(197 days)
The Scepter C 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.
The Scepter C 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. 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 provided text describes a 510(k) premarket notification for a medical device (Scepter C Occlusion Balloon Catheter), not an AI/ML-based device. Therefore, the request for acceptance criteria and study details related to an AI/ML device, as well as specific information like multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for training and test sets, cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to a predicate device through pre-clinical testing, material comparisons, and shared intended use. It does not contain information about AI/ML algorithm performance metrics, human-in-the-loop studies, or the methodologies used to establish ground truth in the context of an AI system.
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K110741
P. 1 of 3
SEP 2 9 2011
510(k) Summary
| Trade Name: | Scepter C Occlusion Balloon Catheter |
|---|---|
| Generic Name: | Occlusion Balloon Catheter |
| Classification: | Class IIMJN - Catheter, intravascular occluding, temporary21 CFR 870.4450 - Vascular clamp |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A.714-247-8000 |
| Date Prepared: | March 15, 2011 |
| Contact: | Naomi Gong |
| Number | Description |
|---|---|
| K091458 | ev3 Neurovascular – HyperForm and |
| K091458 | ev3 Neurovascular – HyperForm andHyperGlide Balloon System | October 15, 2009 |
|---|---|---|
| --------- | ---------------------------------------------------------------- | ------------------ |
Device Description:
The Scepter C 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. 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 C 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 |
| Animal testing - acute study compared to predicate device | Pass |
| Bicompatibility testing (ISO 10993-1) | Pass |
Technological Comparison:
ﮯ
| Predicate Device (K091458) | 510(k) Subject Device | |
|---|---|---|
| Intended Use | For use in the blood vessels of theperipheral and neurovasculature wheretemporary occlusion is desired. Thesecatheters offer a vessel selectivetechnique of temporary vascularocclusion which is useful in selectivelystopping or controlling blood flow andfor balloon assisted embolization ofintracranial aneurysms | Same |
| Lumen configuration | Single lumen | Dual coaxial lumen |
| Inner Diameter | 0.010" | 0.0165" |
| Outer Diameter | 2.2 - 2.8 F | 2.6 - 2.8 F |
| Balloon Diameter/Length | 3-5 mm/ 10-30 mm | 4 mm/10-20 mm |
| Material | Polyether block amide, polyolefin,stainless steel, PTFE, chronoprene,Pt alloy, polypropylene | Polyether block amide,polyolefin, stainless steel, PTFE,polyurethane elastomeric alloy,Pt/Ir, nylon |
| No. of Markers | 2 | 3 |
| Coating | Hydrophilic coating | Same |
| Guidewire compatibility | 0.010" wire | 0.014" or smaller wire |
| Method of supply | Sterile and single use | Same |
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K110741
p. 3 of 3
Summary of Other Information:
Other information provided in the 510(k) included published studies of balloon use. In addition, an in vivo animal study demonstrated safety including performance/handing.
Summary of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the Scepter C Occlusion Catheter when compared with the predicate device, evise HyperForm and HyperGlide Balloon System (K091458).
The devices,
- Have the same intended use, 트
- Use the same operating principle, ■
- 트 Incorporate the same basic design,
- 트 Use similar construction and material,
- Are sterilized using same methods and processes. 트
In summary, the Scepter C Occlusion Balloon Catheter described in this submission is, in our opinion, substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
MicroVention, Inc. c/o Naomi Gong Regulatory Affairs Project Manager l 311 Valencia Avenue Tustin, CA 92780
SEP 29 2011
Re: K110741
Trade/Device Name: Scepter C Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: July 29, 2011 Received: August 01, 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 In Microu in Intelsstate devices that have been reclassified in accordance with the provisions of the Federal Food, Dr io 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, ilsting 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 of educations of class in (FMA).
found in the Galine SE at CE at CE at the major regulations affecting your 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 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 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 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,
ll l
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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Indications for Use
KII 0741 510(k) Number (if known):
Device Name: Scepter C Occlusion Balloon Catheter
Indications For Use:
The Scepter C Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catherer 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 AND/OR (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)
(Division Sign-Off)
vascular Devices
510(k) Number K110741
§ 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).