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.

AI/ML Overview

This document is a 510(k) premarket notification for a modification to an existing medical device, the Isolette® 8000 Plus Neonatal Incubator. The modification involves replacing the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. No AI/ML components are involved in this device, therefore, many of the requested fields are not applicable.

Here's a summary based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document focuses on demonstrating that the modified device remains substantially equivalent to its predicate device (Isolette® 8000 plus, K172154) despite the change in the trolley. The acceptance criteria essentially align with the predicate device's established performance and safety standards. The performance of the modified device is reported as "Same" for nearly all specifications, with "Different – No impact on effect on safety and effectiveness" for the few physical attribute changes.

Specification	Acceptance Criteria (Predicate Device K172154)	Reported Device Performance (Modified Device K182977)	Comments
General Performance
Air temperature mode set point range	20 to 39 C (68-102.2 F)	Same	N/A
Warm-up time at 22C (72F) ambient	<35min	Same	N/A
Variability	<0.5C (<0.9F)	Same	N/A
Uniformity with a level mattress	<0.8C (<1.4F)	Same	N/A
Skin Temperature Mode set point range	34.0 to 37.0C (93.2 to 98.6F)	Same	N/A
Accuracy of incubator temp indication	≤0.8C	Same	N/A
Noise level within the hood environment	<47 dB(A) w/ 37 dB(A) or less ambient	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.
Weight	<98.5 kg (217.1 lb.) without options/accessories	<95.3 kg (210 lb.) without options/accessories	Different – No impact on effect on safety and effectiveness.
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.
Safety and EMC
Instability (mechanical)	Per IEC60601-1	Verified through non-clinical testing	N/A
Electrical Safety	Per IEC60601-1	Verified through non-clinical testing	N/A
Electromagnetic Compatibility (EMC)	Per IEC60601-1-2	Verified through non-clinical testing	N/A

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

This document describes a modification to an existing device, not a study involving human or animal subjects that would typically have a "test set" in the context of clinical data. The "test set" here refers to the engineering verification and validation activities. The document summarizes these activities as having been "carried out under well established methods." There is no information regarding the sample size of devices tested for Instability, Electrical Safety, and EMC, nor is there information on data provenance beyond being "non-clinical testing."

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)

This is not applicable to an engineering verification of a medical device modification. The "ground truth" for the tests performed (Instability, Electrical Safety, EMC) is established by the relevant international standards (IEC60601-1, IEC60601-1-2) which define the pass/fail criteria. Expertise would be in the form of qualified engineers and technicians performing the tests and reviewing the results against these standards.

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

Not applicable. This is not a study involving human reader interpretation or consensus on data. The verification activities are against predefined technical standards.

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 device is a neonatal incubator, not an AI-powered diagnostic tool, and its modification does not involve human readers or AI assistance.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical testing refers to the established standards for medical device safety and performance, specifically IEC60601-1 (general medical electrical equipment safety), IEC60601-1-2 (electromagnetic compatibility), and IEC60601-2-19 (basic safety and essential performance of infant incubators). These standards define the acceptable limits and performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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.

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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

