(41 days)
To be connected to suction / vacuum assemblies to filter smoke particulates / aerosols, and retain aqueous fluids generated during laparoscopic electrosurgery or laser surgery.
Hydrophobic multilayered filter with vacuum tubing for attachment to wall vacuum or suction source.
This document is a 510(k) summary for the Davol Plume Filter and focuses on demonstrating substantial equivalence to a predicate device, the Contain™ Hydrophobic Safety Filter, rather than establishing specific acceptance criteria for a new device's performance through a dedicated study.
Therefore, the provided text does not contain the information needed to answer many of your questions, as it describes a different type of regulatory submission. There is no independent study described here that measures device performance against acceptance criteria in the way you've outlined.
However, I can extract the relevant information where available:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on establishing "substantial equivalence" to a predicate device, not on setting new performance acceptance criteria for a novel device. The key performance claim made is:
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Claimed for both devices) |
|---|---|
| Filter 99.99% of all particles/aerosols 0.12 microns and greater | Will retain 99.99% of all particles/aerosols 0.12 microns and greater |
| Retain all aqueous fluids up to normal vacuum pressures | Retain all aqueous fluids up to normal vacuum pressures |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on the established performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. This type of expert assessment is not relevant for a 510(k) submission focused on substantial equivalence based on design and materials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This document describes a physical filter, not an AI-powered diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This document describes a physical filter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a "ground truth" establishment in the context of a new performance study. It relies on the established performance of the predicate device (Contain™ Hydrophobic Safety Filter), which presumably had its performance validated through testing by a similar claim.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
{0}------------------------------------------------
Davol Inc. Subsidiary of C. R. Bard, Inc 100 Sockanossett Crossroad O. Box 8500 ranston, RI 02920 01 463-7000
Image /page/0/Picture/2 description: The image shows a logo with the word "DAVOL" in the center of an oval shape. The oval is white, and the word "DAVOL" is written in black, sans-serif letters. The oval is surrounded by a thick, black border that is broken at the top and bottom.
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.
Image /page/0/Picture/19 description: The image shows the word "BARD" in a stylized, bold font. The letters are thick and blocky, with a unique design for the letter "A" that resembles a triangle. The overall appearance is clean and modern, with a focus on the geometric shapes of the letters.
{1}------------------------------------------------
Davol Inc Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad P.O. Box 8500 Cranston, RI 02920 401 463-7000
Image /page/1/Picture/1 description: The image shows a logo with the word "DAVOL" in a sans-serif font. The word is centered inside of a white oval. The white oval is surrounded by a thick black oval.
(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.
-
- 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: THE INFORMATION CONTAINED HEREIN IS CONFIDENTIAL, PROPRIETARY AND TRADE SECRET, AND IS THE EXCLUSIVE PROPERTY OF NOVARTIS PHARMACEUTICALS CORPORATION. THIS DOCUMENT CANNOT BE DISCLOSED, REPRODUCED OR USED IN ANY MANNER WITHOUT THE EXPRESS WRITTEN CONSENT OF NOVARTIS PHARMACEUTICALS CORPORATION. ©2016 NOVARTIS
Page 22
Image /page/1/Picture/13 description: The image shows the word "BARD" in a bold, stylized font. The letters are thick and have a slightly rounded appearance. The word is presented in a single line and is the main focus of the image.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.