(94 days)
Not Found
No
The device description explicitly states "The device is not software-driven." and there are no mentions of AI, ML, or related concepts. The functionality described is based on a feedback loop for motor speed and simple pressure adjustments.
Yes
The device is intended to provide Continuous Positive Airway Pressure (CPAP) for the treatment of Obstructive Sleep Apnea, indicating a direct therapeutic purpose.
No
Explanation: The device provides Continuous Positive Airway Pressure (CPAP) for the treatment of Obstructive Sleep Apnea. It is a therapeutic device, not one used for diagnosis. While it has an optional compliance meter that measures patient compliance by changes in motor current, this is not for diagnosing a condition but for monitoring treatment adherence.
No
The device description explicitly states, "The device is not software-driven." It describes hardware components like a motor, power supply, switches, and a pressure display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide Continuous Positive Airway Pressure (CPAP) to spontaneously breathing adult patients for the treatment of Obstructive Sleep Apnea. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical device that delivers pressurized air. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly described as a therapeutic device used to treat a condition by providing mechanical support to the airway.
N/A
Intended Use / Indications for Use
The intended use of the 318 Plus Nasal CPAP System is to provide Continuous Positive Airway Pressure (CPAP) between 3 and 18 cm H2O to spontaneously breathing adult patients for the treatment of Obstructive Sleep Apnea in a homecare environment. This is the same intended use as for the C314 Nasal CPAP System.
Product codes
BZD
Device Description
The 318 Plus Nasal CPAP System is a device used to provide Continuous Positive Airway Pressure between 3 and 18 cm H2O. The device is a modification to the Puritan-Bennett C314 Nasal CPAP System, which adds some additional features. The device is powered by AC Mains from 100 to 240 VAC, 50/60 Hz by utilizing a standard automatic switching power supply similar to the one in the PB335 Respiratory Support System. The device is set up for use by the homecare provider using the Set-up Instructions provided with the device. It is operated using the Patient Guide. The pressure is set to the prescription with the use of a patient circuit, with the pressure being measured at the patient end of the circuit. By using this method, losses associated with the patient circuit are compensated for and thus the device does not require a pressure transducer. The motor maintains a constant speed through the feedback loop from the motor to the motor drive circuit. The device has a ramp function. This allows the patient to reduce the pressure when first going to bed to make it more comfortable to fall asleep. The available ramp times are 0, 5, 10 or 20 minutes. The ramp duration is set up by the homecare provider by use of the Ramp Duration Switches. The ramp starting pressure can be adjusted by the patient using the Ramp Starting Pressure Adjustment switches. The ramp feature can be activated and deactivated by pressing the Ramp Button. Both the prescription pressure and the ramp pressure can be seen in the Pressure Display on the top housing. The optional Compliance Meter measures patierit compliance by measuring changes in the motor current as the patient breathes on the device. The accessories, i.e., the patient tubing, patient masks and headgear are the same ones used with the C314 and PB335. The device is not for life-supporting or life-sustaining situations. The device is for prescription use. The device itself, the air filter and the humidifier are for multiple use. The other accessories, i.e., the patient tube, nasal masks and headgear are for single patient use. The device is not software-driven. Neither the device nor its accessories are sterile
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
homecare provider, homecare environment
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested in accordance with the "Electrical Performance Testing" and "Mechanical and Environmental Testing" sections of Appendix A of the "Draft -Reviewer Guidance for Premarket Notifications, Anesthesiology and Respiratory Branch" document dated November 1993. The device passed all of the tests. Static and dynamic pressure testing was also performed. The results of the testing demonstrated that the 318 Plus performed in the same manner as the primary predicate device, the C314. The device was also tested when powered by a 1.2 volt DC power supply using the optional DC to AC inverter. The results of the testing demonstrated that the device's performance was the same as when powered by AC Mains. All of the testing demonstrated that the 318 Plus is as safe and effective and performs as well or better than the primary predicate device, the C314.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K952292, K903764, K942210, K943509
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
SECTION 16. 510(k) SUMMARY
MAY - 9 1996
(1) Company Information
| Owner/Operator: | Puritan-Bennett Corporation
Registration Number 9919005 |
|------------------------------|----------------------------------------------------------------------------------------------------|
| Manufacturing Site: | Puritan-Bennett Corporation
9728 Pflumm Road
Lenexa, KS 66215
Registration Number 1933149 |
| Official Correspondent: | C. Marshall Smith
Phone: 913-495-4845
Direct Dial 913-495-4845
Fax: 913-394-8764 |
| Date of Summary Preparation: | 2 February 1996 |
| (2) Device Name: | |
| Proprietary Name: | Puritan-Bennett 318 Plus Nasal CPAP System |
Preparing to Install
Common Name: CPAP Machine
Classification Name:
Noncontinuous Ventilator, per 21 CFR 868.5905 and 73 BZD
(3) Equivalent Devices:
Primary Predicate Device:
Other Predicate Devices:
Puritan-Bennett C314 Nasal CPAP System, K952292
Puritan-Bennett C318 Nasal CPAP System, K903764
Puritan-Elennett 335 Respiratory Support System, K942210 (pending)
Healthdyne Tranquility Quest Compact Nasal CPAP System Model 7300, K943509
1
(4) Device Description:
The 318 Plus Nasal CPAP System is a device used to provide Continuous Positive Airway Pressure between 3 and 18 cm H2O.