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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 RoadTelford, PA 18969 USA
Contact Person:	Karen OtrupchakProject Manager, Regulatory AffairsEmail: karen.otrupchak@draeger.comPhone: 215-660-2292Fax: 215-721-5424
Date prepared:	21 November 2018
Device Name:	Trade Name:Classification Name:Regulation Number:Product Code:Class:	Isolette® 8000 plusNeonatal Incubator21 CFR §880.5400FMZII
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/GMDNScode	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 modifieddevice
Indications for Use	The Isolette® 8000 plus incubator isindicated for thermoregulation andcontrolling oxygen (optional), andhumidity (optional) for both prematureand full-term infants up to a maximum of10 kg (22 lbs). The Isolette® 8000 plus isnot intended for home use.	Same	N/A
Target Population/Patient Population	Newly born infants up to 10 kg. (22lbs)	Same	N/A
Environment ofUse	For use in any department of the hospitalthat provides neonatal and infant care,including NICU/Special Care Baby Unitand the Step Down Nursery, NewbornNursery and pediatrics.	Same	N/A
System Specifications
Principle ofOperation	Controller-based incubator that enablessimultaneous control of temperature,oxygen, and humidity parametersaffecting the infant	Same	N/A
Protection class	Class I, Type BF, continuous operation,not AP	Same	N/A
Ingress of liquidsand particulatematter 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 onsafety and effectiveness.
Width	<104 cm (41 in)	Same	N/A
Depth	<76.2 cm (30 in)	Same	N/A
Weight	<98.5 kg (217.1 lb.) withoutoptions/accessories	<95.3 kg (210 lb.) withoutoptions/accessories	Different – No impact on effect onsafety and effectiveness.
Mattress size	>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) withIsolette 8000 plus incubator mounted ontop	Fixed Height / Cabinet Stand with Isolette8000 plus incubator mounted on top	Different – No impact on effect onsafety and effectiveness.
Mobility	Support stand able to raise and lower theincubator on VHA. Storage with swiveldrawer storage. Three (3) dual total lockcastors, one (1) dual steering castor	Support stand without the ability to raiseand lower incubator. Storage abilitypermitted within cabinet stand. Four (4)Single castors with total lock function	Different – No impact on effect onsafety and effectiveness.
Power Routing andConvenienceOutlets	Image: Incubator and VHA	Image: Incubator and Cab Stand	Different – Convenience outletand actuator/electronicscontrolling the VHA removed.No impact on effect on safetyand effectiveness.
Environmental
Operatingtemperature	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 Ambientair 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 Ambientair pressure	110-50 kPa	Same	N/A
Electrical Requirements
Power req.100/120V	100/120V, 50/60 Hz, 1900 W max, 9.9 Amax	Same	N/A
Auxiliary powersockets	All 50/60 Hz100 V, 100W max120 & 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	<35min	Same	N/A
variability	<0.5C (<0.9F)	Same	N/A
overshoot	<0.5C (<0.9F)	Same	N/A
Uniformity with a level mattress	<0.8C (<1.4F)	Same	N/A
Skin Temperature Mode
Set point range	34.0 to 37.0C (93.2 to 98.6F)	Same	N/A
Control override temp range	37.0 to 38.0C (98.6 to 100.4F)	Same	N/A
Set point display range	15.0 to 45.0C (59 to 113F)	Same	N/A
Accuracy of incubator temp indication	≤0.8C	Same	N/A
Deviation limit range	0.3 to 1.0C (0.5 to 1.8F)	Same	N/A
Deviation limit default	1.0C (1.8F)	Same	N/A
Kangaroo Mode
Kangaroo Mode	Yes	Same	N/A
Thermomonitoring
Thermomonitoring	Yes	Same	N/A
Misc. Specifications
Noise level within the hood environment	<47 dB(A) w/ 37 dB(A) or less ambient (w/out servo O2 control)	Same	N/A
Air velocity over the mattress	< 10 cm/second (4 in/second); average of 5 points at 10cm (4 in) above the mattress	Same	N/A
Carbon Dioxide (CO2) level (per IEC60601-2-19, clause 105)	<0.8%	Same	N/A
Oxygen deviation limit range	3% to 5%	Same	N/A
Oxygen deviation limit default	3%	Same	N/A
Set point data retention	Power failures lasting <10 min	Same	N/A
Device Support	Variable Height Adjustable (VHA) trolley	Cabinet Stand (fixed height) trolley	Different - No impact on safety and effectiveness
Acoustical level (all alarms on)	75 dB(A) maximum	Same	N/A
External Communication
COM port (output only)	Only connects to devices that fulfill the requirements of the standard IEC 60950-1 on unearthed SELV circuits or the requirements of the standard IEC 60601-1 on accessible secondary circuits with max. 60 V DC nominal voltage.	Same	N/A
Type	9-pin Sub-D (female), electrically isolated Protocol	Same	N/A
Configurations	Serial Data Output (default) or MEDIBUS.X	Same	N/A
Serial data output
Baud rate	2400	Same	N/A
Parity	None	Same	N/A
Data bits	8	Same	N/A
Stop bits	1	Same	N/A
DraegerMEDIBUS.X, version 6	By the RS-232 port only	Same	N/A
Baud rate	9600	Same	N/A
Parity	Even	Same	N/A
Data bits	8	Same	N/A
Stop bits	1	Same	N/A
Pin assignment
Pin 2	RXD	Same	N/A
Pin 3	TXD	Same	N/A
Pin 5	GND	Same	N/A
Humidification system (optional)
Automatic(Autohumidity)	Yes	Same	N/A
Humidity control duration of operation after refilling	>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 forindirect patientcontact	Metal (e.g. Aluminum) Synthetic material(e.g. TPE, Thermoplastics)	Same	N/A
Material used fordirect patientcontact	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 temperatureprobes, probecovers	Yes	Same	N/A
Oxygen, & air filterinlets	Yes	Same	N/A
Sensor module	Yes	Same	N/A
Hose grommets	Yes	Same	N/A
Accessory railand 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.

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 ●

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.

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).