FILTER

K970102 · Promedic, Inc. · CAH · Jun 24, 1997 · Anesthesiology

Device Facts

• Record ID: K970102
• Device Name: FILTER
• Applicant: Promedic, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

To provide filtration of a patient’s exhaled air and it may reduce the potential of contamination when it is utilized in anesthesia breathing circuit, ventilator circuits, manual resuscitators and during transport.

Device Story

Breathing circuit filter; connects to patient connector, circuit tubing, and manual resuscitators. Translucent housing contains electrostatic, hydrophobic filter media. Used in hospital environments (OR, ICU, PACU) and during transport by clinicians. Device filters exhaled air to reduce cross-contamination between patient and equipment. Features standard 15/22 mm fittings; optional CO2 sampling port. Benefits patient by minimizing potential for contamination in breathing circuits.

Clinical Evidence

Bench testing only. Filtration efficiency (BFE and VFE) reported at 99%+ based on Nelson testing.

Technological Characteristics

Housing: Polyethylene, polystyrene. Filter media: Electrostatic, hydrophobic. Fittings: 15/22 mm per ASTM 1054. Form factor: Compact, low deadspace. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring anesthesia, ventilation, or manual resuscitation in hospital settings (OR, ICU, PACU) or during transport to provide filtration of exhaled air and reduce potential contamination.

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

• Dryden (Gibeck-Dryden) (K833066)
• Med-Plastics (K930760)
• Engstrom wye filter (K954194)

Submission Summary (Full Text)

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K970102
ProMedic, Inc.

# Non-Confidential Summary of Safety and Effectiveness

page 1 of 3
January 7, 1997
JUN 24 1997

ProMedic, Inc.
6329 W. Waterview Ct.
McCordsville, IN 46055

Tel - [phone]
Fax - [phone]

**Official Contact:** Paul E. Dryden, President
**Proprietary or Trade Name:** Filter
**Common/Usual Name:** Breathing circuit filter
**Classification Name:** Filter, bacterial, breathing circuit
**Device:** Filter
**Predicate Devices:**
Dryden (Gibeck-Dryden) - K833066
Med-Plastics - K930760
Engstrom - wye filter - K954194

## Device Description:

A filter with a translucent housing and filter media which connects to the patient connector and the circuit tubing and manual resuscitators.

## Intended Use:

**Indicated Use --**
To provide filtration of a patient’s exhaled air and it may reduce the potential of contamination when it is utilized in anesthesia breathing circuit, ventilator circuits, manual resuscitators and during transport.

**Environment of Use --**
Hospital, OR, anesthesia, ICU, PACU, manual resuscitators and during transport.
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6329 W. Waterview Court • McCordsville, IN 46055-9501
317-335-3780 • 317-335-9270 Fax

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Page 4 of 27
# Non-Confidential Summary of Safety and Effectiveness
(continued)

page 2 of 3
January 7, 1997

## Comparison to Predicate Devices:

## Use

| Intended provide filtration in
a breathing circuit | Yes | Yes | Yes |
| --- | --- | --- | --- |
| Used with anesthesia breathing circuit,
ventilator circuits, resuscitators | Yes | Yes | Yes |
| Environment of use - Hospital, OR,
anesthesia, PACU, ICU, transport | Yes | Yes | Yes |
| Indicated for single patient use | Yes | Yes | Yes |

## Design

| Placed in the breathing circuit | Yes | Yes | Yes |
| --- | --- | --- | --- |
| Standard 15 / 22 mm fitting | Yes | Yes | Yes |
| May have a port for sampling CO_{2} gases | Yes | Yes | Yes |
| Media hydrophobic | Yes | Yes | Yes |
| Has a translucent housing | Yes | Yes | Yes |
| Compact, low deadspace | Yes | Yes | Yes |

## Performance Standards / Specifications

| Filtration efficiency rating of BFE and VFE 99%+ | | | |
| --- | --- | --- | --- |
| | Yes | 99.9% | Yes |
| | (Nelson) | Sangtec | (Nelson) |
| Fittings - ASTM 1054 | Yes | Yes | Yes |

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Page 5 of 27

# Non-Confidential Summary of Safety and Effectiveness

(continued)

page 3 of 3

January 7, 1997

## Materials

| Housing - Polyethylene, polystyrene | Yes | Yes | Yes |
| --- | --- | --- | --- |
| Filter media - Electrostatic | Yes | Yes | Yes |
| Hydrophobic media | Yes | Yes | Yes |

## Differences between Other Legally Marketed Predicate Devices

There is no significant differences between the intended device and the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 24 1997

Mr. Paul E. Dryden
ProMedic, Inc.
6329 W. Waterview Court
McCordsville, Indiana 46055-9501

Re: K970102
ProMedic Wye Filter
Regulatory Class: II (two)
Product Code: 73 CAH
Dated: April 15, 1997
Received: April 21, 1997

Dear Mr. Dryden:

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.

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Page 2 - Mr. Paul E. Dryden

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page 1 of 1

# SECTION 3

## INDICATIONS FOR USE

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number: K970102 (To be assigned)

Device Name: Filter

Intended Use: To provide filtration for reducing possible contamination between patient and equipment.

Environment of use: Hospital - OR, anesthesia, transport, PACU, manual resuscitators, and ICU

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard N. Chilley
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970102

Prescription Use ☑ (Per CFR 801.109)
or
Over-the-counter use ☐

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