Babyleo TN500

K182859 · Dragerwerk AG & CO Kgaa · FMZ · Feb 22, 2019 · General Hospital

Device Facts

• Record ID: K182859
• Device Name: Babyleo TN500
• Applicant: Dragerwerk AG & CO Kgaa
• Product Code: FMZ · General Hospital
• Decision Date: Feb 22, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Babyleo TN500 is intended for use with premature babies and neonates 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).

Device Story

Babyleo TN500 maintains environmental conditions for preterm babies and neonates; functions as both closed incubator and open radiant warmer. Inputs include temperature, humidity, and oxygen levels; device regulates these parameters to provide stable thermal environment. Features include convection heater, humidification system, and optional heated mattress. New 'Touch time' function increases air circulation and silences specific alarms for up to 20 minutes when hand ports are opened to facilitate routine care (diaper changes, washing, sensor checks). Device used in clinical settings; operated by healthcare professionals. Output consists of controlled ambient conditions; visual/audible status monitoring. Benefits include thermal stability during transitions and routine care, reducing stress on neonates.

Clinical Evidence

Bench testing only. Verification and validation testing performed for the 'Touch time' feature in accordance with ISO 14971 and applicable standards (IEC 60601-1, 60601-1-2, 60601-2-19, 60601-2-21). No clinical data presented.

Technological Characteristics

Neonatal incubator/radiant warmer; convective heater; boiling-based humidification. Materials: metal (aluminum), synthetic (TPE), textile (Vowalon Medilind). Biocompatibility per ISO 10993. Connectivity: Serial (RS232), USB, LAN. Power: 100-240V, 50/60Hz. Standards: IEC 60601-1, 60601-1-2, 60601-2-19, 60601-2-21.

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 or radiant warmer.

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

• Babyleo TN500 (K162821)

Submission Summary (Full Text)

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February 22, 2019

Drägerwerk AG & Co. KGaA % Gale Winarsky US Agent Draeger Medical Systems, Inc. 3135 Quarry Road Telford, Pennsylvania 18969

Re: K182859

Trade/Device Name: Babyleo TN500 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: Class II Product Code: FMZ, FMZ, FMT Dated: January 28, 2019 Received: January 30, 2019

Dear Gale 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sapana Patel -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K182859

Device Name Babyleo TN500

### Indications for Use (Describe)

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 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) | |
|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span>☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C</div> |

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C)

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Image /page/3/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color, and the background is white. The two dots above the "a" are also dark blue and are slightly larger than the other letters in the word. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology.

## 510(k) Summary (K182859)

#### l. SUBMITTER

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

Phone: [phone] Fax: [phone]

Contact Person: Dr. Bettina Möbius Submitter's US contact Person: Gale Winarsky Date prepared: February 14th, 2019

#### II. DEVICE

Name of Device: Common or Usual Name: Classification Name: Requlatory Class: Product code:

Babyleo TN500 Incubator and Warmer Incubator, neonatal (21 CFR 880.5400) . FMZ, FMT

#### PREDICATE DEVICE lll.

Babyleo TN500, K162821

#### DEVICE DESCRIPTION IV.

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 tray and height adjustment.

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Image /page/4/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue, and the two dots above the "a" are also blue. The background is white. The word is the logo for the Dräger company, which manufactures medical and safety technology products.

Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package. The subject of this submission is the addition of the optional Touch time function, which can be activated in order to stabilize the thermal environment in the patient compartment when the hand ports are opened. It supports users during routine tasks (e.g. changing diapers, washing the baby, checking sensors). Additionally, the scale resolution is changed from 5q to 10g.

#### V. INDICATIONS FOR USE

Babyleo TN500 is intended for use with premature babies and neonates 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 requlated 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).

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The primary technological characteristics of the Babyleo TN500 remain unchanged. The medical device is an incubator and an open warmer. The modification adds an optional Touch Time feature, which increases air circulation and disables the audio signals of certain alarms for a maximum of 20 minutes. The change in the scale resolution from 5g to 10g does not affect the functionality of the device.

#### VII. PERFORMANCE DATA

The performance specifications of Babyleo TN500 remain unchanged. The results of the risk analysis and verification testing performed for the Touch time feature indicate no new issues related to the safety and effectiveness of the modified device. Testing was performed according to applicable Standards IEC 60601-1-2: 60601-2-19; and 60601-2-21.

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## Software Verification and Validation Testing

Verification and validation testing were conducted in conformance to the FDA recognized standards. Performance data only related to the Touch time feature has been tested and evaluated.

## Risk Analysis

An analysis of the risk for the modification Touch time for the Babyleo TN500 was carried out according to ISO 14971. Possible risks were identified which result from the modification Touch time. Based on the risk identification, Risk Control Measures for the Touch time feature were defined and Verification and Validation activities were carried out in order to ensure risk acceptability criteria have been met and the risks have been mitigated.

