Babyleo TN500

K162821 · Draegerwerk AG & CO Kgaa · FMZ · Jun 23, 2017 · General Hospital

Device Facts

• Record ID: K162821
• Device Name: Babyleo TN500
• Applicant: Draegerwerk AG & CO Kgaa
• Product Code: FMZ · General Hospital
• Decision Date: Jun 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

Device Story

Babyleo TN500 is a dual-mode neonatal incubator and radiant warmer used in NICU settings by clinicians. It maintains a thermally regulated environment for premature infants. Inputs include user-set parameters for temperature, humidity, and oxygen concentration. The device uses a convective heater for incubator mode and radiant heat for open warmer mode; it transitions between modes while maintaining patient warmth. Optional features include a heated mattress, scale, and 'Auto Thermo' package for cooling, warm-up, and weaning. It also offers a 'Developmental Care' package for monitoring ambient noise and light. The device provides a controlled environment to support neonatal development and stability. Clinicians operate the device via an integrated display to monitor and adjust environmental conditions, directly impacting the patient's thermal stability and clinical care.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including electrical safety (IEC 60601-1, 60601-2-19, 60601-2-21, 60601-2-35), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), software verification/validation, human factors usability engineering, and reprocessing validation.

Technological Characteristics

Neonatal incubator/radiant warmer. Materials: Metal (aluminum), synthetic (TPE), textile (Vowalon Medilind). Convective heater and radiant heat source. Connectivity: Serial (RS232), USB, LAN (RJ45). Standards: IEC 60601-1, 60601-2-19, 60601-2-21, 60601-2-35, ISO 10993. Power: 100-240V, 50/60Hz. Non-sterile.

Indications for Use

Indicated for premature babies and neonates up to 5 kg body weight and 55 cm height requiring a thermally regulated environment. Used as an incubator (closed care) or radiant warmer (open care).

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

• Ohmeda Medical Giraffe Incubator (K010222)

Reference Devices

• CALEO (K003067)
• Babytherm 8004/8010 (K971198)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2017

Draegerwerk AG & Co. KGaA % Ms. Beth Zis Director, Regulatory Affairs Draeger Medical Systems, Inc. 6 Tech Drive Andover, Massachusetts 01810

Re: K162821

Trade/Device Name: Babyleo TN500 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: Class II Product Code: FMZ, FMT Dated: May 24, 2017 Received: May 30, 2017

Dear Ms. Beth Zis:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# James P. Bertram -S

for

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K162821

Device Name Babyleo TN500

Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the background is white. The two dots above the "a" are also blue.

### 510(k) Summary

K162821

### Applicants / Manufacturer Name and Address:

Drägerwerk AG & Co. KGaA Moislinger Allee 53-55, 23558 Luebeck, Germany

### Contact Person:

Dr. Bettina Möbius Senior Manager Regulatory Affairs

Tel. No.: 011 49 [phone] Fax No.: 011 49 [phone]

#### Applicants US Contact Person

Beth Zis Director, Regulatory Affairs Draeger Medical Systems, Inc. 6 Tech Drive, Andover, MA 01810 USA

Tel: [phone] Fax: [phone]

### Date submission was prepared:

06/05/2017

#### Device Name:

Device Trade Name: Common / Usual Name: Classification Name Regulatory Class: Product Code:

Babyleo TN500 Incubator and Warmer Incubator, neonatal 21 CFR 880.5400 = FMZ, FMT

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "Dräger" in blue font. The font is bold and sans-serif. The two dots above the "a" are also blue. The background is white.

## Legally Marketed Devices to which Substantial Equivalence is claimed:

Legally Marketed Predicate Device: K010222, Ohmeda Medical Giraffe Incubator Reference Devices: K003067, CALEO K971198, Babytherm 8004/8010

### Device Description:

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer.

Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates.

The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.

### Indications for Use:

Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: Temperature; Humidity; Oxygen (option)

### Substantial Equivalence Comparison:

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The "a" in Dräger has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The logo is simple and modern, and the blue color gives it a professional look.

