(87 days)
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 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.
The provided document describes a 510(k) Pre-market Notification for the Invacare Twilight Full Face Mask, which aims to demonstrate substantial equivalence to legally marketed predicate devices rather than necessarily proving the device meets specific acceptance criteria in a quantitative performance study. The document focuses on comparing the proposed device's specifications and intended use to those of existing devices.
Therefore, the requested information elements related to detailed study methodologies (sample size, ground truth, expert adjudication, MRMC studies, training sets) are largely not applicable in the context of this 510(k) submission, as it relies on a comparison of device characteristics and adherence to general performance standards rather than a clinical efficacy trial.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Acceptance Criteria" here are implicitly defined by the specifications of the predicate devices. The "Reported Device Performance" is the Invacare Twilight Full Face Mask's own specifications. Substantial equivalence is demonstrated by showing that these specifications are comparable.
| Specification | Invacare Twilight Full Face Mask (Reported Performance) | ResMed Mirage Full Face Mask Series 2 (Predicate) | Respironics Spectrum 2 Reusable Full Face Mask (Predicate) | Acceptance Criteria (Implied by Predicates) |
|---|---|---|---|---|
| Intended Use | With PAP devices (CPAP/Bi-Level, 4-20 cmH2O) for adult (>30kg) obstructive sleep apnea. Single/multiple patient re-use. | Multi-patient use for adult (>30kg) CPAP/bi-level therapy. | Adults with Respironics CPAP/bi-level devices. Covers nose/mouth. Built-in exhalation. Single/multiple patient re-use. | Comparable intended use for adult obstructive sleep apnea with PAP devices in the 4-20 cmH2O range, suitable for single or multiple patient re-use. |
| Patient Use | Adults >30Kg | Adults >30Kg | Adults | For adult patients, generally >30kg. |
| Single/Multiple Patient Use | Multiple-patient | Multiple-patient | Multiple-patient | Multiple-patient re-use. |
| Input Device Range | 4-20 cmH2O | 4-20 cmH2O | 3-40 cmH2O | Within a clinically acceptable range for PAP therapy, generally including 4-20 cmH2O. |
| Mask Frame Material | Polycarbonate | Polycarbonate | Polycarbonate | Biocompatible and durable material, such as polycarbonate. |
| Nasal Cushion Material | Silicone | Silicone | Silicone | Biocompatible and comfortable material, such as silicone. |
| Anti-asphyxia Valve | Yes - silicone | Yes - silicone | Yes - silicone | Presence of an anti-asphyxia valve, typically silicone. |
| Hose Connection Input | For Ø22mm hose | For Ø22mm hose | For Ø22mm hose | Standard Ø22mm hose connection. |
| Exhalation Ports | 5 | 6 | 44 | Sufficient exhalation ports to prevent re-breathing (specific number may vary but must be effective). |
| Swivel Connections | 360° Rotation | 360° Rotation | 360° Rotation | 360° rotation for hose flexibility. |
| Ports | 1 port (for pressure measurement) | 2 ports | 1 port (for pressure measurement) | At least one port for pressure measurement. |
| Exhaust Flow | 23 LPM @ 4 cmH2O53 LPM @ 20 cmH2O | 22 LPM @ 4 cmH2O54 LPM @ 20 cmH2O | Below 5 cmH2O, unknown~ 43 LPM @ 20 cmH2O | Comparable exhaust flow rates to ensure proper CO2 washout, particularly at common therapy pressures. |
| Pressure Drop at patient connection | < 0.3 cmH2O @ 50 LPM< 1.0 cmH2O @ 100 LPM | Unknown (for predicate devices) | Unknown (for predicate devices) | Low pressure drop across the mask to ensure effective therapy delivery, likely conforming to relevant standards (e.g., ISO 17510-2 requirements). |
| Internal volume (Dead space) | < 303ml (varies by size) | < 258mL (varies by size) | 274ml - 428ml (varies by size) | Internal volume (dead space) within a clinically acceptable range to minimize re-breathing of exhaled gases, varying by cushion size. |
The study proving the device meets these "acceptance criteria" is the 510(k) submission itself, which argues for substantial equivalence. The document states: "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." This substantial equivalence argument is supported by the detailed comparison table and performance testing against recognized standards.
Specifically, the device performance was evaluated against the following standards:
- ISO 17510-2:2003: Sleep apnoea breathing therapy - Part 2: Masks and application accessories
- ISO 5356-1:2004: Anaesthetic and respiratory equipment - Conical connectors - Part 1: 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
These standards represent the "acceptance criteria" for the performance and safety aspects of the mask, and conformance to them is asserted by the manufacturer.
Information Not Applicable or Not Provided in the Document:
Due to the nature of a 510(k) submission predominantly focused on substantial equivalence to predicate devices and adherence to recognized standards, the following detailed study methodologies are not described or are not relevant to this type of regulatory filing.
