(276 days)
Not Found
No
The document describes a standard incubator with environmental controls and does not mention any AI or ML capabilities.
Yes
The device is used for thermoregulation and controlling oxygen and humidity for infants, which are considered therapeutic functions.
No
The device is an incubator for thermoregulation and environmental control for infants, which is a therapeutic function, not a diagnostic one.
No
The device description clearly lists numerous hardware components (incubator, hand ports, access panel, serial port, trolley, wheels, power receptacle, bed-tilt mechanism, mattress, skin temperature probes, etc.) and describes it as a physical device used to maintain environmental conditions. While it mentions software verification and validation, this is in the context of controlling the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for thermoregulation and controlling environmental factors (oxygen, humidity) for infants. This is a life support/environmental control device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical incubator designed to create a controlled environment for infants. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, assays, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the Isolette® 8000 plus incubator is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
premature and full-term infants
Intended User / Care Setting
any department of the hospital that provides neonatal and infant care, including NICU/Special Care Baby Unit and the Step Down Nursery, Newborn Nursery and pediatrics.
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 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. 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. The software for this device was considered as a "major" level of concern.
Biocompatibility testing: 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 Mode performance testing was performed according to the technical requirements of the Isolette 8000 Plus incubator and provided in the submission.
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: 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.
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.
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and full name are written in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K172154
Device Name Isolette® 8000 plus
Indications for Use (Describe)
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.
| 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) |
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 Drug 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."
3
Image /page/3/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue. The word is centered in the image.
510(k) Summary K172154
| Manufacturer Name and Address: | Dräger Medical Systems, Inc.
3135 Quarry Road
Telford, PA 18969 |
|--------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Gale Winarsky
Manager, Regulatory Affairs
Phone: 215-660-2239
Fax: 215-721-5424 |
| Date summary was prepared: | 2018-04-19 |
| Device Name: | Trade Name: Isolette® 8000 plus
Classification 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:
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.
Indications for Use:
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.
Regulation Number:
Product Code:
Class:
4
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 premature | ||
| baby as well as the healthier full term | |||
| baby. It does this by providing a controlled | |||
| environment, one in which the baby can be | |||
| provided with the necessary care as well | |||
| as being left undisturbed in the security of | |||
| the incubator. |
It is to this end that the product can be
used in any department of the hospital that
provides neonatal and infant care. One
would typically expect the Isolette to be
used in the NICU/Special Care Baby Unit.
The design lends itself to all levels of care
in the NICU making it suitable for use in
level I, II, III, and IV where applicable.
Other departments would include the Step
Down Nursery, Newborn Nursery and
pediatrics. | 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). | Same - While the wording is different, the
intended use of the I8000 plus has not
changed from the predicate C2HS. Both
devices are incubators, both provide a
controlled environment, both are used for the
same patient population.
The patient population has not changed from
the predicate. The weight is now provided in
as 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 is
Imperative to the development of the
premature baby. The Isolette® Infant
Incubator incorporates a unique
bidirectional air flow to help reduce radiant
heat loses from the infant by warming the
inner hood surface. The Hill-Rom Air-
Shields patented Air Curtain has been
incorporated into the Isolette Infant
Incubator to reduce temperature
fluctuations within the incubator when the
access panels are opened. With the
Humidity module installed, operational
evaporative heat losses are minimized.
With the installation of the optional Oxygen
control system, the Oxygen level within the
infant compartment can be monitored and
maintained. | 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. | Similar - While the indications statement has
been simplified, substantial equivalence is
supported by the following:
The functional indications for use for the I8000
plus have not changed from the C2HS. Both
devices provide temperature management.
This wording has been simplified in the I8000
plus Indications by using the term
"thermoregulation", which by definition means
temperature control.
Both devices use the same air flow and "Air
Curtain' technology for thermoregulation.
Both devices offer humidity, and oxygen
control used for the same applications.
Both devices have the same environment of
use.
Neither device is intended for home use. |
| Target
Population/Patient
Population | Premature and full term infants | Newly born infants up to 10 kg. (22lbs) | Same - The patient population has not
changed from the predicate. The weight of
the patient is now provided as additional
information for the user. |
| Environment of Use | Isolette to be used in the NICU/Special
Care Baby Unit and the Step Down
Nursery, Newborn Nursery and pediatrics. | The I8000 plus can be used in any
department of the hospital that provides
neonatal and infant care, including
NICU/Special Care Baby Unit and the
Step Down Nursery, Newborn Nursery
and pediatrics. | Similar - Some hospitals may refer to their
neonatal and infant care areas by other terms
than NICU, Step Down Nursery, Newborn
Nursery and pediatrics. |
| System Specifications | | | |
| Principle of Operation | Controller-based incubator that enables
simultaneous control of temperature,
oxygen, and humidity parameters affecting
the 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) | 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) | |
| Electrical
Requirements | | | |
| Power req. 100/120V | 100/120V $\pm$ 10%, 50/60 Hz, 1900 W max. | 100/120V, 50/60 Hz, 1900 W max, 9.9 A
max | Similar - Amperage was not applicable to the
C2HS as it had a circuit breaker instead of
fuse. Not clinically relevant. |
| Auxiliary power sockets | All 50/60 Hz
100, 120, 220, & 240V $\pm$ 10% 500W max. | All 50/60 Hz
100 V, 100W max
120 & 230 V 300W max | Similar - Both meet current safety standards. |
| Earth Leakage | 24 hours @ 85% RH and 37 deg. C, in air
temp mode | Same as C2HS | Same |
| Humidity control
reservoir capacity | 1000 mL | 1500 mL | Similar - The difference in reservoir capacity
is not clinically relevant. |
| Humidity control range | 30% to 95% in 1% increments (at high
ambient humidity levels, low-level humidity
settings may not be attainable) | Same as C2HS | Same |
| Humidity control
accuracy between 10%
and 90% @ 20 to 40C
(68 to 104F) | ±5% RH | ±6% RH | Similar - The difference in the humidity
control 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 control
system (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 display
resolution | 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 control
system (option) | | | |
| Oxygen inlet pressure | 40psi 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 |
| Weighing System | | | |
| Standard weighing
system (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 EU
countries requiring a scale that complies with
the 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 indirect
patient 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 direct
patient contact | Textile Polyurethane, PVC, Hydrogel | Textile Polyurethane, TPE, Hydrogel | Similar - the materials used for direct patient
contact are the same as the C2HS with the
exception of the TPE material used in the
I8000 plus temperature probes. This material
was tested and found to be biocompatible for
the 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 wheels
with brakes & power
receptacle | 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 cable
wrap | Yes | Yes | |
| Thermonitoring | N/A - only displays skin temperature | Trend display of difference between
central and peripheral skin temperatures | Similar. Skin temperature is displayed for
user in both systems. Isolette 8000 plus
provides additional temperature trend
information. |
5
6
7
8
9
10
11
12
13
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.
14
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.