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The CHS-i1000 Infant Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. The CHS-i1000 Infant Incubators can be used in two operating modes, such as Air Control Mode and Skin Control Mode. The CHS-i1000 incubator is not for the transport of the patient.

The CHS-i1000 Infant Incubator has alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.

The CHS-i1000 Infant Incubator incorporates other features, such as humidification of the infant environment and tilting of the bed.

The CHS-i1000 incubator provides a controlled temperature and humidity for infants. It is designed to minimize the effect of external heat loss on infants.

The incubator is composed of 4 main elements namely, the hood, base, cabinet and controller. Together they measure W1000 x H1367 x D634mm. The foam based mattress that measures W690 x D370mm positions centrally within the confines of the hood. The mattress can also be raised at the head and foot end to a maximum incline of 12°. This is achieved by turning the handles that are located on each end of the base.

The hood is made of a clear acrylic to permit clear visibility of the baby yet provide isolation for the baby. The hood comprised of access ports gives access to the baby without compromising the thermal environment. Four of the access ports(two on the front and two on the rear) allow for regular access by the caregiver. The other two access ports are in the form of iris ports with are used primarily for ventilator tubes and monitoring cables to be channeled into the hood to the baby. Pulling the mattress towards the caregiver can enhance access even further.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets them. Instead, it describes a 510(k) submission for a neonatal incubator (CHS-i1000) seeking substantial equivalence to a predicate device (OHMEDA Medical Model 4000 CARE-PLUS).

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit acceptance criteria with specific quantitative thresholds for the CHS-i1000's performance. Instead, it states that:

• "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 and EN/IEC 60601-2-19 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(1993), and Biocompatibility testing was conducted in accordance with standard ISO 10993-1."
• "All test results were satisfactory."

This indicates that the device's performance was evaluated against the requirements of these standards, and it successfully met those requirements. The specific performance metrics and their acceptance limits as defined by these standards are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical data or human subjects. The testing mentioned (safety, EMC, performance, biocompatibility) likely involved laboratory testing of the device itself rather than a clinical study with patients. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable. The device is a neonatal incubator, and the testing described pertains to its engineering and safety specifications, not a diagnostic or prognostic capability requiring expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or AI-assisted diagnostic tools to assess the impact of technology on human reader performance. The CHS-i1000 is an incubator, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The concept of "standalone performance" typically applies to AI algorithms. The CHS-i1000 is a physical medical device (an incubator), not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The performance testing was for the device itself.

7. The Type of Ground Truth Used:

For the "performance" testing mentioned, the "ground truth" would be the engineering specifications and safety requirements defined by the standards (EN/IEC 60601-1, EN/IEC 60601-2-19, EN/IEC 60601-1-2, ISO 10993-1). The device's measurements and functionalities are compared against these predetermined, objective standards to determine compliance. There is no expert consensus, pathology, or outcomes data used as ground truth in the context of this summary.

8. The Sample Size for the Training Set:

This information is not applicable. The CHS-i1000 is not described as an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above.

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