(27 days)
Not Found
No
The summary describes a respiratory mask, an accessory to a ventilator, with no mention of AI or ML capabilities. The performance studies focus on physical characteristics like pressure-flow and dead space.
No.
The device is described as an "accessory" and "interface accessory" to a non-continuous ventilator, CPAP, and bi-level devices. It does not provide therapy itself but rather facilitates the delivery of therapy from other devices.
No
The device is described as an accessory to a non-continuous ventilator (respirator) for CPAP and bi-level therapy, and its performance studies relate to pressure-flow characteristics and impedance, not disease diagnosis.
No
The device description clearly states it is a "respiratory nasal mask" and an "interface accessory," indicating it is a physical hardware component.
Based on the provided information, the Mirage Activa™ mask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an accessory to a non-continuous ventilator (respirator) for delivering CPAP and bi-level therapy. This is a respiratory support function, not a diagnostic test performed on samples from the human body.
- Device Description: The description confirms it's a respiratory nasal mask, an interface for delivering air pressure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics relevant to a respiratory mask (pressure-flow, dead space, flow impedance), not diagnostic accuracy metrics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Mirage Activa™ mask does not fit this description.
N/A
Intended Use / Indications for Use
The Mirage ActivaTM mask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
Mirage ActivaTM is a respiratory nasal mask using dual cushion design with built-in bellows. It is a single-patient-use interface accessory for use with CPAP and bi-level devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose (implied, as it's a nasal mask)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Hospital, clinic, and home environments.
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 Mirage Activa™ mask was tested to determine the pressure-flow characteristic, dead space (CO2 re-breathing) and flow impedance. The results of the performance data show that the mask is substantially equivalent with the unmodified predicate mask.
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.
Modular Nasal Mask K961783
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
APR 0 9 2003
510(k) SUMMARY---Mirage Activa™ Mask
| Submitter Name: | ResMed Ltd |
|---|---|
| Submitter Address: | 97 Waterloo Road, North Ryde NSW 2113, Australia |
| Contact Person: | David D'Cruz, VP Regulatory & Clinical Affairs US |
| Phone Number: | (858) 746 2238 |
| Fax Number: | (858) 746 2282 |
| Date Prepared: | March 10, 2003 |
| Device Trade Name: | Mirage ActivaTM Mask |
| Device Common Name/ | |
| Classification Name: | Nasal Mask |
| Predicate Devices: | Modular Nasal Mask K961783 |
| Device Description: | Mirage ActivaTM is a respiratory nasal mask using dual cushion |
| design with built-in bellows. It is a single-patient-use interface | |
| accessory for use with CPAP and bi-level devices. | |
| Intended Use: | Mirage ActivaTM mask is an accessory to a non-continuous |
| ventilator (respirator) intended for single-patient use for adult | |
| patients prescribed continuous positive airway pressure | |
| (CPAP) and bi-level therapy in hospital, clinic, and home | |
| environments. |
Device Technological Characteristics and Comparison to Predicate Device(s):
The Mirage Activa™ mask is strapped to the patient's face covering the nose, and connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way.
The Mirage Activa™ mask comes in one frame size and three cushion sizes (standard, large and shallow).
1
| Sponsor: | Mirage Activa™ Mask |
|---|---|
| ResMed Ltd | Special 510(k) Premarket Notification |
The Mirage Activa™ mask is substantially equivalent to the Modular nasal mask. The two masks have the same intended use, operating principle, technological characteristics and manufacturing process. Below is a summary of the similarities and differences in design between the Mirage Activa™ mask and the Modular nasal mask:
- . The functional performance parameters of the Mirage Activa™ mask with respect to pressure-flow characteristic, dead space (CO2 re-breathing) and flow impedance are equivalent with those of the predicate mask, and are aimed at making the mask compatible with existing flow generators.
- . The Activa™ mask has a dual wall cushion design with built-in bellows, which allows relative movement of the mask frame while keeping the cushion seal intact. This design ensures improved mask to patient seal as compared to the predicate mask. To increase the mask stability, the Mirage Activa™ mask has a short air tubing made of polyolefin to remove the weight and drag of the main tube from the elbow. The lightweight tube helps lower the center of gravity and hence improve the stability of the mask.
- The Mirage Activa™ Mask incorporates an elbow able to rotate through 360°, which . allows free rotation of the air supply tube, similar to the Modular mask. But while the elbow of the Modular mask is not removable, the Mirage Activa™ elbow can be removed to enable easy access for cleaning.
- The Mirage Activa™ elbow incorporates a baffle, which creates a separate channel to . improve the exhaust flow and thus reduce CO2 re-breathing.
- . The exhaust vent in the Mirage Activa™ mask is positioned in the elbow, which is similar in layout with the Modular mask. The exhaust vent of the Mirage Activa™ mask is made of silicone, while the exhaust vent of the Modular mask is made of polycarbonate.
- . The Mirage Activa™ mask has a cushion clip to attach the cushion to the frame, allowing the patient to remove the cushion for cleaning. The Modular mask does not have a clip to attach the cushion to the mask frame.
- . The Mirage Activa™ mask has an adjustable angular forehead support with detachable forehead pads to ensure a better fit for a range of facial profiles and to increase patient comfort. The Modular mask has a fixed forehead support with an adhesive forehead pad.
- The Mirage Activa™ mask has a 2-port cap made of silicone that can be used to seal one . or both ports available for connection to pressure sensing tubing. The Modular mask uses polyethylene ports caps.
- The Mirage Activa™ mask has clips for attaching the headgear to the frame to enable fast . removal of the mask, which is an improvement to the Modular mask that uses hook tabs.
- . The Mirage Activa™ headgear is made of "Breathoprene" fabric for the core structure, which allows the skin to breathe whilst the headgear is worn, whereas the Modular mask headgear is made of "Velstrech" fabric.
Performance Data:
The Mirage Activa™ mask was tested to determine the pressure-flow characteristic, dead space (CO2 re-breathing) and flow impedance. The results of the performance data show that the mask is substantially equivalent with the unmodified predicate mask.
The materials used for the mask components, which contact the skin and/or the air-path, are either predicate materials (i.e., cleared previously for the same intended use), or are compliant with ISO 10993 standards.
2
| Sponsor: | Mirage Activa™ Mask |
|---|---|
| ResMed Ltd | Special 510(k) Premarket Notification |
Conclusion:
The Mirage Activa™ mask is substantially equivalent to the Modular mask. The changes in design do not affect safety and effectiveness of the Mirage Activa™ mask.
,
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 9 2003
°Mr. David D'Cruz VP Regulatory & Clinical Affairs ResMed Ltd. c/o ResMed Corporation 14040 Danielson Street Poway, CA 92064-6857
Re: K030798
Trade/Device Name: Mirage Activa Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 11, 2003 Received: March 13, 2003
Dear Mr. D'Cruz:
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.
4
Page 2 – Mr. David D'Cruz
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 (OS) 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Munro
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Sponsor: ResMed Ltd
510(k) Number (if known):
KO30198
Device Name:
Mirage Activa™ Mask
Indications for Use:
The Mirage Activa™ Mask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic and home environments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | |
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| ---------------------- | -- |
| (Optional Format 1-2-96) | |
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| -- | -------------------------- |
(Division Sign-Off)
Division of Anesthesiology General Hospital,
Infection Controle Devices1.030798 510(K, N.ID. 00 ..