Image /page/5/Picture/2 description: The image shows the word "Dräger" in a bold, blue font. The two dots above the "a" are also blue. The word is centered in the image and is the only element present.

| | Babyleo<br>TN500 | Omnibed<br>(Giraffe) | Caleo | Babytherm<br>8004/8010 | Comments |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Status | new device | predicate device | reference device | reference device | |
| Manufacturer | Drägerwerk AG & Co.<br>KGaA | Ohmeda Medical,<br>a Division of<br>Datex-<br>Ohmeda,Inc. A GE<br>Company | Drägerwerk AG &<br>Co. KGaA | Drägerwerk AG &<br>Co. KGaA | |
| Classification Name /<br>Product code | Incubator, neonatal /<br>FMZ | Incubator, neonatal<br>/ FMZ | Incubator, neonatal<br>/ FMZ | Infant Radiant<br>Warmer / FMT | Same |
| 510(k) | K162821 | K010222; | K003067 | K971198 | |
| Regulation Number: | 21 CFR 880.5400 | 21 CFR 880.5400 | 21 CFR 880.5400 | 21 CFR 880.5130 | Same |
| Class: | II | II | II | II | Same |
| Standards | 60601-1: 60601-1-2:<br>60601-2-19: 60601-2-21 | 60601-1: 60601-1-<br>2: 60601-2-19:<br>60601-2-21 | 60601-1: 60601-1-<br>2: 60601-2-19: | 60601-1; 60601-1-2;<br>60601-2-21 | Same |
| Indications for use | The Babyleo TN500 is<br>intended for use with<br>premature babies and<br>neonates and can be<br>used as both an<br>incubator and a radiant<br>warmer. When the<br>product is switched<br>between incubator and<br>radiant warmer<br>operation, patients<br>continue to be kept warm<br>during the transition. The<br>device provides a<br>thermally regulated<br>environment for patients<br>with a body weight of up | The OmniBed is a<br>combination of an<br>infant incubator<br>( | | | |
| Babyleo<br>TN500 | Omnibed<br>(Giraffe) | Caleo | Babytherm<br>8004/8010 | Comments | |
| to 5 kg (11 lbs) and a<br>height of up to 55 cm (22<br>in). The device can be<br>operated as either a<br>closed care unit or an<br>open care unit. As a<br>closed care unit, Babyleo<br>TN500 is an incubator.<br>Neonates are kept warm<br>in the patient<br>compartment with<br>humidifiable air, which<br>can be enriched with<br>oxygen (option). As an<br>open care unit, Babyleo<br>TN500 is a radiant<br>warmer. Babyleo TN500<br>provides controlled<br>ambient conditions for<br>premature babies and<br>neonates. The following<br>parameters are<br>regulated, according to<br>the intended use:<br>Temperature; Humidity;<br>Oxygen (option) | temperature<br>controlled<br>environment and<br>warmers provide<br>infrared heat in an<br>open environment.<br>They may also be<br>used for short<br>periods of time to<br>facilitate the<br>neonate's<br>transition from the<br>uterus to the<br>external<br>environment. | treating twins is<br>limited to 5 kg (11<br>lbs). Caleo is<br>intended for use in<br>clinical<br>environments<br>where premature<br>babies or infants<br>are treated who<br>require a controlled<br>climatic<br>environment. | neonatal and<br>pediatric intensive<br>care units. | | |
| Operating noise | | | | | |
| Operating noise volume in<br>patient compartment | Typically 40 dB(A)<br>(Measured without<br>oxygen application) | <49 dB(A) | 47 $\pm$ 2 dB(A) | no closed patient<br>compartment | Similar |
| | Babyleo<br>TN500 | Omnibed<br>(Giraffe) | Caleo | Babytherm<br>8004/8010 | Comments |
