(96 days)
Not Found
No
The device description focuses on mechanical components and physical properties, with no mention of AI or ML algorithms for image analysis, decision support, or any other function. The performance studies are also focused on physical characteristics and mechanical performance.
No
The device is used to assist in the modeling of self-expanding endoprostheses, not to treat a disease or condition itself.
No
The device is intended to assist in the modeling and apposition of self-expanding endoprostheses in vessels, which is a therapeutic rather than diagnostic function.
No
The device description clearly details physical components like a silicone surface coated catheter, expandable Nitinol mesh, retractable sheath, radiopaque markers, inner lumen, side ports, and handles. The performance studies also focus on physical characteristics and interactions, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The UnBalloon Non-Occlusive Modeling Catheter is a medical device used within the body (in vivo) to physically assist in the modeling of self-expanding endoprostheses (stents) in large blood vessels. It is a tool for a medical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "assisting in the modeling of self-expanding endoprostheses in large diameter vessels," which is an in-vivo application.
- Device Description: The description details its physical components and how it functions within the circulatory system.
- Performance Studies: The performance studies listed are related to the physical properties and function of the device within a biological system (e.g., apposition length, radial outward force, fatigue, animal testing).
Therefore, based on the provided information, the UnBalloon Non-Occlusive Modeling Catheter is a therapeutic/interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of selfexpanding endoprostheses in large diameter vessels.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling Catheter with an expandable Nitinol mesh in a retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.
This submission modifies the current UnBalloon Non-Occlusive Modeline Catheter to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen). this device modification increases the outer diameter of the thoracic models from 14 Fr to 16 Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Large diameter vessels
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been completed to evaluate the performance of the Subject Device the UnBalloon Non-Occlusive Modeling Catheter:
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- Dimensional analysis
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- Apposition length
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- Radial outward force
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- Freedom from leakage
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- Fatigue and simulated use
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- Force at break (i.e., bond strength)
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- Interaction with stent graft materials (light microscope and SEM study)
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- Animal testing (ovine study)
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K 133026 DEC 3 1 2013
510 (k) Summary
Submitter's information:
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA USA 01803 | |
| Phone: | 781-425-1727 |
| Contact Person: | Bryan Cowell, MSc., RAC |
| Date of preparation: | September 24, 2013 |
| Device Name: | UnBalloon Non-Occlusion Modeling Catheter |
| Trade Name: | UnBalloon Non-Occlusion Modeling Catheter |
| Common/ Classification Name: | Catheter, Percutaneous |
| Classification Panel: | 21CFR §870.1250 |
| Class: | II (2) |
| Product Code: | DQY |
Establishment Registration: 1220948
Establishment: LeMaitre Vascular. Inc., 63 Second Avenue, Burlington, MA USA 01803
Owner/Operator: 1220948
Proposed Device Description:
The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling Catheter with an expandable Nitinol mesh in a retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.
This submission modifies the current UnBalloon Non-Occlusive Modeline Catheter to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen). this device modification increases the outer diameter of the thoracic models from 14 Fr to 16 Fr.
1
Intended Use:
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of selfexpanding endoprostheses in large diameter vessels.
Predicate Device:
| 510(k): | K123531 |
|---|---|
| Device Name: | UnBalloon Non-Occlusion Modeling Catheter |
| SE Date: | 12/14/2012 |
| Regulation Number: | 21CFR §870.1250 |
| Device Class Name: | Catheter, Percutaneous |
| Device Class: | 2 |
| 510(k): | K121839 |
|---|---|
| Device Name: | UnBalloon Non-Occlusive Modeling Catheter |
| SE Date: | 08/08/2012 |
| Regulation Number: | 21CFR §870.1250 |
| Device Class Name: | Catheter, Percutaneous |
| Device Class: | 2 |
| 510(k): | K110891 |
|---|---|
| Device Name: | UnBalloon Non-Occlusive Modeling Catheter |
| SE Date: | 09/13/2011 |
| Regulation Number: | 21CFR §870.1250 |
| Device Class Name: | Catheter, Percutaneous |
| Device Class: | 2 |
Substantial Equivalence:
The modified UnBalloon is substantially equivalent to the predicate UnBalloon catheter based on the same intended use and fundamental scientific technological characteristics.
Functional/ Safety testing:
The verification activities conducted on the subject device that the modified UnBalloon Non-Occlusion Modeling Catheter meets the product performance requirements of the device specifications and the modifications presented do not raise additional safety issues.
Sterilization:
The device is validated for ethylene oxide (EO) sterilization according to ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization". The Sterilization process remains unchanged.
2
Biocompatibility:
All blood contact portions of the device were subjected to Biocompatibility testing according to ISO 10993 guidelines for an externally communicating device with limited contact duration (