(263 days)
The Optovent™ RR 9700 is intended as an adjunct to patient assessment and is used to continuously monitor the respiratory rate of adult patients. The device is intended to be used by qualified health care professionals trained in the use of the equipment. The device is not intended for home use.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a medical device called the "Optovent™ RR 9700 Respiratory Monitor." The provided document is a regulatory approval, not a detailed study report. Therefore, most of the requested information about acceptance criteria, study design, and ground truth is not present in this document.
The document confirms that Optovent™ RR 9700 is considered substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This substantial equivalence is based on the device's indications for use and a comparison to existing devices, implying that the device meets some level of performance and safety comparable to these predicates. However, the specific acceptance criteria and the detailed study proving they are met are not described in this letter.
Here's a breakdown of what can and cannot be answered based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not provided in the document. This document is an FDA clearance letter, not a performance study report. It states that the device is "substantially equivalent" to predicate devices, implying it meets comparable performance and safety standards, but the specific metrics are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. No information about a test set sample size, data provenance, or study design is included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided in the document. There is no mention of ground truth establishment or experts in this regulatory letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document. This level of detail regarding a test set or adjudication is not present.
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
- Not applicable/Not provided. This device is a "Respiratory Monitor," likely a sensor or a device that directly measures a physiological parameter (respiratory rate), not an AI-driven image analysis tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. Given that the device is a "Respiratory Monitor R 9700" and "is intended as an adjunct to patient assessment," it implies a device that generates data for healthcare professionals, rather than an AI algorithm acting in a standalone capacity that would typically require such a study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided in the document. There is no mention of how any ground truth was established for performance validation. For a respiratory monitor, ground truth would typically refer to a highly accurate reference method for measuring respiratory rate, but this is not detailed.
8. The sample size for the training set
- Not provided in the document. There is no mention of a training set, which would be relevant for machine learning algorithms, but this device appears to be a direct physiological monitor.
9. How the ground truth for the training set was established
- Not provided in the document. As above, no mention of a training set or its ground truth.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 FEB
Claes Rymond, M.D. Optovent, Incoporated c/o Medicon International Inc. 1350 15th Street, Suite 4H Fort Lee, NJ 07024
K981725 Re: Optovent™ RR 9700 Respiratory Monitor Regulatory Class: II (two) Product Code: 73 BZQ Dated: November 13, 1998 November 16, 1998 Received:
Dear Dr. Rymond:
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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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 - Claes Rymond, M.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,
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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| 510(k) Number: | K 981725 | ||
|---|---|---|---|
| Device Name: | Optovent™ Respiratory Monitor RR 9700 | ||
| Sponsor: | Optovent, Inc. | ||
| Indications For Use: | The Optovent™ RR 9700 is intended as an adjunct topatient assessment and is used to continuously monitor therespiratory rate of adult patients. The device is intended tobe used by qualified health care professionals trained in theuse of the equipment. The device is not intended for homeuse. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| 2/2/99 | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 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).