(194 days)
None
No
The summary describes a mechanical device for temporary vessel occlusion and does not mention any AI or ML components or functionalities.
Yes
The device is used to temporary occlude vessels to selectively stop or control blood flow, which is a therapeutic intervention during endovascular procedures.
No
Explanation: The device is described as an intravascular occluding catheter used for temporary occlusion of vessels to stop or control blood flow, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical catheter with a balloon, constructed of stainless steel and a composite material. It is a hardware device.
Based on the provided information, the ArteriA Occlusion Balloon is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "intravascular occluding catheter" used for "temporary occlusion of vessels" during "endovascular procedures." This describes a device used within the body for a therapeutic or procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical catheter with a balloon, designed for insertion into blood vessels. This aligns with an in-vivo device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on testing samples outside the body.
Therefore, the ArteriA Occlusion Balloon is a medical device used for a procedural intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ArteriA Occlusion Balloon Catheter is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. This technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
Product codes
MJN
Device Description
The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro-vasculature
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)
Biocompatibility of the ArteriA Occlusion Balloon was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the ArteriA Occlusion Balloon when tested as an external communicating, blood contact, short duration (
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
OCT 2 8 2002
Image /page/0/Picture/1 description: The image shows the logo for Arteria. The logo consists of a circular graphic to the left of the company name. The graphic is a circle with three dark sections and a Y-shaped pattern of small circles in the center. The company name "ArteriA" is written in a serif font to the right of the graphic, with a small "TM" symbol next to the "A".
510(k) Summary ArteriA Occlusion Balloon
K021210
Date Prepared: August 14, 2002
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Submitter
ArteriA Medical Science, Inc. The Presidio, Building 220, Suite 120 San Francisco, CA 94129
Company Contact
Alan Hinton, Quality Assurance
Device Name
| Trade Name: | ArteriA Occlusion Balloon |
|---|---|
| Common Name: | Balloon Occlusion Catheter |
Classification Name: Catheter, Intravascular Occluding Temporary
Predicate Devices
MicroTherapeutics, Inc., Equinox 104 Occlusion Balloon Catheter, K990487
MicroTherapeutics, Inc., HyperForm™ Occlusion Balloon Catheter, K011656
Description of Device
The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
1
Intended Use
The ArteriA Occlusion Balloon Catheter is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. This technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
Tests Submitted
Biocompatibility of the ArteriA Occlusion Balloon was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the ArteriA Occlusion Balloon when tested as an external communicating, blood contact, short duration (