(195 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a simple dilator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, a vessel dilator, is used to enlarge an opening in a vessel to facilitate the entry of a catheter. It does not treat or cure a disease or condition, but rather aids in a medical procedure.
No
Explanation: This device is used to dilate a vessel for catheter entry, which is a preparatory step for a procedure and not for diagnosing a condition.
No
The device description clearly states it consists of a plastic hub attached to a plastic cannula, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enlarge the opening in a vessel in preparation of percutaneous entry of a catheter." This is a surgical/interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical tool (dilator) used to manipulate a vessel. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
Therefore, this device falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Vessel Dilator is a device used over a quide wire to dilate the opening in a vessel in preparation of percutaneous entry of a catheter. The device may be used separately or in conjunction with a sheath introducer. The device consists of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist in dilation. The hub proximal end has a female luer lock configuration An optional hub collar may be used to attach the dilator to an introducer. The device is available in sizes 4F through 15F and is supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits,trays, or packs.
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
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)
Results of performance testing indicate that the Vessel Dilator has improved tensile strength characteristics compared to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
MAR I I 1997
510 (k) SUMMARY
ADMINISTRATIVE -
Maxxim Medical, Inc., Argon Division Submitter: 1445 Flat Creek Road Athens, TX 75751 (903) 675-9321
Contact Person: Eddie Monroe
Date of Preparation: August 26, 1996
DEVICE NAME 11.
Proprietary Name: None
Common Name: Vessel Dilator
Classification Name: Vessel Dilator for percutaneous catheterization
PREDICATE DEVICE III.
Vessel Dilator component of Introducer for PTCA Guiding Catheters; K891022; Argon Medical.
IV. DEVICE DESCRIPTION
The Vessel Dilator is a device used over a quide wire to dilate the opening in a vessel in preparation of percutaneous entry of a catheter. The device may be used separately or in conjunction with a sheath introducer. The device consists of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist in dilation. The hub proximal end has a female luer lock configuration An optional hub collar may be used to attach the dilator to an introducer. The device is available in sizes 4F through 15F and is supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits,trays, or packs.
of the device has been established by cytotoxicity, Biocompatibility intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompatibility tests. The device meets the requirements of the USP XXIII physicochemical tests for plastics.
V. INTENDED USE
To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.
1
VI. COMPARISON TO PREDICATE ()EVICE
The Vessel Dilator is identical in design, function and intended use, and similar in composition, to the Vessel Dilator component of the Introducer for PTCA Guiding Catheters (Argon Medical; K891022). Results of performance testing indicate that the Vessel Dilator has improved tensile strength characteristics compared to the predicate device
Accordingly, Maxxim Medical, Inc., Argon Division, concluded that the Vessel Dilator is safe and effective for intended use and performs at least as well as the legally marketed predicate device.