(201 days)
No
The description mentions "microprocessor controlled based on firmware (embedded software)" and "flow signal processing means in firmware to provide self-adjusting capability," which indicates traditional algorithmic control rather than AI/ML. The clinical studies compare the device to predicate devices based on standard sleep metrics and pressure, without mentioning AI/ML performance metrics or training/test data for such models.
Yes
The device is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA), which is a medical treatment.
No
The device is a CPAP system intended for treatment of Obstructive Sleep Apnea, not a diagnostic device. While it monitors pressure and airflow to adjust therapy, its primary function is therapeutic.
No
The device description explicitly states that the primary hardware component is a blower that generates airflow, and it incorporates pressure and airflow sensors. While it includes embedded software and optional PC software, it is fundamentally a hardware device with software control.
Based on the provided text, the Breas PV10i CPAP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description focuses on the mechanical and electronic components that generate and deliver pressurized air. It describes a blower, motor, fan, filters, pressure sensors, and airflow sensors. These are all components of a therapeutic device.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies focus on the efficacy of the therapy (reducing AHI, improving sleepiness) and the device's functional performance (electrical safety, EMC, mechanical safety, environmental testing, software testing). They do not involve evaluating the device's ability to diagnose a condition based on sample analysis.
In summary, the Breas PV10i CPAP System is a therapeutic device used to treat a condition, not a diagnostic device used to identify or characterize a condition through in vitro analysis.
N/A
Intended Use / Indications for Use
The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).
Product codes
73 BZD
Device Description
In the treatment of sleep disorders, CPAP is well established and common practice as a means to prevent upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction. There are a number of devices legally marketed in the United States for this application, including self-adjusting CPAP systems such as the predicate ResMed Sullivan Autoset T. The self-adjusting systems accommodate pressure requirements that may vary (e.g., as patients change bodies positions or enter different sleep stages).
The Breas PV10i CPAP is similar to the predicate Breas PV100 CPAP System, but with the addition of self-adjusting pressure features. Both Breas devices are microprocessor controlled based on firmware (embedded software). Both designs incorporate pressure sensors that monitor output pressure and provide feedback to the microprocessors. The PV10i also incorporates an airflow sensor and flow signal processing means in firmware to provide self-adjusting capability.
The therapy delivered by the Breas PV10i CPAP System can be either:
-
- Self-adjusting in response to variations in patient breathing patterns (CPAP "i" mode), or
-
- Set to a constant pressure level (constant CPAP mode).
The primary hardware component is a blower that generates airflow. The blower assembly consists of a brushless DC motor that drives a fan, entraining ambient air through a filter and pressurizing it to provide the prescribed airflow with CPAP for the patient. The microprocessor controls the motor and hence the speed of the fan.
The PV10i pressure range is 4 - 20 cmH20. Starting pressure and self-adjusting pressure limits are settable by clinical personnel in accordance with the patient's prescription.
The CPAP airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the minimum output pressure setting of 4 cm of H20 are recommended for use with the PV10i.
The pressure transducer incorporated in the PV10i continuously monitors output pressure to the patient and reference ambient pressure. This enables the device to automatically compensate for altitude changes.
The PV10i has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12 - 24 VDC power source when AC mains line voltage is not available. This DC power source capability is not intended as a battery power back-up system for any critical treatment applications. An accessory Remote Control Module may be connected that enables clinicians to operate the PV10i without using the control and setting panels on the device itself. A PC-based software program may also be supplied that provides an optional means for clinicians to set patient parameters (e.g., start and limit pressures) and track patient compliance.
The PV10i and its accessories are not sterile. The outer dimensions of the PV10i housing are 6.3 × 4.5 × 9.3 inches, and the device weighs 3.7 pounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper airways
Indicated Patient Age Range
adult
Intended User / Care Setting
The PV10i may be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments and must be prescribed by a physician. It is not intended for life support or life sustaining applications or for transport of critical care patients.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Non-clinical testing was conducted to verify that the Breas PV10i CPAP System is capable of meeting its stated performance specifications and that all Risk Analysis issues have been appropriately addressed. The device passed all tests.
