(39 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter system, with no mention of AI or ML technologies.
Yes
The device is used to temporarily occlude blood vessels, which directly treats or controls a physiological condition (blood flow).
No
The device is described as an "Occlusion Balloon System" used for temporary occlusion in blood vessels to stop or control blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical balloon catheter system, including a guidewire, designed for temporary vascular occlusion. It does not mention any software components as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to temporarily occlude blood vessels in the peripheral and neuro vasculature. This is a direct intervention on the patient's body.
- Device Description: The device is a balloon catheter system designed for insertion into blood vessels. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is clearly designed for use in vivo.
N/A
Intended Use / Indications for Use
The HYPERGLIDE Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HYPERGLIDE Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
Product codes
MJN
Device Description
The HYPERGLIDE Occlusion Balloon System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a 0.010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall. The HYPERGLIDE Occlusion Balloon System is currently cleared for commercial distribution in sizes 4x10, 4x15, 4x20, 5x15 and 5x20. The System is packaged with a 0.010" X-pedion™ hydrophilic guidewire, also manufactured by Micro Therapeutics Inc. d/b/a ev3 Neurovascular, and cleared under K982543. The System is packaged in a sterile pouch and is 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 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The HYPERGLIDE Occlusion Balloon System was subjected to various testing to demonstrate substantial equivalence to the previously cleared balloon sizes. These tests included dimensional verifications, balloon compliance, balloon fatigue, burst testing, and inflation/deflation timing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP & 2 2009
510(k) Summary
Modification to HYPERGLIDE™ Occlusion Balloon System
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 d/b/a ev3 Neurovascular 9775 Toledo Wav Irvine. CA 92618
Contact Person:
- Submitter Information: Micro Therapeutics d/b/a ev3 Neurovascular 9775 Toledo Wav Irvine. CA 92618
Laurie Cartwright Manager, Global Regulatory Affairs
Summary Date: 13 August 2009
II. Device Name
Proprietary: HYPERGLIDE™ Occlusion Balloon System Common: Occlusion Balloon Catheter Classification: li Product Code: MJN CFR Section: 21 CFR 870.4450
III. Predicate Devices
Micro Therapeutics HYPERGLIDE Occlusion Balloon System cleared under 510(k) numbers K011526, K021066 and K090728.
IV. Device Description
The HYPERGLIDE Occlusion Balloon System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a 0.010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall. The HYPERGLIDE Occlusion Balloon System is currently cleared for commercial distribution in sizes 4x10, 4x15, 4x20, 5x15 and 5x20. The System is packaged with a 0.010" X-pedion™ hydrophilic guidewire, also manufactured by Micro Therapeutics Inc. d/b/a ev3 Neurovascular, and cleared under K982543. The System is packaged in a sterile pouch and is for single use only.
Intended Use V.
The HYPERGLIDE Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HYPERGLIDE Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
1
VII. Nonclinical Data
The HYPERGLIDE Occlusion Balloon System was subjected to various testing to demonstrate substantial equivalence to the previously cleared balloon sizes. These tests included dimensional verifications, balloon compliance, balloon fatigue, burst testing, and inflation/deflation timing.
VIII. Clinical Data
No clinical or animal data were included in this submission.
:
IX. Conclusions
The 3 mm HYPERGLIDE Occlusion Balloon System conforms to its performance specifications and is substantially equivalent to the previously cleared Micro Therapeutics HYPERGLIDE Occlusion Balloon System.
ii
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 2 2009
Micro Therapeutics Inc. d/b/a ev3 Neurovascular c/o Ms. Laurie Cartwright Manager, Global Regulatory Affairs 9775 Toledo Way Irvine, CA 92618
Re: K092495
Trade/Device Name: HyperGlide Occlusion Balloon System -Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: MJN Dated: August 13, 2009 Received: August 14, 2009
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.
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/ReportaProblem/default.htm for the CDRH's Officeof 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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Duna R. Verner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
1/092495
Device Name:
HYPERGLIDE™ Occlusion Balloon System
Indications for Use:
The HYPERGLIDE Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HYPERGLIDE Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
Prescription Use (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 D. Sd. Jones
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_Kog 2495