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510(k) Data Aggregation
(123 days)
The NextGen Transport Incubator is intended for use by personnel care to facilitate the movements of neonates by air or ambulance. The transport incubator provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status. The device provides two modes of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.
The NxtGen Infant Transport Incubator is designed to provide a thermally stable environment for the infant during transport. The incubator is designed to maintain temperatures within desired limits as prescribed by the caregiver.
The NxtGen Infant Transport Incubator has two modes of temperature control available – manual temperature mode and skin temperature control mode (or servo mode). The device includes several optional features including: integrated ambient oxygen monitor, integrated pulse oximeter, integrated phototherapy lighting, integrated electronic suction device, and an integrated heated mattress.
The document describes the K220742 NxtGen Infant Transport Incubator and its comparison to a predicate device, the International Biomedical Voyager Infant Transport Incubator (K103524). The information provided focuses on the device's technological characteristics, intended use, and compliance with various international standards in lieu of a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily discusses substantial equivalence to a predicate device and compliance with established standards. It does not present specific quantitative acceptance criteria and corresponding reported device performance metrics in a single table, as might be seen for diagnostic algorithms. Instead, the "acceptance criteria" are implied by adherence to recognized medical device standards and the device's performance aligning with or improving upon the predicate device's specifications.
Here's a summary of key performance characteristics and how they compare, which can be interpreted as demonstrating the device meets implicit acceptance criteria for functionality and safety based on its predicate and relevant standards:
| Feature/Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (NxtGen Infant Transport Incubator) | Discussion of Differences & Justification (for meeting criteria) |
|---|---|---|---|
| Intended Use | Facilitate neonatal transport with controlled heat, airway management, and monitoring. | Similar to predicate, with added servo temperature control, optional pulse oximetry, suction, heated mattress, and blue LED phototherapy. | Differences (servo control, additional options) do not raise new safety/effectiveness questions as they are common features in other market devices (e.g., Draeger GT-5400) and are defined/tested in standard 60601-2-20. |
| Patient Weight (Max) | 7.3 Kg (16 LBS.) (from predicate) | 10 Kg (22 LBS.) | Larger capacity; safety testing performed to account for this change; no effect on safety and effectiveness. |
| Air Controlled Mode Temp Set Point Range | 17.0°C-38.9°C (from predicate) | 17.0°C-38.9°C | Same as predicate. |
| Air Controlled Alarm Point | ± 1 °C from Temperature Set Point Range-Air Temp (from predicate) | ± 1.5 °C from Temperature Set Point Range-Air Temp | Still within the prescribed range of standard 60601-2-20; more consistent with current technology. |
| Servo Controlled Mode | Not present in predicate; common in other incubators (e.g., K141565 Draeger GT-5400) | Yes (new feature) | Safe and effective heating method, defined and tested in standard 60601-2-20. |
| Servo Temp Set Point Range-Baby Temp | Not present in predicate; common in other incubators | 33°C-37.5°C | Safe and effective heating method, defined and tested in standard 60601-2-20. |
| Servo Controlled Alarm Point | Not present in predicate; defined in 60601-2-20 | ± 0.7 °C from Temperature Set Point Range-Baby Temp | Safe and effective heating method, defined and tested in standard 60601-2-20. |
| PreWarm Mode | Not present in predicate | Yes (new standby mode) | Simply a stand-by mode without a patient; no additional safety and effectiveness impact. |
| Approximate Warm-up Time | 20 Minutes (from predicate) | 12 minutes ± 20% (Low Profile); 16 Minutes ± 20% (XL Chamber) | Faster warm-up time; no impact to safety and effectiveness. |
| Internal Power (Battery) | 1-12 V DC, Lead Acid Battery, sealed, rechargeable (from predicate) | 1-12 V DC, Lead Acid Battery, sealed, rechargeable; 1-12 V DC, Lithium-Iron Phosphate, rechargeable (new option) | Lithium-Iron Phosphate is common in medical devices for superior life; assessed through performance testing. |
