(278 days)
No
The 510(k) summary describes a mechanical balloon catheter and its physical characteristics, intended uses, and performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to selectively stop or control blood flow, deliver diagnostic agents, and assist in embolization of intracranial aneurysms, which are all therapeutic interventions or supportive of therapeutic procedures.
No
Explanation: The device is primarily used for temporary vascular occlusion and delivery of diagnostic or embolic agents, not for generating or interpreting diagnostic images or data itself. While it can deliver diagnostic agents, it is a delivery device, not a diagnostic device.
No
The device description clearly details a physical catheter with lumens, a balloon, marker bands, and a hydrophilic coating, indicating it is a hardware device. The performance studies also focus on physical and material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Scepter Mini Occlusion Balloon Catheter is a physical device inserted into the body's vasculature. Its primary functions are:
- Temporary Occlusion: Physically blocking blood flow.
- Delivery of Agents: Delivering diagnostic agents (like contrast media) or therapeutic agents (like liquid embolics) into the body.
- Lack of Sample Testing: The device does not perform any tests on samples outside of the body. It is an interventional device used within the body.
The intended uses and device description clearly indicate that this is a device used for procedures performed directly on the patient's vascular system, not for analyzing biological samples in a laboratory setting.
N/A
Intended Use / 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.
Product codes
MJN, DQY
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification Test Summary:
- Sterility: Subject device meets SAL 10-6 via Ethylene Oxide sterilization, fulfilling ISO 11135-1 requirements. EtO and ECH residual levels meet ISO 10993-7. Bacterial endotoxin test results are
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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. |
| 35 Enterprise | |
| Aliso Viejo, California 92656, USA | |
| Contact: | Marina Emond |
| Senior Manager, Regulatory Affairs | |
| Marina.Emond@Microvention.com | |
| (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
4
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
Characteristics | Scepter C Occlusion
Balloon Catheter
(K110741, K121785) | Scepter XC Occlusion
Balloon Catheter
(K113698, K121785) | Scepter Mini Occlusion
Balloon Catheter
(Subject Device) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification/
Product Code | Class II/ DQY
(Percutaneous catheters) | Class II/ DQY
(Percutaneous catheters) | Class II/ DQY
(Percutaneous catheters) |
| Intended Use | 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.
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 Occlusion Balloon
Catheters. | 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.
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 Occlusion Balloon
Catheters. | Similar Intended 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. |
| Catheter OD | Proximal = 2.8 Fr
Distal = 2.6 Fr | Proximal = 2.8 Fr
Distal = 2.6 Fr | Proximal = 2.8 Fr
Distal = 1.6 Fr |
| Device
Characteristics | Scepter C Occlusion
Balloon Catheter
(K110741, K121785) | Scepter XC Occlusion
Balloon Catheter
(K113698, K121785) | Scepter Mini Occlusion
Balloon Catheter
(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
Proximal) | Un-tapered inner lumen | Un-tapered inner lumen | Tapered inner lumen |
| | | | The Scepter Mini's inner lumen
incorporates a taper in order to
achieve a 1.6F distal OD, while
the inner lumen of Scepter C
and XC is straight. |
| Lumen
configuration | Dual coaxial lumen | Dual coaxial lumen | Same |
| Balloon Type | Compliant, Polyurethane | Extra Compliant, | Compliant, Polyurethane |
| | Elastomeric | Polyurethane Elastomeric | Elastomeric |
| Balloon
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
Marker Bands | 3 | 3 | 2
The predicate Scepter C and
XC
incorporate 3 radiopaque
marker bands, while the
Scepter Mini allows for
visualization under fluoroscopy
with 2 radiopaque marker
bands (due to the shorter distal
tip segment). |
| Air Purge | Purge hole | Purge hole | The air purge hole is covered by
a semi-permeable membrane
designed to allow the removal
of air from the balloon while
preventing escape of inflation
liquids. |
| Shaping Mandrel | Included in single
catheter package | Included in single catheter
package | None
The Scepter Mini distal tip is
not
shapeable therefore no
shaping mandrel is provided. |
| Introducer sheath | Included in single
catheter package | Included in single catheter
package | Same |
| Guidewire
Compatibility | 0.014" wire or smaller | 0.014" wire or smaller | 0.008" or smaller |
| Device
Characteristics | Scepter C Occlusion
Balloon Catheter
(K110741, K121785) | Scepter XC Occlusion
Balloon Catheter
(K113698, K121785) | Scepter Mini Occlusion
Balloon Catheter
(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
Material | Dispenser hoop: Polyethylene
Mounting card: Polyethylene
Pouch: Tyvek
Carton Box: Bleached Sulfate | Dispenser hoop: Polyethylene
Mounting card: Polyethylene
Pouch: Tyvek
Carton Box: Bleached Sulfate | Same packaging with an
additional stylet inserted in the
guide wire lumen for support of
the catheter while being
inserted in the packaging hoop.