The device is a modification to the Puritan-Bennett C314 Nasal CPAP System, which adds some additional features.
The device is powered by AC Mains from 100 to 240 VAC, 50/60 Hz by utilizing a standard automatic switching power supply similar to the one in the PB335 Respiratory Support System.
The device is set up for use by the homecare provider using the Set-up Instructions provided with the device. It is operated using the Patient Guide.
The pressure is set to the prescription with the use of a patient circuit, with the pressure being measured at the patient end of the circuit. By using this method, losses associated with the patient circuit are compensated for and thus the device does not require a pressure transducer. The motor maintains a constant speed through the feedback loop from the motor to the motor drive circuit.
The device has a ramp function. This allows the patient to reduce the pressure when first going to bed to make it more comfortable to fall asleep. The available ramp times are 0, 5, 10 or 20 minutes. The ramp duration is set up by the homecare provider by use of the Ramp Duration Switches. The ramp starting pressure can be adjusted by the patient using the Ramp Starting Pressure Adjustment switches. The ramp feature can be activated and deactivated by pressing the Ramp Button.
Both the prescription pressure and the ramp pressure can be seen in the Pressure Display on the top housing.
The optional Compliance Meter measures patierit compliance by measuring changes in the motor current as the patient breathes on the device.
The accessories, i.e., the patient tubing, patient masks and headgear are the same ones used with the C314 and PB335.
The device is not for life-supporting or life-sustaining situations.
The device is for prescription use.
The device itself, the air filter and the humidifier are for multiple use. The other accessories, i.e., the patient tube, nasal masks and headgear are for single patient use.
The device is not software-driven.
Neither the device nor its accessories are sterile
2
(5) Intended Use:
The intended use of the 318 Plus Nasal CPAP System is to provide Continuous Positive Airway Pressure (CPAP) between 3 and 18 cm H2O to spontaneously breathing adult patients for the treatment of Obstructive Sleep Apnea in a homecare environment. This is the same intended use as for the C314 Nasal CPAP System.
(6) Technological Characteristics:
The device has the same technological characteristics as the primary predicate device. inasmuch as the two devices use either the same or similar components and the two devices function in the same manner.
(7) Nonclinical Tests Submitted:
The device was tested in accordance with the "Electrical Performance Testing" and "Mechanical and Environmental Testing" sections of Appendix A of the "Draft -Reviewer Guidance for Premarket Notifications, Anesthesiology and Respiratory Branch" document dated November 1993. The device passed all of the tests.
Static and dynamic pressure testing was also performed. The results of the testing demonstrated that the 318 Plus performed in the same manner as the primary predicate device, the C314.
The device was also tested when powered by a 1.2 volt DC power supply using the optional DC to AC inverter. The results of the testing demonstrated that the device's performance was the same as when powered by AC Mains.
(8) Clinical Tests Submitted:
None.
(9) Conclusions from Tests:
As stated in Section (7) above, all of the testing demonstrated that the 318 Plus is as safe and effective and performs as well or better than the primary predicate device, the C314.