(228 days)
The intended use of the GoodKnight 420 Series Devices is to provide Continuous Positive Airway Pressure (C-PAP) between 4 and 20 cmHxO to spontaneously breathing patients over 30 Kg for the treatment of Obstructive Sleep Apnea in a hospital and homecare environment.
The Puritan Bennett GoodKnight 420 Series is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.
The GoodKnight 420 Series Devices consist of the following elements:
- GoodKnight 420G (GK420G) C-PAP Machine;
- GoodKnight 420S (GK420S) C-PAP Machine.
The GoodKnight 420 Series Devices are designed to deliver Continuous Positive Airway Pressure between 4 and 20 cmH2O.
The GoodKnight 420 Series Devices can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 420 Series power supply is double-insulated so that grounding is not required.
The GoodKnight 420 Series Devices are set up for use by the homecare dealer using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.
The GoodKnight 420 Series devices rely on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the treatment of various signals from the devices including signals relating to patient cycle detection.
The GoodKnight 420 Series devices operate only in either Constant mode. In Constant mode, the main function of the device is to deliver constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 20 cmH2O.
Pressure delivery for the GoodKnight 420 Series Devices is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.
The GoodKnight 420 Series Devices use the same pass over humidifier and masks as those approved for use with the GoodKnight 418G. The GoodKnight 420 Series Device tubing is equivalent to that of the GoodKnight 418G with the exception of an additional internal tube used for measuring the pressure at the patient's mask on the 420S model.
The GoodKnight Control clinical remote is also available for use with the GoodKnight 420S Device. The remote is used by the practitioner to configure the devices from a distance via a serial link.
The GoodKnight 420S Device can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the Silverlining™2 software which is required for downloading and displaying compliance data stored in the device memory.
The GoodKnight 420 Series Devices are not for use in life-sustaining situations. The devices and/or their accessories are not intended for sterile use.
The GoodKnight 420 Series Devices and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.
The GoodKnight 420 Series Devices are for use by prescription only and display the appropriate labeling.
The GoodKnight 420 Series Devices are for use in a hospital and homecare environment.
The GoodKnight 420 Series Devices do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen.
The GoodKnight 420 Series Devices are not part of a kit.
The GoodKaight 420 Series Devices use software to set the various device parameters such as the prescription pressure and the ramp starting pressure.
The GoodKnight 420 Series Devices are electrically operated.
The GoodKnight 420 Series Devices comply with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC 60601-1.
The provided 510(k) Summary for the Puritan Bennett GoodKnight 420 Series is for a CPAP machine and does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (number of experts, adjudication methods, MRMC studies, training set details) are not applicable.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The submission refers to "stated performance specifications" without detailing them in a table format. However, it indicates compliance with recognized standards and general functional performance.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Specifications | Capable of meeting stated performance specifications (Passed all tests). |
| Voluntary Standards | Complies with draft ARDB Reviewer Guidance for Premarket Notification Submissions (November 1993) and IEC 60601-1 (Passed all tests). |
| Software Regulations | Complies with "Guidance for the Content of Premarket submissions for Software Contained in Medical Devices" (May 29, 1998) (Passed all tests). |
| Safety and Effectiveness | Will operate safely in its intended environment and be effective in fulfilling its intended use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is functional, standards-compliance, and software validation. It's not clear where these tests were conducted, but the submitter is based in France.
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)
N/A. This is not an AI/ML device, and no ground truth in this context was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable to the type of device and testing described.
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
N/A. Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not applicable. The device is a CPAP machine, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. The testing involves functional testing, compliance with standards, and software validation, not clinical ground truth in the way it's defined for AI/ML devices. The "ground truth" for these tests would be the predefined specifications and regulatory requirements.
8. The sample size for the training set
N/A. Not applicable, as this is not an AI/ML device and therefore has no "training set."
9. How the ground truth for the training set was established
N/A. Not applicable.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).