(77 days)
To drainage excessive body fluid away from the wound site in the Surgery or after Surgery
This Axiom Closed Wound Drain with Trocar is simplicity of design assures effective operation with added convenience. The sterile single-patient-use component includes the following: Radiopaque silicone flat drain with multiple perforations. These perforations are located at the end of the drain. Unique interlocking supports run the full length of the flat drain to maintain ample lumen and ensure unhindered flow. Various sizes starting from 4 mm up to 13 mm for flat drain with Trocars will be offered. Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. An evenly spaced perforations are created to enhance drainage from several directions, these perforations are positioned in alternate 90 degree planes. Various sizes starting from 7 French up to 19 French gauge with Trocars will be offered. Trocar are manufactured from stainless steel. The one end of the trocar is razor sharp to able to make a stab wound with less trauma and the opposite end has barb type fitting or beads blasted surface on small size trocars for silicone wound drain attachment. Trocars will be offered in different length and various matching diameters to silicone wound drain.
The provided text is a 510(k) summary for a medical device (Axiom Closed Wound Drain With Trocar) and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. The document focuses on product description, intended use, and substantial equivalence to legally marketed predicate devices.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and a study that proves the device meets those criteria based solely on the provided text.
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AXIOM MEDICAL, INC.
555 West Victoria Rancho Dominguez, California 90220 Telephone 310-898-1779 • Facsimile 310-632-1326
MAR 1 0 1997
In compliance with the requirements of section 510(k) of the Food, Drug, and Cosmetic Act as amended, and 21 CFR Section 807.92(a)(1), This "510(k) Summary" is on a product we intends to market in 90 days.
- Company name : Axiom Medical Inc.
- Address : 555 W. Victoria Street Rancho Dominguez, Ca. 90220
- (310) 898 1779 Phone number :
- Fax number : (310) 632 - 1326
- Contact person : Ridwan Hardy
Date of Submission: 12/20/1996
Carrely Company
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DEVICE NAMES 1.0
- Trade Name: Axiom Closed Wound Drain With Trocar 1.1
- Common Name: Closed Wound Vacuum Drainage Apparatus 1.2
- 1.3 Classification Name: Suction and Drainage Apparatus and Accessories, single patient use, Nonpowered (per 21 CFR section 878.4680)
2.0 PRODUCT DESCRIPTION
This Axiom Closed Wound Drain with Trocar is simplicity of design assures effective operation with added convenience. The sterile single-patient-use component includes the following:
- 2.1 Radiopaque silicone flat drain with multiple perforations. These perforations are located at the end of the drain. Unique interlocking supports run the full length of the flat drain to maintain ample lumen and ensure unhindered flow. Various sizes starting from 4 mm up to 13 mm for flat drain with Trocars will be offered.
- 2.2 Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. An evenly spaced perforations are created to enhance drainage from several directions, these perforations are positioned in alternate 90 degree planes. Various sizes starting from 7 French up to 19 French gauge with Trocars will be offered.
- 2.3 Trocar are manufactured from stainless steel. The one end of the trocar is razor sharp to able to make a stab wound with less trauma and the opposite end has barb type fitting or beads blasted surface on small size trocars for silicone wound drain attachment. Trocars will be offered in different length and various matching diameters to silicone wound drain.
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3.0 SUBSTANTIAL EQUIVALENCE COMPARISON
This device is substantially equivalent in design, indications for use and sterility to silicone flat and round wound drain system marketed by Davol, Johnson & Johnson and Baxter. These companies offer silicone wound drains system with or without trocars.
INTENDED USE OF THE DEVICE বিত
Typical applications include:
- To drainage excessive body fluid away from the wound site in the Surgery or after Surgery
: 中国 中国
§ 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.