- Testing was conducted to demonstrate compliance with applicable requirements in the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the FDA's Division of Cardiovascular, Respiratory, and Neurological Devices. The testing included but was not limited to:
- Electrical Safety testing per IEC 601
- Electromagnetic Compatibility testing (EMC testing)
- Mechanical Safety testing
- Environmental testing
- Functional testing
The PV10i device passed all tests.
- All device software (the embedded software and the optional PC software) was documented and tested in accordance with the FDA's May 29, 1998 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices". The PV10i software passed all tests.
- Two clinical studies were performed as part of the process of validating the software algorithm for the PV10i CPAP System's self-adjusting pressure features. They involved direct comparisons with predicate devices.
- In a three-way randomized crossover study involving 12 patients (of whom 11 completed all treatments) with symptomatic obstructive sleep apnea, the PV10i in self-adjusting mode was compared with the predicate ResMed AutoSet®T (K980721) and with conventional constant CPAP. Efficacy evaluation was based on analysis of sleep disordered breathing and sleep parameters assessed by nocturnal polysomnography. Further study outcomes were quality of life assessment and subjective preference of each device with respect to comfort.
No significant differences were noted in sleep or ventilatory variables between the devices (mean apnea-hypopnea index (AHI) 6.8, 4.0 and 1.8 with PV10i, Autoset T and constant CPAP respectively). The PV10i applied lower mean pressure (6.7) as compared with the Autoset T (8.4) (p
- In a three-way randomized crossover study involving 12 patients (of whom 11 completed all treatments) with symptomatic obstructive sleep apnea, the PV10i in self-adjusting mode was compared with the predicate ResMed AutoSet®T (K980721) and with conventional constant CPAP. Efficacy evaluation was based on analysis of sleep disordered breathing and sleep parameters assessed by nocturnal polysomnography. Further study outcomes were quality of life assessment and subjective preference of each device with respect to comfort.
§ 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).
0
Image /page/0/Picture/3 description: The image shows a close-up, angled view of a handwritten or printed text string. The text appears to be a combination of letters and numbers, with the sequence "K03098" clearly visible. The characters are bold and dark, contrasting with the lighter background. The angle and close proximity suggest the image is focused on highlighting this specific code or identifier.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | OCT 1 5 2003
Vital Signs, Inc.
20 Campus Road
Totowa, NJ 07512-1200 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony P. Martino
V. P. Quality Assurance & Regulatory Affairs
Phone: (973) 790-1330, ext. 356
Fax: (973) 790-4150 |
| Summary Date: | July 16, 2003 |
| Name of Device: | Breas PV10i CPAP System |
| Common Names: | CPAP System
Self-adjusting CPAP System
Auto-adjusting CPAP System |
| Classification Name: | Non-continuous ventilator (21 CFR 868.5905) |
| Product Code: | 73 BZD |
Predicate Devices:
Breas PV100 CPAP System (K001553)
ResMed Sullivan Autoset® T (K970516, K970771, and K984428)
.
1
Device Description:
In the treatment of sleep disorders, CPAP is well established and common practice as a means to prevent upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction. There are a number of devices legally marketed in the United States for this application, including self-adjusting CPAP systems such as the predicate ResMed Sullivan Autoset T. The self-adjusting systems accommodate pressure requirements that may vary (e.g., as patients change bodies positions or enter different sleep stages).
The Breas PV10i CPAP is similar to the predicate Breas PV100 CPAP System, but with the addition of self-adjusting pressure features. Both Breas devices are microprocessor controlled based on firmware (embedded software). Both designs incorporate pressure sensors that monitor output pressure and provide feedback to the microprocessors. The PV10i also incorporates an airflow sensor and flow signal processing means in firmware to provide self-adjusting capability.
