(247 days)
Not Found
No
The device description focuses on mechanical safety features and fluid delivery/drainage, with no mention of AI or ML capabilities. The performance studies are related to chemical, biological, and physical properties, not algorithmic performance.
No
Explanation: This device is used for administering fluids or sampling blood, and its primary function is delivery/drainage and safety, not treating a disease or condition.
No
The device is described as being used for administering or draining fluids intravenously and is engineered for safety to prevent needle stick injuries. There is no mention of it being used to diagnose a medical condition or to provide information about the presence or absence of a disease.
No
The device description clearly details physical components like a needle, hub, chamber, retraction mechanism, coiled spring, and lever/switch, indicating it is a hardware device.
Based on the provided information, the MedSource IV Safety Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "sample blood or administer fluids intravenously." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the physical mechanism for inserting a catheter into a patient and protecting healthcare workers from needle sticks. It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood or other body fluids, detecting specific substances, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The MedSource IV Safety Catheter is a device used for a therapeutic or sampling procedure directly on the patient.
N/A
Intended Use / Indications for Use
The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Product codes
FOZ
Device Description
The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.
The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.
The device is available in six gauges identified also by specific colors.
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
any patient population
Intended User / Care Setting
healthcare workers / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The submission includes a table comparing the MedSource IV Safety Catheter to the predicate device (Becton Dickinson Angiocath Autogaurd K984059) across several performance characteristics:
- Chemical Tests: Volatile Residue (
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
KISISSE
JAN 3 1 2014
510(K) Summary
Section 5
Medsource International, LLC Submitter: 5346 Shoreline Drive Mound, MN 55364
Contact Person: Jennifer Ness, Quality and Regulatory Affairs Manager 5346 Shoreline Drive Mound, MN 55364 Phone: 952-241-8318
Date Prepared: Wednesday, November 06, 2013
General Information:
Common Name: Catheter, intravascular, therapeutic, short-term Regulatory Reference: 21 CFR §880.5200 Product Code: FOZ Classification: Class II Panel: General Hospital Proprietary Name: MedSource IV Safety Catheter Single Use: Yes Sterile: Yes
Indication for Use:
The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Description of the Device:
The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.
The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This
1
mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.
| Model | Description | Gage | Color |
|---|---|---|---|
| MS-84014 | IV SAFETY CATHETER: 14 GA X 1.75"(50/BX) | 14 | Orange |
| MS-84016 | IV SAFETY CATHETER: 16 GA X 1.16"(50/BX) | 16 | Gray |
| MS-84018 | IV SAFETY CATHETER: 18 GA X 1.16"(50/BX) | 18 | Green |
| MS-84020 | IV SAFETY CATHETER: 20 GA X 1.16" (50/BX) | 20 | Pink |
| MS-84022 | IV SAFETY CATHETER: 22 GA X 1"(50/BX) | 22 | Blue |
| MS-84024 | IV SAFETY CATHETER: 24 GA X .75" (50/BX) | 24 | Yellow |
The device is available in six gauges identified also by specific colors.
Description of the Device Design:
The MedSource IV Safety Catheter is substantially equivalent to the Becton Dickinson Angiocath Autogaurd (K984059)
| Comparison Point | Predicate Devices | Result of Comparison |
|---|---|---|
| Intended Use | Becton Dickinson Angiocath | |
| Autogaud (K984059) | Substantially equivalent | |
| Technological | ||
| Characteristics | ||
| (Materials of | ||
| Construction, | ||
| Dimensions, | ||
| Performance in) | Becton Dickinson Angiocath | |
| Autogaud (K984059) | Materials of construction-same | |
| or similar | ||
| Performance-minor variations | ||
| Dimensions-minor variations | ||
| Instructions for Use | Becton Dickinson Angiocath | |
| Autogaud (K984059) | Very similar |
Summary of Performance Testing Characteristics:
| Submission Device ↓ | Predicate Device ↓ | |
|---|---|---|
| Comparison Point | MedSource IV Safety Catheter | Becton Dickinson Angiocath |
| Autogaurd (K984059) | ||
| Chemical Tests | ||
| Volatile Residue |