K Number

Device Name

Isolette 8000 Plus

Manufacturer

Draeger Medical Systems, Inc.

Date Cleared

2018-11-21

(26 days)

Product Code

FMZ

Regulation Number

880.5400

Intended Use

The Isolette® 8000 plus 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 neonatal incubator that provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen and humidity (both are optional). The predicate device as cleared in K172154 is offered with the hood and shell assembly of the incubator mounted on a variable high adjustable (VHA) trolley. All components and accessories for the device were cleared as part of the system. The modification of the device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. All other components and accessories of the device are identical to those cleared under K172154. The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K172154

Reference Devices

K172154

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states that the modification does not alter the fundamental scientific technology of the predicate device and there are no mentions of AI, ML, or related concepts. The changes are limited to the physical stand.

Therapeutic

Yes
The device is a neonatal incubator indicated for thermoregulation and controlling oxygen and humidity for infants, which are therapeutic functions to support infant health.

Diagnostic

No
The device is a neonatal incubator for thermoregulation and environmental control, not for identifying a disease or condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is a neonatal incubator, which is a physical hardware device. The modification described is the replacement of a physical trolley. There is no mention of the device being solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants." This describes a device used to maintain a controlled environment for a patient, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description clearly states it is a "neonatal incubator that provides a controlled environment." This aligns with a life support or environmental control device, not an IVD.
No mention of biological specimens: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
No mention of diagnostic information: The device provides environmental control, not diagnostic information about the infant's health status based on biological samples.

Therefore, the Isolette® 8000 plus is a medical device, but it falls under a category other than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Isolette® 8000 plus 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

FMZ

Device Description

The predicate device as cleared in K172154 is offered with the hood and shell assembly of the incubator mounted on a variable high adjustable (VHA) trolley. All components and accessories for the device were cleared as part of the system.

The modification of the device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. All other components and accessories of the device are identical to those cleared under K172154.

The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.

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

For use 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.

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)

A risk analysis for the modification to the Isolette 8000 plus was performed according to ISO 14971 Application of Risk Management to Medical Devices and Draeger's standard operating procedure on Product Risk Management. A review of the Product Risk Management Report (PRMR) revealed there were no new hazards or risk control measures (RCMs) associated with the modification of the device.

The following identified verification and validation activities necessary to establish substantial equivalence to the predicate device were carried out under well established methods and their results are summarized within the Design Control Activities Summary table within this submission.

Instability (mechanical) per IEC60601-1 ●
Electrical Safety per IEC60601-1
Electromagnetic Compatibility (EMC) per IEC60601-1-2 ●

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172154

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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November 21, 2018

Draeger Medical Systems, Inc. Karen Otrupchak Project Manager, Regulatory Affairs 3135 Quarry Road Telford, Pennsylvania 18969

Re: K182977

Trade/Device Name: Isolette® 8000 Plus Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: Class II Product Code: FMZ Dated: October 25, 2018 Received: October 26, 2018

Dear Karen Otrupchak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about 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,

Tina
Kiang-S

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

Indications for Use

510(k) Number (if known)

Device Name Isolette® 8000 plus

Indications for Use (Describe)

The Isolette® 8000 plus 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)

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Special 510(k) Premarket Notification Summary K182977

| Submitter: | Draeger Medical Systems, Inc.
3135 Quarry Road
Telford, PA 18969 USA | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Contact Person: | Karen Otrupchak
Project Manager, Regulatory Affairs
Email: karen.otrupchak@draeger.com
Phone: 215-660-2292
Fax: 215-721-5424 | |
| Date prepared: | 21 November 2018 | |
| Device Name: | Trade Name:
Classification Name:
Regulation Number:
Product Code:
Class: | Isolette® 8000 plus
Neonatal Incubator
21 CFR §880.5400
FMZ
II |
| Predicate Device: | Isolette® 8000 plus, K172154 | |

Draeger Medical Systems, Inc. is submitting a special 510(k) premarket notification for a modification to an existing device, the Isolette® 8000 Plus Neonatal Incubator, cleared under K172154.

Device Description

The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.