#### CONCLUSIONS VIII.

The intended use of Babyleo TN500 has not been changed as a result of these modifications. The comparison with the predicate device and the results from a risk analysis and verification testing of the modified Babyleo TN500 demonstrate that it is as safe and effective as the previously cleared predicate in K162821.

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Image /page/6/Picture/2 description: The image shows the word "Dräger" in a stylized, sans-serif font. The word is in blue, and the two dots above the "a" are also blue. The font is bold and the letters are close together.

| | Babyleo TN500 | Babyleo TN500<br>Special 510(k) |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Status | K162821 | |
| Manufacturer | Drägerwerk AG & Co. KGaA | Identical |
| Classification Name / | Incubator, neonatal / Warmer, Infant Radiant | Identical |
| Product code | FMZ/FMT | |
| 510(k) | K162821 | |
| Regulation Number: | 21 CFR 880.5400 | Identical |
| Class: | II | Identical |
| Standards | 60601-1; 60601-1-2;<br>60601-2-19; 60601-2-21 | Identical |
| Indications for use | Babyleo TN500 is intended for use with premature babies and neonates and can be used as both an<br>incubator and a radiant warmer. When the product is switched between incubator and radiant warmer<br>operation, patients continue to be kept warm during the transition. The device provides a thermally<br>regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22<br>in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit,<br>Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air,<br>which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer.<br>Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following<br>parameters are regulated, according to the intended use: Temperature; Humidity; Oxygen (option). | Identical |
| Operating noise | | |
| Operating noise volume in<br>patient compartment | Typically 40 dB(A) (Measured without oxygen application) | Identical |
| | Babyleo TN500 | Babyleo TN500 |
| | | Special 510(k) |
| Alarm Volume | 50 to 70 dB(A) (according to IEC 60601-2-19 and IEC 60601-2-21) | Identical |
| Power failure alarm | Yes (65 dB(A), 10 min) | Identical |
| Principles of operation | | |
| General | Radiant Warmer and Neonatal Incubator | Identical |
| Warmer operation | | |
| Warmer | Radiant Warmer | Identical |
| Maximum Irradiance of<br>Warmer | 32 mW/cm2 (at 100% power); 18 mW/cm2 (at 60% power) 10 mW/cm2 (at 30% Power) | Identical |
| Incubator operation | | |
| Heater | Convective heater | Identical |
| Warm up time | 15 to 20 min | Identical |
| Humidification principle | Boiling of Aquadest (destilled water) | Identical |
| Flow velocity over mattress<br>surface | 10 cm/s (3.94 in/s) (at 36°C) | Identical |
| Maximum Carbon Dioxide<br>(CO2) concentration in the<br>incubator measured in<br>accordance with IEC 60601-<br>2-19 | <0.5 Vol% | Identical |
| Electrical Description | | |
| | Babyleo TN500 | Babyleo TN500<br>Special 510(k) |
| Power supply | 100 V to 240 V, 50/60 Hz | Identical |
| Maximum current / power consumption | 10A / 1000W | Identical |
| Electrical safety | according to IEC 60601-1 | Identical |
| Gas supply (option) | | |
| O2 operating pressure | 270 to 600 kPa | Identical |
| Measured value display | | |
| Radiant Warmer | | |
| Setting range | Off, 10 % to 100 % | Identical |
| Prewarm Mode | Yes | Identical |
| Air temperature regulation | | |
| Measurement regulation | 13 to 45 °C (55.4 to 113 °F) | Identical |
| Measurement uncertainty | $\pm$ 0.8°C (1.44 °F) | Identical |
| Air Mode temperature setting range | 20 to 39 °C (68 to 102.2 °F) in 0.1 ° inc. | Identical |
| Air Mode override | <28 °C (82.4 °F), after confirmation<br>>37 °C (98.6 °F), after confirmation | Identical |
| | Babyleo TN500 | Babyleo TN500 |
| | | Special 510(k) |
| Skin Temperature regulation | | |
| Measurement range | 13 to 43 °C (55.4 to 109.4 °F) | Identical |
| Temperature Sensor for Skin | Thermo Trace (Dräger) | Identical |
| Measurement uncertainty<br>sensors | ± 0.1°C (0.18 °F) | Identical |
| Measurement uncertainty<br>entire system | ± 0.3°C (0.54 °F) | Identical |
| Skin temperature Mode<br>setting range | 34 to 38 °C (93.2 to 100.4 °F) in 0.1 °C | Identical |
| Skin temperature Mode<br>override | >37 °C (98.6 °F), after confirmation | Identical |
| Heated mattress (Option) |…