(167 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and clinical performance of a physical catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to assist in the modeling of self-expanding endoprostheses, which is a therapeutic intervention.
No
The device is intended to assist in the modeling of self-expanding endoprostheses, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like a Nitinol mesh, sheath, handles, and lumens, 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 self-expanding endoprostheses in large diameter vessels." This describes a procedure performed within the body (in vivo) to physically manipulate a medical device.
- Device Description: The description details a catheter with a Nitinol mesh designed for expansion within a blood vessel. This is a physical device used for a therapeutic or procedural purpose.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is clearly designed for use inside the body during a medical procedure.
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 (comma separated list FDA assigned to the subject device)
DOY
Device Description
The UnBalloon Non-Occlusive Modeling Catheter consists of 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
fluoroscopy
Anatomical Site
large diameter vessels (specifically thoracic and abdominal cases using stent grafts)
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)
The following has been assessed through product characterization and validation: Worst case Simulated use, Inflation/Deflation time, Freedom from leakage, Kink resistance, Fatigue, Hemostasis, Bond tensile strength, Radial outward force, Compatibility with endoprostheses, Physiological insult – animal testing (Acute and 28-day).
Between 14-June-2011 and 16-August-2011, LeMaitre Vascular attended 13 cases in Brazil and the European Union using the UnBalloon Non-Occlusive Modeling Catheter. In all cases we achieved technical success with no reported adverse events or device related malfunctions. The device performed successfully in 4 thoracic cases and 9 abdominal cases using a variety of stent grafts. The endoprostheses that were modeled included the LeMaitre TAArget (n=1, 8%); Gore Excluder (n=1, 8%); Cook Zenith TX2, Proform (n=2, 16%); Medtronic Endurant (n=1, 8%); Jotec E-Vita (n=2, 16%); Gore TAG or C-TAG (n=1, 8%); Aorfix (n=1, 8%) and 1 (8%) unknown. Devices ranged in size from 24mm to 40mm at the most proximal diameter. The UnBalloon was used to enhance primary attachment in the landing zone (n=8; 62%) while it was used 1 time (8%) to successfully treat a type 1a endoleak. Other uses included: Enhancement of Primary Attachment Zone + Modeling of device overlap (n=2; 15%); Modeling of Mainbody (n=1; 7.7%); Modeling of overlapping zone (n=1; 7.7%). The UnBalloon was deployed a median 3 times per case with mean deployment time of 36.6 sec +/- 39.2sec (Range 5 - 110sec.). Blood loss through the device was minimal with only 1 recorded result of 3ml that emanated through the guidewire lumen as expected. Radiopacity received an overall rating of 'good' in most cases with 2 cases relaying some difficulty seeing the inner marker bands or sheath marker. The applied modeling force (radial force) was estimated as "appropriate" in 8 (62%) cases while 5 (37%) rated it as "unknown/cannot judge." No device failures were reported in any case. The Nitinol cage was resheathed in all cases without any issues and there were no reports of the Nitinol cage getting hooked or caught in any Endovascular devices. No other complications or adverse events were reported. These initial clinical results indicate that the UnBalloon Non-Occlusive Modeling Catheter performs as intended and is as safe and effective as the predicate devices.
The biocompatibility of the device was tested per ISO10993-1.
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.
Cook Coda Balloon Catheter - K032869, Medtronic Reliant Balloon Catheter - K050038, Gore Tri-Lobe Balloon Catheter - K033670
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
SEP 1 3 2011
SECTION 5: 510(k) SUMMARY
| Submitter: | LeMaitre Vascular, Inc.
