(134 days)
Not Found
No
The description focuses on the physical characteristics, materials, and intended use of a drainage catheter, with no mention of AI or ML capabilities.
No.
This device is for drainage, which is a supportive rather than a therapeutic function (i.e., it doesn't directly treat a disease). Its primary function is to remove excess fluid/blood, which might aid in recovery but isn't a direct treatment itself. Also, the predicate device is a drain, not typically classified as therapeutic.
No
Explanation: The device is described as a "Catheter for drainage of blood and fluid" and "Silicone perforated tubing", which indicates it is used for therapeutic drainage, not for diagnosing a condition.
No
The device description clearly describes a physical, hardware-based medical device (silicone tubing, adapter, etc.) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus." This is a device used within the body for drainage, not for testing samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or testing procedures, which are hallmarks of IVD devices.
This device is a surgical drain, used for therapeutic purposes within the body.
N/A
Intended Use / Indications for Use
Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus
Product codes
79 GBW
Device 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mediastinum
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
The surface of a silicone device, surface treated with Spi-Argent™ II was challenged with the following organisms and proved effective: Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus epidermidis, Escherichia coli.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
8 1000 AUG
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 | Serratia marcescens |
|---|---|
| Staphylococcus epidermidis | 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