The therapy delivered by the Breas PV10i CPAP System can be either:
-
- Self-adjusting in response to variations in patient breathing patterns (CPAP "i" mode), or
-
- Set to a constant pressure level (constant CPAP mode).
The primary hardware component is a blower that generates airflow. The blower assembly consists of a brushless DC motor that drives a fan, entraining ambient air through a filter and pressurizing it to provide the prescribed airflow with CPAP for the patient. The microprocessor controls the motor and hence the speed of the fan.
The PV10i pressure range is 4 - 20 cmH20. Starting pressure and self-adjusting pressure limits are settable by clinical personnel in accordance with the patient's prescription.
The CPAP airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the minimum output pressure setting of 4 cm of H20 are recommended for use with the PV10i.
The pressure transducer incorporated in the PV10i continuously monitors output pressure to the patient and reference ambient pressure. This enables the device to automatically compensate for altitude changes.
The PV10i has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12 - 24 VDC power source when AC mains line voltage is not available. This DC power source
2
capability is not intended as a battery power back-up system for any critical treatment applications. An accessory Remote Control Module may be connected that enables clinicians to operate the PV10i without using the control and setting panels on the device itself. A PC-based software program may also be supplied that provides an optional means for clinicians to set patient parameters (e.g., start and limit pressures) and track patient compliance.
The PV10i and its accessories are not sterile. The outer dimensions of the PV10i housing are 6.3 × 4.5 × 9.3 inches, and the device weighs 3.7 pounds.
Intended Use:
The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).
Comparison of Use and Technological Characteristics:
The PV10i may be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments and must be prescribed by a physician. It is not intended for life support or life sustaining applications or for transport of critical care patients.
As compared with the cited predicate devices, the Breas PV10i CPAP System has:
- Same intended uses
Same environments of use
Similar design (microprocessor-controlled blower as air source)
Same technology (software based flow signal processing means to provide self-adjusting pressure capability)
Same materials (with particular reference to the air flow pathway)
The differences that do exist are minimal and involve primarily user preference features. These features are described in labeling for the device that includes an Operator Manual.
Summary of Performance Testing:
-
- Non-clinical testing was conducted to verify that the Breas PV10i CPAP System is capable of meeting its stated performance specifications and that all Risk Analysis issues have been appropriately addressed. The device passed all tests.
3
-
- Testing was conducted to demonstrate compliance with applicable requirements in the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the FDA's Division of Cardiovascular, Respiratory, and Neurological Devices. The testing included but was not limited to:
- Electrical Safety testing per IEC 601 ●
- Electromagnetic Compatibility testing (EMC testing) .
- Mechanical Safety testing .
- Environmental testing ●
- Functional testing ●
The PV10i device passed all tests.
-
- All device software (the embedded software and the optional PC software) was documented and tested in accordance with the FDA's May 29, 1998 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices". The PV10i software passed all tests.
-
- Two clinical studies were performed as part of the process of validating the software algorithm for the PV10i CPAP System's self-adjusting pressure features. They involved direct comparisons with predicate devices.
- In a three-way randomized crossover study involving 12 patients (of whom 11 A) completed all treatments) with symptomatic obstructive sleep apnea, the PV10i in self-adjusting mode was compared with the predicate ResMed AutoSet®T (K980721) and with conventional constant CPAP. Efficacy evaluation was based on analysis of sleep disordered breathing and sleep parameters assessed by nocturnal polysomnography. Further study outcomes were quality of life assessment and subjective preference of each device with respect to comfort.
No significant differences were noted in sleep or ventilatory variables between the devices (mean apnea-hypopnea index (AHI) 6.8, 4.0 and 1.8 with PV10i, Autoset T and constant CPAP respectively). The PV10i applied lower mean pressure (6.7) as compared with the Autoset T (8.4) (p