The Isolette® 8000 plus incubator is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs).

The Isolette® 8000 plus is not intended for home use.

Device Description

The Isolette 8000 plus is a device used to maintain environmental conditions suitable for neonates. The Isolette 8000 plus incubator provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen (optional) and humidity (optional). It is a controller-based incubator featuring the ability to enable simultaneous control of temperature, and optional oxygen and humidity. The system operates on AC power. Data is provided on a liquid crystal display. It is operated in closed care therapy as an incubator according to IEC60601-2-19.

Components include hand ports or iris ports, access panel, serial port, trolley with height adjustment, castor wheels with brakes, power receptacle, a Trendelenburg bed-tilt mechanism (0° to 12°), softbed mattress, skin temperature probes, probe covers, oxygen inlet, sensor module, hose grommets, accessoryrail and cable wrap. Optional components include IV pole, drawers, water reservoir, collection bottler mount litter bag holder, basket for gloves, breathing hose holder kit, tray, high frequency ventilation (HFV) door with grommets, positioning aids, incubator cover, and monitor shelf.

AI/ML Overview

The provided text describes the regulatory clearance of the Isolette® 8000 plus neonatal incubator and its comparison to a predicate device (Isolette® Infant Incubator, Model C2HS, K001242) for showing substantial equivalence. It does not contain information about an AI-powered device or a study involving human experts or a training set for machine learning. Therefore, many of the requested details are not applicable as this is a traditional medical device submission without AI.

However, based on the provided text, I can extract the acceptance criteria and a summary of the non-clinical studies performed to demonstrate that the device meets those criteria.

Acceptance Criteria and Device Performance for Isolette® 8000 plus (K172154)

This submission is for a traditional medical device (neonatal incubator) and does not involve AI. Therefore, numerous requested sections related to AI performance, human expert evaluation, and training sets are not applicable.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally implied by the stated specifications and compliance with recognized standards. The "Device Under Review" column effectively serves as the reported device performance compared to the predicate.

