(351 days)
Dryden Mini Bacteria Filter
Not Found
No
The device description and intended use focus on mechanical filtration and do not mention any computational or learning capabilities.
No
The device is described as a bacterial filter for breathing circuits, intended to remove microbiological and particulate matter from gases, not to treat or cure a disease or condition.
No
The device is described as a breathing circuit bacterial filter intended to remove microbiological and particulate matter from gases, which is a therapeutic function, not a diagnostic one. While it incorporates a luer port for "connection of carbon dioxide or pressure monitoring equipment," the device itself is a filter, not the monitoring equipment used for diagnosis.
No
The device is described as a physical breathing circuit bacterial filter, which is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove microbiological and particulate matter from the gases in the breathing circuit." This describes a function performed on gases within a breathing circuit, not on biological specimens taken from the body.
- Device Description: The description focuses on the physical design and function of a filter for a breathing circuit. It mentions filtration efficiency for bacteria and viruses in the gases.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis or treatment based on the analysis of such samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates in vivo (within the breathing circuit connected to a patient) to filter gases.
N/A
Intended Use / Indications for Use
Intended to remove microbiological and particulate matter from the gases in the breathing circuit.
Product codes
73 CAH
Device Description
The Iso-Gard Filter Angled/Iso-Gard Filter Straight are similar in design and function to the Dryden Mini Bacteria Filter with reduced size, dead space and lighter weight. The Iso-Gard Filter Angled/Iso-Gard Filter Straight incorporates a luer port in the housing to allow for connection of carbon dioxide or pressure monitoring equipment. The Iso-Gard Filter Angled also incorporates an angled housing to allow for the option of omitting the connection of angled patient connectors. The bacterial/viral filtration efficiency of the filter medium is 99+% for both the Iso-Gard Filter Angled/Iso-Gard Filter Straight and the Dryden Mini Bacteria Filter.
The principal difference between the Iso-Gard Filter Angled/Iso-Gard Filter Straight and the Dryden Mini Bacteria Filter is the size of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Dryden Mini Bacteria Filter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K96505016
# Gibeck
510(k) Summary of Safety and Effectiveness Subject:
Gibeck Iso-Gard™ Filter Angled/ Iso-Product: Gard™ Filter Straight
DEC - 2 1997
Summary:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Iso-Gard Filter Angled/Iso-Gard Filter Straight are breathing circuit bacterial filters intended to remove microbiological and particulate matter from the gases in the breathing circuit as described in 21 CFR 868.5260. This product is substantially equivalent to the Dryden Mini Bacteria Filter.
The Iso-Gard Filter Angled/Iso-Gard Filter Straight are similar in design and function to the Dryden Mini Bacteria Filter with reduced size, dead space and lighter weight. The Iso-Gard Filter Angled/Iso-Gard Filter Straight incorporates a luer port in the housing to allow for connection of carbon dioxide or pressure monitoring equipment. The Iso-Gard Filter Angled also incorporates an angled housing to allow for the option of omitting the connection of angled patient connectors. The bacterial/viral filtration efficiency of the filter medium is 99+% for both the Iso-Gard Filter Angled/Iso-Gard Filter Straight and the Dryden Mini Bacteria Filter.
The principal difference between the Iso-Gard Filter Angled/Iso-Gard Filter Straight and the Dryden Mini Bacteria Filter is the size of the device. This change is not considered to be critical to the intended therapeutic, diagnostic, prosthetic or surgical use of the device nor should this change significantly affect the safety or effectiveness of the device when used as labeled.
Submitter/Contact Person
Submitter/Contact Person
12/10/96
Date
Gibeck, Inc. 10640 East 59th Street · P.O. Box 36430 · Indianapolis, IN 46236 Telephone: (317) 823-6866 · Telefax: (317) 823-1662 A Member of the Gibeck Group
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Rockville MD 20857
DEC - 2 1997
Ms. Chyrell Saunders Gibeck, Inc. P.O. Box 36430 Indianapolis, Indiana 46236
Kaesote Re: Íso-Gard Filter Angled/Iso-Gard Filter Straight Regulatory Class: II (two) Product Code: 73 CAH August 22, 1997 Dated: Received: September 4, 1997
Dear Ms. Saunders:
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 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 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.
2
Page 2 - Ms. Chyrell Saunders
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.qov/cdrh/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
3
Indications For Use
Page_1__ of_1
501(k) Number (if known): K965016
Device name: Iso-Gard Filter Angled/Iso-Gard Filter Straight
Indications For Use: Intended to remove microbiological and particulate matter from the gases in the breathing circuit.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wolf Stephen
(Division Sign-Of Division of Cardiovascular, Respiratory, and Neurological Devices 2965016 510(k) Number _
Prescription Use
OR
Over-The-Counter Use - -
(Optional Format 1-2-96)