CONCENTRIC EMBOLIC PEARLS

K050470 · Concentric Medical, Inc. · KRD · May 6, 2005 · Cardiovascular

Device Facts

• Record ID: K050470
• Device Name: CONCENTRIC EMBOLIC PEARLS
• Applicant: Concentric Medical, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Concentric Embolic Pearls are intended for use in the embolization of hypervascularized tumors in the peripheral vasculature.

Device Story

Concentric Embolic Pearls are non-resorbable, hydrogel-based spherical microbeads. Device delivered via catheter to target site; occludes blood vessels supplying hypervascularized tumors to slow or stop blood flow. Used in peripheral vasculature; operated by clinicians. Benefits include targeted tumor devascularization. Performance verified via bench testing and in-vivo animal studies confirming consistent delivery and lack of vessel damage.

Clinical Evidence

Bench testing and in-vivo animal studies performed. Bench testing confirmed adherence to product specifications and biocompatibility. In-vivo animal testing demonstrated consistent delivery to treatment sites, no vessel damage upon deployment, and performance similar to predicate EmboGold Microspheres. No clinical human data reported.

Technological Characteristics

Non-resorbable, hydrogel-based spherical microbeads. Delivered via catheter. Biocompatible materials. No specific ASTM standards cited. Standalone device; no software or energy source.

Indications for Use

Indicated for embolization of hypervascularized tumors in the peripheral vasculature. Prescription use only.

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

• EMBOSPHERE® Microspheres (K991549)
• EmboGold™ Microspheres (K010026)
• TruFilI™ PVA Particles (K951314)
• TruFilI™ PVA Particles (K965174)

Submission Summary (Full Text)

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# MAY - 6 2005

### 510(k) Summary

| General Information<br>Classification | Class II, Arterial Embolization Device per 21 CFR § 870.3300 |
|---------------------------------------|------------------------------------------------------------------------------------------------|
| Trade Name | Concentric Embolic PearlsTM |
| Submitter | Concentric Medical, Inc.<br>1380 Shorebird Way<br>Mountain View, CA 94043<br>tel: [phone] |
| Contact | Jean M. Caillouette, RAC<br>Manager, Regulatory Affairs |

#### Intended Use

The Concentric Embolic Pearls are intended for use in the embolization of hypervascularized tumors in the peripheral vasculature.

| Predicate Devices | |
|-----------------------------------------|---------|
| EMBOSPHERE® Microspheres | K991549 |
| Manufactured by Biosphere Medical, Inc. | |

EmboGold™ Microspheres K010026 Manufactured by Biosphere Medical, Inc.

K951314, K965174 TruFilI™ PVA Particles Manufactured by Cordis Endovascular Systems

### Device Description

The Concentric Embolic Pearls are non-resorbable, hydrogel-based spherical microbeads. The Embolic Pearls are delivered via a catheter in an amount and size appropriate for the targeted area. The Embolic Pearls slow/stop blood flow to hypervascularized tumors by occluding the blood vessel which provides blood flow to the tumor.

#### Materials

All materials used in the manufacture of the Concentric Embolic Pearls are suitable for the intended use of the device.

### Testing Summary

The Concentric Embolic Pearls have successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification. In all biocompatibility studies performed, the results for the Concentric Embolic Pearls was substantially equivalent to the negative control article and no significant adverse reactions were noted in any study conducted. Results of chemical assays performed clearly demonstrate that no harmful levels of

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residuals, monomers, or leachables are detectable in the Concentric Embolic Pearls following hydration. Results of in-vivo animal testing performed demonstrated consistent delivery of the Embolic Pearls to the treatment site, that no vessel damage occurs when the Embolic Pearls are deployed to the treatment site, and overall, the Embolic Pearls performed similarly to the EmboGold Microspheres.

## Summary of Substantial Equivalence

All characteristics/attributes of the Concentric Embolic Pearls are either identical or substantially equivalent to the existing legally marketed predicate devices identified in this application. As such, Concentric Medical, Inc. believes the Concentric Embolic Pearls are substantially equivalent to the legally marketed predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The caduceus symbol is black, and the text is also black.

MAY - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical, Inc. c/o Ms. Jean M. Caillouette, RAC 1380 Shorebird Way Mountain View, CA 94043

Re: K050470

Trade Name: Embolic Pearls Regulation Number: 21 CFR 870.3300 Regulation Name: Arterial embolization device Regulatory Class: II (two) Product Code: KRD Dated: February 18, 2005 Received: February 23, 2005

Dear Ms. Caillouette:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becally is release is substantially equivalent (for the indications felerenced above and nave determined the arredicate devices marketed in interstate for use stated in the encrosule) to regard cate of the Medical Device Amendments, or to commerce prior to May 20, 1978, the ensordance with the provisions of the Federal Food. Drug. devices mail have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciole, market the device, books of the more of the manual registration, listing of general controls provisions of the tice, 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 If your device is classified (seculory) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA may be subject to sach additional controlior "Entoung thing to the 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.

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Page 2 - Ms. Jean M. Caillouette, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toase oc advisou that I Dr Unstan that your device complies with other requirements of the Act that I DA has made a decemmandis as administered by other Federal agencies. You must or any I cuttar suttates and regulations including, but not limited to: registration and listing (21 comply with an the 7te 31equirements, 01); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty bybellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation contact pro revious marketing your device as described in your Section 510(k) I mis letter will unon you to cognifiating of substantial equivalence of your device to a legally promatics notification: "The Pressification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific aarroliance at [phone]. Also, please note the regulation entitled, Condor the Office of Court Court Cation" (21CFR Part 807.97). You may obtain Whisoranuing of Tereferee to presessonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Dma R. Vachner

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

Enclosure

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Concentric Medical, Inc. Concentric Embolic Pearls™

### Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

K650470 This application

Concentric Embolic Pearls™

ﺒ

The Concentric Embolic Pearls™ are indicated for use in the embolization of hypervascularized tumors in the peripheral vasculature.

Prescription Use X_OR

Over-The-Counter Use -------

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Durich K. 16 C (Division Sin .:- Off)

Division of Cardiovascular Devices

510(K) Number_K050470

Confidential

000009.
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