-cled BPM,pneumaticallydriven logiccircuit	Gas powered,continuousflow, manu-ally cycledBPM	Same asPredicate MVP-10
I:E Ratio	N/A	1:8 to 3:1(adjustable)	Manuallyestimated	Fixed internally at1:2 nominal (1:1.6to 1:2.2) (nonadjustable)	The fixed I:E ratioof the AB fallswithin the normalrange for neona-tal ventilation aspublished in the.Assisted Ventila-tion of the Neo-nate 4th Editioncopyright 2003,(1:1 to 1:3). Addi-tionally the 2010AHA Guidelinesfor neonatal re-suscitation rec-ommend breathrates of 40 -60BPM.All three devicescan provide I:Eratios within therecommendedrangeThe Neopuff ismanually esti-mated and con-trolled by the usertherefore both theI:E ratio and BPMwill vary.The preset I:Eratio of the RW82w/ AB eliminateshuman variationby guaranteeinga consistent I:Eratio.The MVP-10incorporates a
Specification	Predicate	Predicate	Predicate	Device Under Review	Comments
Device Name	Resuscitaire®Radiant Warmer	MVP-10K1Ventilator(MVP10)Predicate forAutoBreathFeature Only	Neopuff In-fant Resusci-tatorPredicate forAutoBreathFeature Only	Resuscitaire®Radiant Warmer
Adjustable PEEP	N/A	Variable up to$18 ± 3$ cm H2Oat a flow of 6l/min	@ 5 LPM 1-5cm H20/mbar@ 8 LPM 1-9cm H20/mbar@ 10 LPM 2-15 cmH20/mbar@ 15 LPM 3-25 cmH20/mbar	@ 5 LPMminimum PEEP<2 cm H2O@ 10 LPMminimum PEEP ≤4 cm H2O@15 LPMmaximum PEEP> 14 cm H2O	ratios includinginversion ratiosfor use outsideL&D and withlarger patients.The RW82 w/ABis only used forclinician adminis-tered short termresuscitation inL&D settings.Although notidentical, thePEEP ranges aresimilar. Based onthe application ofuse the differ-ences are notsignificant.For newborns therecommendationsare: minimumPEEP from 3 to 4cmH2O, and flowrate 5 to 8 LPMfor low birthweight infantsand flow rate 6 to10 LPM for terminfants
AdjustableRespiratory RateRange	Achieved via bagand mask resusci-tation, user de-pendant	Variable from 0to 120 BPM	Achieved viat-piecebreathingcircuit, userdependant	18 to 60 BPM ±10% of setting	Both the RW82w/ AB and theMVP10 allow theuser to set therespiratory rate.The advantage ofa set respiratoryrate is to elimi-nate the humanvariation associ-ated with manu-ally controlledrates (RW82 &Neopuff).The MVP10 hasa larger respira-tory rate range.
	Predicate
evice Name	Resuscitaired	10K1VentilatoMVP10)Predicate foAutoBreathFeature Only	Neopuff In-fant Resusci-arorPredicate forAutoBreathFeature Only	Radiant Warmer
					is due to the pa-tient population ofthe MVP10 whichincludes pediat-rics. The RW82w/ AB is onlyintended for theresuscitation ofnewborns in L&Denvironments.
Adjustable AirwayPressure Relief(range of workingpressure) (PIP)	None	10 cm H20 + 5to 80 cm H2O+ 10	2 to 80 cmH2O	0 to 50 cmH2O +5 cm H2O (0 to4.9 kPa + 0.5kPa)	The MVP10 andthe Neopuff havea larger rangebased on patientpopulations forventilation, whileRW82 w/ AB isonly intended forthe resuscitationof newborns inL&D environ-ments.
Fixed Max Pres-sure (P Lim min)	160 cm H2O(15.7 kPa ) ± 10%	Variable up to70 cm H2O ±10	Variable up to80 cm H2O	50 cm H2O +10% (5.0 kPa +10%)	The differencesbetween the fixedmax pressures ofthe MVP-10,Neopuff & Auto-Breath are re-lated to the envi-ronment in whichresuscitation isprovided.
					The Neopuff usesa T-piece circuitwith manuallyadjustable PEEP& PIP with higherfixed max. pres-sure for use inthe NICU.
					Like the Neopuff,the RW82 w/ ABalso providesmanually adjust-able PEEP & PIP.It differs in that itprovides a lowerfixed max. pres-sure because the
Specification	Predicate	Predicate	Predicate	Device Under Review	Comments
Device Name	Resuscitaire®Radiant Warmer	MVP-10K1Ventilator(MVP10)Predicate forAutoBreathFeature Only	Neopuff In-fant Resusci-tatorPredicate forAutoBreathFeature Only	Resuscitaire®Radiant Warmer
Fixed Min Pressure(P Lim min)	0 cmH2O	0 cmH2O	0 cm H2O ±2	Same aspredicate RW82	intended use islimited to theL&D.The RW82 is nota predicate forthis function.
Logic Circuit	None	Approx 4 LPMat 50 BPM	None	5 LPM	Like the MVP-10the RW82 w/ ABis a pneumaticallycontrolled device.Both circuits con-trol the time inter-vals betweenexhalation andinspiration andthe pressure inthe patient circuit.
Dead Space	N/A	0.5 ml max	6 ml	3.4 ml	Dead space willvary based on themake up/mfg. ofthe patientbreathing circuit.
Body WeightRange	N/A	Applicationsrequiring TV up660 mls.	Up to 10 kg	Same as Neopuff
Patient Interface	N/A	EndotrachealTube	Face Mask orEndotrachealTube	Face Mask
InfantResuscitatorFeature
Patient Gas SupplyAirway PressureLimit, OperatorAdjustable	0 to 50 cm H2O(0 to 4.9 kPa) ±10% of max set-ting	N/A	N/A	Same aspredicate RW82
Patient Outlet FlowControl Range	0 to 15 LPM ± 3%of full scale or ±10% of setting,whichever isgreater	N/A	N/A	Same aspredicate RW82
Fixed Airway Pres-sure Limit, Preset	60 cm H2O (4.9kPa) ± 20 % ofsetting	N/A	N/A	Same aspredicate RW82
Auxiliary SupplyPressure Limit	160 cm H2O(15.7 kPa) ± 10%of setting	N/A	N/A	Same aspredicate RW82
Specification	Predicate	Predicate	Predicate	DeviceUnderReview	Comments
Device Name	Resuscitaire®Radiant Warmer	MVP-10K1Ventilator(MVP10)Predicate forAutoBreathFeature Only	Neopuff In-fant Resusci-tatorPredicate forAutoBreathFeature Only	Resuscitaire®Radiant Warmer
Auxiliary FlowControl Range	0 to 15 LPM ± 3%of full scale or ±10 % of settingwhichever isgreater	N/A	N/A	Same aspredicate RW82

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September 2017

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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

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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.

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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.

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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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Digitally signed by Anthony D. Watson DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300092402 Date: 2012.11.02 12:55:46 -04'00"

Anthony D. Watson, B.S., M.S., M.B.A.

Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_K120642

Device Name: Resuscitaire Radiant Warmer

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ·

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhi Chy 11/2/12
K120642

Page 1 of 1 __

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesionomial Devices Division of Anesthoolor Device

510(k) Number: K/20642

510(k) Number:

Regulation Number and Section

§ 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.