SCEPTER C OCCLUSION BALLOON CATHETER

K121785 · MicroVention, Inc. · MJN · Aug 10, 2012 · Cardiovascular

Device Facts

• Record ID: K121785
• Device Name: SCEPTER C OCCLUSION BALLOON CATHETER
• Applicant: MicroVention, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Aug 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is intended for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms. It is intended for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. It is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.

Device Story

Dual coaxial lumen catheter with nondetachable, low-inflation-pressure compliant balloon at distal end; tracks over steerable guidewire. Inner lumen enables infusion of diagnostic/therapeutic agents; outer lumen controls balloon inflation/deflation independently of guidewire. Radiopaque marker bands at balloon ends and distal tip facilitate fluoroscopic visualization. Outer surface features hydrophilic coating for lubricity. Used by physicians in clinical settings for vessel-selective temporary occlusion and balloon-assisted embolization of intracranial aneurysms. Provides controlled blood flow management and targeted delivery of embolic materials (e.g., Onyx). Benefits include improved procedural control during aneurysm treatment and vascular interventions.

Clinical Evidence

Bench testing only. Testing included visual inspection, tensile strength, leakage, burst pressure, simulated use, flexural fatigue, balloon performance (burst, compliance, deflation time), DMSO compatibility, and comprehensive biocompatibility (ISO 10993-5, -10, -4, -11). All tests passed.

Technological Characteristics

Dual coaxial lumen catheter; materials include polyether block amide, polyolefin, stainless steel, PTFE, polyurethane elastomeric alloy, Pt alloy, polypropylene. Hydrophilic coating. Radiopaque marker bands. Sterile, single-use. 2.6-2.8F outer diameter. 0.0165" inner lumen. Compatible with 0.014" guidewires.

Indications for Use

Indicated for patients requiring temporary vascular occlusion or balloon-assisted embolization of intracranial aneurysms in peripheral and neurovasculature. Also indicated for infusion of diagnostic/therapeutic agents in peripheral and neurovasculature.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Scepter C Occlusion Balloon Catheter (K110741)
• Scepter XC Occlusion Balloon Catheter (K113698)
• Headway 17 Microcatheter (K083343)

Submission Summary (Full Text)

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510(k) Summary

AUG 10 2012

| Trade Name: | Scepter C Occlusion Balloon Catheter<br>Scepter XC Occlusion Balloon Catheter |
|-----------------|---------------------------------------------------------------------------------------------------|
| Generic Name: | Occlusion Balloon Catheter |
| Classification: | Class II<br>MJN, 21 CFR 870.4450 (Vascular Clamp)<br>DQY, 21 CFR 870.1250 (Percutaneous Catheter) |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Date: | June 15, 2012 |
| Contact: | Naomi Gong |

### Predicate Device:

| 510(k) Number | Description | Clearance Date |
|---------------|---------------------------------------|----------------|
| K110741 | Scepter C Occlusion Balloon Catheter | Sep 29, 2011 |
| K113698 | Scepter XC Occlusion Balloon Catheter | Jan 13, 2012 |
| K083343 | Headway 17 Microcatheter | Dec 4, 2008 |

#### · Device Description:

The Scepter C and XC Occlusion Balloon Catheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. The inner lumen can be used for infusion/delivery of diagnostic and therapeutic agents. The outer lumen is used for the inflation and deflation of the balloon independent of guidewire position. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.

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### Indications For Use:

It is intended for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.

It is intended for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.

It is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter."

| Pre-clinical Testing | Result |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Visual Inspection | Pass |
| Tensile strength | Pass |
| Leakage (liquid and air) | Pass |
| Static and dynamic burst pressure | Pass |
| Simulated use | Pass |
| Catheter flexural fatigue | Pass |
| Compatibility with diagnostic and therapeutic agents<br>Delivery of embolization materials (i.e. Onyx®) | Pass |
| Balloon testing - burst, compliance, deflation time, fatigue | Pass |
| DMSO Compatibility | Pass |
| Bicompatibility testing:<br>Cytotoxicity (ISO 10993-5)<br>MEM elution assay<br>Sensitization/Irritation (ISO 10993-10)<br>- Guinea pig maximization sensitization<br>- Intracutaneous reactivity<br>Hemocompatibility (ISO 10993-4)<br>- Hemolysis<br>- UPTT<br>- Complement activation C3a and SC5b-9<br>- 4 hour thromboresistance in dogs<br>Systemic Toxicity (ISO 10993-11) | Pass |

#### Verification and Test Summary:

Scepter C and Scepter XC have been verified to be compatible for use with diagnostic agents (such as contrast media) and liquid embolic devices (such as Onyx liquid embolic systems).

