(198 days)
Not Found
Not Found
No
The summary describes a bacterial/viral filter for respiratory circuits, focusing on physical properties and intended use, with no mention of AI or ML.
No.
The device is designed to reduce bacterial/viral transmission and the loss of patient heat and humidity, not to directly treat a disease or medical condition.
No
The text describes devices used for reducing bacterial/viral transmission and maintaining heat and humidity in respiratory systems, not for diagnosing medical conditions.
No
The device description and intended use clearly describe physical filters designed to reduce bacterial/viral transmission and manage heat/humidity in respiratory circuits. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description focuses on the device's function in reducing bacterial/viral transmission and managing heat/humidity in respiratory circuits. It describes a physical filter/humidifier used in a breathing system.
- Intended Use: The intended use clearly states its purpose in respiratory equipment connections and patient connections to reduce transmission and manage heat/humidity. This is a therapeutic/supportive function, not a diagnostic one.
The text describes a medical device used in respiratory care, not a test performed on biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
1644 & 1644-T: For use at the equipment connection. Designed to reduce bacterial transmission to and from patient, equipment and environment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1831 & 1831-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions: Do not use this product in conjunction with other humidification sources. 1644, 1644-T, 1831, 1831-T: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier; Do not use this product between the patient and a source of nebulized drugs; When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure; Federal law restricts this device to sale by or on the order of a physician.
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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 30 999
Mr. Thomas R. Gunerman Intersurqical Incorporated 417 Electronics Parkway Liverpool, NY 13088
Re: K983610 Breathing Filters Models 1644, 1644T, 1831 and 1831T Requlatory Class: II (two) Product Code: 73 CAH February 1, 1999 Dated: February 4, 1999 Received:
Dear Mr. Gunerman:
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 Requlation (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.
1
Page 2 - Mr. Thomas R. Gunerman
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,
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
2
Appendix I. Indication For Use
510(k) Number (if known): K983610
Device Name: 1644 Clear-Guard Midi 1644-T Clear-Guard Midi with Flextube 1831 Clear-Therm Mini 1831-T Clear-Therm Mini with Flextube
Indications For Use:
1644 & 1644-T: For use at the equipment connection. Designed to reduce bacterial transmission to and from patient, equipment and environment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1831 & 1831-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions: Do not use this product in conjunction with other humidification sources. 1644, 1644-T, 1831, 1831-T: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier; Do not use this product between the patient and a source of nebulized drugs; When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure; Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH. Office of Device Evaluation (ODE)
Ath. A. Giarlow, L.
5100k) Numb
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)