(53 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its intended use and performance testing. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The intended use states that the device is for the "infusion of ... therapeutic agents" and for "balloon assisted embolization of intracranial aneurysms," which are therapeutic applications.
Yes
The device is indicated for the infusion of diagnostic agents, such as contrast media, for fluoroscopic visualization, which falls under the definition of providing information for diagnosis.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for temporary vascular occlusion and infusion of agents directly into blood vessels. IVDs are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with a balloon for occlusion and lumens for infusion. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Anatomical Site: The specified anatomical site is "blood vessels of the peripheral and neurovasculature," which are internal body structures.
- Input Imaging Modality: Fluoroscopic visualization is an imaging technique used to view structures inside the body.
- Performance Studies: The performance studies described involve testing the physical properties of the catheter and its compatibility with agents and biological systems, which are relevant to an in vivo device. There are no studies related to analyzing biological specimens.
In summary, the Scepter C/XC Balloon Catheter is a medical device used for interventional procedures within the body, not for analyzing samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MJN, DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels of the peripheral and neurovasculature, peripheral vasculature, 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:
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 agents Delivery 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 assay Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization - Intracutaneous reactivity Hemocompatibility (ISO 10993-4) - Hemolysis - UPTT - Complement activation C3a and SC5b-9 - 4 hour thromboresistance in dogs Systemic 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).
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
AUG 10 2012
| Trade Name: | Scepter C Occlusion Balloon Catheter
Scepter XC Occlusion Balloon Catheter |
|-----------------|---------------------------------------------------------------------------------------------------|
| Generic Name: | Occlusion Balloon Catheter |
| Classification: | Class II
MJN, 21 CFR 870.4450 (Vascular Clamp)
DQY, 21 CFR 870.1250 (Percutaneous Catheter) |
| Submitted By: | MicroVention, Inc
1311 Valencia Avenue
Tustin, 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.
1
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 agents | |
| Delivery 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 assay | |
| Sensitization/Irritation (ISO 10993-10) |
- Guinea pig maximization sensitization
- Intracutaneous reactivity
Hemocompatibility (ISO 10993-4) - Hemolysis
- UPTT
- Complement activation C3a and SC5b-9
- 4 hour thromboresistance in dogs
Systemic 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).
2
K121785 page 3 of 4
.
.
・
Technological Comparison:
| | Predicate Device
Scepter C/XC
(K110741/K113698) | Predicate Device
Headway 17
(K083343) | 510(k) Subject Device |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 also offers
balloon assisted
embolization of intracranial
aneurysms. | For general
intravascular use,
including the
peripheral,
coronary, and
neurovasculature,
for the infusion of
diagnostic agents,
such as contrast
media, and
therapeutic agents,
such as occlusion
coils. | 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 also offers balloon assisted
embolization of intracranial aneurysms.
For general intravascular use, including the
peripheral and neurovasculature, for the
infusion of diagnostic agents, such as
contrast media, and therapeutic agents, such
as embolization materials. |
| Lumen
configuration | Dual coaxial lumen | Single lumen | Same as Scepter C/XC |
| Inner Center
Lumen Diameter | 0.0165" | 0.017" | Same as Scepter C/XC |
| Outer Diameter | 2.6 - 2.8F | | Same as Scepter C/XC |
| Balloon
Diameter/Length | 4 mm/ 10-20 mm | N/A | Same as Scepter C/XC |
| Material | Polyether block amide,
polyolefin, stainless
steel, PTFE,
polyurethane elastomeric
alloy, Pt alloy,
polypropylene | | Same as Scepter C/XC |
| Introducer
sheath | N/A | Yes | Yes |
| Shaping
·Mandrel | N/A | Yes | Yes |
| Distal tip
shaping | N/A | Yes | Yes |
| Guidewire
compatibility | 0.014" wire or smaller | Same | Same |
| Method of
supply | Sterile and single use | Same | Same |
・
:
. : ·
3
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.
4
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
5
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
6
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_
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