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.

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.

AI/ML Overview

This document describes the acceptance criteria and study that proves the Micrus Ascent Occlusion Balloon Catheter meets these criteria, supporting its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (Study Results)	Type of Study
Balloon cycling and fatigue	Modified device met acceptance for balloon cycling and fatigue. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Balloon burst diameter and volume changes	Modified device met acceptance for balloon burst diameter and volume changes. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Coating integrity of the balloon	Modified device met acceptance for coating integrity of the balloon. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Pressure at the design diameter of the balloon	Modified device met acceptance for pressure at the design diameter of the balloon. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Inflation and deflation functions	Modified device met acceptance for inflation and deflation functions. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Trackability of the device in a simulated tortuous anatomy	Modified device met acceptance for trackability in a simulated tortuous anatomy. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Adequacy and acceptability of the preparation method	The preparation method was adequate and acceptable in both in-vitro and in-vivo settings. (In-vivo study demonstrated this.)	In-vitro and In-vivo (porcine model)
Device deployment effectiveness	The device deployed effectively and as expected in an animal model. (Specific quantifiable measures of effectiveness not provided, but deemed acceptable by physicians in the in-vivo study.)	In-vivo (porcine model)
Trackability meeting physicians' acceptance	The trackability of the device met physicians' acceptance during the in-vivo study. (Qualitative assessment by medical professionals.)	In-vivo (porcine model)
Balloon stability in position after placement	The balloon remained stable in position after placement in the animal model. (Stability was observed and deemed acceptable in the in-vivo study.)	In-vivo (porcine model)

2. Sample Size Used for the Test Set and Data Provenance

In-vitro tests: The exact sample size for each in-vitro test is not specified in the summary, but multiple tests were conducted across various performance aspects.
In-vivo study: The test set for the in-vivo study consisted of 7 devices in a porcine model.
Data Provenance: The data provenance is from in-vitro laboratory testing and an in-vivo animal study (porcine model). This is prospective data generated specifically for the 510(k) submission. No country of origin is explicitly stated, but it can be inferred the testing was conducted by or for Micrus Endovascular Corporation, based in San Jose, CA, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For the in-vivo study, the summary states that "the trackability of the device met physicians' acceptance" and "the device deployed effectively and as expected." This implies subjective assessment by medical professionals.

Number of experts: Not explicitly stated, but the phrasing "physicians' acceptance" suggests more than one, or at least a general consensus attributed to medical professionals involved in the study.
Qualifications of those experts: Not explicitly stated, but it can be inferred they were veterinarians or medical researchers with expertise in animal models and catheter deployment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "physicians' acceptance" in the in-vivo study seems to refer to a qualitative observation and concurrence, rather than a structured adjudication process for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This was a substantial equivalence submission for a modified device, focusing on demonstrating performance against established benchmarks and the predicate device's performance, not comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" is not applicable. The studies assessed the physical device's performance characteristics.

7. The Type of Ground Truth Used

In-vitro tests: The ground truth for in-vitro tests was based on engineering specifications, design parameters, and established industry standards for catheter performance (e.g., balloon burst pressure, cycling durability, coating integrity).
In-vivo study: The ground truth for the in-vivo study was based on direct observation, successful deployment, stability, and "physicians' acceptance" within the porcine model, indicating successful functionality in a biological system.

8. The Sample Size for the Training Set

This device did not involve machine learning or AI algorithms requiring a training set. The term "training set" is not applicable in this context.

9. How the Ground Truth for the Training Set Was Established

As there was no training set (see point 8), this question is not applicable.

Summary

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Ascent Occlusion Balloon Catheters 510(k) Premarket Notification

K103780

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 Corporation821 Fox LaneSan Jose, CA 95131Phone: 408-433-1400,Est. Registration No. 2954740
Contact Person:	Patrick LeeManager, Regulatory AffairsPhone: (408) 433-1428plee@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

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DEVICE DESCRIPTION

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.

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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

: :

. . . . . . . .

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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

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Indications for Use

K103780 510(k) Number (if known): _ _ _ _

Device Name: Micrus Ascent Occlusion Balloon Catheter

Indications For Use:

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

Page 1 of __ 1 __

Regulation Number and Section

§ 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).