OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE

K093813 · Imbiotechnologies · KRD · May 10, 2010 · Cardiovascular

Device Facts

• Record ID: K093813
• Device Name: OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
• Applicant: Imbiotechnologies
• Product Code: KRD · Cardiovascular
• Decision Date: May 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.

Device Story

Occlusin® 500 is a collagen-coated polymeric microparticle designed for vascular embolization. Delivered via catheter under angiographic control to target organs; particles physically occlude blood flow to hypervascularized tumors. Used in clinical settings by physicians; provides mechanical blockage of tumor vasculature to reduce blood supply. Benefits include therapeutic intervention for otherwise unresectable tumors.

Clinical Evidence

No clinical testing was conducted. Evidence consists of bench testing (biocompatibility per ISO 10993-1, stability, catheter compatibility, and product characterization) and in vivo animal studies (porcine model for acute/1-month; ovine model for 3, 6, and 12-month performance).

Technological Characteristics

Collagen-coated polymeric microspheres. Sterile, non-pyrogenic. Delivered via catheter. Characterization includes mass per vial, density, particle size distribution, residual PVA, molecular weight, and collagen content. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients with unresectable or inoperable hypervascularized tumors requiring vascular embolization.

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

• Biosphere Medical Embosphere® (K021397; K991549)

Submission Summary (Full Text)

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# MAY 1 0 2010

# Revised 510(k) Summary for IMBiotechnologies Ltd. Occlusin® 500 Artificial Embolization Device (per 21CFR 807.92)

(per 21 CFR 807.92 and http://www.fda.qov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

### 1. SUBMITTER/510(K) HOLDER

IMBiotechnologies Ltd. Suite 113 - Advanced Technology Centre Edmonton Research Park 9650 20th Avenue, NW Edmonton, AB T6N 1G1

| Contact Person: | Michael W. Stewart |
|-----------------|--------------------|
| Telephone: | 780-945-6609 |

May 7, 2010 Date Prepared:

### 2. DEVICE NAME

| Proprietary Name: | Occlusin® 500 Artificial Embolization Device |
|----------------------|----------------------------------------------|
| Common/Usual Name: | Vascular embolization device |
| Classification Name: | Device, vascular, for promoting embolization |

### 3. PREDICATE DEVICES

Biosphere Medical Embosphere® (K021397; K991549)

### 4. DEVICE DESCRIPTION

The Occlusin® 500 Artificial Embolization Device is a collagen-coated polymeric embolization microparticle. It is provided sterile and non-pyrogenic.

### 5. INTENDED USE

The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.

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## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The claim of substantial equivalence of the Occlusin® 500 Artificial Embolization Device with the cited predicate device is based on indication for use, operational principles, and fundamental design and operational characteristics. The Occlusine 500 Artificial Embolization Device, like the predicate device, are microspheres delivered to target organs via catheter under angiographic control. Differences in technology were addressed with additional non-clinical testing.

# 7. SUMMARY OF PERFORMANCE TESTING AS THE BASIS FOR SUBSTANTIAL EQUIVALENCE

Prospectively defined verification and validation testing included biocompatibility testing in compliance with ISO 10993-1; stability testing; catheter compatibility testing; characterization of the finished product to demonstrate compliance with release specifications (including visual examination of appearance, packaging integrity, mass per vial, density, particle count per gram, particle size distribution, residual PVA, molecular weight, collagen content, sterility, endotoxin and melting range; shelf life); and in vivo testing in two animal models. Short term testing (acute and 1 month) was performed in the porcine model and long term testing (3 months, 6 months, and 12 months) was performed in the ovine model. These studies compared the performance of the Occlusin® 500 Artificial Embolization Device with the cited predicate device.

### 8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No clinical testing was conducted to support this submission.

### 9. SUMMARY OF OTHER INFORMATION

Other information provided in the 510(k) included published studies of embolization.

### 10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Design verification and validation testing demonstrate that the Occlusin® 500 Artificial Embolization Device fulfills prospectively defined design specifications. Testing in the two well-accepted animal models shows that the Occlusin® 500 Artificial Embolization Device does not raise new issues of safety or effectiveness.

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

MAY 1 0 2010

IMBiotechnologies Ltd. c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K093813

Occlusin® 500 Artificial Embolization Device Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: April 22, 2010 Received: April 26, 2010

Dear Ms. Robinson:

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 - Ms. Rosina Robinson

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.html 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,

Dina R. Holmes

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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### Indications for Use

#### 510(k) Number (if known): K093813

Device Name: Occlusin® Artificial Embolization Device

#### Indications for Use:

The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dunae R. Vihner

(Division Sign-Off) (Division Sign On) vascular Devices

510(k) Number_k og 38 | 3