| Battery Life Expectancy | 3 hours (from predicate) | 4.5 hours | Increased; makes long transports safer; assessed through performance testing. |
| Integrated Heated Mattress | Not present in predicate; common in other incubators (e.g., K141565 Draeger GT-5400) | Yes (new functionality) | Not new technology, common in transport incubators; compliant with ISO 80601-2-35 (per Intertek Safety Report 104427163LAX-005). |
| Phototherapy Light Maximum Irradiance | 27 μW/cm2/nm (predicate) | Low Chamber: 35 μW/cm2/nm; XL Chamber: 22 μW/cm2/nm | Difference due to chamber size; values are within common range for neonatal phototherapy lights (e.g., K120168 GE Healthcare Lullaby Phototherapy System). Compliant with 60601-2-50. |
| Phototherapy Light Effective Irradiated Area | 10 in x 8 in ellipse (predicate) | Low Chamber: 12.3 in x 9.2 in ellipse; XL Chamber: 15.1 in x 10.8 in ellipse | Greater area; increases treatment area; no new safety/effectiveness questions. |
| Integrated Electronic Suction | Not present in predicate | Yes (new option) | Not new technology; common in transport incubators (though typically stand-alone); compliant with ISO 10079-1 (per Intertek Safety Report 104427163LAX-008). |
| Compliance with Standards | Various IEC and ISO standards (e.g., 60601-1, 60601-2-20, 10079-1) | Demonstrated compliance through performance testing. | Confirms safety and essential performance. |
2. Sample Size for the Test Set and Data Provenance:
This document is a 510(k) summary for a medical device (an infant transport incubator), not an AI/ML software as a medical device (SaMD). Therefore, the typical concepts of "test set sample size" and "data provenance" for algorithm performance evaluation do not directly apply in the same way.
The "testing" mentioned in the document primarily refers to bench testing, software verification and validation, biocompatibility testing, human factors evaluation, and reprocessing evaluation to confirm compliance with recognized performance standards (e.g., IEC 60601 series, ISO 10079-1, IEC 80601-2-35/50/55/61).
- Sample Size: The document does not specify a "sample size" of patient cases or data in the context of diagnostic/predictive performance. Instead, testing involves the physical device and its components under various simulated conditions as prescribed by the relevant engineering and safety standards.
- Data Provenance: Not applicable in the context of patient data for algorithm training/testing. The testing involves engineering and performance characteristics of the hardware and software systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable for this type of device submission. There is no mention of "ground truth" established by human experts in the context of diagnostic or predictive performance, as this is a hardware device with integrated functionalities, not an AI diagnostic tool. Expert involvement would be in establishing test protocols, assessing human factors usability, and evaluating compliance with standards by qualified engineers and technical personnel.
4. Adjudication method for the test set:
Not applicable. There is no test set in the context of diagnostic performance requiring adjudication of results based on expert consensus.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
Not applicable. This is not an AI/ML software requiring comparison of human reader performance with and without AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study:
Not applicable. This device is an infant transport incubator; it is not a standalone algorithm. The device's functionalities (e.g., temperature control, pulse oximetry, phototherapy, suction) operate autonomously or with human interaction. Testing of these components (e.g., accuracy of temperature sensors, irradiance of phototherapy, suction pressure) would be considered "standalone" in their specific functional performance but not as a diagnostic algorithm.
7. Type of ground truth used:
Not applicable in the context of diagnostic or predictive ground truth. For the NxtGen Infant Transport Incubator, "ground truth" would relate to metrological standards for accuracy (e.g., precise temperature/pressure measurements, calibrated light intensity), and adherence to safety and performance specifications outlined in the referenced standards (e.g., IEC 60601-2-20 for transport incubators, ISO 10079-1 for suction equipment). These are established through validated test equipment and procedures.
8. Sample size for the training set:
Not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data for learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
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