Isolette 8000 Plus

K182977 · Draeger Medical Systems, Inc. · FMZ · Nov 21, 2018 · General Hospital

Device Facts

• Record ID: K182977
• Device Name: Isolette 8000 Plus
• Applicant: Draeger Medical Systems, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: Nov 21, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 Story

Neonatal incubator providing controlled environment for premature and full-term infants up to 10 kg. Controls temperature, oxygen, and humidity. Used in hospital departments including NICU, Special Care Baby Unit, Step Down Nursery, Newborn Nursery, and pediatrics. Operated by clinical staff. Device consists of hood/shell assembly mounted on fixed-height cabinet stand. Provides thermomonitoring and Kangaroo mode. Healthcare providers monitor infant status and incubator parameters via device display; adjustments affect infant thermal stability and respiratory support. Benefits include stable microenvironment for vulnerable neonates.

Clinical Evidence

Bench testing only. Verification and validation activities included mechanical instability testing per IEC 60601-1, electrical safety per IEC 60601-1, and electromagnetic compatibility per IEC 60601-1-2.

Technological Characteristics

Controller-based neonatal incubator. Materials: Metal (e.g., Aluminum), synthetic (e.g., TPE, Thermoplastics), textile, polyurethane, hydrogel. Biocompatibility per ISO 10993. Class I, Type BF, continuous operation. Connectivity: RS-232 serial port (MEDIBUS.X protocol). Power: 100/120V, 50/60 Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-19.

Indications for Use

Indicated for thermoregulation, oxygen control (optional), and humidity control (optional) for premature and full-term infants up to 10 kg (22 lbs). Not 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® 8000 plus (K172154)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------|--|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |
| <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |

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# Special 510(k) Premarket Notification Summary K182977

| Submitter: | Draeger Medical Systems, Inc.<br>3135 Quarry Road<br>Telford, PA 18969 USA | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Contact Person: | Karen Otrupchak<br>Project Manager, Regulatory Affairs<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] | |
| Date prepared: | 21 November 2018 | |
| Device Name: | Trade Name:<br>Classification Name:<br>Regulation Number:<br>Product Code:<br>Class: | Isolette® 8000 plus<br>Neonatal Incubator<br>21 CFR §880.5400<br>FMZ<br>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 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.

### 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<br>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<br>device |
| Indications for Use | 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 of<br>10 kg (22 lbs). The Isolette® 8000 plus is<br>not intended for home use. | Same | N/A |
| Target Population/<br>Patient Population | Newly born infants up to 10 kg. (22lbs) | Same | N/A |
| Environment of<br>Use | For use in any department of the hospital<br>that provides neonatal and infant care,<br>including NICU/Special Care Baby Unit<br>and the Step Down Nursery, Newborn<br>Nursery and pediatrics. | Same | N/A |
| System Specifications | | | |
| Principle of<br>Operation | Controller-based incubator that enables<br>simultaneous control of temperature,<br>oxygen, and humidity parameters<br>affecting the infant | Same | N/A |
| Protection class | Class I, Type BF, continuous operation,<br>not AP | Same | N/A |
| Ingress of liquids<br>and particulate<br>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<br>safety 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.) without<br>options/accessories | <95.3 kg (210 lb.) without<br>options/accessories | Different – No impact on effect on<br>safety and effectiveness. |
| Mattress size | >38 x 74 x3 cm (15 x 29.1 x 1.2 in) | Same | N/A |
| Trendelenburg/<br>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<br>Isolette 8000 plus incubator mounted on<br>top | Fixed Height / Cabinet Stand with Isolette<br>8000 plus incubator mounted on top | Different – No impact on effect on<br>safety and effectiveness. |
| Mobility | Support stand able to raise and lower the<br>incubator on VHA. Storage with swivel<br>drawer storage. Three (3) dual total lock<br>castors, one (1) dual steering castor | Support stand without the ability to raise<br>and lower incubator. Storage ability<br>permitted within cabinet stand. Four (4)<br>Single castors with total lock function | Different – No impact on effect on<br>safety and effectiveness. |
| Power Routing and<br>Convenience<br>Outlets | Image: Incubator and VHA | Image: Incubator and Cab Stand | Different – Convenience outlet<br>and actuator/electronics<br>controlling the VHA removed.<br>No impact on effect on safety<br>and effectiveness. |
| Environmental | | | |
| Operating<br>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<br>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<br>air pressure | 110-50 kPa | Same | N/A |
| Electrical Requirements | | | |
| Power req.<br>100/120V | 100/120V, 50/60 Hz, 1900 W max, 9.9 A<br>max | Same | N/A |
| Auxiliary power<br>sockets | All 50/60 Hz<br>100 V, 100W max<br>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 | <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 |
| <b>Kangaroo Mode</b> | | | |
| Kangaroo Mode | Yes | Same | N/A |
| <b>Thermomonitoring</b> | | | |
| Thermomonitoring | Yes | Same | N/A |
| <b>Misc. Specifications</b> | | | |
| 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 |
| Draeger<br>MEDIBUS.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<br>(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 |…