(87 days)
The Sandman Info and Sandman Auto are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are designed to deliver Continuous Positive Airway Pressure between 3 and 20 cmHJO, and may come in different configurations including an optional integrated pass-over or heated humidifier.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto 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 Puritan Bennett Sandman Info and the Puritan Bennett Sandman Auto are double-insulated so that grounding is not required.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are for use by prescription only and displays the appropriate labeling.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are configured for patient use by a homecare dealer according to the prescription using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen.
The device and accessories are not supplied sterile, nor are they intended to be sterilized.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are for multiple use.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto contain no patient contact components.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto tubing is equivalent to that of the CPAP predicate device.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto rely on 1 microprocessor for setting and viewing various control parameters and turning features on and off, and for controlling the heated humidification.
The Puritan Bennett Sandman Info operates only 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.
The Puritan Bennett Sandman Auto operates in either Constant or Automatic mode. In Constant mode, the main function of each device is to delier constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 20 cmHO.
In Automatic mode (APAP mode), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmH2O. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of events detected.
Pressure delivery for the Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto use software to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to provide heated humidification.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto comply with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC60601-1.
The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are not part of a kit.
The provided text describes a 510(k) summary for the Puritan Bennett Sandman Info and Sandman Auto CPAP devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with acceptance criteria for a novel algorithm.
Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria for algorithm performance, a dedicated study proving device meets acceptance criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets.
The submission focuses on:
- Predicate Device Equivalence: Asserting the new devices are equivalent to existing Puritan Bennett GoodKnight CPAP devices (K020886 and K042184).
- Performance Testing: Stating that "Functional testing confirms that the Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are capable of meeting its stated performance specifications. The device passed all tests."
- Compliance with Standards: Highlighting compliance with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" and the May 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Safety and Effectiveness: Concluding that the devices meet performance specifications and criteria, operate safely, and are effective for their intended use based on these tests and compliance.
In summary, this 510(k) submission does not provide the specific details usually associated with proving an AI/algorithm's performance against predefined acceptance criteria for a novel functionality. It focuses on demonstrating that the new CPAP devices perform as expected for a CPAP device and are substantially equivalent to a predicate.
§ 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).