Scepter Mini Occlusion Balloon Catheter
Device Facts
| Record ID | K182829 |
|---|---|
| Device Name | Scepter Mini Occlusion Balloon Catheter |
| Applicant | MicroVention, Inc. |
| Product Code | DQY · Cardiovascular |
| Decision Date | Jul 10, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
For use in the peripheral and neuro vasculature 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. For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter. For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
Device Story
Dual co-axial lumen balloon catheter; tracks over steerable guidewire. Outer lumen inflates balloon; inner lumen delivers diagnostic/embolic agents. Radiopaque marker bands facilitate fluoroscopic visualization. Hydrophilic coating increases lubricity. Used in peripheral and neuro vasculature by physicians. Device provides temporary vascular occlusion to control blood flow or assist in aneurysm embolization. Benefits include selective flow control and targeted delivery of therapeutic agents in tortuous anatomy.
Clinical Evidence
No clinical data. Evidence consists of bench testing (sterility, physical attributes, leakage, burst pressure, coating durability, simulated use, compatibility with embolic agents, radio-detectability, kink resistance, particle testing) and animal testing (acute swine model) leveraged from the predicate Scepter C device.
Technological Characteristics
Dual co-axial lumen catheter; polyurethane elastomeric balloon; hydrophilic coating. Dimensions: 1.6F-2.8F OD, 165cm working length. Connectivity: Luer fitting. Sterilization: Ethylene oxide. No software/algorithm.
Indications for Use
Indicated for patients requiring temporary vascular occlusion in peripheral and neuro vasculature, including balloon-assisted embolization of intracranial aneurysms, and for delivery of compatible diagnostic or liquid embolic agents.
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Predicate Devices
- Scepter C Occlusion Balloon Catheter (K110741, K121785)
- Scepter XC Occlusion Balloon Catheter (K113698, K121785)
Reference Devices
- Headway 17 Microcatheter (K083343)
Submission Summary (Full Text)
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July 10, 2019
MicroVention, Inc. Marina Emond Senior Manager, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656
Re: K182829
Device Name: Scepter Mini Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY Dated: June 7, 2019 Received: June 10, 2019
Dear Marina Emond:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K182829
Device Name Scepter Mini Occlusion Balloon Catheter
Indications for Use (Describe) The Scepter Mini Occlusion Balloon Catheter is intended:
For use in the peripheral and neuro vasculature 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.
For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
Type of Use (Select one or both, as applicable)
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 11pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 11pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |
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### 510(K) Summary
| Trade Name: | Scepter Mini Occlusion Balloon Catheter |
|-------------------|-------------------------------------------------------------------------------------------------------|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.4450 (MJN) and 21 CFR 870.1250 (DQY) |
| Submitted By: | MicroVention, Inc.<br>35 Enterprise<br>Aliso Viejo, California 92656, USA |
| Contact: | Marina Emond<br>Senior Manager, Regulatory Affairs<br>Marina.Emond@Microvention.com<br>(714) 247-8296 |
| Date: | October 4, 2018 |
| Predicate Device: | Scepter C Occlusion Balloon Catheter (K110741, K121785) |
| | Scepter XC Occlusion Balloon Catheter (K113698, K121785) |
| Reference Device: | Headway 17 Microcatheter (K083343) |
#### Device Description:
Scepter Mini Occlusion Balloon Catheter is a dual co-axial lumen balloon catheter. The catheter is designed to track over a steerable guidewire. The outer lumen is used for the inflation of the balloon independent of guidewire position. The inner lumen can be used to deliver diagnostic agents or liquid embolics to distal locations in tortuous anatomy. Radiopaque marker bands are located at each end of the balloon 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 catheter is packaged sterile for single use only.
The Scepter Mini has similar indications for use as the predicates, however, incorporates several minor design differences. The Scepter Mini has a slightly longer length and a slightly smaller diameter. The balloon of the
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Scepter Mini is slightly shorter. The distal tip of the Scepter Mini extends a shorter distance from the distal end of the balloon than that of the Scepter C and XC. For the Scepter Mini, the purge hole is covered by a semi-permeable membrane designed to allow air to escape while preventing liquids from passing. The predicate Scepter C and XC incorporate 3 radiopaque marker bands, while the design of the Scepter Mini allows for visualization under fluoroscopy with only 2 radiopaque marker bands (due to shorter distal tip segment). All Scepter catheters have a hydrophilic coating.
### Indications for Use:
The Scepter Mini Occlusion Balloon Catheter is intended:
For use in the peripheral and neuro vasculature 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.
For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
#### Technological Characteristics and Product Feature Comparison:
The subject device, Scepter Mini Occlusion Balloon Catheter, is substantially equivalent to the predicate devices in terms of:
- Intended use
- · Scientific technology
- Fundamental design
- · Materials and processes for packaging and sterilization of devices
A tabular comparison of the technological characteristics between the predicate devices and subject device is provided below.
