(28 days)
Not Found
No
The description focuses on the mechanical design and function of the catheter, with no mention of AI or ML.
No
The device is described as a "modeling catheter" intended to "assist in the modeling of self-expanding endoprostheses," which suggests it is used to shape or position other therapeutic devices rather than directly provide therapy itself.
No
The device is described as a modeling catheter intended to assist in the physical modeling of self-expanding endoprostheses, not to provide information about a patient's health status or diagnose a condition.
No
The device description clearly details physical components such as a silicone-coated catheter, Nitinol mesh, sheath, handles, and lumens, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a catheter designed to be used inside the body (in vivo) to assist in the modeling of self-expanding endoprostheses in large diameter vessels. It's a surgical tool used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, based on the provided information, the UnBalloon Non-Occlusive Modeling Catheter is a surgical device used for a therapeutic procedure, not an IVD.
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
DQY
Device Description
The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F 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 Modeling Catheter by expanding the product family line with additional nitinol mesh cage sizes and catheter lengths.
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
vascular surgeons
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 following tests have been completed to evaluate the performance of the catheter with shorter cage: .
Radial outward force
Apposition
Length
Simulated Anatomical Use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510 (k) Summary
Submitter's information:
DEC 1 4 2012
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA USA 01803 | |
| Phone: | 781-425-1727 |
| Contact | Bryan Cowell, MSc., RAC |
| Person: |
| Date of preparation: | 14 Nov 2012 |
|---|---|
| Device Name: | UnBalloon Non-Occlusive Modeling Catheter |
| Trade Name. | UnBalloon Non-Occlusive Modeling Catheter |
Common/ Classification Catheter, Percutaneous / Modeling Catheter Name: Classification Panel: 21CFR §870.1250 Class: II (2)
DQY
Product Code:
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 14F 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 Modeling Catheter by expanding the product family line with additional nitinol mesh cage sizes and catheter lengths.
1
Proposed 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): | K121839 |
|---|---|
| Device Name: | UnBalloon Non-Occlusive Modeling Catheter |
| SE Date: | 08/08/2012 |
| Regulation Number: | 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: | 870.1250 |
| Device Class Name: | Catheter, Percutaneous |
| Device Class: | 2 |
Substantial Equivalence:
Fundamental Scientific Technological Characteristics:
The UnBalloon Non-Occlusive Modeling Catheter is a silicone surface coated percutaneous/modeling catheter designed for vascular surgeons. This submission is to include additional product sizes.
Functional/ Safety testing:
The verification activities conducted indicate that UnBalloon Non-Occlusive Modeling Catheter device meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Sterilization:
The device is validated for ethylene oxide (EO) sterilization according to ANSVAAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization"
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 (