Specification (Acceptance Criterion implied by predicate/standards)	Predicate (Isolette® Infant Incubator, Model C2HS) Performance	Device Under Review (Isolette® 8000 plus) Performance	Comments (Device Meets or is Similar to Predicate)
Intended Use	Care for premature and full-term babies, controlled environment in NICU/Special Care Baby Unit etc.	Controlled environment for premature and full-term infants up to 10 kg (22lbs). Controls temperature, oxygen (optional), and humidity (optional). Not for home use.	Same - Wording different, but intended use unchanged.
Indications for Use	Effective temperature management, reduces radiant heat loss, minimizes evaporative heat loss, monitors/maintains O2 levels.	Thermoregulation and controlling oxygen (optional), and humidity (optional) for premature and full-term infants up to 10 kg (22lbs). Not for home use.	Similar - Simplified wording; functional indications unchanged; similar technology.
Target Population	Premature and full term infants	Newly born infants up to 10 kg (22lbs)	Same - Weight added as information.
Environment of Use	NICU/Special Care Baby Unit, Step Down Nursery, Newborn Nursery and pediatrics.	Any department of the hospital that provides neonatal and infant care, including NICU/Special Care Baby Unit, Step Down Nursery, Newborn Nursery and pediatrics.	Similar - Broader phrasing for hospital areas.
Principle of Operation	Controller-based incubator, simultaneous control of temp, O2, humidity.	Same as C2HS	Same
Protection Class	Class I, Type BF, continuous, not AP	Same as C2HS	Same
Ingress of liquids and particulate matter (IEC 60601-1)	IPXO	Same as C2HS	Same
Height	133.4-152.4 cm (52.5-60 in)	133.3 to 153.7 cm (52.5 to 60.5 in)	Similar - No effect on function.
Width	99 cm (38.0 in)	<104 cm (41 in)	Similar - No effect on function.
Depth	59.7 cm (23.5in)	<76.2 cm (30 in)	Similar - No effect on function.
Weight	99 kg (198 lb.)	<98.5 kg (217.1 lb.) without options/accessories	Similar - No effect on function.
Mattress size	40.6 x 78.7cm(16 x 31.5 in)	>38 x 74 x3 cm (15 x 29.1 x 1.2 in)	Similar - No effect on function.
Trendelenburg/Reverse Trendelenburg	Continuously variable to 12 deg. +1 deg.	Same as C2HS	Same
Infant Weight	Not published	10 kg (22 lbs.) maximum	Same - Specification not previously published.
Operating temperature	20-30°C (68-86°F)	Same as C2HS	Same
Operating humidity	5-99% RH non-condensing	5-95% RH non-condensing	Similar
Operating altitude	3048m (10,000 ft.)	Up to 3000 m (9800 ft.)	Similar - Meets IEC 60601-1.
Operating Ambient air pressure	Not available	110-70 kPa	Same - Design elements unchanged.
Storage temperature	-30 to 70°C (-22 to 158°F)	-20 to 60°C (-4 to 140°F)	Similar - Device packaging marked with requirements.
Storage humidity	0-99% RH, non-condensing	5-95% RH non-condensing	Similar
Storage Ambient air pressure	Not available	110-50 kPa	Same - Design elements unchanged.
Power req. 100/120V	100/120V ± 10%, 50/60 Hz, 1900 W max.	100/120V, 50/60 Hz, 1900 W max, 9.9 A max	Similar - Amperage added; not clinically relevant.
Auxiliary power sockets	All 50/60 Hz, 100, 120, 220, & 240V ± 10% 500W max.	All 50/60 Hz, 100 V, 100W max; 120 & 230 V 300W max	Similar - Both meet current safety standards.
Earth Leakage	< 300µA 100 & 120V; < 500µA 220 & 240V	< 500 µA	Similar - Both meet current safety standards.
Air temperature mode - Set point range	20-37°C (68-98.6°F)	20 to 39°C (68-102.2°F)	Same - I8000 plus publishes entire range.
Control override range	37-39°C (98.6-102.2 F)	Same as C2HS	Same
Set point display range	15 to 45°C (59-113 F)	Same as C2HS	Same
Upwards deviation limit	Fixed +1.5°C	+1.5 to +2.5°C (+2.7 to 4.5°F)	Similar - I8000 plus allows adjustment.
Upwards deviation limit default	Fixed +1.5°C	+1.5°C (+2.7°F)	Similar - Default value is same.
Downwards deviation limit range	Fixed -2.5°C	-1.5 to -2.5°C (-2.7 to-4.5F)	Similar - I8000 plus allows adjustment.
Downwards deviation limit default	Fixed -2.5°C	-2.5°C (-4.5F)	Similar - Default value is same.
Warm-up time at 22°C (72°F) ambient	<35min	Same as C2HS	Same
Variability	<0.5°C (<0.9°F)	Same as C2HS	Same
Overshoot	<0.5°C (<0.9°F)	Same as C2HS	Same
Uniformity with a level mattress	<0.8°C (<1.4°F)	Same as C2HS	Same
Skin Temperature Mode - Set point range	34.0 to 37.0°C (93.2 to 98.6°F)	Same as C2HS	Same
Control override temp range	37.0 to 38.0°C (98.6 to 100.4°F)	Same as C2HS	Same
Set point display range (skin temp)	15.0 to 45.0°C (59 to 113°F)	Same as C2HS	Same
Accuracy of incubator temp indication	≤0.8°C	Same as C2HS	Same
Deviation limit range (skin temp)	0.5 to 1.0°C	0.3 to 1.0°C (0.5 to 1.8°F)	Similar - I8000 plus has tighter limit.
Deviation limit default (skin temp)	1.0°C (1.8°F)	Same as C2HS	Same
Kangaroo Mode	No	Yes	Different - New feature, details tested.
Noise level within the hood environment	≤47 dB(A) w/ 37 dB(A) or less ambient	Same as C2HS	Same
Air velocity over the mattress	<10 cm/second (4 in/second); average of 5 points at 10cm (4 in) above the mattress	Same as C2HS	Same
Carbon Dioxide (CO2) level (per IEC60601-2-19, clause 105)	<0.8%	Same as C2HS	Same
Oxygen deviation limit range	3% fixed	3% to 5%	Similar - User-adjustable to reduce nuisance alarms.
Oxygen deviation limit default	3%	Same as C2HS	Same
Set point data retention (power failure)	<10 min	Same as C2HS	Same
Acoustical level (all alarms on)	75 dB(A) maximum	Same as C2HS	Same
External Communication - Type	9-pin Sub-D (female), electrically isolated Protocol	Same as C2HS	Same
Configurations	Serial Data Output	Serial Data Output (default) or MEDIBUS.X	Similar - MEDIBUS.X addition not clinically relevant.
Baud rate (Serial Data Output)	2400	Same as C2HS	Same
Humidification system	Manual adjustment of humidity setpoints	Automatic based on user setpoint (Autohumidity)	Similar - Both provide humidity control.
Humidity control duration of operation after refilling	>24 hours @ 85% RH and 37°C, in air temp mode	Same as C2HS	Same
Humidity control reservoir capacity	1000 mL	1500 mL	Similar - Difference not clinically relevant.
Humidity control range	30% to 95% in 1% increments	Same as C2HS	Same
Humidity control accuracy (10-90% @ 20-40°C)	±5% RH	±6% RH	Similar - 1% difference not clinically relevant.
Oxygen control range	21% to 65%	Same as C2HS	Same
Oxygen display accuracy (100% calibration)	±3%	Same as C2HS	Same
Material used for direct patient contact	Textile Polyurethane, PVC, Hydrogel	Textile Polyurethane, TPE, Hydrogel	Similar - TPE material tested for biocompatibility.
Biocompatibility	According to ISO 10993	Same as C2HS	Same
Thermonitoring	N/A - only displays skin temperature	Trend display of difference between central and peripheral skin temperatures	Similar. Isolette 8000 plus provides additional trend info.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The studies were non-clinical bench testing, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a non-AI medical device submission, and the ground truth was established through engineering specifications, regulatory standards compliance, and bench testing, not human expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a non-AI medical device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-AI medical device submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a non-AI medical device submission. The device performs as a standalone incubator without human-in-the-loop performance in the context of an AI algorithm; however, human operators are inherently part of its use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on engineering specifications, recognized international standards (e.g., IEC 60601-1, IEC 60601-2-19, IEC 60601-1-2, ISO-10993), and internal design control procedures. Performance benchmarks are set by these standards and the predicate device's capabilities.