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| Device<br>Characteristics | Scepter C Occlusion<br>Balloon Catheter<br>(K110741, K121785) | Scepter XC Occlusion<br>Balloon Catheter<br>(K113698, K121785) | Scepter Mini Occlusion<br>Balloon Catheter<br>(Subject Device) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification/<br>Product Code | Class II/ DQY<br>(Percutaneous catheters) | Class II/ DQY<br>(Percutaneous catheters) | Class II/ DQY<br>(Percutaneous catheters) |
| Intended Use | Intended for use in the blood vessels of the peripheral<br>and neurovasculature where temporary occlusion is<br>desired. These catheters offer a vessel selective<br>technique of temporary vascular occlusion which is<br>useful in selectively stopping or controlling blood flow<br>and for balloon assisted embolization of intracranial<br>aneurysms.<br><br>Intended for use in the peripheral vasculature for the<br>infusion of diagnostic agents, such as contrast media,<br>and therapeutic agents, such as embolization materials.<br>It is intended for neurovascular use for the infusion of<br>diagnostic agents, such as contrast media, and<br>therapeutic agents, such as embolization materials, that<br>have been approved or cleared for use in the<br>neurovasculature and are compatible with the inner<br>diameter of the Scepter C/XC Occlusion Balloon<br>Catheters. | Intended for use in the blood vessels of the peripheral<br>and neurovasculature where temporary occlusion is<br>desired. These catheters offer a vessel selective<br>technique of temporary vascular occlusion which is<br>useful in selectively stopping or controlling blood flow<br>and for balloon assisted embolization of intracranial<br>aneurysms.<br><br>Intended for use in the peripheral vasculature for the<br>infusion of diagnostic agents, such as contrast media,<br>and therapeutic agents, such as embolization materials.<br>It is intended for neurovascular use for the infusion of<br>diagnostic agents, such as contrast media, and<br>therapeutic agents, such as embolization materials, that<br>have been approved or cleared for use in the<br>neurovasculature and are compatible with the inner<br>diameter of the Scepter C/XC Occlusion Balloon<br>Catheters. | Similar Intended Use<br><br>For use in the peripheral and<br>neuro vasculature where<br>temporary occlusion is desired.<br>The balloon catheter provides<br>temporary vascular occlusion<br>which is useful in selectively<br>stopping or controlling blood<br>flow. The balloon catheter also<br>offers balloon assisted<br>embolization of intracranial<br>aneurysms.<br><br>For use in the peripheral<br>vasculature for the delivery of<br>diagnostic agents, such as<br>contrast media, that have been<br>approved or cleared for use in<br>the peripheral vasculature and<br>are compatible with the inner<br>lumen of the Scepter Mini<br>Occlusion Balloon Catheter.<br><br>For neurovascular use for the<br>delivery of diagnostic agents,<br>such as contrast media, and<br>liquid embolic agents that have<br>been approved or cleared for<br>use in the neurovasculature and<br>are compatible with the inner<br>lumen of the Scepter Mini<br>Occlusion Balloon Catheter. |
| Catheter OD | Proximal = 2.8 Fr<br>Distal = 2.6 Fr | Proximal = 2.8 Fr<br>Distal = 2.6 Fr | Proximal = 2.8 Fr<br>Distal = 1.6 Fr |
| Device<br>Characteristics | Scepter C Occlusion<br>Balloon Catheter<br>(K110741, K121785) | Scepter XC Occlusion<br>Balloon Catheter<br>(K113698, K121785) | Scepter Mini Occlusion<br>Balloon Catheter<br>(Subject Device) |
| Inner Lumen | 0.0165" | 0.0165" | 0.0100" - 0.0155" |
| Diameter | (0.419 mm) | (0.419 mm) | (0.254 mm - 0.394 mm) |
| (Distal to<br>Proximal) | Un-tapered inner lumen | Un-tapered inner lumen | Tapered inner lumen |
| | | | The Scepter Mini's inner lumen<br>incorporates a taper in order to<br>achieve a 1.6F distal OD, while<br>the inner lumen of Scepter C<br>and XC is straight. |
| Lumen<br>configuration | Dual coaxial lumen | Dual coaxial lumen | Same |
| Balloon Type | Compliant, Polyurethane | Extra Compliant, | Compliant, Polyurethane |
| | Elastomeric | Polyurethane Elastomeric | Elastomeric |
| Balloon<br>Diameter | 4 mm | 4 mm | 2.2 mm |
| Balloon Length | 10, 15, 20 mm | 11 mm | 9 mm |
| Working Length | 150 cm | 150 cm | 165 cm |
| Radiopaque<br>Marker Bands | 3 | 3 | 2<br>The predicate Scepter C and<br>XC<br>incorporate 3 radiopaque<br>marker bands, while the<br>Scepter Mini allows for<br>visualization under fluoroscopy<br>with 2 radiopaque marker<br>bands (due to the shorter distal<br>tip segment). |
| Air Purge | Purge hole | Purge hole | The air purge hole is covered by<br>a semi-permeable membrane<br>designed to allow the removal<br>of air from the balloon while<br>preventing escape of inflation<br>liquids. |
| Shaping Mandrel | Included in single<br>catheter package | Included in single catheter<br>package | None<br>The Scepter Mini distal tip is<br>not<br>shapeable therefore no<br>shaping mandrel is provided. |
| Introducer sheath | Included in single<br>catheter package | Included in single catheter<br>package | Same |
| Guidewire<br>Compatibility | 0.014" wire or smaller | 0.014" wire or smaller | 0.008" or smaller |
| Device<br>Characteristics | Scepter C Occlusion<br>Balloon Catheter<br>(K110741, K121785) | Scepter XC Occlusion<br>Balloon Catheter<br>(K113698, K121785) | Scepter Mini Occlusion<br>Balloon Catheter<br>(Subject Device) |
| Coating | Hydrophilic Coating | Hydrophilic Coating | Same |
| Hub | 2 port design | 2 port design | Same |
| Strain Relief | Dynaflex material | Dynaflex material | Pebax material |
| Packaging<br>Materi…
