Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a radiant warmer with basic control and monitoring functions, including an APGAR timer and optional resuscitation features. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on the safety and effectiveness of the modifications compared to predicate devices, not on the performance of an AI/ML algorithm.

Therapeutic

Yes
The device is described as providing thermoregulation, resuscitation (with suction and oxygen delivery), and is used for newly born infants, which are all therapeutic interventions.

Diagnostic

No

Explanation: The device is a radiant warmer for thermoregulation, monitoring, and resuscitation, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of hardware components including a bassinet, warmer, controller module, and optional resuscitation hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for thermoregulation, skin temperature monitoring, APGAR timing, and resuscitation of newly born infants. These are all direct patient care activities, not laboratory testing of samples from the body.
Device Description: The description details a physical device (bassinet, warmer, controller module, resuscitation components) used for direct patient support and monitoring. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or laboratory procedures.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is entirely focused on providing external support and monitoring to the infant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FMT

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.

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

newly born infants

Intended User / Care Setting

Labor and delivery room in a Healthcare Facility. Clinician administered.

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)

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.

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.

K003335, K896381, K892885

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.

Not Found

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

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.

Summary

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 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.

:

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5

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 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

10

Indications for Use

510(k) Number (if known):_K120642

Device Name: Resuscitaire Radiant Warmer

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.

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: