(152 days)
The Puritan Bennett GoodKnight 425ST is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.
The GoodKnight 425ST is designed to deliver Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O). The GoodKnight 425ST 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 425 is doubleinsulated so that grounding is not required. The GoodKnight 425ST is 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 425ST 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. Pressure delivery for the GoodKnight 4253T is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKaight 425ST uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 425. The GoodKnight 425ST tubing is equivalent to that of the GoodKnight 425. The GoodKnight 425ST can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the SilverLining™ software which is required for downloading and displaying compliance data stored in the device memory. The GoodKnight 425ST is not for use in life-supporting or life-sustaining situations. The devices and/or their accessories are not intended for sterile use. The GoodKnight 425ST is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 425ST is for use by prescription only and display the appropriate labeling. The GoodKnight 425ST is for use in a hospital and homecare environment. The GoodKnight 425ST does not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The GoodKnight 425ST is not part of a kit. The GoodKnight 425ST uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.
The provided document, K050072 for the PURITAN BENNETT GoodKnight 425ST, largely focuses on establishing substantial equivalence to a predicate device (GoodKnight 425) and does not detail a study proving specific acceptance criteria in the manner of an AI/ML medical device submission.
Instead, the submission for this conventional medical device relies on:
- Functional testing: To confirm the device meets its stated performance specifications.
- Compliance with guidance documents and standards: Specifically, the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" and international standards like IEC 60601-1 and EN ISO 17510-1.
- Comparison to a predicate device: Demonstrating that the technological characteristics and performance are sufficiently similar to a device already cleared for market.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this 2005 510(k) submission for a CPAP system.
Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets stated performance specifications | "The GoodKnight 425ST is capable of meeting its stated performance specifications. The device passed all tests." |
| Complies with November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" (Division of Cardiovascular, Respiratory, and Neurological Devices) | "The device passed all tests." |
| Complies with IEC 60601-1 (Medical electrical equipment) | "The GoodKnight 425ST complies with... IEC 60601-1" |
| Complies with EN ISO 17510-1 (Sleep apnoea breathing therapy equipment) | "The GoodKnight 425ST complies with... EN ISO 17510-1." |
| Delivers Positive Airway Pressure in specified ranges | "Delivers Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O)." (This is a specification rather than a test result, but implicitly confirmed by functional testing.) |
| Functions in Bi-level and C-PAP modes with specified settings | The device lists detailed functions for both modes, implying these are functional and perform as designed. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. This type of submission for a conventional device typically involves bench testing on a limited number of manufactured units, rather than a "test set" of patient data as would be used for an AI/ML device.
- Data Provenance: Not applicable in the context of patient data. The testing is bench testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the context of device performance verification, is established by measurement against known standards and specifications, not by expert consensus on clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Functional tests typically have clear pass/fail criteria based on objective measurements and specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, this type of study was not done. MRMC studies are typically used to assess the impact of an AI algorithm on human reader performance, which is not relevant for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm's performance. The device itself has software, but its performance is measured as part of the integrated system (e.g., pressure delivery accuracy, adherence to settings), not as a standalone "algorithm."
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this device's performance validation is its engineering specifications and established regulatory standards (e.g., IEC 60601-1, EN ISO 17510-1, FDA guidance documents). Functional testing verifies that the device operates within these predefined parameters.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use machine learning in a way that requires a "training set" of data to learn patterns or make predictions. The software controls predefined functions.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the same reason as above.
§ 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).