HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 by EV3 NEUROVASCULAR

The MTI HyperForm™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vesscl selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms,

The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms.

Device Description

The HyperForm™ Occlusion Balloon Catheter is a single lumen tapered catheter with a non-detachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic

AI/ML Overview

The provided 510(k) summary for the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters does not include any acceptance criteria or details of a study that proves the device meets specific acceptance criteria related to its performance.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices. The approach taken is that no new performance data specific to these devices was deemed necessary.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
No specific acceptance criteria are defined in terms of measurable performance metrics (e.g., occlusion effectiveness, inflation/deflation times, material strength, clinical outcomes).	No new performance data is reported for the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters. The submission states that "No bench testing and biocompatibility testing was performed to support a determination of substantial equivalence."

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

Sample Size for Test Set: Not applicable, as no new performance testing data is provided or referenced for these specific devices.
Data Provenance: Not applicable. The basis for equivalence relies on the established performance and safety of predicate devices.

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

Not applicable, as no new clinical or performance test data requiring expert review for ground truth establishment is presented.

4. Adjudication Method for the Test Set:

Not applicable, as there is no test set or related adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No MRMC comparative effectiveness study was done or reported. The submission does not involve AI assistance or human-in-the-loop performance studies.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable. As no new performance or clinical studies were conducted for these devices, there was no ground truth established for them. The safety and effectiveness are inferred from the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria (based on the provided document):

The "study" proving the device meets acceptance criteria is primarily a comparison to predicate devices to demonstrate substantial equivalence, rather than direct performance testing of the new devices.

Mechanism of Proof: The submission aims to prove substantial equivalence by highlighting the shared characteristics with legally marketed predicate devices. The core argument is stated as: "The proposed HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are identical to the predicate devices and use the same basic technology as the predicate devices."
Key Similarities Listed for Substantial Equivalence:
- Same intended use (all predicates)
- Same balloon technology and specifications (all predicates)
- Same catheter technology and characteristics (all predicates)
- Same other product technology and specifications (all predicates)
Predicate Devices:
- Equinox Occlusion Balloon Catheter (K001237)
- HyperForm Occlusion Balloon Catheter (K011656) (Note: This suggests an update or re-submission for an existing HyperForm catheter)
- HyperGlide Occlusion Balloon Catheter (K011526, K090728) (Note: Similar to HyperForm, suggests updates/re-submissions for existing HyperGlide catheters)
Conclusion: Based on these similarities in intended use, technological characteristics, and prior performance (of the predicate devices), Micro Therapeutics, Inc. (dba ev3 Neurovascular) concluded that the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are substantially equivalent to the listed predicate devices. The FDA concurred with this determination for market clearance.

Summary

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K091458

510(k) Summary

OCT 1 5 2009

HyperForm™ Occlusion Balloon Catheter HyperGlide™ Occlusion Balloon Catheter

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510(k) Summary	This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R § 807.92.
Applicant	Micro Therapeutics, Inc. dba ev3 Neurovascular
Submitter	Micro Therapeutics, Inc.9775 Toledo WayIrvine, CA 92618Tel: 949-680-1237Fax: 949-465-1737
Contact Person	Tom DaughtersDirector, Regulatory Affairs
Date Prepared	May 8, 2009
Device Trade Name	HyperForm™ Occlusion Balloon CatheterHyperGlide™ Occlusion Balloon Catheter
Device Common Name	Occlusion Balloon Catheter
Classification Name	Catheter, Intravascular Occluding, Temporary (21 CFR 870.4450,Product Code MJN
Classification Panel	Cardiovascular
Predicate Devices	Equinox Occlusion Balloon Catheter (K001237), HyperFormOcclusion Balloon Catheter (K011656), and HyperGlide OcclusionBalloon Catheter (K011526, K090728).
Intended use	The MTI HyperForm™ Occlusion Balloon Catheters are indicated foruse in blood vessels of the peripheral and neuro vasculature wheretemporary occlusion is desired. These catheters offer (1) a vesselselective technique of temporary vascular occlusion, which is useful inselectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.
Intended use	The MTI HyperGlide™ Occlusion Balloon Catheters are indicated foruse in blood vessels of the peripheral and neuro vasculature wheretemporary occlusion is desired. These catheters offer (1) a vesselselective technique of temporary vascular occlusion, which is useful inselectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.
Device Description	The HyperForm™ Occlusion Balloon Catheter is a single lumentapered catheter with a non-detachable low inflation pressurecompliant balloon attached to the distal end of the catheter. Thecatheter is designed to track over a 0.010" guidewire, and requiresinsertion of the guidewire to occlude the catheter shaft lumen to allowinflation of the balloon. Two platinum markers provide angiographic
Performance data	No bench testing and biocompatibility testing was performed to support a determination of substantial equivalence. Results from submitters experience and literature review provides assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Summary of SubstantialEquivalence	The proposed HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are identical to the predicate devices and use the same basic technology as the predicate devices. The proposed devices share the following similarities to the predicate devices:Same intended use (all predicates) Same balloon technology and specifications (all predicates) Same catheter technology and characteristics (all predicates) Same other product technology and specifications (all predicates)
Conclusion	Based on the similar indications for use, technological characteristics and performance testing, ev3 believes the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are substantially equivalent to the Equinox Occlusion Balloon Catheter (K001237), the HyperForm™ Occlusion Balloon Catheter (K011656), and the HyperGlide™ Occlusion Balloon Catheter (K011526, K090728).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

ev3 Neurovascular ATTN: Tom Daughters Director, Regulatory Affairs 9775 Toledo Way Irvine, CA 92618

OCT 1 5 2009

Re: K091458

Trade/Device Name: Hyperform & Hyperglide Occlusion Balloon Catheters Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 18, 2009 Received: September 21, 2009

Dear Mr. Daughters:

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. Ilsting 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

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Page 2 - Mr. Daughters

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/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,

Duna R. Hohner

Image /page/3/Picture/7 description: The image shows a black and white drawing of a signature. The signature is stylized and difficult to read, but it appears to have a loop at the top and a sharp angle at the bottom. The signature is on a white background.

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

1091458 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: HyperForm™ Occlusion Balloon Catheters

HyperGlide™ Occlusion Balloon Catheters

Indications for Use:

Prescription Use X (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)

Duma R. Lielmes
Division Sign-Off)

ivision of Cardiovascular Devices

510(k) Number K091458

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).