| Alarm Volume | 50 to 70 dB(A)<br>(according to IEC 60601-<br>2-19 and IEC 60601-2-<br>21) | according to IEC<br>60601-2-19 | according to IEC<br>60601-2-19 | Not provided | Similar |
| Power failure alarm | Yes (65 dB(A), 10 min) | Yes | Yes | Yes | Same |
| General | Radiant Warmer and<br>Neonatal Incubator | Radiant Warmer<br>and Neonatal<br>Incubator | Neonatal Incubator | Radiant Warmer | Same |
| Warmer | Radiant Warmer | Radiant Warmer | NA (Incubator only) | Radiant Warmer | Same |
| Maximum Irradiance of<br>Warmer | 32 mW/cm2 (at 100%<br>power); 18 mW/cm2 (at<br>60% power) 10 mW/cm2<br>(at 30% Power) | Not provided | NA (Incubator only) | 30 mW/cm2 (heat<br>level 10); 10mW/cm2<br>(heat level 3) | Same |
| Heater | Convective heater | Convective heater | Convective heater | NA (Radiant Warmer<br>only) | Same |
| Warm up time | 15 to 20 min | < 50 min | 20 min | NA (warmer only) | Similar |
| Humidification principle | Boiling of Aquadest<br>(destilled water) | Drawover<br>Evaporator | Boiling of Aquadest | NA (warmer only) | Similar |
| Flow velocity over matress<br>surface | 10 cm/s (3.94 in/s) (at<br>36°C) | <10 cm/s | < 8 cm/s | NA (warmer only) | Same |
| Maximum Carbon Dioxide<br>(CO2) concentration in the<br>incubator measured in<br>accordance with IEC<br>60601-2-19 | <0.5 Vol% | 0.2 % | <0.5 Vol% | max 0.5 Vol% (with<br>bed canopy) | Same |
| | Babyleo<br>TN500 | Omnibed<br>(Giraffe) | Caleo | Babytherm<br>8004/8010 | Comments |
| Electrical Description | | | | | |
| Power supply | 100 V to 240 V, 50/60 Hz | 100V, 115V, 220V,<br>230V, 240V, 50/60 Hz | 100V, 110V, 120 V,<br>127V, 220V to<br>240V; 50 Hz / 60 Hz | 100V, 110 - 127 V;<br>220 - 240 V | Same |
| Maximum current / power<br>consumption | 10A / 1000W | not provided | 8.7A / 732W | 15A / 1750 W | Similar |
| Electrical safety | according to IEC 60601-1 | according to IEC 60601-1 | according to IEC 60601-1 | according to IEC 60601-1 | Same |
| Gas supply (option) | | | | | |
| O2 operating pressure | 270 to 600 kPa | not provided | 300 and 600 kPa<br>(43.5 and 87 psi). | NA (warmer only) | Similar |
| Measured value display | | | | | |
| Radiant Warmer | | | | | |
| Setting range | Off, 10 % to 100 % | 0 to100 % in 5%<br>INC | NA (Incubator only) | not provided | Same |
| Prewarm Mode | Yes | Yes | NA (Incubator only) | Yes | Same |
| Air temperature<br>regulation | | | | | |
| Measurement regulation | 13 to 45 °C (55.4 to 113 °F) | Not provided | 13 to 42 °C (55.4 °F to 107.6 °F) | NA (warmer only) | Similar |
| Measurement uncertainty | $\pm$ 0.8°C (1.44 °F) | Not provided | $\pm$ 0.8°C (1.44 °F) | NA (warmer only) | Same |
| Air Mode temperature<br>setting range | 20 to 39 °C (68 to 102.2 °F) in 0.1 ° inc. | 20 to 39 °C in 0.1 ° inc. | 20 to 39 °C (68 to 102.2 °F) | NA (warmer only) | Same |
| Air Mode override | <28 °C (82.4 °F), after<br>confirmation<br>>37 °C (98.6 °F), after<br>confirmation | Not provided | <28 °C (82.4 °F),<br>after confirmation<br>>37 °C (98.6 °F),<br>after confirmation | NA (warmer only) | Same |
| | Babyleo<br>TN500 | Omnibed<br>(Giraffe) | Caleo | Babytherm<br>8004/8010 | Comments |
| Skin Temperature<br>regulation | | | | | |
| Measurement range | 13 to 43 °C (55.4 to<br>109.4 °F) | Not provided | NA (Incubator only) | 15 °C to 42 °C | Similar |
| Temperature Sensor for<br>Skin | Thermo Trace (Dräger)…