(139 days)
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.
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).
This document is a 510(k) summary for the ResMed Mirage Vista™ Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and specific statistical results for a device like an AI algorithm.
Therefore, many of the requested categories for describing an AI algorithm study cannot be directly answered from the provided text. The device in question is a physical medical device (a mask for ventilation), not a software or AI-driven diagnostic tool.
Here's an attempt to extract relevant information and explain why other points cannot be addressed:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states the device was tested to determine certain characteristics and that the results show substantial equivalence to the predicate mask. It doesn't present specific numerical acceptance criteria or performance metrics in the format you might expect for an AI algorithm (e.g., sensitivity, specificity thresholds).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pressure-flow characteristic | Substantially equivalent to predicate mask | Substantially equivalent to predicate mask |
| Functional dead space (CO2 re-breathing) | Substantially equivalent to predicate mask | Substantially equivalent to predicate mask |
| Flow impedance | Substantially equivalent to predicate mask | Substantially equivalent to predicate mask |
| Multiple-patient use | Validation for multiple-patient use | Validated for multiple-patient use |
| Biocompatibility | Compliant with ISO 10993 standards or predicate materials | Materials are predicate or compliant with ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission references "performance data" and "validation for multiple-patient use" but does not detail the specific test methodologies, number of subjects/masks tested, or the origin of any data (e.g., country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided. The device is a physical mask; its performance is assessed through engineering and clinical testing, not by establishing a ground truth label for data using human experts as would be done for an AI diagnostic.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication typically refers to resolving disagreements among experts when labeling data for AI, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable/not provided. An MRMC study is designed for diagnostic algorithms evaluated by human readers. This submission concerns a physical medical device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This is not an algorithm, so the concept of standalone performance does not apply.
7. The Type of Ground Truth Used
The "ground truth" here is the physical and functional performance of the mask, compared against established standards for medical devices and the performance of the predicate device. This is evaluated through:
- Engineering tests (pressure-flow, dead space, flow impedance).
- Biocompatibility testing against ISO 10993 standards.
- Validation for its stated use (multiple-patient use).
It is not "expert consensus, pathology, or outcomes data" in the context of an AI diagnostic.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided. As above, this is not an AI model requiring a training set.
Summary of Limitations:
The provided text is a 510(k) summary for a physical medical device (a mask) seeking clearance based on substantial equivalence to a predicate device. It is structured to meet regulatory requirements for such a device, focusing on intended use, technological characteristics, and a high-level summary of performance testing to support equivalence. It does not contain the detailed statistical analysis, reader studies, ground truth establishment, or dataset specifics that would be present in a submission for an AI/software as a medical device (SaMD).
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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 92064-6857USA |
| 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).
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| 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.
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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.
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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
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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)
§ 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).