(139 days)
Not Found
No
The 510(k) summary describes a physical mask accessory for ventilation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an accessory to a non-continuous ventilator and is intended to deliver therapy, not to provide therapy itself.
No
This device is a mask for delivering continuous positive airway pressure (CPAP) or bi-level therapy, which is a treatment rather than a diagnostic tool. Its purpose is to assist with ventilation, not to diagnose a condition.
No
The device description clearly describes a physical mask and its components, which are hardware. It is an accessory to a ventilator, also a hardware device.
Based on the provided information, the Mirage Vista™ mask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the mask is an accessory to a non-continuous ventilator for delivering CPAP and bi-level therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical design and function of the mask for delivering positive pressure ventilation. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Mirage Vista™ mask does not interact with or analyze such specimens.
Therefore, the Mirage Vista™ mask is a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mirage Vista™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Mirage Vista™ mask has an unobtrusive design, which increases the patient's field of vision and allows wearing of glasses whilst the mask is in use. The new design reduces the perceived size and weight of the mask when compared to the predicate mask.
The Mirage Vista™ 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 manner.
Mirage Vista™ mask comes in one frame size and two cushion sizes (standard and deep).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose (patient's face covering the nose)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Hospital, clinical, 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 Vista™ mask was tested to determine the pressure-flow characteristic, functional dead space (CO2 re-breathing) and flow impedance. The results of the performance data show that the mask is substantially equivalent to the predicate mask. In addition, the Mirage Vista mask was validated for multiple-patient use.
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 the ISO 10993 standards.
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
Image /page/0/Picture/0 description: The image shows a handwritten text string at an angle. The text appears to be a combination of letters and numbers, specifically "K631043". The characters are written in a simple, somewhat crude style, with varying stroke thicknesses. The background is plain white.
510(K) SUMMARY 3
510(k) SUMMARY-Mirage Vista™ Mask
| Submitter Name: | ResMed Corp. |
|---|---|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857 |
| USA | |
| Contact Person: | Roger Kotter, QA&RA Director |
| Phone Number: | (858) 746 2400 |
| Fax Number: | (858) 746 2900 |
| Date Prepared: | March 28, 2003 |
| Device Trade Name: | Mirage Vista™ Mask |
| Device Common Name/ | |
| Classification Name: | Nasal Mask |
| Predicate Devices: | Modular Nasal Mask K961783 |
Device Description:
The Mirage Vista™ mask has an unobtrusive design, which increases the patient's field of vision and allows wearing of glasses whilst the mask is in use. The new design reduces the perceived size and weight of the mask when compared to the predicate mask.
Intended Use:
The Mirage Vista™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
Device Technological Characteristics and Comparison to Predicate Device(s):
The Mirage Vista™ 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 manner.
Mirage Vista™ mask comes in one frame size and two cushion sizes (standard and deep).
1
| Sponsor: | Mirage Vista™ Mask |
|---|---|
| ResMed Ltd | Traditional 510(k) Premarket Notification |
The Mirage Vista™ mask is substantially equivalent to the Modular mask. The two masks have the same intended use except reuse (the Mirage Vista™ mask is a multiple-patient use mask, whereas the Modular mask is a single-patient use mask); the same operating principle; the same technological characteristics; and the same type of manufacturing process.
Performance Data:
The Mirage Vista™ mask was tested to determine the pressure-flow characteristic, functional dead space (CO2 re-breathing) and flow impedance. The results of the performance data show that the mask is substantially equivalent to the predicate mask. In addition, the Mirage Vista mask was validated for multiple-patient use.
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 the ISO 10993 standards.
Conclusion:
The Mirage Vista™ mask is substantially equivalent to the Modular mask.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus or a symbol representing health and medicine.
Public Health Service
AUG 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. Roger Kotter Quality Assurance & Regulatory Affairs Director ResMed Corporation 14040 Danielson Street Poway, CA 92064-6857
Re: K031047
Trade/Device Name: Mirage Vista™ Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 28, 2003 Received: April 2, 2003
Dear Mr. Kotter:
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.
3
Page 2 -Mr. Kotter
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 Russe
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
4
INDICATIONS FOR USE 4
510(k) Number (if known):
KO31047
Device Name:
Mirage Vista™ Mask
Indications for Use:
The Mirage Vista™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
signature
ion Sign-Off) on of Anesthesiology, General Hospital, fection Control Der
510(k) Number
(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
(Optional Format 1-2-96)