8. The sample size for the training set

Not applicable. This is a non-AI medical device submission; there is no "training set" in the machine learning sense.

9. How the ground truth for the training set was established

Not applicable.

Summary of Studies to Prove Acceptance Criteria are Met (Non-Clinical Testing):

The Isolette® 8000 plus underwent a series of non-clinical bench tests and evaluations to demonstrate its safety and effectiveness and substantial equivalence to the predicate device. These include:

Performance Testing: Conducted in accordance with applicable standards and technical system requirements, as well as the device's Instructions for Use (IFU) Technical Data Section. This covers all the operational specifications listed in the table above (e.g., temperature control ranges, humidity accuracy, oxygen control, noise levels, warm-up times).
Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-2-19 (safety and performance), and IEC 60601-1-2 (EMC).
Software Verification and Validation Testing: Conducted following FDA guidance for medical device software. The software was considered a "major" level of concern.
Biocompatibility Testing: Conducted in accordance with FDA guidance on ISO 10993 standards. Tests included:
- Integral Test for volatile organic compounds
- Photogenic bacteria test
- Emission of particles
- Material characterization (ISO 10993-18)
- Toxicological Evaluation (ISO 10993-17)
- Cytotoxicity
- Irritation
- Sensitization
Human Factors: Usability evaluation conducted in accordance with FDA guidance on Human Factors and Usability Engineering.
Reprocessing: Assessed following FDA guidance ("Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling").
Cleaning/Disinfection: Macroscopic and microbiological validation performed with Oxycide by an accredited laboratory (DIN EN ISO/IEC 17025).
Kangaroo Mode Performance Testing: Performed according to the technical requirements for this new feature.
Autohumidity Performance Testing: Performed according to technical requirements for the optional humidification system.
Thermomonitoring Performance Testing: Performed according to technical requirements.
External Communication (Serial data output or Medibus X) Performance Testing: Performed according to technical requirements.
Trendelenburg (Tilt Mechanism) Regression Testing: Performed for mechanical changes compared to the predicate device.