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K121785 page 3 of 4

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# Technological Comparison:

| | Predicate Device<br>Scepter C/XC<br>(K110741/K113698) | Predicate Device<br>Headway 17<br>(K083343) | 510(k) Subject Device |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the blood vessels<br>of the peripheral and<br>neurovasculature where<br>temporary occlusion is<br>desired. These catheters<br>offer a vessel selective<br>technique of temporary<br>vascular occlusion which is<br>useful in selectively<br>stopping or controlling<br>blood flow and also offers<br>balloon assisted<br>embolization of intracranial<br>aneurysms. | For general<br>intravascular use,<br>including the<br>peripheral,<br>coronary, and<br>neurovasculature,<br>for the infusion of<br>diagnostic agents,<br>such as contrast<br>media, and<br>therapeutic agents,<br>such as occlusion<br>coils. | For use in the blood vessels of the<br>peripheral and neurovasculature where<br>temporary occlusion is desired. These<br>catheters offer a vessel selective technique<br>of temporary vascular occlusion which is<br>useful in selectively stopping or controlling<br>blood flow and also offers balloon assisted<br>embolization of intracranial aneurysms.<br>For general intravascular use, including the<br>peripheral and neurovasculature, for the<br>infusion of diagnostic agents, such as<br>contrast media, and therapeutic agents, such<br>as embolization materials. |
| Lumen<br>configuration | Dual coaxial lumen | Single lumen | Same as Scepter C/XC |
| Inner Center<br>Lumen Diameter | 0.0165" | 0.017" | Same as Scepter C/XC |
| Outer Diameter | 2.6 - 2.8F | | Same as Scepter C/XC |
| Balloon<br>Diameter/Length | 4 mm/ 10-20 mm | N/A | Same as Scepter C/XC |
| Material | Polyether block amide,<br>polyolefin, stainless<br>steel, PTFE,<br>polyurethane elastomeric<br>alloy, Pt alloy,<br>polypropylene | | Same as Scepter C/XC |
| Introducer<br>sheath | N/A | Yes | Yes |
| Shaping<br>·Mandrel | N/A | Yes | Yes |
| Distal tip<br>shaping | N/A | Yes | Yes |
| Guidewire<br>compatibility | 0.014" wire or smaller | Same | Same |
| Method of<br>supply | Sterile and single use | Same | Same |

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#### Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the Scepter C and XC Occlusion Balloon Catheter when compared with the predicate devices, Scepter C/XC Occlusion Balloon Catheter (K110741/K113698) and Headway 17 (K083343).

- The devices: " Have the same intended use,
- · Use the same operating principle,
- · Incorporate the same basic design,
- · Use similar construction and material,
- · Are sterilized using same methods and processes.

In summary, the Scepter C and XC Occlusion Balloon Catheters described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol.

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

AUG 10 2012

Micro Vention, Inc. % Naomi Gong 1311 Valencia Avenue Tustin, CA 92780 US

Re: K121785

Trade/Device Name: Scepter C and XC occlusion balloon catheters Regulation Number: 21 CFR 870.4450 Regulation Name: Occlusion Balloon Catheter Regulatory Class: Class II Product Code: MJN. DOY Dated: June 15, 2012 Received: June 18. 2012

Dear Ms. Gong:

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.

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

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Page 2 – Ms. Naomi Gong

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 1 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,

ykille

- 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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MicroVention, Inc.

# Indications for Use

510(k) Number (if known):

Device Name: Scepter C Occlusion Balloon Catheter Scepter XC Occlusion Balloon Catheter

Indications For Use:

For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.

For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.

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

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)

.S. Hillebert

(Division Sign-Off) Division of Cardiovascular Devices

1421785 510(k) Number_

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