The stylet is removed and
disposed of before use of the
catheter. |
| Package
Configuration | Microcatheter is placed in a dispenser hoop and
accessories on a mounting card that is then inserted
into the pouch. The pouch is then placed inside a
carton box. | Microcatheter is placed in a dispenser hoop and
accessories on a mounting card that is then inserted
into the pouch. The pouch is then placed inside a
carton box. | Same packaging with an
additional stylet inserted in the
guide wire lumen for support of
the catheter while being
inserted in the packaging hoop.
The stylet is removed and
disposed of before use of the
catheter. |
| Method of
Supplying | Sterile and single use | Sterile and single use | Same |
| Method of
Sterilization | Ethylene oxide | Ethylene oxide | Same |
Technological Characteristics Comparison of Subject Device with Predicate Device
6
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Verification Test Summary:
The results of verification and validation testing conducted on the subject device demonstrate that it performs as intended and are summarized as follows:
| Test Description | Result |
|---|---|
| Sterility | Subject device is processed under the same sterilization |
| method (Ethylene Oxide) and meets the same sterility | |
| assurance level (SAL 10-6) as predicates Scepter C/XC | |
| (K121785). | |
| Validation of the EtO sterilization method for Scepter Mini | |
| was conducted in accordance with requirements of ISO | |
| 11135-1, using the overkill method. | |
| The EtO and ECH residual levels were 0.2 mg per device | |
| respectively, meeting the residual level | |
| requirements per ISO 10993-7. | |
| The bacterial endotoxin test results were | |
| Physical Attributes | Pass |
| Physical dimensions of subject device meet design | |
| specifications. | |
| Force at break | Pass |
| Subject device does not break during use and meets same | |
| specification for force at break as predicates Scepter C/XC | |
| (K121785). | |
| Freedom from Leakage – Fluids (low | |
| pressure, long duration) | Pass |
| Subject device does not leak fluids at low pressure/long | |
| duration and meets same specification for freedom from | |
| leakage as predicates Scepter C/XC (K121785). | |
| Freedom from Leakage – Air | Pass |
| Air does not leak into subject device meeting same | |
| specification as predicates Scepter C/XC (K121785). | |
| Freedom from Leakage - Liquid (high | |
| pressure, short time) | Pass |
| Subject device does not leak fluids at high pressure/short | |
| duration and meets same specification for freedom from | |
| leakage as predicates Scepter C/XC (K121785). | |
| Test Description | Result |
| Burst Pressure of Catheter | Pass |
| Subject device does not burst statically below rated burst | |
| pressure meeting same specification as predicates Scepter | |
| C/XC (K121785). | |
| Gauging Test | Pass |
| Catheter luer compatible to other standard luer fittings. | |
| Data leveraged from predicate Scepter C (K110741, | |
| K121785) due to the same hub design. | |
| Separation Force | Pass |
| Catheter luer compatible to other standard luer fittings. | |
| Data leveraged from predicate Scepter C (K110741, | |
| K121785) due to the same hub design. | |
| Unscrewing Torque | Pass |
| Catheter luer compatible to other standard luer fittings. | |
| Data leveraged from predicate Scepter C (K110741, | |
| K121785) due to the same hub design. | |
| Ease of Assembly | Pass |
| Subject device luer mates together with other compatible | |
| fittings. | |
| Resistance to Overriding | Pass |
| Catheter luer mates with other compatible fittings. | |
| Data leveraged from predicate Scepter C (K110741, | |
| K121785) due to the same hub design. | |
| Stress Cracking | Pass |
| Catheter hub does not leak. | |
| Data leveraged from predicate Scepter C (K110741, | |
| K121785) due to the same hub design. | |
| Durability of Hydrophilic Coating | Pass |
| Hydrophilic coating does not flake off during use, is of the | |
| same material and meets same specification as predicates | |
| Scepter C/XC (K121785). | |
| Test Description | Result |
| Lubricity of Hydrophilic Coating | Pass |
| Hydrophilic coating is lubricious, of the same material and | |
| meets same specification as predicates Scepter C/XC | |
| (K121785). | |
| Simulated Use | Pass |
| Subject device demonstrated equivalent performance | |
| during simulated use with similar ratings to predicates | |
| Scepter C/XC (K121785). | |
| Compatibility with device/agents: | |
| Embolic material, contrast media, | |
| dimethyl sulfoxide (DMSO). | Pass |