Indications for Use

The Isolette® 8000 plus 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 (22 lbs). The Isolette® 8000 plus is not intended for home use.

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	Predicate Device	Modified Device
Specification	Isolette®8000 plus	Isolette®8000 plus (with cabinet stand)	Comments
Manufacturer	Draeger Medical Systems, Inc.	Draeger Medical Systems, Inc.	N/A
510(k)	K172154	K182977	N/A
Regulation #	880.5400	Same	N/A
Product Code	FMZ	Same	N/A
Classification	II	Same	N/A
UMDNS/GMDNS
code	12-113/36025	Same	N/A
Standards	60601-1; 60601-1-2; 60601-2-19	Same	N/A
Part number	MU20602	Same	N/A
Model number	I8KP-1	I8KP-1C	Different – Identifier for modified
device
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 (22 lbs). The Isolette® 8000 plus is
not intended for home use.	Same	N/A
Target Population/
Patient Population	Newly born infants up to 10 kg. (22lbs)	Same	N/A
Environment of
Use	For use 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.	Same	N/A
System Specifications
Principle of
Operation	Controller-based incubator that enables
simultaneous control of temperature,
oxygen, and humidity parameters
affecting the infant	Same	N/A
Protection class	Class I, Type BF, continuous operation,
not AP	Same	N/A
Ingress of liquids
and particulate
matter IEC60601-1	IPXO	Same	N/A
Physical Attributes
Height	133.3 to 153.7 cm (52.5 to 60.5 in)	140 cm ± 1.2 cm (55 in ± 0.5 in)	Different – No impact on effect on
safety and effectiveness.
Width	38 x 74 x3 cm (15 x 29.1 x 1.2 in)	Same	N/A
Trendelenburg/
Reverse Trendelenburg	Continuously variable to 12 deg. +1 deg.	Same	N/A
Infant Weight	10 kg (22 lbs.) maximum	Same	N/A
Appearance	Variable Height Stand (VHA) with
Isolette 8000 plus incubator mounted on
top	Fixed Height / Cabinet Stand with Isolette
8000 plus incubator mounted on top	Different – No impact on effect on
safety and effectiveness.
Mobility	Support stand able to raise and lower the
incubator on VHA. Storage with swivel
drawer storage. Three (3) dual total lock
castors, one (1) dual steering castor	Support stand without the ability to raise
and lower incubator. Storage ability
permitted within cabinet stand. Four (4)
Single castors with total lock function	Different – No impact on effect on
safety and effectiveness.
Power Routing and
Convenience
Outlets	Image: Incubator and VHA	Image: Incubator and Cab Stand	Different – Convenience outlet
and actuator/electronics
controlling the VHA removed.
No impact on effect on safety
and effectiveness.
Environmental
Operating
temperature	Yes	Same	N/A
Operating humidity	5-95% RH non-condensing	Same	N/A
Operating altitude	Up to 3000 m (9800 ft.)	Same	N/A
Operating Ambient
air pressure	110-70 kPa	Same	N/A
Storage temperature	-20 to 60 deg. C (-4 to 140 deg. F)	Same	N/A
Storage humidity	5-95% RH non-condensing	Same	N/A
Storage Ambient
air pressure	110-50 kPa	Same	N/A
Electrical Requirements
Power req.
100/120V	100/120V, 50/60 Hz, 1900 W max, 9.9 A
max	Same	N/A
Auxiliary power
sockets	All 50/60 Hz
100 V, 100W max
120 & 230 V 300W max	Same	N/A
Earth Leakage	$≤$ 500 μΑ	Same	N/A
General Performance
Air temperature mode
Set point range	20 to 39 C (68-102.2 F)	Same	N/A
Control override range	37-39 C (98.6- 102.2 F)	Same	N/A
Set point display range	15 to 45 C (59-113 F)	Same	N/A
Upwards deviation limit	+1.5 to +2.5 C (+2.7 to 4.5 F)	Same	N/A
Upwards deviation limit default	+1.5 C (+2.7 F)	Same	N/A
Downwards deviation limit range	-1.5 to -2.5C (-2.7 to -4.5F)	Same	N/A
Downwards deviation limit default	-2.5C (-4.5F)	Same	N/A
Warm-up time at 22C (72F) ambient	Kangaroo Mode
Kangaroo Mode	Yes	Same	N/A
Thermomonitoring
Thermomonitoring	Yes	Same	N/A
Misc. Specifications
Noise level within the hood environment	24 hours @ 85% RH and 37 deg. C, in air temp mode	Same	N/A
Humidity control reservoir capacity	1500 mL	Same	N/A
Humidity control range	30% to 95% in 1% increments (at high ambient humidity levels, low-level humidity settings may not be attainable)	Same	N/A
Humidity control accuracy between 10% and 90% @ 20 to 40C (68 to 104F)	±6% RH	Same	N/A
Humidity display range	10% to 100%	Same	N/A
Maximum humidity levels	>85% (incubator set temp at 39C with at least 30% RH at ambient)	Same	N/A
Oxygen control system (optional)
Servo oxygen control system	Yes	Same	N/A
Oxygen inlet pressure	40 to 150 psi (2.8 kg/cm2 to 10.5 kg/cm2)	Same	N/A
Oxygen inlet flow rate	30 L/min	Same	N/A
Oxygen control range	21% to 65%	Same	N/A
Oxygen display	1%	Same	N/A
resolution
Oxygen display	±3%	Same	N/A
accuracy (100%
calibration)
Oxygen display	±5%	Same	N/A
accuracy (21%
calibration)
Oxygen display	18% to 100%	Same	N/A
range
Oxygen control	±2% of full scale	Same	N/A
accuracy
Manual oxygen control system (optional)
Oxygen inlet	40psi to 150 psi (2.8 kg/cm² to 10.5	Same	N/A
pressure	kg/cm²)
Oxygen inlet flow	30 L/min	Same	N/A
rate
Weighing System
Standard weighing system (accessory)
Weight display	0 kg (0 lb.) to 7 kg (15.4 lbs.)	Same	N/A
range
Weight display	1 g or 1oz	Same	N/A
resolution
Weight display	0 to 2 kg: ±2 g (0 to 4.4 lb.: ±0.07 oz.)	Same	N/A
accuracy	> 2 kg: ±5 g (>4.4 lb.: ±0. 18 oz.)
Tare weight	≤4.0 kg (8.82 lb.)	Same	N/A
OIML weighing	Yes	Same	OIML weighing system is only for
system (accessory)			EU countries requiring a scale that
			complies with the NAWI directive.

