(63 days)
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No
The summary describes a physical filter/sleeve for breathing circuits and contains no mention of AI, ML, or any related computational technologies.
No.
The device's intended use is to reduce gross contamination on breathing circuits, which is a protective measure rather than a direct therapeutic intervention for a patient's medical condition.
No
Explanation: The device is described as a 'Sleeved Filter' or 'Sleeved HME/Fitter' used to reduce gross contamination on breathing circuits. Its function is to cover the patient end of a breathing circuit with a protective sleeve, which is a shielding/filtration function, not a diagnostic one. There is no mention of it detecting, analyzing, or identifying any medical conditions or parameters.
No
The device description clearly indicates a physical product ("Sleeved Filter or Sleeved HME/Fitter") used to cover a breathing circuit, which is a hardware component. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve." This describes a physical barrier function within a breathing circuit, not a test performed on samples taken from the human body.
- Device Description: The device is described as a "Sleeved Filter, Sleeved HME/Filter." This aligns with a component of a breathing circuit, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, this device falls under the category of a medical device used in respiratory care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.
Product codes
CAH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows a logo with a bird-like symbol inside a circle. The bird has three curved lines representing its body and wings, and two short lines for its legs. The circle surrounds the bird, and there is some text around the top portion of the circle, although the text is not clear enough to read.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2001
Mr. Charles A. Burt King Systems Corporation 15011 Herriman Boulevard Noblesville, IN 46060
K010040 Re: Sleeved Filter or Sleeved HME/Filter Regulatory Class: II (two) Product Code: CAH Dated: December 27, 2000 Received: January 5, 2001
Dear Mr. Burt:
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 regulation may result in regulatory action. In addition, FDA may publish
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Page 2 - Mr. Charles A. Burt
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.
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 regulation (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,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section #3
Device name: Sleeved Filter, Sleeved HME/Filter.
Intended Use:
The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 868.5260)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Klaus Roberts MD 3/7/11
Division of Cardiovascular & Respiratory Devices