| Subject device is compatible with embolic material, | |
| contrast media, and DMSO, meeting same specification as | |
| predicates Scepter C/XC (K121785). | |
| Dynamic Burst Pressure | Pass |
| Subject device does not burst dynamically below rated | |
| burst pressure and meets same specification as predicates | |
| Scepter C/XC (K121785). | |
| Radio-Detectability | Pass |
| Radiopaque marker bands are visualized under | |
| fluoroscopy. | |
| Kink resistance | Pass |
| Subject device does not kink during normal use meeting | |
| same specification as predicates Scepter C/XC. | |
| Non-pyrogenic | Pass |
| Subject device bacterial endotoxins level is less | |
| than 2.15 EU/device. | |
| Simulated Shipping and Packaging | |
| Testing | Pass |
| Subject device showed no defects that compromise | |
| integrity of package, met seal strength, creep to burst, and | |
| dye penetration specification. | |
| Catheter Flexural Fatigue | Pass |
| Subject device met same specification as predicates | |
| Scepter C/XC (K121785) for flexural fatigue, pressure | |
| integrity, and hoop stress. | |
| Test Description | Result |
| In Vivo Testing | |
| · In vivo performance characteristics | |
| • Histopathology evaluation | Pass |
| Data from the predicate device Scepter C | |
| (K110741 ) used to support safety and performance of the subject | |
| device due to its larger OD profile, higher stiffness and | |
| trackability force. | |
| Balloon Rated Burst Volume | Pass |
| Balloon does not burst during use meeting same | |
| specification as predicates Scepter C/XC (K121785). | |
| Balloon Compliance (rated volume) | Pass |
| Balloon consistently inflates to the desired OD meeting | |
| same specification as predicates Scepter C/XC (K121785). | |
| Balloon Inflation/Deflation Times | Pass |
| Balloon inflates and deflates within an acceptable time | |
| range meeting same specification as predicates Scepter | |
| C/XC (K121785). | |
| Balloon Fatigue Test | Pass |
| Balloon does not burst before acceptable minimum | |
| cycle(s) meeting same specification as predicates Scepter | |
| C/XC (K121785). | |
| Torque Test | Pass |
| Subject device maintains acceptable torque during use | |
| meeting same specification as predicates Scepter C/XC | |
| (K121785). | |
| Packaging and Shelf Life | Pass |
| Sterile barrier is maintained during shelf life of product. | |
| Insertion tool performance: Ease to | |
| enter RHV. | Pass |
| Ease to enter RHV rated 3 or higher in tested category | |
| meeting same specification as predicates Scepter C/XC | |
| (K121785). | |
| Decay Test | Pass |
| Balloon maintains rated burst OD for a minimum of 30 | |
| min meeting same specification as predicates Scepter | |
| C/XC (K121785). | |
| Test Description | Result |
| Surface Contamination | Pass |
| Subject device samples were inspected for surface | |
| contamination for uncured coating, particulate greater than | |
| 0.02 mm², sharp edges, and embedded particulate. All | |
| samples passed the acceptance criteria of | |
| No Contamination. | |
| Corrosion Resistance | Pass |
| Metallic components show no signs of corrosion. | |
| Data leveraged from reference device Headway 17 | |
| (K083343) as the metal components are of the same | |
| material. | |
| Catheter Particle Testing | Pass |
| Subject device demonstrated less than 25 particles greater | |
| than 10 microns and less than 3 particles greater than 25 | |
| microns per 1mL meeting same specification as predicates | |
| Scepter C/XC (K121785). |
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Animal Testing Summary:
Evaluation of the in-vivo performance characteristics of the MicroVention Scepter balloon catheters was performed using the predicate device Scepter C in an acute swine animal model compared with a commercially equivalent device. There were no significant differences between the Scepter C balloon catheter and the control catheter in categories of performance and histopathologic evaluation. There was no denudation, perforation, dissection, or clinicant injury to the target vasculature where the test device and the control device maneuvered through the swine anatomy. The Scepter C is considered the worst case for the Scepter Balloon Catheters in terms of in-vivo performance characteristics due to its larger OD profile, higher stiffness and trackability force. The proposed Scepter Mini device has smaller outer diameter profile and, based on the stiffness data, is softer, easier to track, and is less traumatic to the vessel. Therefore, the animal study results were leveraged from the predicate device.
