Predicate Devices

K 94 5467

Reference Devices

RH 600 (K 95 3489), PT 4000 (K 95 4611), Microlite™ (K 91 2908)

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard infant warmer system with radiant heating, a heated mattress, and optional phototherapy. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices. The control modes mentioned ("manual mode" and "skin temperature control") suggest traditional feedback control mechanisms.

Therapeutic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended as a therapeutic device providing warmth for premature and full-term neonates and infants". Additionally, it mentions an optional phototherapy system "for treatment of Hyperbilirubinemia".

Diagnostic

No

The device is described as a "therapeutic device providing warmth" and for "treatment of Hyperbilirubinemia," indicating a treatment rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a heated mattress, radiant heater, and optional phototherapy system, indicating it is not a software-only device.

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 to provide warmth for infants as a therapeutic device. This is a direct treatment or support function, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a warmer system with a radiant heater, heated mattress, and optional phototherapy. These are all physical interventions or support systems, not diagnostic tools.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.

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

FMT

Device Description

Babytherm 8004 / 8010 is a warmer system for infants that provides a combination of a heated mattress (Babytherm 8010, only), a radiant heater and an optional phototherapy system. The radiant heater is in a fixed position over the mattress and is equipped with an examination light. The phototherapy system can be installed by the manufacturer or by the biomedical engineer in the housing of the radiant heater.

Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control".

Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth.

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

premature and full-term neonates and infants

Intended User / Care Setting

It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units.

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)

Not Found

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.

Babytherm 8000 WB (K 94 5467)

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.

RH 600 (K 95 3489), PT 4000 (K 95 4611), Microlite™ (K 91 2908)

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

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Image /page/0/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font, with two dots above the "a". Above the word "Dräger" is the number "1971/98" written in a cursive style. The text is black and the background is white. The image appears to be a logo or a label.

Datei: Summary.RTF Date:Jan.08, 1997 Author: Frank Clanzett

510(k) SUMMARY Summary of Safety and Effectiveness

- 3 1997

APPLICANTS NAME AND ADDRESS:

Drager Inc. Critical Care Systems 4101-100 Pleasant Valley Road Chantilly, VA 20151

APPLICANTS TELEPHONE NUMBER: (703)-817-0100

APPLICANTS FACSIMILE NUMBER: (703)-817-0101

APPLICANTS CONTACT PERSON: Harald Kneuer

Regulatory Affairs Manager

DATE THE SUMMARY WAS PREPARED:

January 08, 1997

DEVICE NAME:

Trade Name: Common Name: Classification Name: Babytherm 8004 / 8010 Babytherm 8004 / 8010 System. Thermal Regulating

LEGALLY MARKETED DEVICE TO WHICH DRAGER INC. IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Babytherm 8000 WB - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

RH 600 (Radiant Heater) - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

PT 4000 (Phototherapy) - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

Microlite™ (Phototherapy) - Manufactured by Air Shields, USA

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Table of Comparison

	Dräger	Dräger Radiant	Dräger	AirShields	Dräger
	Babytherm 8000 WB	Heater RH 600	PT4000	Microlite™	Babytherm 8004 / 8010
510(k) Number	K 94 5467	K 95 3489	K 95 4611	K 91 2908
Intended Use	Heated bassinet intended
as a therapeutic device
providing warmth for
premature and full-term
neonates and infants with
a weight up to 16 lbs.	Radiant warmer
system to
compensate for
heat lost by
infants during
medical
examinations or
therapy.	PT 4000 is used
to decrease
blood bilirubin
levels via
phototherapy in
premature and
full term infants
who are treated
in incubators or
on radiant
warmer beds.	Phototherapy for
treatment of Hyp
erbilirubinemia	Babytherm 8004 / 8010 is an infant warmer
system intended as a therapeutic device
providing warmth for premature and full-term
neonates and infants with a weight up to 16 lbs.
It is intended for use in delivery rooms, neonatal
wards, neonatal and paediatric intensive care
units.
Both Systems can be equipped with the optional
phototherapy system for treatment of
Hyperbilirubinemia.
Physical Size (mm)
Height (mm)	1220 to 1515 with height
adjustment	-----	-----	-----	1820 to 2385 with height
adjustment
Length (mm)	1070	-----	-----	-----	1315
Width (mm)	750	-----	-----	-----	like Babytherm 8000 WB
Weight	85 kg max	-----	-----	-----	135 kg max
Mattress Size (mm)	750 x 490	-----	-----	-----	like Babytherm 8000 WB
Bassinet Tilt	$\pm$ 10° from horizontal	-----	-----	-----	like Babytherm 8000 WB
Case Material	PS-TSG	-----	-----	-----	like Babytherm 8000 WB
Case Color	blue	-----	-----	-----	like Babytherm 8000 WB
Power Input
Voltage	120 VAC, 60 Hz	110 / 127 VAC,
60 Hz	110 / 127V	110 / 120 VAC	like Babytherm 8000 WB
Total	135 W