- Sample size used for the test set and the data provenance: Not applicable. Performance testing typically involves engineering tests on prototypes/production samples, not a clinical "test set" in the sense of patient data for a diagnostic algorithm. No country of origin for such data is specified beyond the device being from Invacare Corporation in Elyria, Ohio, USA. The testing is laboratory-based, not retrospective/prospective patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and performance benchmarks from international standards, not expert clinical assessment of a diagnostic outcome.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (face mask), not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (face mask), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is adherence to the specified technical parameters (e.g., exhaust flow, pressure drop, internal volume) and compliance with relevant international standards (ISO, EN). This is established through engineering testing and quality management systems.
- The sample size for the training set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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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 < 070321
Date: February 1, 2007
Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190
Telephone: 440-326-6356 Fax: 440-326-3607
Contact Person: Mr. Carroll Martin
Trade Name: Twilight Full Face Mask
Common Name: Mask
Classification Name: Ventilator, non-continuous (respirator) per 21 CFR 868.5905
Legally Marketed Predicate Device(s): ResMed Mirage Full Face Mask Series 2: K023244 November 27, 2002 Respironics Spectrum 2 Reusable Full Face Mask, Model 1004884; K002465, September 8, 2000
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.
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.
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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Substantial Equivalence:
| Specification | Twilight Full Face Mask | ResMed Mirage FullFace Mask Series 2 | Respironics Spectrum 2Reusable Full Face Mask, Model1004884 |
|---|---|---|---|
| 510(k) Number | TBD | K023244 | K002465 |
| Date Cleared | TBD | November 27, 2002 | September 8, 2000 |
| Intended Use | The Invacare Twilight Full Face Maskis intended to be used with positiveairway pressure (PAP) devices, such asCPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adultobstructive sleep apnea. There is aport on the mask to allow for pressuremeasurement. The mask is to be usedon adult patients (>30 kg) for whompositive airway pressure therapy hasbeen prescribed. The mask is intendedfor single or multiple patient re-use. | The Ultra Mirage Full Face Mask isintended for multi-patient use for adultpatients (>30 kg) prescribed continuouspositive airway pressure (CPAP) or bi-level therapy in hospital, clinic, and/orhome environments. | The ComfortFull 2 Reusable Fullface Mask and Headgear areintended for use by adults as aninterface with Respironics CPAPor bi-level devices. The maskcovers the nose and mouth. Anexhalation port is built into theComfortFull 2 mask so that aseparate exhalation port is notrequired. Before using this mask,the home care provider shouldverify device pressure(s). Thismask is not suitable for providinglife support ventilation. |
| Patient Use | Adults >30Kg | Adults >30Kg | Adults |
| Single/MultiplePatient Use | Multiple-patient | Multiple-patient | Multiple-patient |
| Input DeviceRange | 4-20 cmH2O | 4-20 cmH2O | 3-40 cmH2O |
| Mask FrameMaterial | Polycarbonate | Polycarbonate | Polycarbonate |
| Nasal CushionMaterial | Silicone | Silicone | Silicone |
| Anti-asphyxiaValve | Yes - silicone | Yes - silicone | Yes - silicone |
| Hose ConnectionInput | For Ø22mm hose | For Ø22mm hose | For Ø22mm hose |
| Exhalation Ports | 5 | 6 | 44 |
| SwivelConnections | 360° Rotation | 360° Rotation | 360° Rotation |
| Ports | 1 port | 2 ports | 1 port |
| Exhaust Flow | 23 LPM @ 4 cmH2O53 LPM @ 20 cmH2O | 22 LPM @ 4 cmH2O54 LPM @ 20 cmH2O | Below 5 cmH2O, unknown~ 43 LPM @ 20 cmH2O |
| Pressure Drop atpatientconnection | < 0.3 cmH2O @ 50 LPM< 1.0 cmH2O @ 100 LPM | Unknown | Unknown |
| Internal volume(Dead space) | Dead space varies according tocushion sizes but is less than 303ml | Dead space varies according to cushionsizes but is less than 258mL | Dead space varies according tocushion sizes and is between274ml and 428ml |
As the chart above shows, the Invacare Full Face Mask incorporates features from both predicate devices. All of the above devices have the same intended use for the same patient population, are made of similar materials, have exhalation ports to prevent re-breathing of exhaled gases, have an anti-
INVACARE CORPORATION
One Invacare Way P.O. Box 4028 Elyria, OH 44 440-329-6000 Fax: 440-366-1803 www.inv.
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asphyxia valve to guard against possible suffocation if the PAP unit shuts down while the patient is wearing the mask and ports in the mask frame to allow for pressure measurement devices.
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: Conesand sockets |
| ISO 13485:2003: | Medical devices - Quality management systems -- Requirements for regulatorypurposes |
| 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.
One Invacare Way P.O. Box 4028 Elyria, OH 4 440-329-6000 Fax: 440-366-1803 www.inv
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Carroll Martin Regulatory Specialist Invacare Corporation One Invacare Way Elyria, Ohio 44035-4190
APR 3 0 2007
Re: K070321
Trade/Device Name: Twilight Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 1. 2007 Received: February 5, 2007
Dear Mr. Martin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Martin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): |くんつじろく
Device Name: Twilight Full Face Mask
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.
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:
Page 1 of
§ 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).