(45 days)
The V-2100G Advanced Infant Incubator is a hooded container that is intended to provide a controlled thermal environment and isolation from ambient air for premature and neonatal infants. The V-2100G is not intended for the transport of infants.
The V-2100G Infant Incubator provides standard functions to control the incubator temperature, either by manual (air) or servo (baby) control, and air humidity. The incubator also provides an external communication function that allows data to be exported to the user's PC for evaluation and storage. In addition, the incubator provides the following optional functions: oxygen controller, pulse oximeter, and weight monitor.
The temperature in the incubator can be controlled using one of two modes: manual control mode or servo control mode. In manual control mode, the incubator air temperature is controlled to maintain the desired infant temperature. The air temperature is initially set based on the user's training and experience and is then adjusted based on the infant's needs and clinical status. In the servo control mode, a skin temperature probe is attached to the infant and is monitored by the incubator controller. The heater output is controlled to maintain the infant's skin temperature at a set value. Changes to the heater output are made gradually, so as to minimize temperature overshoot and infant stress.
The provided text is a 510(k) Summary for a medical device called the "V-2100G Advanced Infant Incubator." This document is used for regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results typical for novel devices or AI/software-as-a-medical-device (SaMD) clearances.
Therefore, many of the requested categories related to clinical studies, AI performance, ground truth, and expert adjudication are not applicable or extractable from this specific document. The performance testing mentioned is for functional and design verification against recognized consensus standards for medical electrical equipment and infant incubators, not for evaluating accuracy or effectiveness in an AI context.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| IEC 60601-1 (1988-12) Medical Electrical Equipment, Part 1: General Requirements for Safety | "demonstrates that the V-2100G Infant Incubator is in compliance with... IEC 60601-1" |
| EN 60601-1-2 (1993) Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility – Requirements and Tests | "demonstrates that the V-2100G Infant Incubator is in compliance with... EN 60601-1-2" |
| IEC 60601-2-19 (1990-12) Medical Electrical Equipment, Part 2: Particular Requirements for Safety of Baby Incubators | "demonstrates that the V-2100G Infant Incubator is in compliance with... IEC 60601-2-19" |
| ISO 7767 (1997) Oxygen Monitors for Monitoring Patient Breathing Mixtures – Safety Requirements | "demonstrates that the V-2100G Infant Incubator is in compliance with... ISO 7767" (if optional oxygen controller is included and subject to this standard for monitoring) |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Performance testing for the V-2100G Infant Incubator has been conducted for functional and design verification." The summary states this testing "demonstrates that the V-2100G Infant Incubator is in compliance with the following recognized consensus standards."
Summary of Device Performance:
The device is reported to be in compliance with the listed IEC, EN, and ISO standards for medical electrical equipment safety, electromagnetic compatibility, and particular requirements for baby incubators. This indicates that the incubator meets the established safety and performance benchmarks defined by these standards for its designated function of providing a controlled thermal environment.
Further Requested Information (Not Applicable or Extractable):
- Sample size used for the test set and the data provenance: Not applicable. This document describes performance testing against safety and design standards, not a clinical study with a "test set" of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical "ground truth" or expert review is mentioned for this type of device and submission.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-powered device nor is it a diagnostic device that involves "human readers."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specifications and requirements of the engineering and safety standards it complies with.
- The sample size for the training set: Not applicable. This device does not use AI or machine learning that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The 510(k) summary for the V-2100G Advanced Infant Incubator demonstrates substantial equivalence through comparisons with predicate devices and compliance with recognized consensus standards for functional and design verification. It does not contain information related to clinical trials, AI performance, or expert-adjudicated ground truth, as it is a traditional medical device, not an AI/SaMD product.
§ 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).