(39 days)
Not Found
No
The description focuses on the mechanical function of a balloon catheter for temporary vascular occlusion and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes
The device is used to temporarily stop blood flow in vessels and assist in embolization, which are therapeutic interventions.
No
The device is described as an occlusion balloon catheter used for temporary vascular occlusion, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter with a balloon, guidewire, and packaging, indicating it is a hardware medical 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 within the body for temporary vascular occlusion and balloon-assisted embolization. This is an in vivo application.
- Device Description: The description details a catheter designed for insertion into blood vessels, which is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a therapeutic and interventional device used directly within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral The BVS Occusion Balloon Outlotors are indication is desired. These catheters offer a vessely aria neuro vasculature where temporary ooskular is which is useful in selectively stopping
selective technique of temporary vascular occlusion, which is useful in selectively selective lechnique of temporary valocular Catheters may also be used in balloonassisted embolization of intracranial aneurysms.
Product codes
MJN
Device Description
The ev3 Occlusion Balloon Catheters are single lumen, open-ended balloon catheters designed for advancement into the vasculature over a 0.010" guidewire. Balloon inflation is accomplished by advancement of the guidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall.
The Occlusion Balloon Catheters are available in diameters ranging from 3 to 7 mm and lengths ranging from 7 to 30 mm.
The devices are packaged in a sterile pouch and are intended 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 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
No nonclinical data was included in this submission.
Description of the test set, sample size, data source, and annotation protocol
No clinical or animal data were included in this submission.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No nonclinical data was included in this submission. No clinical or animal data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K990487, K001237, K010162, K011526, K011656, K021066, K090728, K091458, K092495 and K100063
Reference Device(s)
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
JUL 1 3 2010
ev3 Occlusion Balloon Catheters
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter Information: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618 |
|------------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Laurie Cartwright
Manager, Global Regulatory Affairs |
Summary Date: 27 May 2010
II. Device Name
| Proprietary: | HYPERGLIDE TM and HYPERFORM TM |
|---|---|
| Common: | Occlusion Balloon Catheter |
| Classification: | II |
| Product Code: | MJN |
| CFR Section: | 21 CFR 870.4450 |
III. Predicate Devices
The ev3 Occlusion Balloon Catheters are substantially equivalent to the previously cleared occlusion balloon catheters cleared under 510(k)s K990487, K001237, K010162, K011526, K011656, K021066, K090728, K091458, K092495 and K100063.
IV. Device Description
The ev3 Occlusion Balloon Catheters are single lumen, open-ended balloon catheters designed for advancement into the vasculature over a 0.010" guidewire. Balloon inflation is accomplished by advancement of the guidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall.
The Occlusion Balloon Catheters are available in diameters ranging from 3 to 7 mm and lengths ranging from 7 to 30 mm.
The devices are packaged in a sterile pouch and are intended for single use only.
V. Intended Use
The ev3 Occlusion Balloon Catheters are intended for use in the peripheral and neuro vasculature wherever temporary occlusion is desired as well as for balloonassisted embolization of intracranial aneurysms.
1
Nonclinical Data VII.
No nonclinical data was included in this submission.
VIII. Clinical Data
No clinical or animal data were included in this submission.
Conclusions IX.
The ev3 Occlusion Balloon Catheters are substantially equivalent to the previously The CVS Occludion Balloon Satholor Clearers on Balloon Systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Micro Therapeutics DBA ev3 Neurovascular c/o Ms. Laurie Cartwright Manager, Global Regulatory Affairs 9775 Toledo Way Irvine, CA 92618
JUL 1 3 2010
Re: K101570
HyperGlide and HyperForm Occlusion Balloons Regulation Number: 21 CFR§ 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (Two) Product Code: MJN Dated: May 27, 2010 Received: June 4, 2010
Dear Ms. Cartwright:
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.
3
Page 2 - Ms. Laurie Cartwright
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcestoYou/Industry/default.htm.
Sincerely yours.
una R. Varner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K10 | 570
HYPERGLIDE™ and HYPERFORM™ Occlusion Balloon Systems Device Name:
Indications for Use:
The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral The BVS Occusion Balloon Outlotors are indication is desired. These catheters offer a vessely aria neuro vasculature where temporary ooskular is which is useful in selectively stopping
selective technique of temporary vascular occlusion, which is useful in selectively selective lechnique of temporary valocular Catheters may also be used in balloonassisted embolization of intracranial aneurysms.
Prescription Use |X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vi line
(Division Sign-Off) Division of Cardiovascular Devices Page 1 of 1
510(k) Number_K_10) 570