No animal or clinical studies were conducted for this submission. The conclusion drawn from these non-clinical studies was that the Isolette® 8000 plus meets performance requirements and standards and is substantially equivalent to the predicate device K001242.

Summary

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April 19, 2018

Dräger Medical Systems, Inc. Gale Winarsky Manager, Regulatory Affairs 3135 Quarry Road Telford. Pennsylvania 18969

Re: K172154

Trade/Device Name: Isolette® 8000 plus Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: Class II Product Code: FMZ Dated: March 16. 2018 Received: March 19, 2018

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. 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

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801); medical device 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.

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.

For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -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) K172154

Device Name Isolette® 8000 plus

Indications for Use (Describe)

The Isolette® 8000 plus is not intended for home use.

Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K172154

Manufacturer Name and Address:	Dräger Medical Systems, Inc.3135 Quarry RoadTelford, PA 18969
Contact Person:	Gale WinarskyManager, Regulatory AffairsPhone: 215-660-2239Fax: 215-721-5424
Date summary was prepared:	2018-04-19
Device Name:	Trade Name: Isolette® 8000 plusClassification Name: Neonatal Incubator

Legally Marketed Device Identification: Substantial equivalence is claimed to the legally marketed predicate; Isolette Infant Incubator, Model C2HS, K001242.

21 CRF 880.5400

FMZ

DeviceDescription:

Indications for Use:

The Isolette® 8000 plus is not intended for home use.

Regulation Number:

Product Code:

Class:

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Comparison of Technological Characteristics with Predicate Device:

Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
Manufacturer	Hill-Rom Air-Shields	Draeger Medical Systems, Inc.
510(k)	K001242	K172154
Regulation #	880.5400	880.5400
Product Code	FMZ	FMZ
Classification	II	II	Same
UMDNS/GMDNS code	12-113/36025	12-113/36025	Same
Standards	60601-1; 60601-1-2; 60601-2-19	60601-1; 60601-1-2; 60601-2-19	Same
Intended Use	Designed to care for the smaller prematurebaby as well as the healthier full termbaby. It does this by providing a controlledenvironment, one in which the baby can beprovided with the necessary care as wellas being left undisturbed in the security ofthe incubator.It is to this end that the product can beused in any department of the hospital thatprovides neonatal and infant care. Onewould typically expect the Isolette to beused in the NICU/Special Care Baby Unit.The design lends itself to all levels of carein the NICU making it suitable for use inlevel I, II, III, and IV where applicable.Other departments would include the StepDown Nursery, Newborn Nursery andpediatrics.	The Isolette® 8000 plus incubatorprovides a controlled environment forboth premature and full-term infants upto a maximum of 10 kg (22lbs). Itcontrols temperature, oxygen (optional)and humidity (optional).	Same - While the wording is different, theintended use of the I8000 plus has notchanged from the predicate C2HS. Bothdevices are incubators, both provide acontrolled environment, both are used for thesame patient population.The patient population has not changed fromthe predicate. The weight is now provided inas additional information for the user.
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
Indications for Use	Effective temperature management isImperative to the development of thepremature baby. The Isolette® InfantIncubator incorporates a uniquebidirectional air flow to help reduce radiantheat loses from the infant by warming theinner hood surface. The Hill-Rom Air-Shields patented Air Curtain has beenincorporated into the Isolette InfantIncubator to reduce temperaturefluctuations within the incubator when theaccess panels are opened. With theHumidity module installed, operationalevaporative heat losses are minimized.With the installation of the optional Oxygencontrol system, the Oxygen level within theinfant compartment can be monitored andmaintained.	The Isolette® 8000 plus incubator isindicated for thermoregulation andcontrolling oxygen (optional), andhumidity (optional) for both prematureand full-term infants up to a maximumof 10 kg (22lbs).The Isolette® 8000 plus is not intendedfor home use.	Similar - While the indications statement hasbeen simplified, substantial equivalence issupported by the following:The functional indications for use for the I8000plus have not changed from the C2HS. Bothdevices provide temperature management.This wording has been simplified in the I8000plus Indications by using the term"thermoregulation", which by definition meanstemperature control.Both devices use the same air flow and "AirCurtain' technology for thermoregulation.Both devices offer humidity, and oxygencontrol used for the same applications.Both devices have the same environment ofuse.Neither device is intended for home use.
TargetPopulation/PatientPopulation	Premature and full term infants	Newly born infants up to 10 kg. (22lbs)	Same - The patient population has notchanged from the predicate. The weight ofthe patient is now provided as additionalinformation for the user.
Environment of Use	Isolette to be used in the NICU/SpecialCare Baby Unit and the Step DownNursery, Newborn Nursery and pediatrics.	The I8000 plus can be used in anydepartment of the hospital that providesneonatal and infant care, includingNICU/Special Care Baby Unit and theStep Down Nursery, Newborn Nurseryand pediatrics.	Similar - Some hospitals may refer to theirneonatal and infant care areas by other termsthan NICU, Step Down Nursery, NewbornNursery and pediatrics.
System Specifications
Principle of Operation	Controller-based incubator that enablessimultaneous control of temperature,oxygen, and humidity parameters affectingthe infant	Same as C2HS	Same
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
Protection class	Class I, Type BF, continuous operation, not AP	Same as C2HS	Same
Ingress of liquids and particulate matter (IEC 60601-1)	IPXO	Same as C2HS	Same
Physical Attributes
Height	133.4-152.4 cm (52.5-60 in)	133.3 to 153.7 cm (52.5 to 60.5 in)	Similar - No effect on function
Width	99 cm (38.0 in)	<104 cm (41 in)	Similar - No effect on function
Depth	59.7 cm (23.5in)	<76.2 cm (30 in)	Similar - No effect on function
Weight	99 kg (198 lb.)	<98.5 kg (217.1 lb.) without options/accessories	Similar - No effect on function
