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 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 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.

AI/ML Overview

Here's the analysis of the provided text regarding the MO.MA® ULTRA Proximal Cerebral Protection Device:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the MO.MA® ULTRA Proximal Cerebral Protection Device focuses on establishing substantial equivalence to a predicate device and relies on clinical data compared against a pre-established performance goal. It does not explicitly define traditional "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) but rather sets a performance goal for a clinical outcome.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Goal	Reported Device Performance
30-day major adverse cardiac and cerebrovascular events (MACCE) composite rate compared to a performance goal derived from previous carotid stenting trials.	"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." (Specific quantitative rate not provided in the abstract)

Note: The exact quantitative performance goal for MACCE and the device's actual MACCE rate are not explicitly stated in this 510(k) summary, only that the device met the goal.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: 262 patients
Data Provenance: Prospective, multi-center study conducted in the United States (184 patients at 20 sites) and Europe (78 patients at 5 sites).

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on clinical outcomes (MACCE), which are typically assessed by physicians and clinical staff involved in patient care and follow-up, but no independent expert panel for ground truth assessment is described.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Clinical endpoints like MACCE are usually determined by the treating physicians and confirmed through medical records, but there's no mention of a specific adjudication panel or method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study described. This device is a physical medical device (cerebral protection device) used during a procedure, not an AI/software product requiring human reader interpretation or assistance. Therefore, the concept of human readers improving with or without AI assistance does not apply.

6. Standalone (Algorithm Only) Performance

This question is not applicable as the device is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used was outcomes data, specifically the 30-day major adverse cardiac and cerebrovascular events (MACCE) composite rate.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI/software requiring a training set.

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

This question is not applicable as there was no training set for an algorithm.

Summary

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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: +39 030 258 93 11
	Fax: +39 030 258 93 12
	Email: Peter.Muster@invatec.com
Contact Person:	Steve Camp, VP, Clinical and Regulatory Affairs
	Invatec Inc., US
	Emrick Blvd. 3101, Suite 113
	Bethlehem, PA 18020
	Tel: (610) 625-1402
	Fax: (610) 625-1436
	Email: steve.camp@invatec-us.com
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 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

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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with a bird-like figure above it.

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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).