(90 days)
K936047, K# unknown
Not Found
No
The device description and performance studies focus on mechanical components and physical performance, with no mention of AI or ML.
No.
The device is described as a "Patient interface accessory for Respironics CPAP and BiPAP® Systems" and is designed to provide a seal for positive pressure, rather than delivering therapy itself. The therapeutic action comes from the CPAP/BiPAP system, not the mask.
No
Explanation: The device description clearly states that the Spectrum Reusable Full Face Mask is a "Patient interface accessory for Respironics CPAP and BiPAP® Systems" and is "intended to provide a seal so that positive pressure from a positive pressure source is directed to the patient's nose and mouth." This indicates its role in delivering therapy (positive pressure) rather than diagnosing a medical condition.
No
The device description clearly describes a physical mask, headgear, and valves, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Patient interface accessory for Respironics CPAP and BiPAP® Systems." This describes a device used to deliver positive pressure therapy to a patient, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mask that covers the nose and mouth to create a seal for positive pressure delivery. It discusses physical components like an entrainment valve, quick-release mechanism, and headgear. There is no mention of analyzing biological samples or performing any diagnostic tests.
- Lack of IVD Characteristics: 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 or conditions
The device is clearly a medical device used for respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indicated Use -- Patient interface accessory for Respironics CPAP and BiPAP® Systems
Targeted Population -- Adult
Environment of Use -- Hospital and Home
Intended Use -- Adult Obstructive Sleep Apnea (OSA)
Intended to be used with devices such as Respironics CPAP Systems and BiPAP Systems producing positive pressures ≥ 3.0 cm H2O at the mask.
Intended Environment - Hospital: Adult OSA
Intended Environment - Home: Adult OSA
Product codes
Not Found
Device Description
The Spectrum Reusable Full Face Mask is an externally placed mask covering the nose and mouth (full face) of a patient. It is intended to provide a seal so that positive pressure from a positive pressure source is directed to the patient's nose and mouth. It connects to a patient circuit that contains an exhalation valve, tubing, and perhaps a humidifier and/or bacteria fitter. It incorporates an Entrainment Valve which permits entrainment of ambient air when positive pressure to the patient ceases. The entrainment valve opens and closes based upon positive pressure being delivered to the patient. In addition, the mask incorporates a quick-release mechanism allowing the patient to quickly and easily remove the mask if desired. It is held in place with an adjustable headgear system. It is intended to be cleaned with soap and water. The cleaning process requires limited disassembly.
The Spectrum Reusable Full Face Mask may be used with an optional thin, pliable flap which may be used to improve the comfort and sealing of the basic unit. This accessory is referred to as the Comfort Flap. It is available either with the mask or sold seperately as a replacement part.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth (full face)
Indicated Patient Age Range
Adult
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)
Qualification tests were performed with samples of the intended device covering the following basic areas:
- Initial performance characteristics of the device and components .
- . Environmental performance simulating shipping, storage and usage, including cleaning
- Performance after environmental simulations of the device and components .
- . Performance at extreme user conditions
- Performance of repeated disassembly of the Entrainment Valve .
Test results show that the Spectrum Reusable Full Face Mask meets all functional and key requirements as defined in the product design specifications.
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.
Respironics Spectrum Disposable Full Face Mask - K936047, Vacumed Comfo-Seal Reusable Full Face Mask - K# unknown
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
Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K961915'. The characters are written in a bold, dark font, which makes them stand out against the white background. The handwriting style is somewhat casual, with slight variations in the thickness and shape of the strokes.
AUG 1 5 199
Image /page/0/Picture/2 description: The image shows the logo for Respironics Inc. The logo consists of a stylized figure inside a triangle, with the words "RESPIRONICS INC." printed below. The figure appears to be a person with a circular head and a triangular body. The logo is black and white.
