BACT-TRAP HEPA MIDI

K093426 · Pharma Systems AB · CAH · Feb 22, 2010 · Anesthesiology

Device Facts

• Record ID: K093426
• Device Name: BACT-TRAP HEPA MIDI
• Applicant: Pharma Systems AB
• Product Code: CAH · Anesthesiology
• Decision Date: Feb 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml. May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.

Device Story

Bact-Trap™ HEPA Midi is a disposable bacterial/viral filter for use in breathing circuits. Device utilizes electrostatic media to capture particulates from inspired/expired gases. Features standard 15/22 mm connectors and a gas sampling luer port. Used in hospitals, home care, sub-acute institutions, and emergency services; operated by clinicians or trained personnel. Positioned at machine or patient end of circuit. Provides high-efficiency filtration (BFE/VFE 99.9999%) to protect patients and equipment from cross-contamination. Single-patient use design.

Clinical Evidence

Bench testing only. Performance validated via BFE/VFE testing (Nelson Labs) showing 99.9999% efficiency. HEPA filtration tested per DOE 3020-97 and ASTM D2986-95a. Resistance to flow measured at < 3.1 cm H2O at 60 lpm. No clinical data provided.

Technological Characteristics

Polystyrene housing; electrostatic filter media. Standard 15/22 mm conical connectors (ISO 5356-1); luer fittings (ISO 594-2). Dead space: 46-48 ml. Weight: 32 gm. Passive filtration mechanism. No electronic components or software.

Indications for Use

Indicated for patients with Tidal Volumes > 150 ml requiring filtration of inspired and/or expired gases during use with ventilators, anesthesia machines, or open flow systems.

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

• ARC Medical - FilterFlo™ HEPA (K063125)
• Air Safety - Model 6500/01 (K033008)

Submission Summary (Full Text)

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K093426

FEB 2 2 2010

510(k) Summary Page 1 of 2 11-Feb-10

| Pharma Systems AB | Tel - 011 46 18 34 95 00 | |
|----------------------------|---------------------------------------------------------------------------------|--|
| Rubanksgatan 9 | Fax - 011 46 18 34 95 30 | |
| S741 71 Knivsta Sweden | | |
| Official Contact: | Viljar Salumaa, Product Manager | |
| Proprietary or Trade Name: | Bact-Trap™ HEPA Midi | |
| Common/Usual Name: | Bacterial / Viral Filter | |
| Classification Name: | Filter, Bacterial, Breathing Circuit,<br>CAH - 21 CFR 868.5260 | |
| Predicate Devices: | ARC Medical - FilterFlo™ HEPA – K063125<br>Air Safety - Model 6500/01 - K033008 | |

### Device Description

The Bact-Trap™ HEPA Midi filter incorporates standard 15 / 22 mm connectors with a gas sampling luer port. It utilizes an electrostatic media for the filtration function. The "HEPA" performance was tested in accordance to DOE 3020-97 and ASTM D2986 - 95a DOP at 30 Ipm.

The filter functions by electrostatic capture.

#### Indications for Use

For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is intended for patients with Tidal Volumes > 150 ml.

May be positioned at the machine end of the expiratory limb of the circuit, or at the patient end of the circuit.

## Environment of Use

Home, Hospital, Sub-acute Institutions, Emergency services

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# 510(k) Summary Page 2 of 2 11-Feb-10

# General Technical Characteristics

| Attribute | Proposed devices |
|---------------------------------------------------------------------|-----------------------------------------------|
| Indications for use - To filter inspired and / or<br>expired gases. | Yes |
| Intended for single patient use | Yes |
| Prescription | Yes |
| Intended population | > 150 ml tidal volume |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 46 ml for straight, 48 ml for angled |
| Resistance to flow | < 3.1 cm H2O @ 60 lpm |
| Bacterial filtration - BFE - Nelson Lab. | 99.9999% |
| Viral filtration - VFE - Nelson Lab. | 99.9999% |
| HEPA Filtration | >99.97% |
| Weight (gm) | 32 gm |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Electrostatic |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| DOE 3020-97 and ASTM D2986 - 95a DOP | Yes |

# Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol on the right side, which is composed of three curved lines. To the left of the caduceus is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

FEB 2 2 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Pharma Systems AB C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K093426

Trade/Device Name: Bact-Trap™ HEPA Midi Regulation Number: 21CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Regulatory Class: II Product Code: CAH Dated: February 11, 2010 Received: February 16, 2010

Dear Mr. Dryden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your 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. Dryden

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 (QS) 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Critthon V. Nim

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use Statement

Page 1 of 1

510(k) Number: K093426 (To be assigned)

Device Name: Bact-Trap™ HEPA Midi

Indications for Use:

For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml.

May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.

| Prescription Use <span style="text-decoration: underline;">XX</span> | or | Over-the-counter use <span style="text-decoration: underline;">_</span> |
|----------------------------------------------------------------------|----|-------------------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arbuthno

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

11093426 510(k) Number: