Who is the manufacturer of ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

Sil-Med Corp. filed the 510(k) submission for ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (K961194).

What is the FDA product code for ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

GBW. It is classified under 21 CFR 878.4200 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN

Q: What are the predicate devices for ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

Mediastinal Silicone Drain (K942709); Antimicrobial Multi-Luman Venous Catheter (K900263).

K961194 · Sil-Med Corp. · GBW · Aug 8, 1996 · General, Plastic Surgery

Device Facts

Record ID	K961194
Device Name	ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
Applicant	Sil-Med Corp.
Product Code	GBW · General, Plastic Surgery
Decision Date	Aug 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus

Device Story

Silicone perforated tubing with flattened profile; blue radiopaque stripe; surface treated with Spi-Argent II antimicrobial coating. Used for mediastinal drainage post-chest surgery/trauma; connects to suction apparatus. Clinician-operated in surgical/clinical settings. Antimicrobial treatment reduces microbial colonization on catheter surface. Benefits include potential reduction in infection risk associated with drainage catheters.

Clinical Evidence

Bench testing only. Efficacy of Spi-Argent II antimicrobial surface treatment demonstrated via challenge testing against Pseudomonas aeruginosa, Staphylococcus epidermidis, Serratia marcescens, and Escherichia coli.

Technological Characteristics

Silicone perforated tubing; flattened profile; blue radiopaque stripe; Spi-Argent II silver-based antimicrobial surface treatment. Dimensions include drain size imprinting. External end features cutaway adapter.

Indications for Use

Indicated for patients requiring drainage of blood and fluid from the mediastinum following chest surgery or trauma.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

Mediastinal Silicone Drain (K942709)
Antimicrobial Multi-Luman Venous Catheter (K900263)

Related Devices

K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR · Sil-Med Corp. · Jun 26, 1996
K063245 — ELUTIA COATED CLOSED SURGICAL WOUND DRAIN · Bacterin International, Inc. · Nov 28, 2007
K960099 — PENROSE DRAIN MODELS 6001 - 6007 · Sil-Med Corp. · Mar 11, 1996
K993592 — AXIOM MULTIPURPOSE WOUND DRAIN · Axiom Medical, Inc. · May 17, 2000
K210509 — Rocket Platinum Cured Cathter · Rocket Medical Plc · Sep 9, 2021

Submission Summary (Full Text)

{0} K961194 AUG - 8 1996 # 510 (k) Summary | Company: | Sil-Med Corporation 700 Warner Boulevard Taunton, MA 02780 | | --- | --- | | Telephone: | (508) 823-7701 | | Fax: | (508) 823-1438 | | Contact Person: | Karen K. Sylvia QA/QC Manager | | Trade Name: | *Antimicrobial* Mediastinal Silicone Drain | | --- | --- | | Common Name: | Silicone Drainage Catheter | | Classification Name: | 79 GBW Introduction/drainage catheter and accessories. (878.4200) | | Description: | Silicone perforated tubing, flattened profile, blue radiopaque stripe; surface treated to reduce friction and Antimicrobial; perforations ("eyes") on both flattened surfaces of tubing; external end has cutaway adapter; imprinted with drain size | | --- | --- | | Predicate Device: | Mediastinal Silicone Drain: K942709 Antimicrobial Multi-Luman Venous Catheter: K900263 | | --- | --- | | Intended Use: | Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus | | --- | --- | The surface of a silicone device, surface treated with Spi-Argent™ II was challenged with the following organisms and proved effective: | *Pseudomonas aeruginosa* *Staphylococcus epidermidis* | *Serratia marcescens* *Escherichia coli* | | --- | --- | Sil-Med Corporation’s Antimicrobial Mediastinal Silicone Drain is the same drain as the Mediastinal Silicone Drain, K942709. Sil-Med Corporation is adding “Antimicrobial” to the product labeling only. The silver coating in the Arrow International, Inc. 510(k) Number, K900263 for their Antimicrobial Multi-Luman Central Venous Catheter, is approved for the use of Antimicrobial in their labeling. Sil-Med Corporation 510(k) Submission: Antimicrobial Mediastinal Silicone Drain 25 March 1996