← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K964211 # DAVOL PLUME FILTER (5541420) (K964211) _Davol Inc., Sub. C. R. Bard, Inc. · GEX · Dec 2, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964211 ## Device Facts - **Applicant:** Davol Inc., Sub. C. R. Bard, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Dec 2, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: 401-463-7000 Fax: 401-463-3845 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: ![img-0.jpeg](img-0.jpeg) Page 22 BAIRD --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964211](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964211) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com