(87 days)
Not Found
No
The description focuses on the physical components and function of a mask for PAP therapy, with no mention of AI or ML capabilities.
No
This device is a mask intended to be used with positive airway pressure devices for the treatment of obstructive sleep apnea; it does not itself provide the therapy.
No
Explanation: The Invacare Twilight Full Face Mask is a medical device accessory designed to be used with positive airway pressure (PAP) devices for the treatment of sleep apnea. Its function is to deliver positive airway pressure, not to diagnose a condition. The mention of a "port on the mask to allow for pressure measurement" refers to the ability to monitor the pressure delivered by the PAP device, not to perform a diagnostic assessment of the patient's condition.
No
The device description clearly outlines physical components like a mask, headgear, cushion, frame, exhalation ports, swivels, and an anti-asphyxia valve, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is a mask used to deliver positive airway pressure directly to a patient's airway.
- The intended use is for the treatment of obstructive sleep apnea. This is a therapeutic application, not a diagnostic one.
- The device description details a physical mask and headgear. It does not involve any reagents, test strips, or analytical components typically found in IVD devices.
- The performance studies focus on physical and functional characteristics of the mask (e.g., exhaust flow, pressure drop, compliance with standards for respiratory equipment), not on the accuracy of a diagnostic test.
This device is a medical device used for therapy, specifically for delivering positive airway pressure for the treatment of sleep apnea.
N/A
Intended Use / Indications for Use
The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
Product codes
BZD
Device Description
The Twilight full Face Mask consists of a mask that fits over the nose and mouth of a patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose and mouth. The cushion mounts to a rigid clear plastic frame. The frame has built in exhalation ports, a full swivel for locating the pressure device hose, a tubing swivel to allow for twisting of the hose, and a built in anti-asphyxia valve to allow the inner volume of the mask to be open to the outer atmosphere when there is no pressure being supplied by the flow generator device. Mounted to the frame is an adjustable forehead support for resting against the patient's forehead. The headgear has quick release clips and loop adjustment on the straps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adults (>30 kg)
Intended User / Care Setting
Not Found
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)
Performance Testing: The Invacare Twilght Full Face Mask has been tested in accordance with the following:
ISO 17510-2:2003: Sleep apnoea breathing therapy - Part 2: Masks and application accessories
ISO 5356-1:2004: Anaesthethic and respiratory equipment - Conical connectors - Part1: Cones and sockets
ISO 13485:2003: Medical devices - Quality management systems -- Requirements for regulatory purposes
ISO 14971:2000: (Amendment 2003) Medical devices -- Application of risk management to Medical Devices
EN 980:2003: Graphical symbols for use in the labeling of medical devices
EN 1041:1998: Information supplied by the manufacturer with medical devices
Performance Data: The performance data found in this submission shows that the Invacare Full Face Mask performs as intended and in a manner that is substantially equivalent to the predicate devices.
Conclusion: The data presented in this submission shows that the Invacare Twilight Full Face Mask performs as intended and in a manner that is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Exhaust Flow: 23 LPM @ 4 cmH2O, 53 LPM @ 20 cmH2O
Pressure Drop at patient connection:
§ 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 the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, sans-serif font. The word is placed inside of a black oval shape. The oval has a white outline.
APR 3 0 2007
510(K) SUMMARY FOR INVACARE'S TWILIGHT FULL FACE MASK
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
The assigned 510(k) number is 30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
INVACARE CORPORATION
One Invacare Way P.O. Box 4028 Elvria, OH 440 440-329-6000 Fax: 440-366-1803 www.inva
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Image /page/1/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, sans-serif letters. The word is enclosed in a black oval shape with a white outline. The logo is simple and modern.
Substantial Equivalence:
| Specification | Twilight Full Face Mask | ResMed Mirage Full
Face Mask Series 2 | Respironics Spectrum 2
Reusable Full Face Mask, Model
1004884 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K023244 | K002465 |
| Date Cleared | TBD | November 27, 2002 | September 8, 2000 |
| Intended Use | The Invacare Twilight Full Face Mask
is intended to be used with positive
airway pressure (PAP) devices, such as
CPAP and Bi-Level, which provide 4-
20 cmH2O for the treatment of adult
obstructive sleep apnea. There is a
port on the mask to allow for pressure
measurement. The mask is to be used
on adult patients (>30 kg) for whom
positive airway pressure therapy has
been prescribed. The mask is intended
for single or multiple patient re-use. | The Ultra Mirage Full Face Mask is
intended for multi-patient use for adult
patients (>30 kg) prescribed continuous
positive airway pressure (CPAP) or bi-
level therapy in hospital, clinic, and/or
home environments. | The ComfortFull 2 Reusable Full
face Mask and Headgear are
intended for use by adults as an
interface with Respironics CPAP
or bi-level devices. The mask
covers the nose and mouth. An
exhalation port is built into the
ComfortFull 2 mask so that a
separate exhalation port is not
required. Before using this mask,
the home care provider should
verify device pressure(s). This
mask is not suitable for providing
life support ventilation. |
| Patient Use | Adults >30Kg | Adults >30Kg | Adults |
| Single/Multiple
Patient Use | Multiple-patient | Multiple-patient | Multiple-patient |
| Input Device
Range | 4-20 cmH2O | 4-20 cmH2O | 3-40 cmH2O |
| Mask Frame
Material | Polycarbonate | Polycarbonate | Polycarbonate |
| Nasal Cushion
Material | Silicone | Silicone | Silicone |
| Anti-asphyxia
Valve | Yes - silicone | Yes - silicone | Yes - silicone |
| Hose Connection
Input | For Ø22mm hose | For Ø22mm hose | For Ø22mm hose |
| Exhalation Ports | 5 | 6 | 44 |
| Swivel
Connections | 360° Rotation | 360° Rotation | 360° Rotation |
| Ports | 1 port | 2 ports | 1 port |
| Exhaust Flow | 23 LPM @ 4 cmH2O
53 LPM @ 20 cmH2O | 22 LPM @ 4 cmH2O
54 LPM @ 20 cmH2O | Below 5 cmH2O, unknown
~ 43 LPM @ 20 cmH2O |
| Pressure Drop at
patient
connection | 30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chilton
( E-Mon of Ancolnoon Dental Devices
C(k) Number:
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