(41 days)
Contain™ Hydrophobic safety filter
Not Found
No
The description focuses on the physical filtration properties of the device and does not mention any computational or learning capabilities.
No
The device is described as a filter for smoke particulates and aerosols generated during surgery. Its function is to retain these by-products and fluids, not to treat a medical condition or restore health.
No
Explanation: The device description indicates it is a filter for smoke particulates, aerosols, and fluids generated during surgery, and its key metric is filtering efficiency. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description clearly indicates a physical filter and tubing, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter smoke particulates and retain fluids generated during surgical procedures (laparoscopic electrosurgery or laser surgery). This is a surgical accessory used during a medical procedure on a patient.
- Device Description: The description of a filter with vacuum tubing aligns with a device used for managing surgical byproducts.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological specimens.
Therefore, this device falls under the category of a surgical device or accessory, not an IVD.
N/A
Intended Use / Indications for Use
To be connected to suction / vacuum assemblies to filter smoke particulates / aerosols, and retain aqueous fluids generated during laparoscopic electrosurgery or laser surgery.
Product codes
Not Found
Device Description
Hydrophobic multilayered filter with vacuum tubing for attachment to wall vacuum or suction source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Contain™ Hydrophobic safety filter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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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.