(29 days)
Not Found
No
The document describes a physical medical device (balloon catheter) and its intended use for temporary vascular occlusion and delivery of agents. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
Yes
The device is described as assisting in the delivery of "therapeutic agents such as occlusion coils" into the vasculature, indicating its role in a therapeutic process. Additionally, its primary intended use is for "temporary vascular occlusion," which is a therapeutic intervention to control blood flow.
No
This device is intended for temporary occlusion of blood vessels for the delivery of agents, not for the purpose of diagnosing a condition or disease.
No
The device description clearly describes a physical catheter with lumens, a balloon, guidewire compatibility, and radiopaque markers, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states the Micrus Ascent and Summit Occlusion Balloon Catheters are used within the blood vessels for temporary occlusion and delivery of agents. They are used in vivo (within the living body), not in vitro (in a lab setting with specimens).
The intended use and device description focus on a therapeutic and diagnostic delivery function within the patient's body, which is characteristic of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Micrus® Ascent™ and Summit™ 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 and Summit 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 and Summit 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.
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)
Not Found
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
Micrus Occlusion Balloon Catheters 510(k) Premarket Notification
10.0 510(k) Summary
Micrus Endovascular Corporation Micrus® Ascent™ Occlusion Balloon Catheter and Micrus® Summit™ Occlusion Balloon Catheter
JUN 19 2009
S
This 510(k) Summary for the Micrus® Ascent™ Occlusion Balloon Catheter and the Micrus® Summit ™ Occlusion Balloon 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
Phone: (408) 433-1428
Fax: (408) 433-1585 |
Date Prepared: May 19, 2009
DEVICE CLASSIFICATION
| Classification: | Class II |
|---|---|
| Trade Names: | Micrus® Ascent™ Occlusion Balloon Catheter |
| Micrus® Summit™ Occlusion Balloon Catheter | |
| Generic/Common Name: | catheter, intravascular occluding, temporary (21CFR |
| 870.4450) |
PREDICATE DEVICES
- 510(k) no. K080861, Micrus Ascent Occlusion Balloon Catheter, August 27, 2008 .
1
INDICATION FOR USE
The Micrus® Ascent™ and Summit™ 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 and Summit 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,
DEVICE DESCRIPTION
The Micrus Ascent and Summit 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.
SUBSTANTIAL EQUIVALENCE
The Micrus Ascent and Summit Occlusion Balloon Catheters are substantially equivalent to the Micrus Ascent Occlusion Balloon Catheter (4x7mm) in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials. These systems are all intended for use to assist in the temporary occlusion of peripheral vessels, as its predicate. The modification to the device has not altered the fundamental technology of the predicate devices.
CONCLUSION
As described in this 510(k) Summary, Micrus Endovascular Corporation considers the modified Micrus Ascent Occlusion Balloon Catheters and the Micrus Summit Occlusion Balloon Catheters to be substantially equivalent to the predicate device.
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Public Health Service
JUN 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micrus Endovascular Corporation c/o Patrick Lee Manager of Regulatory Affairs 821 Fox Lane San Jose, CA 95131
Re: K091504
Trade/Device Name: Micrus® Ascent™ Occlusion Balloon Catheter Micrus® Summit™ Occlusion Balloon Catheter
Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: May 19, 2009 Received: May 21, 2009
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.
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.
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.
3
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Kesia Alexander for
Malvina B. Eydelman, M.D. 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
11091504 510(k) Number (if known):
Device Name: Micrus Ascent Occlusion Balloon Catheter and
Micrus Summit Occlusion Balloon Catheter
Indications For Use:
The Micrus Ascent and Summit 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 and Summit 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 HUTTER
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K091504
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