DAVOL PLUME FILTER (5541420)

K964211 · Davol Inc., Sub. C. R. Bard, Inc. · GEX · Dec 2, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K964211
• Device Name: DAVOL PLUME FILTER (5541420)
• Applicant: Davol Inc., Sub. C. R. Bard, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

To be connected to suction / vacuum assemblies to filter smoke particulates / aerosols, and retain aqueous fluids generated during laparoscopic electrosurgery or laser surgery.

Device Story

Device is a hydrophobic multilayered filter with pre-attached vacuum tubing; connects to wall vacuum or suction source. Used during laparoscopic electrosurgery or laser surgery to capture smoke particulates, aerosols, and aqueous fluids. Operated by surgical staff in clinical settings. Retains 99.99% of particles/aerosols ≥0.12 microns. Protects suction systems from fluid ingress and filters surgical smoke.

Clinical Evidence

No clinical data; bench testing only. Device performance verified by filtration efficiency (99.99% of particles/aerosols ≥0.12 microns) and fluid retention capabilities under normal vacuum pressures.

Technological Characteristics

Hydrophobic multilayered filter; includes pre-attached suction/vacuum tubing. Designed for connection to standard wall vacuum or suction sources. Mechanical filtration mechanism.

Indications for Use

Indicated for use during laparoscopic electrosurgery or laser surgery to filter smoke particulates/aerosols and retain aqueous fluids.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Contain™ Hydrophobic safety filter

Submission Summary (Full Text)

{0}

Davol Inc.
Subsidiary of C. R. Bard, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston, RI 02920
401 463-7000

K964211

DAVID

DEC - 2 1996

# Section VI. 510(k) Summary of Safety and Effectiveness (page 1 of 2)

## Submitter Information:

### Company Name:
Davol Inc
100 Sockanossett Crossroads
Cranston, RI 02920
Phone: [phone]
Fax: [phone]
Contact: Christine Nichols
Date of Preparation: 10/2/96

### Device name:
Trade Name: Davol® Plume Filter (hydrophobic)
Common name: Laparoscopic Plume Filter
Classification name: Laparoscope, General & Plastic Surgery; Gynecological (and accessories); Endoscopic tube, smoke removal

## Predicate Device Name:
Contain™ Hydrophobic safety filter

## Device description:
Hydrophobic multilayered filter with vacuum tubing for attachment to wall vacuum or suction source.

## Intended Use
To be connected to suction / vacuum assemblies to filter smoke particulates / aerosols, and retain aqueous fluids generated during laparoscopic electrosurgery or laser surgery.

## Technological Characteristics Summary:
The Davol® Plume Filter proposed in this submission is substantially equivalent to the currently marketed Contain™ Hydrophobic Safety Filter.
The 510(k) “Substantial equivalence decision making process (detailed) decision tree” was utilized to make a determination of substantial equivalence.

BARD

{1}

Davol Inc.
Subsidiary of C. R. Bard, Inc.
100 Sockanosett Crossroad
P.O. Box 8500
Cranston, RI 02920
401 463-7000

DAVOL

# (510(k) Summary of Safety and Effectiveness Continued) (page 2 of 2)

1. Does the new device have the same indication statement?

YES. Both the Davol Plume filter and the Contain filter are intended to be connected to wall suction or suction assemblies to filter smoke particulates / aerosols and retain aqueous fluids generated during surgical procedures. The filter will retain 99.99% of all particles / aerosols 0.12 microns and greater, and all aqueous fluids up to normal vacuum pressures.

2. Does the new device have the same technological characteristics, e.g. design, materials, etc?

YES. The Davol Plume filter is identical in design, function, and materials to the Contain filter currently manufactured and commercialized. A suction/vacuum tube will be provided pre-attached to the Davol Plume filter for user convenience in attaching to a suction/ vacuum source (users of the Contain filter presently have to supply the suction tube).

3. Are the Descriptive Characteristics precise enough to ensure equivalence?

YES. The Contain filter is identical to the Davol Plume filter proposed in this 510(k) submission. Therefore, the descriptive characteristics are enough to ensure equivalence.

## Conclusion:

Based upon the above information, the Davol Plume filter is substantially equivalent to the Contain Hydrophobic safety filter.

Typed Name: Christine E. Nichols
Title: Regulatory Affairs Associate
Signature: 

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BAIRD