Biocompatibility Evaluation:
The in vitro and in vivo biocompatibility safety studies performed on the Scepter Mini Occlusion Balloon Catheter have demonstrated the biocompatibility of the proposed device and support compliance with the ISO 10993-1:2009 and FDA guidelines. The device was determined to be nonsensitizing, intracutaneously non-irritating, systemically non-toxic, non-pyrogenic (material-mediated),
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non-hemolytic, non-complement activating, non-mutagenic, have no effect on clotting and hematological parameters, and have no clastogenic effect. The results of biocompatibility evaluation are summarized as follows:
| Test | Test Summary | Conclusions |
|---|---|---|
| Cytotoxicity - | ||
| Medium Eluate | ||
| Method | The test article extract exhibited between no cell lysis | |
| (grade 0) to slight reactivity (grade 1). | Non-cytotoxic | |
| Sensitization: | ||
| Maximization Test | ||
| in Guinea Pigs | No irritation was present on any of the test or negative | |
| control (0% sensitized) guinea pigs. | Non-sensitizer | |
| Intracutaneous | ||
| Reactivity | No evidence of irritation (score 0.0). | Non-irritating |
| Systemic Injection | ||
| Test in Mice | No weight loss, mortality, or evidence of systemic | |
| toxicity from the extract exposure to the mice was | ||
| observed. | Systemically | |
| non-toxic | ||
| Rabbit Pyrogen Test | The rise of rabbit temperatures during the three hours | |
| of observation did not exceed 0.5 ℃. | Nonpyrogenic | |
| ASTM Blood | ||
| Compatibility - | ||
| Direct and Indirect | ||
| Contact Hemolysis | The test article demonstrated 0.59% hemolysis in direct | |
| contact and 1.25% hemolysis in indirect contact. | Non-hemolytic | |
| Unactivated Partial | ||
| Thromboplastin | ||
| Time Test | An average clotting time of the test article showed no | |
| significant difference from the control. | No effect on | |
| clotting | ||
| Complement | ||
| Activation | The plasma exposed to the test article for 90 minutes was | |
| found to exhibit no statistically significant increase in | ||
| SC5b-9. | Non-activated | |
| In Vitro | ||
| Hemocompatibility | ||
| Test -Human Blood, | ||
| Direct Contact | The concentration of White Blood Cells (WBC) and | |
| Platelets in human blood exposed to the test article was | ||
| not statistically significantly decreased. | No effect on | |
| hematological | ||
| parameters | ||
| Salmonella | ||
| thvpimurium and | ||
| Escherichia coli | ||
| Reverse Mutation | ||
| Assay | The test article extracts did not induce a statistically | |
| significant increase in the number of revertant colonies. | Non-mutagenic | |
| Mouse Lymphoma | ||
| Mutagenesis Assay | The increased mutant frequency (IMF) of the cells | |
| exposed to the test article extracts was less than | ||
| the Global Evaluation Factor (GEF) 126 x 10-6. | Non-mutagenic | |
| Rodent Blood | ||
| Micronucleus Assay | The test article did not result in a statistically significant increase in | |
| the percentage of reticulocytes containing micronuclei. | No clastogenic | |
| effect |
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Summary of Substantial Equivalence:
The information presented in this 510(k) demonstrates the substantial equivalence between the predicates and the Scepter Mini Occlusion Balloon Catheter with regard to the design, construction materials, operating principle and intended use.