SCEPTER XC OCCLUSION BALLOON CATHETER

K113698 · MicroVention, Inc. · MJN · Jan 13, 2012 · Cardiovascular

Device Facts

• Record ID: K113698
• Device Name: SCEPTER XC OCCLUSION BALLOON CATHETER
• Applicant: MicroVention, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Jan 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

Device Story

Scepter XC Occlusion Balloon Catheter is a dual coaxial lumen catheter with a nondetachable, low-inflation-pressure compliant balloon at the distal end. Designed for tracking over a steerable guidewire; features radiopaque marker bands for fluoroscopic visualization; outer surface coated with hydrophilic polymer for lubricity. Used by physicians in clinical settings (neuro/peripheral vascular procedures) to provide temporary vascular occlusion; facilitates balloon-assisted embolization of intracranial aneurysms. Device is supplied sterile for single use. Physician operates catheter under fluoroscopic guidance to position balloon; inflation provides flow control or aneurysm neck remodeling. Benefits include improved procedural control during embolization and temporary flow cessation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included surface/physical attributes, tensile strength, leakage (liquid/air), static/dynamic burst pressure, simulated use, device compatibility, kink resistance, flexural fatigue, hydrophilic coating performance, hub/torque testing, and balloon-specific testing (burst, compliance, deflation time, fatigue). Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Dual coaxial lumen catheter; 0.0165" inner diameter; 2.6-2.8 F outer diameter; 4 mm diameter/10 mm length balloon. Materials: polyether block amide, polyolefin, stainless steel, PTFE, polyurethane elastomeric alloy, Pt/Ir, nylon, polyimide. Hydrophilic coating. Radiopaque markers. Compatible with 0.014" or smaller guidewires. Sterile, single-use.

Indications for Use

Indicated for patients requiring temporary vascular occlusion in peripheral and neurovasculature to control blood flow or assist in embolization of intracranial aneurysms.

Regulatory Classification

Identification

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

Predicate Devices

• MicroVention Scepter C Occlusion Balloon Catheter (K110741)

Submission Summary (Full Text)

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## 510(k) Summary

JAN 1 3 2012

| Trade Name: | Scepter XC Occlusion Balloon Catheter |
|-------------------|------------------------------------------------------------------------|
| Generic Name: | Occlusion Balloon Catheter |
| Classification: | Class II, 21 CFR 870.4450 |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Naomi Gong |
| Date Prepared: | December 15, 2011 |
| Predicate Device: | |

| Number | Description | Clearance Date |
|---------|------------------------------------------------------|--------------------|
| K110741 | MicroVention Scepter C Occlusion<br>Balloon Catheter | September 29, 2011 |

#### Device Description:

The Scepter XC Occlusion Batheter 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. 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.

#### Indication For Use:

The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

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# Verification and Test Summary:

: .

.

.

| Pre-clinical Testing | Result |
|--------------------------------------------------------------|--------|
| Surface and physical attributes | Pass |
| Tensile strength | Pass |
| Leakage (liquid and air) | Pass |
| Static and dynamic burst pressure | Pass |
| Simulated use | Pass |
| Compatibility with devices | Pass |
| Kink resistance | Pass |
| Catheter flexural fatigue | Pass |
| Hydrophilic coating | Pass |
| Hub testing | Pass |
| Torque testing | Pass |
| Balloon testing - burst, compliance, deflation time, fatigue | Pass |
| Bicompatibility testing (ISO 10993-1) | Pass |

# Technological Comparison:

.

| | Predicate Device | 510(k) Subject Device |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Lumen configuration | Dual coaxial lumen | Same |
| Inner Diameter | 0.0165" | Same |
| Outer Diameter | 2.6 - 2.8 F | Same |
| Balloon Diameter/Length | 4 mm/ 10-20 mm | 4 mm/10 mm |
| Material | Polyether block amide, polyolefin,<br>stainless steel, PTFE, polyurethane<br>elastomeric alloy, Pt/Ir, nylon,<br>polyimide | Same |
| No. of Markers | 3 | Same |
| Coating | Hydrophilic coating | Same |
| Guidewire compatibility | 0.014" or smaller wire | Same |
| Method of supply | Sterile and single use | Same |

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#### Summary of Substantial Equivalence:

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

The devices,

- Have the same intended use, .
- Use the same operating principle, .
- Incorporate the same basic design, 트
- Use similar construction and material,
- 트 Are sterilized using same methods and processes.

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.

-Public Health Service

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

JAN 1 3 2012

MicroVention, Inc. c/o Naomi Gong Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

Re: K113698

Trade/Device Name: Scepter XC Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: December 15, 2011 Received: December 16, 2011

#### 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.

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### Page 2 - Ms. Naomi Gong

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 that I DA has made a determinations administered by other Federal agencies. You must of ally I-cuttal statutes and regulations, including, but not limited to: registration and listing (21 Comply with an the Her of required 801); medical device reporting (reporting of medical CFK Fatt 607), labeling (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 If you desire specific advice for your device on our accessor offices/ucm115809.htm for go to into.//www.idd.gov.itRadiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radioneground by reference to premarket notification (21 CFR Pattigen (1 note the regulation childred. "Misoranans 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 You may other general mionnations one Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

[phone] 01 (501) 721 (2017) 721 Devices for You/Industry/default.htm.

Sincerely yours,

M. A. Hilliker

Bram D. Zuckerman, M.D. Ser 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): K1136 98

Device Name: Scepter XC Occlusion Balloon Catheter

Indications For Use:

The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

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)

. S. Hilleben

(Division Sign-Off) Division of Cardiovascular Devices

K113698 510(k) Number

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