(53 days)
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.
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.
The Scepter C and XC Occlusion Balloon Catheter is intended for temporary occlusion in peripheral and neurovasculature, controlling blood flow for balloon-assisted embolization of intracranial aneurysms, and infusing diagnostic and therapeutic agents in peripheral and neurovascular applications.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes pre-clinical testing performed on the Scepter C and XC Occlusion Balloon Catheter. The acceptance criterion for each test is implicitly "Pass," indicating that the device must meet the specified performance standards for each category.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual Inspection must pass | Pass |
| Tensile strength must pass | Pass |
| Leakage (liquid and air) must pass | Pass |
| Static and dynamic burst pressure must pass | Pass |
| Simulated use must pass | Pass |
| Catheter flexural fatigue must pass | Pass |
| Compatibility with diagnostic and therapeutic agents must pass | Pass |
| Delivery of embolization materials (i.e. Onyx®) must pass | Pass |
| Balloon testing (burst, compliance, deflation time, fatigue) must pass | Pass |
| DMSO Compatibility must pass | Pass |
| Biocompatibility testing (Cytotoxicity, Sensitization/Irritation, Hemocompatibility, Systemic Toxicity) must pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each pre-clinical test. The testing is referred to as "Pre-clinical Testing," which typically involves laboratory-based assessments rather than human or animal studies with large sample sizes.
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's pre-clinical testing for a 510(k) submission, it's virtually certain to be prospective, laboratory-based testing conducted by the manufacturer, MicroVention, Inc., based in Tustin, California, U.S.A.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For pre-clinical engineering and biocompatibility tests, ground truth is established by standardized test methods and criteria, not by expert consensus on clinical images or patient outcomes. The "ground truth" is defined by the physical or chemical properties being measured against established regulatory standards (e.g., ISO standards for biocompatibility).
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or image interpretation studies where there's variability in expert assessment. For pre-clinical engineering tests, results are typically objective measurements against defined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices, especially those involving human interpretation of medical images (e.g., radiologists reading scans with and without AI assistance). The Scepter C and XC Occlusion Balloon Catheter is an interventional device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. This type of study is specifically for evaluating the performance of AI algorithms without human intervention. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used:
The ground truth used for these pre-clinical tests is based on engineering specifications, standardized test methods, and regulatory requirements (e.g., ISO 10993 for biocompatibility). For example, "Tensile strength Pass" implies the device met a pre-defined tensile strength threshold established by engineering design and industry standards; "Cytotoxicity (ISO 10993-5) Pass" means the device met the criteria outlined in that specific ISO standard for cytotoxicity.
8. Sample Size for the Training Set:
Not applicable. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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510(k) Summary
AUG 10 2012
| Trade Name: | Scepter C Occlusion Balloon CatheterScepter XC Occlusion Balloon Catheter |
|---|---|
| Generic Name: | Occlusion Balloon Catheter |
| Classification: | Class IIMJN, 21 CFR 870.4450 (Vascular Clamp)DQY, 21 CFR 870.1250 (Percutaneous Catheter) |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, 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 agentsDelivery of embolization materials (i.e. Onyx®) | Pass |
| Balloon testing - burst, compliance, deflation time, fatigue | Pass |
| DMSO Compatibility | Pass |
| Bicompatibility testing:Cytotoxicity (ISO 10993-5)MEM elution assaySensitization/Irritation (ISO 10993-10)- Guinea pig maximization sensitization- Intracutaneous reactivityHemocompatibility (ISO 10993-4)- Hemolysis- UPTT- Complement activation C3a and SC5b-9- 4 hour thromboresistance in dogsSystemic 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 DeviceScepter C/XC(K110741/K113698) | Predicate DeviceHeadway 17(K083343) | 510(k) Subject Device | |
|---|---|---|---|
| Intended Use | For use in the blood vesselsof the peripheral andneurovasculature wheretemporary occlusion isdesired. These cathetersoffer a vessel selectivetechnique of temporaryvascular occlusion which isuseful in selectivelystopping or controllingblood flow and also offersballoon assistedembolization of intracranialaneurysms. | For generalintravascular use,including theperipheral,coronary, andneurovasculature,for the infusion ofdiagnostic agents,such as contrastmedia, andtherapeutic agents,such as occlusioncoils. | For use in the blood vessels of theperipheral and neurovasculature wheretemporary occlusion is desired. Thesecatheters offer a vessel selective techniqueof temporary vascular occlusion which isuseful in selectively stopping or controllingblood flow and also offers balloon assistedembolization of intracranial aneurysms.For general intravascular use, including theperipheral and neurovasculature, for theinfusion of diagnostic agents, such ascontrast media, and therapeutic agents, suchas embolization materials. |
| Lumenconfiguration | Dual coaxial lumen | Single lumen | Same as Scepter C/XC |
| Inner CenterLumen Diameter | 0.0165" | 0.017" | Same as Scepter C/XC |
| Outer Diameter | 2.6 - 2.8F | Same as Scepter C/XC | |
| BalloonDiameter/Length | 4 mm/ 10-20 mm | N/A | Same as Scepter C/XC |
| Material | Polyether block amide,polyolefin, stainlesssteel, PTFE,polyurethane elastomericalloy, Pt alloy,polypropylene | Same as Scepter C/XC | |
| Introducersheath | N/A | Yes | Yes |
| Shaping·Mandrel | N/A | Yes | Yes |
| Distal tipshaping | N/A | Yes | Yes |
| Guidewirecompatibility | 0.014" wire or smaller | Same | Same |
| Method ofsupply | 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 (800) 638-2041 or (301) 796-7100 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_
Page 1 of 1
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).