(35 days)
No
The summary describes a CPAP mask and its intended use, with no mention of AI or ML technologies. The performance studies focus on substantial equivalence to predicate devices based on physical characteristics and disinfection protocols, not algorithmic performance.
Yes
The device is described as "intended for Multiple Patient Reuse by adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy" and "designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy," which are therapeutic applications.
No
Explanation: The device is a ventilatory support mask used for delivering continuous positive airway pressure or bi-level therapy, not for diagnosing medical conditions.
No
The device description clearly indicates a physical mask ("minimally obtrusive to the user providing a high level of comfort, ease-ofuse and seal") intended for delivering ventilatory support, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description of the Mirage Swift clearly states its purpose is for "delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy." This is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is for "adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy." This further reinforces its therapeutic function for treating conditions like sleep apnea.
- No Mention of Samples or Testing: There is no mention of collecting or analyzing biological samples, which is a core characteristic of IVDs.
Therefore, the Mirage Swift is a therapeutic medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mirage Swift is intended for Multiple Patient Reuse by adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy for use in home, hospitals or clinics.
Product codes
BZD
Device Description
The Mirage Swift is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for multiple patient re-use and is minimally obtrusive to the user providing a high level of comfort, ease-of-use and seal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients (>30 Kg)
Intended User / Care Setting
home, hospitals or clinics.
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 data and rationale are provided in order to demonstrate that the Mirage Swift is substantially equivalent to the Mirage Activa and Mirage Full Face Mask Series 2. The Mirage Swift can therefore be labeled as a multiple patient use device. ResMed has adopted the labeling model from the Mirage Activa and intends to include the Disinfection Guide provided in Appendix A with the sale of Mirage Swift masks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032433, K980721, K032916, K023244, K023306, K023284
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Sponsor:
ResMed Ltd
Mirage Swift MPMU Traditional 510(k) Premarket Notification
3 510(K) SUMMARY
510(k) SUMMARY-Mirage Activa™ Mask
| Submitter Name: | ResMed Corp. |
|---|---|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857 |
| USA | |
| Contact Person: | David D'Cruz, VP US Clinical & Regulatory Affairs |
| Phone Number: | (858) 746 2238 |
| Fax Number: | (858) 746 2915 |
| Date Prepared: | September 1, 2004 |
| Device Trade Name: | Mirage Swift |
| Device Common Name/ | |
| Classification Name: | Nasal Mask |
| Predicate Devices: | K032433 Mirage Swift (Nasal Jacks) |
| K980721 Mirage Nasal Mask (cleared as part of the Sullivan | |
| Autoset Nasal CPAP Submission) | |
| K032916 Mirage Activa Multiple Patient Reuse | |
| K023244 MIRAGE FULL FACE SERIES 2 (Cidex Plus, Cidex OPA) | |
| K023306 MIRAGE FULL FACE SERIES 2 (Sterrad) | |
| K023284 MIRAGE FULL FACE SERIES 2 (High Level Thermal) |
Device Description:
The Mirage Swift is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for multiple patient re-use and is minimally obtrusive to the user providing a high level of comfort, ease-ofuse and seal.
Intended Use:
The Mirage Swift is intended for Multiple Patient Reuse by adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy for use in home, hospitals or clinics.
Device Technological Characteristics and Comparison to Predicate Device(s):
The Mirage Swift is supported by headgear to allow a seal with the patients nostrils via the nasal cushions, then 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.
The Mirage Swift comes in one frame size and has three nasal cushion sizes.
1
The Mirage Swift was cleared by FDA in K032433 as a single patient re-use device. The fundamental technological characteristics and scientific principle of the Mirage Swift are unchanged. The indications for use have been extended to include Multiple Patient Reuse. The Mirage Swift is shown to be substantially equivalent to the Mirage Activa and Mirage Full Face mask series 2 masks, cleared by FDA for Multiple Patient Reuse.
Performance Data:
Performance data and rationale are provided in order to demonstrate that the Mirage Swift is substantially equivalent to the Mirage Activa and Mirage Full Face Mask Series 2. The Mirage Swift can therefore be labeled as a multiple patient use device. ResMed has adopted the labeling model from the Mirage Activa and intends to include the Disinfection Guide provided in Appendix A with the sale of Mirage Swift masks.
Conclusion:
The Mirage Swift mask is substantially equivalent to the previously cleared predicate masks
and can be relabeled for multiple-patient, multiple-use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol for healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 - 2004
ResMed Limited C/O Mr. David D' Cruz Vice President US Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K042403
Trade/Device Name: Mirage Swift Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 25, 2004 Received: September 3, 2004
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.
3
Page 2 - Mr. 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. or the recomply 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
4
INDICATION FOR USE 4
510(k) Number (if known):
Device Name: Mirage Swift
Indications for Use:
The Mirage Swift is intended for Multiple Patient Reuse by adult patients (>30 Kg) prescribed The "Mirage" Switt 13" mendou" for "Mallipro" (herapy for use in home, hospitals or clinics.
Deen Jackson
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042403
Over-The-Counter Use_ AND/OR Prescription Use × (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)