(276 days)
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.
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.
The provided text describes the regulatory clearance of the Isolette® 8000 plus neonatal incubator and its comparison to a predicate device (Isolette® Infant Incubator, Model C2HS, K001242) for showing substantial equivalence. It does not contain information about an AI-powered device or a study involving human experts or a training set for machine learning. Therefore, many of the requested details are not applicable as this is a traditional medical device submission without AI.
However, based on the provided text, I can extract the acceptance criteria and a summary of the non-clinical studies performed to demonstrate that the device meets those criteria.
Acceptance Criteria and Device Performance for Isolette® 8000 plus (K172154)
This submission is for a traditional medical device (neonatal incubator) and does not involve AI. Therefore, numerous requested sections related to AI performance, human expert evaluation, and training sets are not applicable.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by the stated specifications and compliance with recognized standards. The "Device Under Review" column effectively serves as the reported device performance compared to the predicate.
| Specification (Acceptance Criterion implied by predicate/standards) | Predicate (Isolette® Infant Incubator, Model C2HS) Performance | Device Under Review (Isolette® 8000 plus) Performance | Comments (Device Meets or is Similar to Predicate) |
|---|---|---|---|
| Intended Use | Care for premature and full-term babies, controlled environment in NICU/Special Care Baby Unit etc. | Controlled environment for premature and full-term infants up to 10 kg (22lbs). Controls temperature, oxygen (optional), and humidity (optional). Not for home use. | Same - Wording different, but intended use unchanged. |
| Indications for Use | Effective temperature management, reduces radiant heat loss, minimizes evaporative heat loss, monitors/maintains O2 levels. | Thermoregulation and controlling oxygen (optional), and humidity (optional) for premature and full-term infants up to 10 kg (22lbs). Not for home use. | Similar - Simplified wording; functional indications unchanged; similar technology. |
| Target Population | Premature and full term infants | Newly born infants up to 10 kg (22lbs) | Same - Weight added as information. |
| Environment of Use | NICU/Special Care Baby Unit, Step Down Nursery, Newborn Nursery and pediatrics. | Any department of the hospital that provides neonatal and infant care, including NICU/Special Care Baby Unit, Step Down Nursery, Newborn Nursery and pediatrics. | Similar - Broader phrasing for hospital areas. |
| Principle of Operation | Controller-based incubator, simultaneous control of temp, O2, humidity. | Same as C2HS | Same |
| Protection Class | Class I, Type BF, continuous, not AP | Same as C2HS | Same |
| Ingress of liquids and particulate matter (IEC 60601-1) | IPXO | Same as C2HS | Same |
| 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. |
| Operating temperature | 20-30°C (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 - Meets IEC 60601-1. |
| Operating Ambient air pressure | Not available | 110-70 kPa | Same - Design elements unchanged. |
| Storage temperature | -30 to 70°C (-22 to 158°F) | -20 to 60°C (-4 to 140°F) | Similar - Device packaging marked with requirements. |
| Storage humidity | 0-99% RH, non-condensing | 5-95% RH non-condensing | Similar |
| Storage Ambient air pressure | Not available | 110-50 kPa | Same - Design elements unchanged. |
| Power req. 100/120V | 100/120V ± 10%, 50/60 Hz, 1900 W max. | 100/120V, 50/60 Hz, 1900 W max, 9.9 A max | Similar - Amperage added; not clinically relevant. |
| Auxiliary power sockets | All 50/60 Hz, 100, 120, 220, & 240V ± 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°C, in air temp mode | Same as C2HS | Same |
| Humidity control reservoir capacity | 1000 mL | 1500 mL | Similar - Difference not clinically relevant. |
| Humidity control range | 30% to 95% in 1% increments | Same as C2HS | Same |
| Humidity control accuracy (10-90% @ 20-40°C) | ±5% RH | ±6% RH | Similar - 1% difference not clinically relevant. |
| Oxygen control range | 21% to 65% | Same as C2HS | Same |
| Oxygen display accuracy (100% calibration) | ±3% | Same as C2HS | Same |
| Material used for direct patient contact | Textile Polyurethane, PVC, Hydrogel | Textile Polyurethane, TPE, Hydrogel | Similar - TPE material tested for biocompatibility. |
| Biocompatibility | According to ISO 10993 | Same as C2HS | Same |
| Thermonitoring | N/A - only displays skin temperature | Trend display of difference between central and peripheral skin temperatures | Similar. Isolette 8000 plus provides additional trend info. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies were non-clinical bench testing, not clinical studies involving patient data.
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)
Not applicable. This is a non-AI medical device submission, and the ground truth was established through engineering specifications, regulatory standards compliance, and bench testing, not human expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-AI medical device submission.
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 is a non-AI medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-AI medical device submission. The device performs as a standalone incubator without human-in-the-loop performance in the context of an AI algorithm; however, human operators are inherently part of its use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, recognized international standards (e.g., IEC 60601-1, IEC 60601-2-19, IEC 60601-1-2, ISO-10993), and internal design control procedures. Performance benchmarks are set by these standards and the predicate device's capabilities.
8. The sample size for the training set
Not applicable. This is a non-AI medical device submission; there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable.
Summary of Studies to Prove Acceptance Criteria are Met (Non-Clinical Testing):
The Isolette® 8000 plus underwent a series of non-clinical bench tests and evaluations to demonstrate its safety and effectiveness and substantial equivalence to the predicate device. These include:
- Performance Testing: Conducted in accordance with applicable standards and technical system requirements, as well as the device's Instructions for Use (IFU) Technical Data Section. This covers all the operational specifications listed in the table above (e.g., temperature control ranges, humidity accuracy, oxygen control, noise levels, warm-up times).
- Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-2-19 (safety and performance), and IEC 60601-1-2 (EMC).
- Software Verification and Validation Testing: Conducted following FDA guidance for medical device software. The software was considered a "major" level of concern.
- Biocompatibility Testing: Conducted in accordance with FDA guidance on ISO 10993 standards. Tests included:
- Integral Test for volatile organic compounds
- Photogenic bacteria test
- Emission of particles
- Material characterization (ISO 10993-18)
- Toxicological Evaluation (ISO 10993-17)
- Cytotoxicity
- Irritation
- Sensitization
- Human Factors: Usability evaluation conducted in accordance with FDA guidance on Human Factors and Usability Engineering.
- Reprocessing: Assessed following FDA guidance ("Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling").
- Cleaning/Disinfection: Macroscopic and microbiological validation performed with Oxycide by an accredited laboratory (DIN EN ISO/IEC 17025).
- Kangaroo Mode Performance Testing: Performed according to the technical requirements for this new feature.
- Autohumidity Performance Testing: Performed according to technical requirements for the optional humidification system.
- Thermomonitoring Performance Testing: Performed according to technical requirements.
- External Communication (Serial data output or Medibus X) Performance Testing: Performed according to technical requirements.
- Trendelenburg (Tilt Mechanism) Regression Testing: Performed for mechanical changes compared to the predicate device.
No animal or clinical studies were conducted for this submission. The conclusion drawn from these non-clinical studies was that the Isolette® 8000 plus meets performance requirements and standards and is substantially equivalent to the predicate device K001242.
§ 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).