Mattress size	40.6 x 78.7cm(16 x 31.5 in)	>38 x 74 x3 cm (15 x 29.1 x 1.2 in)	Similar - No effect on function
Trendelenburg/Reverse Trendelenburg	Continuously variable to 12 deg. +1 deg.	Same as C2HS	Same
Infant Weight	Not published	10 kg (22 lbs.) maximum	Same - Specification not previously published.
Environmental
Operating temperature	20-30C (68-86 F)	Same as C2HS	Same
Operating humidity	5-99% RH non-condensing	5-95% RH non-condensing	Similar
Operating altitude	3048m (10,000 ft.)	Up to 3000 m (9800 ft.)	Similar - 3000 m meets the criteria from IEC 60601-1 and internal requirements.
Operating Ambient air pressure	Not available	110-70 kPa	Same - Operating ambient air pressure is not documented for the predicate. The incubator design elements related to the ambient air pressure have not changed from C2HS predicate to the I8000 plus.
Storage temperature	-30 to 70 deg. C (-22 to 158 deg. F)	-20 to 60 deg. C (-4 to 140 deg. F)	Similar - Device packaging is marked with storage temperature requirements
Storage humidity	0-99% RH, non-condensing	5-95% RH non-condensing	Similar
Storage Ambient air pressure	Not available	110-50 kPa	Same - Only the operating altitude is available for the predicate. The incubator design elements related to the ambient air pressure have not changed from C2HS predicate to the I8000 plus.
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
ElectricalRequirements
Power req. 100/120V	100/120V $\pm$ 10%, 50/60 Hz, 1900 W max.	100/120V, 50/60 Hz, 1900 W max, 9.9 Amax	Similar - Amperage was not applicable to theC2HS as it had a circuit breaker instead offuse. Not clinically relevant.
Auxiliary power sockets	All 50/60 Hz100, 120, 220, & 240V $\pm$ 10% 500W max.	All 50/60 Hz100 V, 100W max120 & 230 V 300W max	Similar - Both meet current safety standards.
Earth Leakage	< 300μA 100 & 120V< 500μA 220 & 240V	< 500 µA	Similar - Both meet current safety standards.
General Performance
Air temperature mode
Set point range	20-37 C (68-98.6 F)	20 to 39 C (68-102.2 F)	Same - Both devices have a range of 20-39 C(68-102.2 F). The I8000 plus publishes theentire range including the Control OverrideRange from 37-39 C, rather than just thegeneral range as published by the C2HS 20-37C.
Control override range	37-39 C ( 98.6- 102.2 F)	Same as C2HS	Same
Set point display range	15 to 45 C (59-113 F)	Same as C2HS	Same
Upwards deviation limit	Fixed +1.5	+1.5 to +2.5 C (+2.7 to 4.5 F)	Similar - Both devices have an airtemperature deviation limit. The I8000 plusallows the user to adjust the deviation rangefor the set point at which an alarm willactivate.
Upwards deviation limitdefault	Fixed +1.5	+1.5 C (+2.7 F)	Similar - Default value is the same
Downwards deviationlimit range	Fixed -2.5C	-1.5 to -2.5C (-2.7 to-4.5F)	Similar - Both devices have an airtemperature deviation limit. The I8000 plusallows the user to adjust the deviation rangefor the set point at which an alarm willactivate.
Downwards deviationlimit default	Fixed -2.5	-2.5C (-4.5F)	Similar - Default value is the same
Warm-up time at 22C(72F) ambient	<35min	Same as C2HS	Same
variability	<0.5C (<0.9F)	Same as C2HS	Same
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
overshoot	<0.5C (<0.9F)	Same as C2HS	Same
Uniformity with a levelmattress	<0.8C (<1.4F)	Same as C2HS	Same
Skin TemperatureMode
Set point range	34.0 to 37.0C (93.2 to 98.6F)	Same as C2HS	Same
Control override temprange	37.0 to 38.0C (98.6 to 100.4F)	Same as C2HS	Same
Set point display range	15.0 to 45.0C (59 to 113F)	Same as C2HS	Same
Accuracy of incubatortemp indication	≤0.8C	Same as C2HS	Same
Deviation limit range	0.5 to 1.0C	0.3 to 1.0C (0.5 to 1.8F)	Similar - the I8000 plus has a tighter limit
Deviation limit default	1.0C (1.8F)	Same as C2HS	Same
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
Kangaroo Mode	No	Yes	Different - The C2HS does not includeKangaroo Mode. Kangaroo Care iscommonly used in neonatal care to allowskin to skin contact between the patient andparent/caregiver. The features of KangarooMode are provided under the Discussion ofNon-Clinical Testing.
Misc. Specifications
Noise level within thehood environment	≤47 dB(A) w/ 37 dB(A) or less ambient(w/out servo O2 control)	Same as C2HS	Same
Air velocity over themattress	<10 cm/second (4 in/second); average of5 points at 10cm (4 in) above the mattress	Same as C2HS	Same
Carbon Dioxide (CO2)level (per IEC60601-2-19, clause 105)	<0.8%	Same as C2HS	Same
Oxygen deviation limitrange	3% fixed	3% to 5%	Similar - In the I8000 plus the alarm limitdeviation can be adjusted by the user tominimize nuisance alarms.
Oxygen deviation limitdefault	3%	Same as C2HS	Same
