(224 days)
The S7™ ELITE CPAP System is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 21™) is indicated for the humidification and warming of air from the S7 Elite flow generator device. The S7 ELITE CPAP flow generator and HUMIDAIRE 21 are for home and hospital use.
The S7 ELITE CPAP SYSTEM is a non-invasive Continuous Positive Airway Pressure (CPAP) system, including the following system components:
- Flow generator device
- Integrated Humidifier (HUMIDAIRE 2i)
- a Mask and air tubing
- D Clinical Interface (AutoScan) Software
The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask.
The S7 ELITE CPAP FLOW GENERATOR has one (1) mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixedpressure as set by the clinician.
AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.
The provided text describes the S7 ELITE CPAP System and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance, or a study proving it meets those criteria in the way requested.
The document is a 510(k) summary for regulatory approval, which focuses on demonstrating substantial equivalence to existing devices rather than a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested table and study details. However, I can extract what is available regarding the device and its regulatory context:
Device Description and Regulatory Information:
- Device Name: S7™ ELITE CPAP System
- Intended Use: Treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 2i™) is indicated for humidification and warming of air. For home and hospital use.
- Operating Mode: Fixed-pressure CPAP mode only.
- Key Features: Stores patient usage, treatment pressure, mask leak, and incidence of apneas and hypopneas (for clinician review only).
- Predicate Devices:
- Standards and Guidance Documents Tested To:
- EN 60601-1: Medical electrical equipment. Part 1: General requirements for safety.
- EN 60601-1-2: Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility.
- IEC 529: 1989: Degrees of protection provided by enclosures (Code IP).
- ISO 8185:1997: Humidifiers for medical use - General requirements.
- PrEN ISO 17510: Sleep Apnoea Therapy Devices (1998).
- Reviewer Guidance for Premarket Notification Submissions, November 1993, ARDB, CDRH, FDA.
- FDA Heated Humidifier Review Guide, Shelf # 780, 8/30/91 (applicable requirements).
- Nature of Evidence: "This submission presents the results of bench testing, and together with detailed descriptions demonstrates Substantial Equivalence of the S7 ELITE CPAP System to the predicate devices."
Missing Information:
The document explicitly states that the submission relies on "bench testing" and "detailed descriptions" to demonstrate substantial equivalence to predicate devices. It does not include:
- A table of specific acceptance criteria (e.g., pressure accuracy within X mmHg, leak detection sensitivity of Y%).
- Reported device performance values against such criteria.
- Details of a study proving the device meets specific performance criteria.
- Sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance data, type of ground truth used for performance, training set size, or ground truth establishment for a training set.
The focus of this 510(k) summary is on demonstrating that the S7 ELITE CPAP System is substantially equivalent to already approved devices by meeting relevant safety and electrical standards and sharing core design features, rather than presenting a de novo performance study against detailed, novel acceptance criteria.
§ 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).