(166 days)
A qualitative measure of respiratory airflow for recording onto a data acquisition system.
Target Population: Children and adult patients who are screened during sleep disorder studies
Environment of Use: The majority of the screenings occur at a sleep laboratory although the sensor can also be used in home-studies.
Ultima Airflow Sensor, 1051
This document, a 510(k) clearance letter for the Ultima Airflow Sensor, provides very limited information regarding detailed acceptance criteria or a specific study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision, correlation coefficients) or a table of performance results for the Ultima Airflow Sensor.
However, the "Indications for Use Statement" (page 2) implies its intended performance:
- Acceptance Criterion (Implied): The device must provide "a qualitative measure of respiratory airflow."
- Reported Device Performance (Implied): The device is capable of providing "a qualitative measure of respiratory airflow for recording onto a data acquisition system."
The FDA's determination of "substantial equivalence" (K981445) is the primary "proof" mentioned that the device meets the necessary criteria for its intended use, based on comparison to already approved predicate devices. This typically means the device performs at least as well as, or equivalently to, the predicate device for its intended use, but the specific performance results from comparative testing are not detailed in this letter.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided document.
- Data provenance: Not specified in the provided document. The 510(k) process relies on demonstrating equivalence to predicate devices which were previously cleared, rather than necessarily describing new, independent clinical trials with detailed test sets. Therefore, the "data" would likely refer to engineering evaluations, bench testing, and potentially some limited clinical performance data demonstrating equivalence, but no specifics are given here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified.
5. 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:
- MRMC study: No indication of an MRMC study being performed. This is not an AI device, but a physical sensor. The document does not mention human "readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a physical sensor, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable in the context of this document. The device provides raw data ("qualitative measure of respiratory airflow for recording onto a data acquisition system").
7. The type of ground truth used:
- The document implies that the "ground truth" for demonstrating substantial equivalence would be the performance characteristics of its legally marketed predicate device(s). The specific performance data and the methods to establish their "ground truth" are not detailed for either the subject device or the predicate. For a device measuring respiratory airflow, the ground truth would typically be established against highly accurate reference methods (e.g., spirometry, polysomnography channels) in controlled studies.
8. The sample size for the training set:
- Not applicable/Not specified. As this is a sensor (hardware) and not a machine learning algorithm, there isn't a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, for the reasons mentioned above.
Summary of Limitations Based on Document:
This 510(k) clearance letter serves as a regulatory approval notice and does not contain the detailed technical report or study data that would lay out acceptance criteria and performance results directly. The "proof" of meeting criteria primarily stems from demonstrating "substantial equivalence" to a predicate device, meaning its safety and effectiveness are similar to a device already on the market for the same intended use. The specifics of the testing (sample sizes, expert involvement, ground truth methods for the predicate or the new device) are not part of this summary document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1898
Richard A. Bonato, Ph.D. Braebon Medical Corporation 63 Acklam Terrace Kanata, Ontario Canada K2K 2P4
Re: K981445 Ultima Airflow Sensor, 0510 Regulatory Class: II (two) Product Code: 73 BZQ Dated: July 8, 1998 Received: July 13, 1998
Dear Dr. Bonato:
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, Druq, 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 regulation 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 - Richard A. Bonato, Ph.D.
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 regulation 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,
Thomas J. Callahon
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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Indications for Use Statement
1981445 (To be assigned) 510 (k) Number_
| Device Name: | Ultima Airflow Sensor, 1051 |
|---|---|
| Indications for Use: | A qualitative measure of respiratory airflow for recordingonto a data acquisition system. |
| Target Population: | Children and adult patients who are screened during sleepdisorder studies |
| Environment of Use: | The majority of the screenings occur at a sleep laboratoryalthough the sensor can also be used in home-studies. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lank Mador 10-4-98
(Division Sign-Off) Division of Cardiovascular and Neurological Devi
Prescription Use
(Per 21 CFR 801.109) OR
Over-The-Counter Use_
,
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).