(259 days)
No
The summary does not mention AI, ML, or any related concepts like neural networks, deep learning, or image processing for analysis. The device description focuses on standard medical device components and functions for temperature, humidity, and oxygen regulation.
Yes.
The device provides a thermally regulated environment for premature babies and neonates, which is a therapeutic function to maintain their health.
No
The device is an incubator and radiant warmer, providing a thermally regulated environment for premature babies and neonates. It focuses on maintaining and regulating physical parameters for patient care, not on diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including an incubator, trolley, radiant warmer, display, mattress, x-ray, and height adjustment, in addition to software.
Based on the provided text, the Babyleo TN500 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a thermally regulated environment for premature babies and neonates, functioning as an incubator and radiant warmer. This is a life support and environmental control function, not a diagnostic test performed on samples from the body.
- Device Description: The description focuses on maintaining environmental conditions (temperature, humidity, oxygen) and the physical components of the device (incubator, warmer, mattress, etc.). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The Babyleo TN500 is a medical device used for patient care and environmental control, not for in vitro diagnostic testing.
N/A
Intended Use / 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 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)
Product codes
FMZ, FMT
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.
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 babies and neonates
Intended User / Care Setting
Not Found
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 following performance data were provided:
Electrical safety and electromagnetic compatibility (EMC), incl. performance testing.
Software Verification and Validation Testing.
Biocompatibility testing.
Human Factor (usability evaluation).
Reprocessing.
No animal study have been conducted.
No Clinical testing has been done.
Conclusion: Based on device comparison information and non-clinical bench testing data, the proposed device is substantially equivalent to legally marketed predicate device K010222.
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.
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.
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
§ 880.5400 Neonatal incubator.
(a)
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.(b)
Classification. Class II (performance standards).
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 PRAStaff@fda.hhs.gov
"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
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 (451) 882-4100 Fax No.: 011 49 (451) 882-3018
Applicants US Contact Person
Beth Zis Director, Regulatory Affairs Draeger Medical Systems, Inc. 6 Tech Drive, Andover, MA 01810 USA
Tel: +1 (978) 379-8265 Fax: +1 (978) 379-8335
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
TN500 | Omnibed
(Giraffe) | Caleo | Babytherm
8004/8010 | Comments |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Status | new device | predicate device | reference device | reference device | |
| Manufacturer | Drägerwerk AG & Co.
KGaA | Ohmeda Medical,
a Division of
Datex-
Ohmeda,Inc. A GE
Company | Drägerwerk AG &
Co. KGaA | Drägerwerk AG &
Co. KGaA | |
| Classification Name /
Product code | Incubator, neonatal /
FMZ | Incubator, neonatal
/ FMZ | Incubator, neonatal
/ FMZ | Infant Radiant
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:
60601-2-19: 60601-2-21 | 60601-1: 60601-1-
2: 60601-2-19:
60601-2-21 | 60601-1: 60601-1-
2: 60601-2-19: | 60601-1; 60601-1-2;
60601-2-21 | Same |
| Indications for use | The 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 | The OmniBed is a
combination of an
infant incubator
( | | | |
| Babyleo
TN500 | Omnibed
(Giraffe) | Caleo | Babytherm
8004/8010 | Comments | |
| 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) | temperature
controlled
environment and
warmers provide
infrared heat in an
open environment.
They may also be
used for short
periods of time to
facilitate the
neonate's
transition from the
uterus to the
external
environment. | treating twins is
limited to 5 kg (11
lbs). Caleo is
intended for use in
clinical
environments
where premature
babies or infants
are treated who
require a controlled
climatic
environment. | neonatal and
pediatric intensive
care units. | | |
| Operating noise | | | | | |
| Operating noise volume in
patient compartment | Typically 40 dB(A)
(Measured without
oxygen application) | 37 °C (98.6 °F), after
confirmation | Not provided | 37 °C (98.6 °F),
after confirmation | NA (warmer only) | Same |
| | Babyleo
TN500 | Omnibed
(Giraffe) | Caleo | Babytherm
8004/8010 | Comments |
| Skin Temperature
regulation | | | | | |
| Measurement range | 13 to 43 °C (55.4 to
109.4 °F) | Not provided | NA (Incubator only) | 15 °C to 42 °C | Similar |
| Temperature Sensor for
Skin | Thermo Trace (Dräger) | Not provided | Thermo Trace
(Dräger) | Thermo Trace
(Dräger) | Same |
| Measurement uncertainty
sensors | ± 0.1ºC (0.18 °F) | Not provided | ± 0.1ºC (0.18 °F) | ± 0.1ºC (0.18 °F) | Same |
| Measurement uncertainty
entire system | ± 0.3°C (0.54 °F) | ± 0.3°C (0.54 °F) | ± 0.3°C (0.54 °F) | ± 0.3°C (0.54 °F) | Same |
| Skin temperature Mode
setting range | 34 to 38 °C (93.2 to
100.4 °F) in 0.1 °C | 35 to 37.5 °C in 0.1
°C | 34 to 38 °C (93.2
to 100.4 °F) | not provided | Same |
| Skin temperature Mode
override | >37 °C (98.6 °F), after
confirmation | Not provided | >37 °C (98.6 °F),
after confirmation | not provided | Same |
| Heated mattress (Option) | | | | | |
| Setting range | Off, 35°C to 39°C, AUTO | Not provided | NA | Off, 30°C to 38.5°C | Similar |
| Oxygen regulation
(Option) | | | | | |
| measurement range | Normal range: 18 to 65
Vol %
Extended range: 66 to
99 Vol% | Not provided | Normal range: 18
to 65 Vol %
Extended range:
66 to 99 Vol% | NA (warmer only) | Same |
| Measurement uncertainty | ± 2.5 Vol% (+ 2.5 % of
measured value) | 5% | ± 3 Vol% | NA (warmer only) | Same |
| Setting range | 21 to 65 Vol%
(>40 Vol%, after
confirmation) | 21 to 65% | 21 to 75 Vol% | NA (warmer only) | Same |
| 02 rise time from 21 to 65
Vol% |