(28 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 software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to temporarily stop or control blood flow in blood vessels, which is a therapeutic intervention.
No
The device is indicated for temporary occlusion of blood vessels to 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, and mentions performance testing standards related to physical device characteristics (dimensional verification, balloon fatigue, tensile strength, etc.). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary occlusion... in the blood vessels of the peripheral and neuro vasculature." This describes a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The description details a balloon catheter and guidewire, which are instruments used for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely mechanical and interventional.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HyperGlide™ Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. The HyperGlide™ Occlusion Balloon System 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 .010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end, redirecting inflation media to the balloon through side-holes in the catheter wall. The HyperGlide™ Occlusion Balloon System is currently cleared for commercial distribution for sizes 4x10, 4x15, 4x20, and 4x30. The HyperGlide™ Occlusion Balloon System is packaged with a .010" Xpedian™ hydrophilic guidewire, manufactured by Micro Therapeutics, Inc., d/b/a ev3 Neurovascular and cleared under K982543. The device is sold and packaged with a .010" guidewire in a sterile pouch and 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
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)
The HyperGlide™ Occlusion Balloon System was verified and tested according to performance testing standards ISO 10555 Sterile, Single Use Intravascular Catheters - Parts 1 and 4 These tests include dimensional verification. balloon fatigue, catheter tensile strength, torque strength, flexibility, burst testing, and so on. The test results demonstrated in this submission meet or exceed the requirements of these standards and prove that the subject device of this submission is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
$\overline{1690728}$
510(k) Summary 7.
APR 1 6 2009
| Applicant: | Micro Therapeutics, Inc., dba ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
USA
Phone: 949.680.1293
Fax: 949.859.7228 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 16, 2009 |
| Contact Person: | Jason K. Lyon
Manager, Regulatory Affairs |
| Proprietary Device Name: | HyperGlide™ Occlusion Balloon System |
| Common Device Name: | Occlusion Balloon Catheter
(21 CFR 870.4450, Product Code MJN) |
| Classification: | Class II |
| Predicate Devices: | Micro Therapeutics, Inc. Equinox™ Occlusion
Balloon Catheter (later changed to HyperGlide™)
cleared under K011526.
Micro Therapeutics, Inc., HyperGlide™ Occlusion
Balloon System
cleared under K021066 |
| Manufacturer: | Micro Therapeutics, Inc., ev3 Neurovascular a
division of ev3, Inc.
9775 Toledo Way
Irvine, CA 92618
USA |
| 7.1
Substantially Equivalent To: | |
| The HyperGlide™ Occlusion Balloon (5mm version) is substantially equivalent to
the HyperGlide™ Occlusion Balloon family (4mm version) and the HyperForm™
Occlusion Balloon System (7mm version) in that the intended use, design, | |
Confidential
. ' .
1
specifications, and materials are the same. The HyperGlide™ Occlusion Balloon (5mm version) is affixed (thermally bonded) to the same catheter size 2.8F proximal and 2.2F distal as the cleared HyperGlide™ Occlusion Balloon (4mm version). The methods, materials in construction, packaging, and sterilization are the same as the predicate versions. Furthermore, the Indications For Use is identical and does not alter the fundamental scientific technology of the HyperGlide™ Occlusion Balloon System. A summary of equivalency is below. (See Section 11 and ATTACHMENT 3 for DVT Test Report and Balloon Data).
7.2 Description of the Device Subject to Premarket Notification:
The HyperGlide™ Occlusion Balloon System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a .010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end, redirecting inflation media to the balloon through side-holes in the catheter wall. The HyperGlide™ Occlusion Balloon System is currently cleared for commercial distribution for sizes 4x10, 4x15, 4x20, and 4x30. The HyperGlide™ Occlusion Balloon System is packaged with a .010" Xpedian™ hydrophilic guidewire, manufactured by Micro Therapeutics, Inc., d/b/a ev3 Neurovascular and cleared under K982543. The device is sold and packaged with a .010" guidewire in a sterile pouch and for single use only.
- 7.3
Indications For Use:
The HyperGlide™ Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. The HyperGlide™ Occlusion Balloon System offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow,
- 7.4
Performance Data:
The HyperGlide™ Occlusion Balloon System was verified and tested according to performance testing standards ISO 10555 Sterile, Single Use Intravascular Catheters - Parts 1 and 4 These tests include dimensional verification. balloon fatigue, catheter tensile strength, torque strength, flexibility, burst testing, and so on. The test results demonstrated in this submission meet or exceed the requirements of these standards and prove that the subject device of this submission is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2009
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular c/o Mr. Jason K. Lyon Manager, Regulatory Affairs 9775 Toledo Way Irvine, CA 92618
Re: K090728
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: March 18, 2009 Received: March 19, 2009
Dear Mr. Lyon:
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 - Mr. Jason K. Lyon
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely Mours,
t
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use 6.
Indications for Use
510(k) Number (if known):
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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 16090728
Page 1 of __
Confidential