Set point data retention	Power failures lasting <10 min	Same as C2HS	Same
Acoustical level (allalarms on)	75 dB(A) maximum	Same as C2HS	Same
ExternalCommunication
COM port (output only)	Only connects to devices that fulfill therequirements of the standard IEC 60950-1on unearthed SELV circuits or therequirements of the standard IEC 60601-1on accessible secondary circuits with max.60 V DC nominal voltage.	Same as C2HS	Same
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
Type	9-pin Sub-D (female), electrically isolatedProtocol	Same as C2HS	Same
Configurations	Serial Data Output	Serial Data Output (default) orMEDIBUS.X	Similar - The addition of Medibus.X as analternate for the output of data is not clinicallyrelevant to the function of the incubator.
Serial data output
Baud rate	2400	Same as C2HS	Same
Parity	None	Same as C2HS	Same
Data bits	8	Same as C2HS	Same
Stop bits	1	Same as C2HS	Same
Draeger MEDIBUS.X,version 6	By the RS-232 port only	Same as C2HS	Same
Baud rate	9600	Same as C2HS	Same
Parity	Even	Same as C2HS	Same
Data bits	8	Same as C2HS	Same
Stop bits	1	Same as C2HS	Same
Pin assignment			Same
Pin 2	RXD	Same as C2HS	Same
Pin 3	TXD	Same as C2HS	Same
Pin 5	GND	Same as C2HS	Same
Humidification system(option)	Manual adjustment of humidity setpoints	Automatic based on user setpoint(Autohumidity)	Similar - Both provide humidity control
Humidity control durationof operation after refilling	>24 hours @ 85% RH and 37 deg. C, in airtemp mode	Same as C2HS	Same
Humidity controlreservoir capacity	1000 mL	1500 mL	Similar - The difference in reservoir capacityis not clinically relevant.
Humidity control range	30% to 95% in 1% increments (at highambient humidity levels, low-level humiditysettings may not be attainable)	Same as C2HS	Same
Humidity controlaccuracy between 10%and 90% @ 20 to 40C(68 to 104F)	±5% RH	±6% RH	Similar - The difference in the humiditycontrol of 1% is not clinically relevant
Humidity display range	10% to 100%	Same C2HS	Same
Maximum humidity levels	>85% (incubator set temp at 39C with at	Same C2HS	Same
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
	least 30% RH at ambient)
Oxygen control system(option)
Servo oxygen controlsystem (option)	Yes	Same C2HS	Same
Oxygen inlet pressure	40 to 150 psi (2.8 kg/cm2 to 10.5 kg/cm2)	Same as C2HS	Same
Oxygen inlet flow rate	30 L/min	Same as C2HS	Same
Oxygen control range	21% to 65%	Same as C2HS	Same
Oxygen displayresolution	1%	Same as C2HS	Same
Oxygen display accuracy(100% calibration)	±3%	Same as C2HS	Same
Oxygen display accuracy(21% calibration)	±5%	Same as C2HS	Same
Oxygen display range	18% to 100%	Same as C2HS	Same
Oxygen control accuracy	±2% of full scale	Same as C2HS	Same
Manual oxygen controlsystem (option)
Oxygen inlet pressure	40psi to 150 psi (2.8 kg/cm² to 10.5kg/cm²)	Same as C2HS	Same
Oxygen inlet flow rate	30 L/min	Same as C2HS	Same
Weighing System
Standard weighingsystem (accessory)
Weight display range	0 kg (0 lb.) to 7 kg (15.4 lbs.)	Same as C2HS	Same
Weight display resolution	1 g or 1oz	Same as C2HS	Same
Weight display accuracy	0 to 2 kg: ±2 g (0 to 4.4 lb.: ±0.07 oz.)	Same as C2HS	Same
	> 2 kg: ±5 g (>4.4 lb.: ±0. 18 oz.)
Tare weight	4±0.5kg	≤4.0 kg (8.82 lb.)	Same
OIML weighing system(accessory)			OIML weighing system is only for EUcountries requiring a scale that complies withthe NAWI directive.
Material - no implants
Specification	Predicate	Device Under Review	Comments
Device Name	Isolette® Infant Incubator, Model C2HS	Isolette®8000 plus (I8000 plus)
Material used for indirectpatient contact	Metal (e.g. Aluminum) Synthetic material(e.g. TPE, Thermoplastics)	Metal (e.g. Aluminum) Synthetic material(e.g. TPE, Thermoplastics)	Same
Material used for directpatient contact	Textile Polyurethane, PVC, Hydrogel	Textile Polyurethane, TPE, Hydrogel	Similar - the materials used for direct patientcontact are the same as the C2HS with theexception of the TPE material used in theI8000 plus temperature probes. This materialwas tested and found to be biocompatible forthe intended use.
Biocompatibility	According to ISO 10993	Same as C2HS	Same
Components
hand ports	Yes	Yes
iris ports,	Yes	Yes
access panel	Yes	Yes
serial port,	Yes	Yes
trolley with height ad-justment, castor wheelswith brakes & powerreceptacle	Yes	Yes
skin temperature probes,probe covers	Yes	Yes
Oxygen, & air filter inlets	Yes	Yes
sensor module	Yes	Yes
hose grommets	Yes	Yes
accessory rail and cablewrap	Yes	Yes
Thermonitoring	N/A - only displays skin temperature	Trend display of difference betweencentral and peripheral skin temperatures	Similar. Skin temperature is displayed foruser in both systems. Isolette 8000 plusprovides additional temperature trendinformation.

