(28 days)
Not Found
No
The document describes a physical medical device (balloon catheter) and its intended use and performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for temporary vascular occlusion to control blood flow and for balloon-assisted embolization of intracranial aneurysms, which are therapeutic interventions.
No
The Scepter XC Occlusion Balloon Catheter is used for temporary vascular occlusion and balloon-assisted embolization, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly details a physical catheter with a balloon, lumens, marker bands, and a hydrophilic coating. It is a hardware device used for temporary vascular occlusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used within the body (in vivo) for temporary vascular occlusion and balloon-assisted embolization. IVDs are used to examine specimens from the body (in vitro) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a catheter designed to be inserted into blood vessels, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, nor any indication of providing diagnostic information based on such analysis.
The Scepter XC Occlusion Balloon Catheter is a medical device used for interventional procedures within the vascular system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MJN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neurovasculature, intracranial aneurysms
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)
Pre-clinical Testing:
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| Contact: | Naomi Gong |
| Date Prepared: | December 15, 2011 |
| Predicate Device: |
| Number | Description | Clearance Date |
|---|---|---|
| K110741 | MicroVention Scepter C Occlusion | |
| 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.
1
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, | |
| stainless steel, PTFE, polyurethane | ||
| elastomeric alloy, Pt/Ir, nylon, | ||
| 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 |
2
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.
3
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.
4
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
(800) 036-2041 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
5
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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