SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR

K961295 · Sil-Med Corp. · GBX · Jun 26, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961295
• Device Name: SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
• Applicant: Sil-Med Corp.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Jun 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system

Device Story

Silicone drainage catheter; flat perforated, ribbed section for fluid collection; round tubing connects to suction reservoir; optional introduction trocar; silver ion surface treatment (Spi-Argent II) to facilitate insertion/removal; blue radiopaque stripe for visualization. Used in clinical/post-operative settings by healthcare providers to manage wound exudate; closed system prevents contamination; aids healing by removing fluid accumulation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Silicone; silver ion surface treatment. Features: Flat perforated/ribbed drain section, blue radiopaque stripe, optional trocar. Connectivity: None. Energy: None (passive suction).

Indications for Use

Indicated for post-operative patients requiring drainage of serosanguineous fluids and blood from surgical sites using a closed wound drain system.

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)
• Sil-Slip Flat Suction Drain/Kit (with and without Trocar) (K926408)

Submission Summary (Full Text)

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K961295

JUN 26 1996

# 510 (k) Summary

| Company: | Sil-Med Corporation
700 Warner Boulevard
Taunton, MA 02780 |
| --- | --- |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Karen K. Sylvia
QA/QC Manager |

**Trade Name:** Flat Suction Drain/Kit with Spi-Argent™II (with and without Trocar)

**Common Name:** Silicone Drainage Catheter

**Classification Name:** 79 GBW Introduction/drainage catheter and accessories. (878.4200)

**Description:** Two joined silicone tubing sections; flat drain section is partially perforated for fluid collection, is ribbed to prevent collapse as suction is applied, and has blue radiopaque stripe; round tubing is connected to suction reservoir inlet; offered with an introduction Trocar attached as an option; silver ion surface treated to ease insertion and removal.

**Predicate Device:** Mediastinal Silicone Drain: K942709<br/>Sil-Slip Flat Suction Drain/Kit (with and without Trocar): K926408

**Intended Use:** For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system

Sil-Med Corporation’s Flat Suction Drain/Kit with Spi-Argent™II, (with and without Trocar) is the same drain as the Sil-Slip Flat Suction Drain/Kit (with and without Trocar), K926408. The surface treatment is the same as the surface treatment on Sil-Med Corporation’s Mediastinal Silicone Drain, K942709. No further claims will be made for the Flat Suction Drain/Kit with Spi-Argent™II than made on K942709.

Sil-Med Corporation<br/>510(k) Submission: Flat Suction Drain/Kit with Spi-Argent™II (with and without Trocar)

03 April 1996