Non-Confidential Summary of Safety and Effectiveness
page 1 of 4
May 13, 1996
Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA Tel - (412) 733-5801 Fax - (412) 733-0299
| Official Contact: | Francis X. Dobscha, Manager, Regulatory Affairs |
|---|---|
| Proprietary or Trade Name: | Spectrum Reusable Full Face Mask |
| Common/Usual Name: | Face Mask |
| Classification Name: | Noncontinuous Ventillator (IPPB) Accessory |
| Device: | Respironics Spectrum Reusable Full Face Mask |
| Predicate Devices: | Respironics Spectrum Disposable Full Face Mask - K936047 |
| Vacumed Comfo-Seal Reusable Full Face Mask - K# unknown |
Device Description:
The Spectrum Reusable Full Face Mask is an externally placed mask covering the nose and mouth (full face) of a patient. It is intended to provide a seal so that positive pressure from a positive pressure source is directed to the patient's nose and mouth. It connects to a patient circuit that contains an exhalation valve, tubing, and perhaps a humidifier and/or bacteria fitter. It incorporates an Entrainment Valve which permits entrainment of ambient air when positive pressure to the patient ceases. The entrainment valve opens and closes based upon positive pressure being delivered to the patient. In addition, the mask incorporates a quick-release mechanism allowing the patient to quickly and easily remove the mask if desired. It is held in place with an adjustable headgear system. It is intended to be cleaned with soap and water. The cleaning process requires limited disassembly.
The Spectrum Reusable Full Face Mask may be used with an optional thin, pliable flap which may be used to improve the comfort and sealing of the basic unit. This accessory is referred to as the Comfort Flap. It is available either with the mask or sold seperately as a replacement part.
page 3 of 86
1
Non-Confidential Summary of Safety and Effectiveness (continued)
page 2 of 4
May 13, 1996
Intended Use:
| Indicated Use -- | Patient interface accessory for Respironics CPAP and BiPAP® Systems |
|---|---|
| Targeted Population -- | Adult |
| Environment of Use -- | Hospital and Home |
Comparison to Predicate Devices:
| Attribute | Respironics
Reusable
Spectrum
Full Face
Mask | Respironics
Disposable
Full Face
Mask | Vacumed
Comfo-Seal
Reusable
Full Face
Mask |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------|--------------------------------------------------------|
| Use | | | |
| Intended Use -- Adult Obstructive Sleep Apnea
(OSA) | Yes | Yes | Yes |
| Intended to be used with devices such as
Respironics CPAP Systems and BiPAP Systems
producing positive pressures $≥$ 3.0 cm H2O at the
mask. | Yes | Yes | Yes |
| Intended Environment - Hospital: Adult OSA | Yes | Yes | Yes |
| Intended Environment - Home: Adult OSA | Yes | Yes | Yes |
page 4 of 86
:
2
Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 4
May 13, 1996
Comparison to Predicate I nued) ======================================================================================================================================================================== : (cont
| Attribute | Respironics
Reusable
Spectrum
Full Face
Mask | Respironics
Disposable
Full Face
Mask | Vacumed
Comfo-Seal
Reusable
Full Face
Mask |
| ----------- | ---------------------------------------------------------- | ------------------------------------------------ | -------------------------------------------------------- |
|---|
| Design | |||
|---|---|---|---|
| Offered in various sizes | Yes | Yes | Yes |
| Intended for single patient multi-use | Yes | No | Yes |
| Made to be cleaned with soap and water | Yes | No | Yes |
| Provided non-sterile | Yes | Yes | Yes |
| Incorporates an Entrainment Valve | Yes | Yes | No |
| Adapts to headgear | Yes | Yes | Yes |
| Performance Standards/Specifications | |||
| Entrainment valve activation pressure of 3.0 cm | |||
| H2O minimum | Yes | Yes | Not Available |
| Meets design requirements after cleaning | Yes | Yes | Yes |
page 5 of 86
3
Non-Confidential Summary of Safety and Effectiveness (continued)
page 4 of 4
May 13, 1996
Performance Features:
Qualification tests were performed with samples of the intended device covering the following basic areas:
- Initial performance characteristics of the device and components .
- . Environmental performance simulating shipping, storage and usage, including cleaning
- Performance after environmental simulations of the device and components .
- . Performance at extreme user conditions
- Performance of repeated disassembly of the Entrainment Valve .
Test results show that the Spectrum Reusable Full Face Mask meets all functional and key requirements as defined in the product design specifications.