Isolette 8000 plus

K172154 · Draeger Medical Sytems, Inc. · FMZ · Apr 19, 2018 · General Hospital

Device Facts

• Record ID: K172154
• Device Name: Isolette 8000 plus
• Applicant: Draeger Medical Sytems, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: Apr 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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).

Device Story

The Isolette 8000 plus is a controller-based neonatal incubator providing a controlled environment for premature and full-term infants up to 10 kg. It regulates temperature, oxygen, and humidity. The device features a Trendelenburg bed-tilt mechanism, skin temperature probes, and an optional Kangaroo Mode for skin-to-skin contact. It is operated by healthcare professionals in hospital departments such as the NICU, Step Down Nursery, and pediatrics. The system uses a liquid crystal display to provide data and supports external communication via serial port or MEDIBUS.X. The device helps maintain stable environmental conditions to support infant development and thermoregulation. Healthcare providers use the output to monitor the infant's status and adjust therapy parameters, potentially benefiting the patient by reducing heat loss and maintaining physiological stability.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance testing of environmental controls (temperature, humidity, oxygen), biocompatibility (ISO 10993), human factors/usability engineering, and reprocessing validation.

Technological Characteristics

Controller-based incubator; AC power; liquid crystal display. Materials: Aluminum, TPE, Thermoplastics, Polyurethane, Hydrogel. Standards: IEC 60601-1, IEC 60601-2-19, IEC 60601-1-2. Connectivity: Serial port, MEDIBUS.X. Features: Trendelenburg tilt (0-12°), skin temperature probes, optional humidity/oxygen control. Biocompatibility per ISO 10993.

Indications for Use

Indicated for thermoregulation and controlling oxygen (optional) and humidity (optional) for premature and full-term infants up to 10 kg (22 lbs). Not intended for home use.

Regulatory Classification

Identification

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

Predicate Devices

• Isolette Infant Incubator, Model C2HS (K001242)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### 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.<br>3135 Quarry Road<br>Telford, PA 18969 |
|--------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Gale Winarsky<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date summary was prepared: | 2018-04-19 |
| Device Name: | Trade Name: Isolette® 8000 plus<br>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<br>baby as well as the healthier full term<br>baby. It does this by providing a controlled<br>environment, one in which the baby can be<br>provided with the necessary care as well<br>as being left undisturbed in the security of<br>the incubator.<br><br>It is to this end that the product can be<br>used in any department of the hospital that<br>provides neonatal and infant care. One<br>would typically expect the Isolette to be<br>used in the NICU/Special Care Baby Unit.<br>The design lends itself to all levels of care<br>in the NICU making it suitable for use in<br>level I, II, III, and IV where applicable.<br>Other departments would include the Step<br>Down Nursery, Newborn Nursery and<br>pediatrics. | The Isolette® 8000 plus incubator<br>provides a controlled environment for<br>both premature and full-term infants up<br>to a maximum of 10 kg (22lbs). It<br>controls temperature, oxygen (optional)<br>and humidity (optional). | Same - While the wording is different, the<br>intended use of the I8000 plus has not<br>changed from the predicate C2HS. Both<br>devices are incubators, both provide a<br>controlled environment, both are used for the<br>same patient population.<br><br>The patient population has not changed from<br>the predicate. The weight is now provided in<br>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<br>Imperative to the development of the<br>premature baby. The Isolette® Infant<br>Incubator incorporates a unique<br>bidirectional air flow to help reduce radiant<br>heat loses from the infant by warming the<br>inner hood surface. The Hill-Rom Air-<br>Shields patented Air Curtain has been<br>incorporated into the Isolette Infant<br>Incubator to reduce temperature<br>fluctuations within the incubator when the<br>access panels are opened. With the<br>Humidity module installed, operational<br>evaporative heat losses are minimized.<br>With the installation of the optional Oxygen<br>control system, the Oxygen level within the<br>infant compartment can be monitored and<br>maintained. | The Isolette® 8000 plus incubator is<br>indicated for thermoregulation and<br>controlling oxygen (optional), and<br>humidity (optional) for both premature<br>and full-term infants up to a maximum<br>of 10 kg (22lbs).<br>The Isolette® 8000 plus is not intended<br>for home use. | Similar - While the indications statement has<br>been simplified, substantial equivalence is<br>supported by the following:<br>The functional indications for use for the I8000<br>plus have not changed from the C2HS. Both<br>devices provide temperature management.<br>This wording has been simplified in the I8000<br>plus Indications by using the term<br>"thermoregulation", which by definition means<br>temperature control.<br>Both devices use the same air flow and "Air<br>Curtain' technology for thermoregulation.<br>Both devices offer humidity, and oxygen<br>control used for the same applications.<br>Both devices have the same environment of<br>use.<br>Neither device is intended for home use. |
| Target<br>Population/Patient<br>Population | Premature and full term infants | Newly born infants up to 10 kg. (22lbs) | Same - The patient population has not<br>changed from the predicate. The weight of<br>the patient is now provided as additional<br>information for the user. |
| Environment of Use | Isolette to be used in the NICU/Special<br>Care Baby Unit and the Step Down<br>Nursery, Newborn Nursery and pediatrics. | The I8000 plus can be used in any<br>department of the hospital that provides<br>neonatal and infant care, including<br>NICU/Special Care Baby Unit and the<br>Step Down Nursery, Newborn Nursery<br>and pediatrics. | Similar - Some hospitals may refer to their<br>neonatal and infant care areas by other terms<br>than NICU, Step Down Nursery, Newborn<br>Nursery and pediatrics. |
| System Specifications | | | |
| Principle of Operation | Controller-based incubator that enables<br>simultaneous control of temperature,<br>oxygen, and humidity parameters affecting<br>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) | <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…