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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Hsiner Filters and Filtered HME, which are disposable bacterial/viral filters for breathing circuits. The document focuses on establishing substantial equivalence to predicate devices. It does not contain sections detailing acceptance criteria, study methodologies, or performance data in the format of a clinical study report.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in the provided text. The document is a regulatory submission summary and focuses on the declaration of substantial equivalence to existing devices rather than a detailed presentation of performance data from a specific study against acceptance criteria.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance. The document mentions the devices are "equivalent in design and performance" to predicate devices, implying performance testing was done, but does not provide details of such tests beyond stating BFE/VFE filters are "highly effective."
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Information on standalone algorithm performance (as this is a physical device, not an AI algorithm).
The type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

The document is a declaration of intent to market and a statement of substantial equivalence based on the device's design and intended use being similar to existing cleared devices. It does not describe a study in the way outlined in your request.

Summary

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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

Intended Use of the Device 1.5.

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.

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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.

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

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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: _______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).