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Discussion of Non-clinical Testing

The Isolette 8000 plus was tested in accordance with applicable standards, quidance and internal design control procedures including performance testing, functional/operation and validation, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components.

The following performance data were provided in accordance with standards or technical system requirements and as identified in the IFU Technical Data Section:

Electrical safety and electromagnetic compatibility (EMC), incl. performance testing

Electrical safety and EMC testing were conducted on the Isolette 8000 plus. The device complies with the IEC 60601-1, IEC 60601-2-19, standards for safety and performance and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."2005. The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Biocompatibility testing

The biocompatibility evaluation for the Isolette 8000 plus was conducted in accordance with the FDA quidance on Biocompatibility on the International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, ', and International Standard ISO 10993-1 Biological Evaluation of edical evices Part 1: Evaluation and Testing Within a Risk Manaqement Process," as recognized by FDA. Testing included the following tests:

Integral Test for volatile organic compounds
Photogenic bacteria test
Emission of particles
Material characterization according to ISO 10993-18
_ Toxicological Evaluation according to ISO 10993-17
Cytotoxicity
Irritation
_Sensitization

Human Factor

The usability evaluation for the Isolette 8000 plus was conducted in accordance with the FDA quidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2016.

Reprocessing

The Isolette 8000 plus was assessed in accordance with the FDA guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff, 2015.

Cleaning/Disinfection

Macroscopic and microbiological validation with Oxycide was performed by an accredited laboratory pursuant to DIN EN ISO/IEC 17025 and provided in the submission.

Kangaroo Mode

Kangaroo Care is commonly used in neonatal care to allow skin to skin contact between the parent careqiver. In kangaroo mode, the patient is warmed by the parents or caregivers body heat instead of the device. The patient is removed from the incubator and placed on the caregivers naked breast. To prevent heat loss, the patient may also be covered with a blanket. Skin temperature probes remain on the patient during Kangaroo Mode and function the same as if the patient were inside the incubator. Numerous studies have documented the clear benefits of this simple technique on the physiologic and emotional well-being of infants and mothers, especially for preterm babies. Kangaroo Mode performance testing was performed according to the technical requirements of the Isolette 8000 Plus incubator and provided in the submission.

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Animal Study

No animal study has been conducted.

Clinical Studies None

Sterilization

Not applicable

Humidification System (Optional)

Autohumidity performance testing was performed according to the technical requirements of the Isolette 8000 Plus incubator and provided in the submission.

Thermomonitoring

Thermomonitoring performance testing was performed according to the technical requirements of the Isolette 8000 Plus incubator and provided in the submission.

External Communication

Serial data output or Medibus X performance testing was performed according to the technical requirements of the Isolette 8000 Plus incubator and provided in the submission.

Trendelenburg (Tilt Mechanism)

Regression testing was performed for a mechanical change to the tilt mechanism from the predicate to the Isolette 8000 plus according to the technical requirements and provide in the submission.

Conclusion Drawn from Non-Clinical Studies

The results of the non-clinical bench testing, and comparison to the predicate device show that the Isolette® 8000 plus meets the performance requirements of the standards and guidance mentioned above and is substantially equivalent to the predicate device K001242.

Regulation Number and Section

§ 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).