560 W for height
adjustment | 735 W | 120 W | 300 W | 670 W for Babytherm 8004
790 W for Babytherm 8010
+120 W for variable height adjust
440 W for Phototherapy |
| Fuses | 2 x 1.6 A / 2 x 6,3 A | 2 x 6.3 A | 2 x 1.6 A | 2 x 4 A | 2 x 15 A |
| Leakage Current | 5 | ------ | ------ | Actuates after 15 minutes in manual mode with
level > 3, and heater output is reduced to
level 212 |
| Visuable Alarm | Yes | Yes | ------ | ------ | Yes. |
| Audible Alarm | Yes | Yes | ------ | ------ | Yes. |

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September 19.

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Explanation of Differences related to the Table of Comparison:

The ThermoMonitoring function uses two sensors for temperature measurement: One for the core 1 sensor.
2 For the Babytherm 8004 / 8010 other types of ceramic heaters are used. The geometry of the reflectors was improved. The performance still meets the requirements of IEC 601-2-21.
3 The maximum irradiance was improved because of better reflector geometry. The device still meets the requirements of IEC 601-2-21.
4 This is an improved performance. The device still meets the requirements of IEC 601-2-21.
Two temperature channels for core and peripheral temperature with a range from 15°C to 42°C.
This is an improved safety requirement of IEC 601-2-21.
ഗ്രന്ഥം പത്രശ്വ By this modification an even distribution of the irradiance over an area of 20 x 40 cm is achieved.
see explanation number 7.
Change in LED Colour to fullfill exactely this requirement of IEC 601.
10 This is an improved safety feature for the radiant heater.
The allowable deviation may be changed by the user in a range from 0.3℃ to 1.0℃ 11
For the Babytherm 8004/8010 at level 3 the heater output is approximately 9 mWcm², level 2 corresponds to heater output of 12 6 mW/cm². According to 601-2-21 the 15 Minutes-Alarm has to be activated at a heater output of more than 10 mW/cm².

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DESCRIPTION OF THE DEVICE:

Babytherm 8004 / 8010 is a warmer system for infants that provides a combination of a heated mattress (Babytherm 8010, only), a radiant heater and an optional phototherapy system. The radiant heater is in a fixed position over the mattress and is equipped with an examination light. The phototherapy system can be installed by the manufacturer or by the biomedical engineer in the housing of the radiant heater.

Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control".

Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES:

The Babytherm 8004 / 8010 are substantially equivalent to the predicate devices Babytherm 8000 WB, Radiant Heater RH 600, Phototherapy PT 4000 and Phototherapy Microlite™

The function of the Babytherm 8004 / 8010 including the optional Phototherapy is also covered by the predicate devices and the equivalent intended use is covered by these devices, too.

The Babytherm 8004 / 8010 fulfil at least the same international standards as the predicate devices of Dräger and has been tested according to these standards. Therefore the Babytherm 8004 / 8010 are as safe and effective as the predicate devices.

Quulle/

Frank Clanzett Regulatory Affairs Specialist (Dragerwerk AG, Germany)

Jan. 08.1997

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 3 1997

Mr. Harald Kneuer Requlatory Affairs Manager Drager Incorporated 4101 Pleasant Valley Road, Suite 100 Chantilly, VA 20151

Re : K971198 Babytherm 8004 Babytherm 8010 Trade Name: Requlatory Class: II Product Code: FMT Dated: July 7, 1997 Received: July 9, 1997

Dear Mr. Kneuer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Kneuer

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celaterud

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

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INTENDED USE OF THE DEVICE:

Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.

Gllullly

Frank Clanzett Regulatory Affairs Specialist (Dragerwerk AG, Germany)

Jan. 08.1997

Patrizia Cucuzza

(Division Sign-Off) (Division of Dental, Infection Control, Division of Hospital Devices

510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

00019