Material - no implants
Material used for
indirect patient
contact	Metal (e.g. Aluminum) Synthetic material
(e.g. TPE, Thermoplastics)	Same	N/A
Material used for
direct patient
contact	Textile Polyurethane, TPE, Hydrogel	Same	N/A
Biocompatibility	According to ISO 10993	Same	N/A
Components
Hand ports	Yes	Same	N/A
Iris ports	Yes	Same	N/A
Access panel	Yes	Same	N/A
Serial port	Yes	Same	N/A
Skin temperature
probes, probe
covers	Yes	Same	N/A
Oxygen, & air filter
inlets	Yes	Same	N/A
Sensor module	Yes	Same	N/A
Hose grommets	Yes	Same	N/A
Accessory rail
and cable wrap	Yes	Same	N/A

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Isolette 8000 plus Special 510(k) Comparison to Predicate

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Isolette 8000 plus Special 510(k) Comparison to Predicate

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Discussion of Non-clinical Testing

The modification to the predicate device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand. A risk analysis for the modification to the Isolette 8000 plus was performed according to ISO 14971 Application of Risk Management to Medical Devices and Draeger's standard operating procedure on Product Risk Management. A review of the Product Risk Management Report (PRMR) revealed there were no new hazards or risk control measures (RCMs) associated with the modification of the device.

Instability (mechanical) per IEC60601-1 ●
Electrical Safety per IEC60601-1
Electromagnetic Compatibility (EMC) per IEC60601-1-2 ●

Conclusion

Based on the intended use, technological characteristics, performance/non-clinical testing, and comparison to the predicate device, the modified device is substantially equivalent to the predicate device K172154 and does not raise different questions of safety and effectiveness than the predicate device.