MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6

K092177 · Invatec S.P.A. · NTE · Oct 15, 2009 · Cardiovascular

Device Facts

• Record ID: K092177
• Device Name: MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
• Applicant: Invatec S.P.A.
• Product Code: NTE · Cardiovascular
• Decision Date: Oct 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

Device Story

Multi-lumen catheter system with two compliant occlusion balloons; used during carotid artery stenting. Device occludes common carotid artery (CCA) and external carotid artery (ECA) to block antegrade/retrograde blood flow at carotid bifurcation; prevents distal embolization of particulate debris; allows aspiration/removal of debris. Operated by physicians in clinical settings. Output is physical containment and removal of embolic material. Benefits patient by reducing risk of stroke during carotid revascularization.

Clinical Evidence

ARMOUR study: prospective, multi-center, non-randomized, sequential enrollment. 262 patients (184 US, 78 Europe) undergoing carotid stenting. Primary endpoint: 30-day major adverse cardiac and cerebrovascular events (MACCE) composite rate compared to performance goal. Results met performance goal, demonstrating safety and efficacy.

Technological Characteristics

Multi-lumen shaft with two compliant occlusion balloons. Includes hollow mandrel, hemostatic valve, two-way stopcock, extension tubing, 40 um filter baskets, 30 cc syringe, T-safety connector, and 1-way stopcocks. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients undergoing angioplasty and stenting of the internal carotid artery or carotid bifurcation requiring embolic protection. Requires external carotid artery diameter 3-6 mm and common carotid artery diameter 5-13 mm.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• GORE Flow Reversal System (K083300)

Submission Summary (Full Text)

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K092177

OCT 1 5 2009

#### 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).

| Applicant: | Invatec S.p.A. |
|--------------------|--------------------------------------------------------|
| | Via Martiri della Libertá, 7 |
| | 25030 Roncadelle (Brescia) Italy |
| | Peter Muster PhD, VP QA & RA Invatec S.p.A. |
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Contact Person: | Steve Camp, VP, Clinical and Regulatory Affairs |
| | Invatec Inc., US |
| | Emrick Blvd. 3101, Suite 113 |
| | Bethlehem, PA 18020 |
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | July 17, 2009 |
| Device Information | |
| Trade Name: | MO.MA® ULTRA Proximal Cerebral Protection Device |
| Common Name: | Cerebral Protection Device |
| Regulation Name: | Catheter, carotid, temporary, for embolization capture |
| Predicate Device | |
| | • GORE Flow Reversal System (K083300) |

#### Device Description

The MO.MA® ULTRA Proximal Cerebral Protection Device consists of a multi-lumen shaft integrating two compliant occlusion balloons. The device is packaged with one hollow mandrel, one hemostatic valve with two-way stopcock and extension tubing, three 40 um filter baskets, one 30 cc syringe with male luer, one T-safety connector and two 1-way stopcocks.

The MO.MA® ULTRA Proximal Cerebral Protection Device achieves cerebral protection by occluding the common carotid artery (CCA) and the external carotid artery (ECA) with two

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compliant balloons. Occluding the CCA and ECA produces blockage of antegrade and retrograde blood flow at the carotid bifurcation to prevent distal embolization of particulate debris and allow removal of particulate debris by blood aspiration.

### Indications for Use

The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

# Technological Characteristics

- The MO.MA® ULTRA Proximal Cerebral Protection Device has the similar design, materials and fundamental technology as the previously cleared GORE Flow Reversal System (K083300).
# Performance Data

Non-clinical testing of the MO.MA® ULTRA Proximal Cerebral Protection Device consisted of performance testing, biocompatibility, sterilization, packaging, and product shelf life testing. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate device. A GLP animal study was conducted to support the safety and performance of the device prior to the pivotal clinical study.

Clinical Data: The ARMOUR study was a pivotal, prospective, multi-center, non-randomized study with sequential enrollment of all qualified patients undergoing carotid interventional procedures. All eligible patients who provided informed consent and met inclusion/exclusion criteria underwent percutaneous revascularization of the carotid artery using the Mo.Ma"Ma" Proximal Cerebral Protection Device and a stent approved by the FDA for carotid artery stenting. Follow-up took place at pre-discharge and at 30 days post-procedure. Results were compared to a performance goal for the 30-day major adverse cardiac and cerebrovascular events (MACCE) composite rate, which was derived from previous carotid stenting trials. A total of 262 patients were enrolled at 25 sites in the United States and in Europe. 184 patients were enrolled at 20 sites in the US and 78 patients were enrolled at 5 sites in Europe. The primary endpoint results of the trial were successful compared to the established performance goal and thus demonstrated the safety and efficacy of the Mo.Ma" device.

# Conclusion

Based on similar intended use, technological characteristics, and performance characteristics, the MO.MA® ULTRA Proximal Cerebral Protection Device is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Invatec, Inc. ATTN: Steve Camp Vice President Clinical and Regulatory Affairs 3101 Emrick Blvd., Suite 113 Bethlehem, PA 18020

OCT 1 5 2009

Re: K092177

Trade/Device Name: MO.MA ULTRA Proximal Cerebral Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: October 6, 2009 Received: October 7, 2009

Dear Mr. Camp:

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

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#### Page 2 - Mr. Camp

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/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

er R. Lehner

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

Enclosure

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#### STATEMENT OF INDICATIONS FOR USE 5

#### Indications for Use

510(k) Number (if known): K092177

Device Name: MO.MA® ULTRA Proximal Cerebral Protection Device

Indications for Use:

The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

> Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Duna R. Vacher
(Division Chief)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K092177