(87 days)
Not Found
Not Found
No
The device description details a purely mechanical valve mechanism with no mention of software, algorithms, or learning capabilities.
No
The device is described as an in-line one-way valve designed to prevent backflow into a CPAP or BiPAP device, indicating it is an accessory to a therapeutic device rather than a therapeutic device itself.
No
The device description states its function is to prevent backflow of oxygen or water, not to diagnose a condition. It is a control or safety mechanism.
No
The device description clearly states it is a physical valve with a disc, spring, and housing, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent backflow of oxygen or water into a CPAP/BiPAP device. This is a mechanical function related to the delivery of respiratory therapy, not the diagnosis of a disease or condition using in vitro examination of specimens.
- Device Description: The description details a mechanical valve that vents backflow. There is no mention of analyzing biological samples or performing any diagnostic tests.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly a component used in respiratory therapy equipment to ensure proper function and prevent damage to the main device.
N/A
Intended Use / Indications for Use
To prevent backflow of oxygen or water from patient circuit into Respironics CPAP or BiPAP device when the unit is not functioning
Product codes
Not Found
Device Description
The Pressure Valve is an in-line one-way valve which prevents oxygen or water in the patient circuit from backflowing into the Respironics CPAP or bi-level device when the unit is not functioning. The Pressure Valve incorporates a valve disc, spring, and housing. The device vents any backflow to the atmosphere when the pressure output of the Respironics CPAP or BiPAP unit drops below 0.5 cm H2O.
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
Not Found
Intended User / Care Setting
Hospital and Home
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Instrumentation Industries, Inc. - Reusable One-Way Valve (Preamendment)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1 4 1000
Image /page/0/Picture/2 description: The image shows the logo for RESPIRONICS INC. The logo consists of a triangle with a stylized figure inside, above the text "RESPIRONICS INC." The figure inside the triangle appears to be a person with a circular head and a stylized body. The text is in a bold, sans-serif font.
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3 August 16, 1996
Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA Tel - (412) 733-0200 Fax - (412) 733-0299
| Official Contact: | Francis X. Dobscha, Manager, Regulatory Affairs |
|---|---|
| Proprietary or Trade Name: | Pressure Valve |
| Common/Usual Name: | One-way valve |
| Classification Name: | Accessory for Ventilator, Passive Exhaust Port, Critical |
| Care | |
| Device: | Respironics Pressure Valve |
| Predicate Devices: | Instrumentation Industries, Inc. - Reusable One-Way |
| Valve (Preamendment) |
Device Description:
10
The Pressure Valve is an in-line one-way valve which prevents oxygen or water in the patient circuit from backflowing into the Respironics CPAP or bi-level device when the unit is not functioning. The Pressure Valve incorporates a valve disc, spring, and housing. The device vents any backflow to the atmosphere when the pressure output of the Respironics CPAP or BiPAP unit drops below 0.5 cm H2O.
Intended Use:
| Indicated Use -- | To prevent backflow of oxygen or water from patient
circuit into Respironics CPAP or BiPAP device when the
unit is not functioning |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospital and Home |
| Equipment -- | Respironics CPAP and bi-level systems indicated for use
with supplemental oxygen and/or humidifiers. |
page 3 of 54
1
Non-Confidential Summary of Safety and Effectiveness (continued)
page 2 of 3 August 16, 1996
Comparison to Predicate Devices:
| Attribute | Intended device:
Respironics, Inc.
Pressure Valve | Instrumentation
Industries, Inc.
One-Way Valve |
|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------|
| Use | | |
| Intended Use -- placed in-line in patient
circuits | Yes | Yes |
| Intended equipment - to be used only with
Respironics, Inc. CPAP and bi-level systems | Yes | No |
| Indicated - to establish directional flow in a
patient circuit and thus prevent backflow | Yes | Yes |
| Indicated - prevents backflow of oxygen or
water into CPAP or bi-level device when the
unit is not functioning. | Yes | No |
| Intended environment - Hospital and Home | Yes | Yes |
| Design | | |
| Placed in-line in patient breathing circuit | Yes | Yes |
| Has standard 22 mm fittings | Yes | Yes |
| Vents backflow to atmosphere | Yes | No |
| Reusable - multiple use, can be cleaned | Yes | Yes |
| Materials - Body
Valve
Spring | Polycarbonate
Polycarbonate
Phosphor Bronze | Polycarbonate
Silicone Rubber
N/A |
| Performance Standards/Specifications | | |
| Has minimal resistance to flow while in-line | Yes | Yes |
| Meets design requirements after cleaning | Yes | Yes |
page 4 of 54
2
Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 3 August 16, 1996
Differences Compared To Other Legally Marketed Predicate D
The differences between the intended device and the Instrumentation Industries, Inc., One-Way Valve are -
- The intended device is designed to be used only with the Respironics, Inc., CPAP * and bi-level systems.
- The intended device vents any backflow of oxygen or water to the atmosphere, * whereas the predicate device is generally placed in a circle type of circuit and is not required to vent to atmosphere.
There are no other significant differences in design, intended use, safety and effectiveness between the Pressure Valve and the predicate device.
page 5 of 54