ACTA VESSEL OCCLUSION SYSTEM (VOS)

K091952 · Nfocus Neuromedical, Inc. · KRD · Sep 10, 2010 · Cardiovascular

Device Facts

• Record ID: K091952
• Device Name: ACTA VESSEL OCCLUSION SYSTEM (VOS)
• Applicant: Nfocus Neuromedical, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Sep 10, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.

Device Story

Acta VOS is a sterile, single-use, self-expandable ovoid implant designed for vascular occlusion. Constructed from double-layer Nitinol wire mesh with platinum marker bands at proximal and distal ends. Delivered via commercially available catheters; detachment from delivery device achieved by operator activation of delivery handle. Used in peripheral vasculature (abdominal/thoracic cavities) to create physical barrier for embolization. Intended for use by physicians. Benefits patient by providing controlled vascular occlusion.

Clinical Evidence

Bench testing only. No clinical data provided. Testing includes dimensional, tensile strength, corrosion resistance, force to deploy, recapture force, radial force, MRI compatibility, radiopacity, fatigue, and simulated device use.

Technological Characteristics

Implant: Ovoid, double-layer Nitinol wire mesh with platinum marker bands. Delivery: Catheter-based, handle-activated detachment. Sterilization: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for arterial and venous embolizations in the peripheral vasculature, specifically within the abdominal and thoracic cavities.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Amplatzer Vascular plug

Submission Summary (Full Text)

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K 0.911952

#### PREMARKET NOTIFICATION [510(K)] SUMMARY 5.

Applicant:

Nfocus™ Neuromedical, Inc. 2191 E. Bayshore Road, Suite 100 Palo Alto, CA 94303 . USA Tel: [phone] Fax: [phone] June 29, 2009 " Robert H. O'Holla Vice President, Regulatory Acta" VESSEL OCCLUSION SYSTEM Arterial Embolization Device (KRD) Class II, 21 CFR 870.3300, Product Code KRD

Contact Person:

Date Prepared:

Proprietary Device Name:

Common Device Name:

Classification:

Legally marketed device to which your firm is claiming equivalence:

# SEP 1 0 2010

#### Device Description:

The Acta "Vessel Occlusion System (VOS) is provided sterile and is intended for one-time use. The implant is a self-expandable, ovoid shaped implant with delivery device. The implant is made from a double layer of Nitinol wire mesh which is secured at proximal and distal ends with platinum marker bands. The delivery device allows the implant to be delivered through commercially available catheters. Detachment of the implant from the delivery device is achieved by operator activation of the delivery handle.

Amplatzer Vascular plug

#### Intended Use:

The Acta VOS is indicated for arterial and venous embolizations in the peripheral vasculature.

Technological Characteristics of the Device Compared to the Predicate Device: The Acta VOS uses similar technology, has similar intended use, functions and method of operation as the predicate device.

| | Acta VOS | Amplatzer Plug |
|-------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Intended Use | The Acta VOS is indicated for arterial and venous embolizations in the peripheral vasculature. | Amplatzer vascular plug is indicated for arterial and venous embolizations in the peripheral vasculature. |
| Device Function | Creates a physical barrier to effect vascular occlusion | Creates a physical barrier to effect vascular occlusion |
| Implant Materials | Nitinol | Nitinol |

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| | Acta VOS | Amplatzer Plug |
|-------------------------------------------------|----------------------------------------|----------------------------------------|
| Implant Shape | Ovoid | Cylindrical |
| Method of<br>detachment from<br>delivery system | Controlled detachment from<br>catheter | Controlled detachment from<br>catheter |

## Summary of Studies: ·

As per the guidance for Abbreviated 510(k)s and the applicable standards, performance, sterilization and biocompatibility testing will be conducted and the results of the testing will verify that the Acta VOS product and system requirements are met ensuring that the product design conforms to the user needs and intended uses.

The following tests have been or will be performed prior to commercialization:

#### Delivery System

- Dimensional .
- Tensile Strength
- Corrosion Resistance
- Force to Deploy

#### Implant

- Dimensional .
- Tensile Testing
- Recapture Force
- Radial Force
- Corrosion
- MRI Compatibility
- Radiopacity
- Fatigue

- System • Simulated Device Use
## Conclusion:

NFocus Neuromedical considers the Acta VOS to be substantially equivalent to the legally marketed predicate device with respect to the device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Acta VOS and the predicate device do not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Nfocus Neuromedical c/o Mr. Robert O'Holla Vice President, Regulatory Affairs 2191 E. Bayshore Road, Suite 100 Palo Alto, CA 94303

SEP 1 0 2010

Re: K091952

Trade/Device Name: Acta Vessel Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: September 2, 2010 Received: September 3, 2010

Dear Mr. O'Holla:

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.

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Page 2 - Mr. Robert O'Holla

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W.M.

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

Enclosure

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#### INDICATION FOR USE STATEMENT 4.

1091952 510(K) Number (if known):

Device Name: Nfocus™ Neuromedical Acta™ Vessel Occlusion System

Indications for Use:

The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.

Prescription Use ___X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

SEP 1 0 2010

(PLEASE DO NOT WRITE BELOW THIS LINE-COINTNUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.P

n Sian-C of Cardiovascular Devices

**510(k) Number**

3-1