(47 days)
Not Found
No
The device description focuses on mechanical components and materials, and there is no mention of AI, ML, or related concepts in the provided text.
No
The device is intended to assist in the modeling of endoprostheses, not to treat a disease or condition itself.
No
The device is described as a "modeling catheter" intended to "assist in the modeling of self-expanding endoprostheses" in large diameter vessels, which points to a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components such as a silicone surface coated catheter, expandable Nitinol mesh, retractable sheath, inner lumen, side ports, and handles, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the modeling of selfexpanding endoprostheses in large diameter vessels." This describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The description details a catheter with a Nitinol mesh, sheath, guidewire lumen, and handles. This is a medical device designed for physical manipulation within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such analysis. IVDs are specifically designed for in vitro (outside the body) examination of specimens.
- Anatomical Site: The device is used in "large diameter vessels," which are internal anatomical structures.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize the device's position within the body during the procedure.
In summary, the UnBalloon Non-Occlusive Modeling Catheter is a surgical or interventional medical device used for a procedure within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
Product codes
DOY, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 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.
The following has been assessed through product characterization and validation: Worst case simulated use * Fatigue Hemostasis Bond tensile strength* Radial outward force Compatibility with endoprostheses Lubricity testing* Silicone curing characterization* Bilicone curing churacterization Silicone curing process characterization study* Silicone shelf life validation* Bushing & seal process qualification* *testing specific to the silicone addition to the UnBalloon
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
8 2012 AUG
LeMaitre Vascular, Inc. c/o Mr. Andrew Hodgkinson Vice President of Regulatory, Quality & Clinical Affairs 63 Second Avenue Bedford, MA 01803
Re: K121839
Trade/Device Name: UnBalloon Non-Occlusive Modeling Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: June 20, 2012 Received: July 9, 2012
Dear Mr. Hodgkinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 – Mr. Andrew Hodgkinson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of R Far 60 7), accember (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Allehan
, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number (if known) | K121839 |
|---|---|
| Device Name | UnBalloon Non-Occlusive Modeling Catheter |
| Indications for Use | The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801. 109) | X OR Over-The-Counter Use |
|---|---|
| ---------------------------------------- | --------------------------- |
CM & Weller
(Division Sign-Off)
Division of Cardiovascular Devices
Division of Cardiovass -------------------------------------------------------------------------------------------------------------------------------------------------------