70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER

K091185 · Hsiner Co., Ltd. · CAH · Jul 24, 2009 · Anesthesiology

Device Facts

• Record ID: K091185
• Device Name: 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
• Applicant: Hsiner Co., Ltd.
• Product Code: CAH · Anesthesiology
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Disposable, single-use, bidirectional barrier filters; designed for use in ventilatory and anesthesia circuits. Device consists of molded plastic housing enclosing filter media; filtered HME variant includes reticulated foam for heat and moisture exchange. Operates by capturing aerosols and particulates from patient exhaled gas to prevent contamination of equipment valves and hoses. Used in clinical settings by healthcare providers; reduces infection risk from airborne pathogens. No electronic components or software.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable, single-use, bidirectional filter. Materials: molded plastic housing, filter media, reticulated foam (in HME model). Mechanical filtration principle. Non-sterile. No energy source, connectivity, or software.

Indications for Use

Indicated for all patient populations requiring filtration of respiratory gases to reduce bacterial and viral cross-contamination in ventilatory and anesthesia equipment.

Regulatory Classification

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.

Predicate Devices

• Hudson RCI Bacterial/Viral Filter (961914)
• Gibeck Humid Vent filter Compact (K964382)

Submission Summary (Full Text)

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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: [phone]

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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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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

1

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: _______________________________________________________________________________________________________________________________________________________________