(30 days)
Not Found
No
The document describes a physical medical device (balloon catheter) and its mechanical function. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is intended for temporary occlusion of blood vessels and to assist in the delivery of therapeutic agents, a direct medical intervention for treatment.
No
The device is intended for temporary occlusion of blood vessels and to assist in the delivery of diagnostic and therapeutic agents. Its primary functions are interventional, not diagnostic.
No
The device description clearly details a physical catheter with lumens, a balloon, guidewire compatibility, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the blood vessels) for temporary occlusion and delivery of agents. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a catheter with a balloon designed to be inserted into blood vessels. This aligns with an in vivo medical device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition. Its function is mechanical (occlusion) and delivery.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The Micrus Ascent Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning. Certain balloon catheter sizes may have a third radiopaque marker band 3 cm proximal to the tip to facilitate fluoroscopic visualization.
The modification made to the predicate device included: (1) an extended coating to cover the balloon body, (2) a change to a tighter tolerance on the PTFE inner liner, (3) changing the vent hole size from a circular shape to a larger rectangular shape, (4) modifying a manufacturing step to accommodate a better fusing of the proximal sections, (5) revised IFU to clarify the instructions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels of the 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)
- in-vitro tests, verifying that the modified device met acceptance in terms of:
- balloon cycling and fatigue
- balloon burst diameter and volume changes
- coating integrity of the balloon
- pressure at the design diameter of the balloon
- inflation and deflation functions
- trackability of the device in a simulated tortuous anatomy
- the preparation method is adequate and acceptable
- in-vivo study 1 porcine model with 7 devices, demonstrating that
- the preparation method is adequate and acceptable
- the device deployed effectively and as expected in a animal model
- the trackability of the device met physicians' acceptance
- the balloon remained stable in position after placement
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
§ 870.4450 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
Ascent Occlusion Balloon Catheters 510(k) Premarket Notification
510(k) Summary
(
JAN 2 6 2011
Micrus Endovascular Corporation Micrus® Ascent® Occlusion Balloon Catheter
This 510(k) Summary for the Micrus Ascent Occlusion Balloon Catheter is submitted in accordance with the requirements of 21 C.F.R. § 807.92.
GENERAL INFORMATION
| Manufacturer: | Micrus Endovascular Corporation
821 Fox Lane
San Jose, CA 95131
Phone: 408-433-1400,
Est. Registration No. 2954740 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Lee
Manager, Regulatory Affairs
Phone: (408) 433-1428
plee@micruscorp.com |
Date Prepared: December 21, 2010
DEVICE CLASSIFICATION
| Classification: | Class II |
|---|---|
| Trade Names: | Micrus® Ascent® Occlusion Balloon Catheter |
| Generic/Common Name: | catheter, intravascular occluding, temporary |
| (21CFR § 870.4450) |
PREDICATE DEVICES
- 510(k) no. K091504, Micrus Ascent and Summit Occlusion Catheter, June 19, 2009 ●
INDICATIONS FOR USE
The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
·
1
DEVICE DESCRIPTION
The Micrus Ascent Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning. Certain balloon catheter sizes may have a third radiopaque marker band 3 cm proximal to the tip to facilitate fluoroscopic visualization.
The modification made to the predicate device included: (1) an extended coating to cover the balloon body, (2) a change to a tighter tolerance on the PTFE inner liner, (3) changing the vent hole size from a circular shape to a larger rectangular shape, (4) modifying a manufacturing step to accommodate a better fusing of the proximal sections, (5) revised IFU to clarify the instructions
SUBSTANTIAL EQUIVALENCE
The modification to the device has not altered the fundamental technology of the predicate devices. The Micrus Ascent Occlusion Balloon Catheters are substantially equivalent to the predicate device in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials.
The tests that were conducted to establish substantial equivalence includes:
- · in-vitro tests, verifying that the modified device met acceptance in terms of:
- . balloon cycling and fatigue
- balloon burst diameter and volume changes
- coating integrity of the balloon �
- . pressure at the design diameter of the balloon
- � inflation and deflation functions
- trackability of the device in a simulated tortuous anatomy .
- . the preparation method is adequate and acceptable
- in-vivo study 1 porcine model with 7 devices, demonstrating that �
- the preparation method is adequate and acceptable
- . the device deployed effectively and as expected in a animal model
- . the trackability of the device met physicians' acceptance
- the balloon remained stable in position after placement
CONCLUSION
As described in this 510(k) Summary, Micrus Endovascular Corporation considers the modified Micrus Ascent Occlusion Balloon Catheters to be as safe, as effective, and performs as well as or better than the legally marketed device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Micrus Endovascular Corp. c/o Mr. Patrick Lee Manager of Regulatory Affairs 821 Fox Lane San Jose, CA 95131
JAN 2 6 2011
Re: K103780
Trade/Device Name: Micrus Ascent Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp (Catheter, Intravascular Occluding, Temporary) Regulatory Class: Class II Product Code: MJN Dated: December 21, 2010 Received: December 27, 2010
Dear Mr. Lee:
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.
:
. . . . . . .
and the same of the same of
: :
. . . . . . . .
3
Page 2 - Mr. Patrick Lee
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 (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 go to 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Evelyn Hammond
Malvina B. Eydelman, M Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K103780 510(k) Number (if known): _ _ _ _
Device Name: Micrus Ascent Occlusion Balloon Catheter
Indications For Use:
The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUNTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K103780 510(k) Number
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