(29 days)
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.
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.
The provided text is a 510(k) Premarket Notification for medical devices (Micrus Occlusion Balloon Catheters). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting clinical study data to prove the device meets specific acceptance criteria related to efficacy or performance in a clinical setting.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this 510(k) summary.
Here's a breakdown of what can be inferred and what is explicitly unobtainable from the provided text:
1. A table of acceptance criteria and the reported device performance
- UNOBTAINABLE from this document. This 510(k) focuses on demonstrating "substantial equivalence" based on design, specifications, materials, and intended use, not on specific performance metrics or clinical acceptance criteria. There are no performance criteria or corresponding results reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- UNOBTAINABLE from this document. There is no mention of a "test set" or clinical study data in the traditional sense. The submission likely relies on non-clinical (bench) testing and comparisons to the predicate device to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- UNOBTAINABLE from this document. As no specific clinical test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- UNOBTAINABLE from this document. No clinical test set means no adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- UNOBTAINABLE from this document. This document describes a medical device (balloon catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- UNOBTAINABLE from this document. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- UNOBTAINABLE from this document. No clinical ground truth is established or discussed. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- UNOBTAINABLE from this document. This is not an AI device, so there's no concept of a "training set."
9. How the ground truth for the training set was established
- UNOBTAINABLE from this document. Not applicable.
Summary of Device and 510(k) Approach (based on the provided text):
The Micrus Ascent and Summit Occlusion Balloon Catheters are being submitted for 510(k) clearance by claiming substantial equivalence to an existing predicate device: K080861, Micrus Ascent Occlusion Balloon Catheter.
Key points from the document regarding the "study" (which is primarily a comparison for substantial equivalence):
- Rationale for Equivalence: The submission asserts that the new devices are substantially equivalent to the predicate in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials. The modification to the device (new sizes or slight variations) has not altered the fundamental technology of the predicate devices.
- Intended Use: The devices are intended for temporary occlusion in peripheral and neuro vasculature, to stop/control blood flow, and to assist in the delivery of diagnostic/therapeutic agents.
- Device Description: Coaxial dual lumen balloon catheters with an inner guidewire lumen and an outer inflation/deflation lumen. Designed for use over 0.014" or smaller guidewires, with a vent hole and two radiopaque markers.
- Predicate Device: Micrus Ascent Occlusion Balloon Catheter (4x7mm) cleared under K080861.
In essence, the "study" here is the compilation of documentation and analysis demonstrating that the new devices are so similar to an already cleared device that they do not raise new questions of safety or effectiveness, and therefore do not require extensive clinical trials or performance studies as would be seen for novel devices.
{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 Corporation821 Fox LaneSan Jose, CA 95131Phone: 408-433-1400,Est. Registration No. 2954740 |
|---|---|
| Contact Person: | Patrick LeePhone: (408) 433-1428Fax: (408) 433-1585 |
Date Prepared: May 19, 2009
DEVICE CLASSIFICATION
| Classification: | Class II |
|---|---|
| Trade Names: | Micrus® Ascent™ Occlusion Balloon CatheterMicrus® Summit™ Occlusion Balloon Catheter |
| Generic/Common Name: | catheter, intravascular occluding, temporary (21CFR870.4450) |
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
Page 1 of 1.
§ 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).