(92 days)
No
The device description and intended use focus on physical filtration mechanisms and do not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a filter intended to reduce cross-contamination of equipment from bacteria and viruses in exhaled gas, not to treat a patient's disease or condition.
No.
The device is a filter designed to reduce bacterial and viral cross-contamination in ventilatory and anesthesia equipment. It does not identify or diagnose any medical condition.
No
The device description explicitly states it is a physical filter made of molded plastic housings and filter media, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas." This describes a barrier or filtering function for respiratory gases, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description focuses on the physical components and function of the filter (molded plastic housings, filter media, reticulated foam for HME). It describes a mechanical barrier and heat/moisture exchange, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
The device is a respiratory filter intended to prevent the spread of pathogens during ventilation and anesthesia.
N/A
Intended Use / Indications for Use
Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
Product codes
CAH
Device Description
The BFE/VFE filters, manufactured by Hsiner, ITD are disposable, single-use barrier type, bi-directional devices supplied to the customer packaged and non-sterile. These filter devices are fabricated with a filtering medium that is highly effective at reducing the numbers of both bacterial and viral contaminates present in a patient's exhaled gas. The devices are designed to minimize the resistance to air flow. They consist of two molded plastic housings enclosing a disk of filter media. The Hsiner filtered HME device also includes a reticulated foam that captures heat and moisture from the patient's breath.
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
all patient populations
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
t Hudson RCI Bacterial/Vial Filter (961914), Gibeck Humid Vent filter Compact (K964382)
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
Hsiner Company Filter and Filtered HME Traditional 510(k) Submission
K 091185
1. 510(k) Summary
In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.
1.1. Submitter Information
Hsiner Company, LTD No.312, Jhongshan Rd., Shengang Township, Taichung County 429 Taiwan, ROC
Phone: +86-4-25152480
Registration No .: 3003862188 Owner/Operator No .: 9053474
1.2. Name of Device
Device Name: Filter, Bacterial, Breathing-Circuit Product Code: CAH Regulation #: 868.5260 Device Class: 2
FDA CDRH DMC
JUL 2 4 2009
APR 2 3 2009
Received
1.3. Substantially equivalent to:
- t Hudson RCI Bacterial/Vial Filter (961914)
---Gibeck Humid Vent filter Compact (K964382)
1.4. Description of the device
The BFE/VFE filters, manufactured by Hsiner, ITD are disposable, single-use barrier type, bi-directional devices supplied to the customer packaged and non-sterile. These filter devices are fabricated with a filtering medium that is highly effective at reducing the numbers of both bacterial and viral contaminates present in a patient's exhaled gas. The devices are designed to minimize the resistance to air flow. They consist of two molded plastic housings enclosing a disk of filter media. The Hsiner filtered HME device also includes a reticulated foam that captures heat and moisture from the patient's breath.
Intended Use of the Device 1.5.
Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
Comparison to Predicate Devices 1.6.
The Hsiner Reusable Filters are equivalent in design and performance to the Hudson RCI Bacterial/Viral Filter and the Gibeck Humid Vent Filter Compact.
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Image /page/1/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem resembling an eagle or bird in flight, with three curved lines representing its wings. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hsiner Company, Limited C/O Mr. Tom Shanks Principal MDVentures 29201 Via Norte Temecula, California 92591
Re: K091185
Trade/Device Name: Hsiner 70530, 70536 Filters and 70531 Filtered HME Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: . II Product Code: CAH Dated: July 13, 2009 Received: July 21, 2009
JUL 2 4 2009
Dear Mr. Shanks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Shanks
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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Kwame Ulmer, M.S. Acting Associate Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (K091185):
Device Name: Hsiner 70530, 70536 Filters and 70531 Filtered HME
Indications for Use:
Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from acrosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schutter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________