(259 days)
The disposable KC 9-P one-way valve with removable cap allows a single breath measurement of auto-PEEP when used with certain ventilator circuits.
KC 9-P Auto-PEEP Measurement Device
The provided document is an FDA 510(k) clearance letter for the Instrumentation Industries, Inc. Auto-PEEP Measurement Device (K983631). It confirms substantial equivalence to a predicate device and outlines regulatory information. However, this document does not contain the detailed information necessary to describe the acceptance criteria, reported device performance, or the study that proves the device meets the acceptance criteria as requested in the prompt.
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...". This means the device was cleared based on its substantial equivalence to an older, already-marketed device, rather than requiring a detailed comparative clinical study against specific acceptance criteria for a novel device.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. The letter focuses on regulatory substantial equivalence, not performance metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, and highly unlikely for a device cleared through substantial equivalence without a new claim of improved diagnostic or therapeutic performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This device appears to be a physical measurement device (one-way valve) rather than an AI/algorithm-driven one.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-driven device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ms. Tricia Wood Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re: K983631 Auto-PEEP Measurement Device Regulatory Class: II (two) Product Code: 73 СВР May 6, 1999 Dated: Received: May 7, 1999
Dear Ms. Wood:
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 Existing major regulations affecting your device additional controls. 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 requlation (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 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 - Ms. Tricia Wood
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. 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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Indications for Use
Center for Devices and Radiological Health
Page 1 of 1
510(k) Number (if known): K983631
Device Name: KC 9-P Auto-PEEP Measurement Device
Indications for Use:
The disposable KC 9-P one-way valve with removable cap allows a single breath
measurement of auto-PEEP when used with certain ventilator circuits.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Ur. Ruy
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription USC
(Optional Format 3-10-98)
(Posted July 1, 1998)
Back to the Indications for Use Page
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).