(77 days)
Not Found
Not Found
No
The device description focuses on the mechanical components and function of a wound drain system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended to drain excessive body fluid away from a wound site, which is a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" states the device is for "drainage excessive body fluid away from the wound site." This describes a therapeutic, rather than a diagnostic, function. The device description further details components that facilitate fluid removal, such as drains and trocars, without mentioning any diagnostic capabilities.
No
The device description explicitly details physical components such as silicone drains, trocars made of stainless steel, and various sizes and configurations, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "drainage excessive body fluid away from the wound site in the Surgery or after Surgery." This is a direct therapeutic intervention on the body, not a test performed on samples taken from the body to provide information about a patient's health status.
- Device Description: The description details a physical device (drains and trocars) used for surgical drainage. It does not describe reagents, instruments, or systems intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, providing diagnostic information, or any of the typical components or functions associated with IVD devices.
Therefore, this device falls under the category of a surgical drainage device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Typical applications include: To drainage excessive body fluid away from the wound site in the Surgery or after Surgery
Product codes
Not Found
Device 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.
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
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Davol, Johnson & Johnson and Baxter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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
1
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.
2
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
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