63 Second Avenue
Burlington, MA 01803 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrew Hodgkinson
Vice President, Clinical, Regulatory and Quality Affairs
Phone: 781-221-2266 x108
Fax: 781-425-5049
Email: ahodgkinson@lemaitre.com |
| Date Prepared: | 9/13/2011 |
| Trade Name: | The UnBalloon Non-Occlusive Modeling Catheter |
| Common Name: | Modeling Catheter |
| Classification Name: | Percutaneous Catheter |
| Predicate Devices: | Cook Coda Balloon Catheter - K032869
Medtronic Reliant Balloon Catheter - K050038
Gore Tri-Lobe Balloon Catheter - K033670 |
| Device Description: | The UnBalloon Non-Occlusive Modeling Catheter consists of 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. |
| Intended Use: | The UnBalloon Non-Occlusive Modeling Catheter is intended to assist
in the modeling of self-expanding endoprostheses in large diameter
vessels. |
| Summary of | The UnBalloon is a percutaneous catheter designed to assist in |
| Technological
Characteristics: | modeling of self-expanding endoprostheses without obstructing blood
flow. This device differs from the predicate devices as it is designed
to eliminate the pressure that typically builds up on the proximal end
of those devices when inflated. By eliminating occlusion (or partial
occlusion), the risks associated with occlusion during ballooning of an
endovascular prosthesis may be minimized, potentially allowing the
surgeon to more accurately model grafts that have been deployed. |
| Summary of Product
Testing: | The following has been assessed through product characterization and
validation:
Worst case Simulated use
Inflation/Deflation time
Freedom from leakage
Kink resistance
Fatigue
Hemostasis
Bond tensile strength
Radial outward force
Compatibility with endoprostheses
Physiological insult – animal testing (Acute and 28-day) |
| Summary of OUS
Post Market
Surveillance | Between 14-June-2011 and 16-August-2011, LeMaitre Vascular
attended 13 cases in Brazil and the European Union using the
UnBalloon Non-Occlusive Modeling Catheter. In all cases we
achieved technical success with no reported adverse events or device
related malfunctions. The device performed successfully in 4 thoracic
cases and 9 abdominal cases using a variety of stent grafts. The
endoprostheses that were modeled included the LeMaitre TAArget
(n=1, 8%); Gore Excluder (n=1, 8%); Cook Zenith TX2, Proform
(n=2, 16%); Medtronic Endurant (n=1, 8%); Jotec E-Vita (n=2, 16%);
Gore TAG or C-TAG (n=1, 8%); Aorfix (n=1, 8%) and 1 (8%)
unknown. Devices ranged in size from 24mm to 40mm at the most
proximal diameter.
The UnBalloon was used to enhance primary attachment in the landing
zone (n=8; 62%) while it was used 1 time (8%) to successfully treat a
type 1a endoleak. Other uses included: Enhancement of Primary
Attachment Zone + Modeling of device overlap (n=2; 15%); Modeling
of Mainbody (n=1; 7.7%); Modeling of overlapping zone (n=1; 7.7%).
The UnBalloon was deployed a median 3 times per case with mean
deployment time of 36.6 sec +/- 39.2sec (Range 5 - 110sec.).
Blood loss through the device was minimal with only 1 recorded result
of 3ml that emanated through the guidewire lumen as expected.
Radiopacity received an overall rating of 'good' in most cases with 2
cases relaying some difficulty seeing the inner marker bands or sheath
marker.
The applied modeling force (radial force) was estimated as
"appropriate" in 8 (62%) cases while 5 (37%) rated it as
"unknown/cannot judge."
No device failures were reported in any case. The Nitinol cage was
resheathed in all cases without any issues and there were no reports of
the Nitinol cage getting hooked or caught in any Endovascular
devices. No other complications or adverse events were reported.
These initial clinical results indicate that the UnBalloon Non-
Occlusive Modeling Catheter performs as intended and is as safe and
effective as the predicate devices. |
| Summary of Pre-
clinical Study: | The biocompatibility of the device was tested per ISO10993-1. |
| Conclusion: | LeMaitre Vascular has demonstrated that The UnBalloon Non-
Occlusive Modeling catheter is substantially equivalent to the
predicate devices based on its indications for use and fundamental
scientific technology. |
1043
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LeMaitre Vascular, Inc. c/o Mr. Andrew Hodgkinson Vice President. Clinical, Regulatory and Quality Affairs 63 Second Avenue Burlington, MA 01803
1 3 2011
Re: K110891
Trade Name: UnBalloon Non-Occlusive Modeling Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: August 30, 2011 Received: August 31, 2011
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 comply 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/Aboutl7DA/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/ReportalProblem/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.
Juc
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4: INDICATION FOR USE STATEMENT
510(k) Number : _ K 110891
Device Name: The 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.
Prescription Use______________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K110891