(234 days)
The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system's labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.
Not Found
Based on the document provided, this is a 510(k) clearance letter for the Sullivan Autoset Nasal CPAP System and a separate "Indications for Use" statement for the Sullivan Mirage Mask System. This document does not include acceptance criteria or the study details proving specific performance.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements...".
This means the device was cleared based on its substantial equivalence to a predicate device, not on specific performance criteria demonstrated through a new clinical effectiveness study with a predefined acceptance criterion.
Therefore, I cannot provide the requested information from the given document as it does not contain:
- A table of acceptance criteria and the reported device performance: This information is not part of a 510(k) clearance letter that relies on substantial equivalence.
- Sample size used for the test set and the data provenance: Not provided for a substantial equivalence claim.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of clearance.
- Adjudication method: 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: This is a CPAP system, not an AI diagnostic/imaging device. MRMC studies are not relevant here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable for a substantial equivalence claim.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory approval notice based on "substantial equivalence" to a predicate device, not a detailed technical report of a clinical performance study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Mr. Scott Dudevoir Resmed Ltd. c/o Resmed Corp. 10121 Carroll Canyon Road San Diego, CA 92131
K984428 Re: Sullivan Autoset Nasal CPAP System Requlatory Class: II (two) Product Code: 73 BZD Dated: April 23, 1999 Received: April 26, 1999
Dear Mr. Dudevoir:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Scott Dudevoir
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
4428 510(k) Number (if known): _ K98
Sullivan MIRAGE MASK SYSTEM Device Name:
Indications For Use: The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system's labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
M.
(Sign-Off)
Cardiovascular, Respiratory,
ical Devices
K984428
(Optional Format 3-10-98)
↙ Prescription Use
§ 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).