(22 days)
Not Found
No
The document describes a mechanical balloon catheter and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for use in selectively stopping or controlling blood flow and for balloon-assisted embolization of intracranial aneurysms, which are therapeutic interventions.
No
The device is described as an occlusion balloon catheter used for temporary vascular occlusion and balloon-assisted embolization, which are interventional procedures, not diagnostic ones.
No
The device description clearly describes a physical catheter and guidewire, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the body.
- Device Description and Intended Use: The provided information clearly describes a device used within the body (in blood vessels) for a therapeutic purpose (temporary occlusion and balloon-assisted embolization). It is an interventional device, not a diagnostic one.
- Lack of Diagnostic Information: The description does not mention any analysis of biological samples or the generation of diagnostic information.
Therefore, based on the provided text, the HyperForm™ Occlusion Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Occlusion Balloon Catheter is designed for the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.
The HyperForm™ Occlusion Balloon Catheters are indicated for the use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.
Product codes
MJN
Device Description
The Occlusion Balloon Catheter is a single lumen balloon catheter that requires the insertion of the 0.010" guidewire to occlude the central lumen to allow inflation of the balloon. When the distal 10 cm platinum coil tip of the guidewire is advanced to or past the catheter tip, it occludes the inflation holes allowing the balloon to inflate through catheter sideholes. The Occlusion Balloon Catheters are marketed as the HyperForm™ and HyperGlide™ Occlusion Balloon Systems which include a guidewire.
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 where temporary occlusion is desired, 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
The Occlusion Balloon Catheter devices have not changed; therefore there is no performance data included in this submission.
Key Metrics
Not Found
Predicate Device(s)
K092495, K091458, K090728, K021066, K011656
Reference Device(s)
Not Found
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
Special 510K ev3 Occlusion Balloon Catheters
3. 510(K) SUMMARY
Applicant - Manufacturer Name and Address Micro Therapeutics dba ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 Establishment Registration No. 2029214
Date: January 08, 2010
Contact Information
Laura Heaton Senior Regulatory Affairs Specialist Main: (949) 837-3700 Direct: (949) 680-1241 Fax: (949) 859-7228
Trade Names
HyperForm™ Occlusion Balloon Catheter HyperGlide™ Occlusion Balloon Catheter
Device Classification & Common Name
Product Code: MJN, 21CFR Part 870.4450 Classification: Class II Classification Name: Catheter, Intravascular Occluding, Temporary Common Name: Occlusion Balloon Catheter
Predicate Devices - 510(k) References
| HyperGlide™ Occlusion Balloon Catheter | K092495 |
|---|---|
| HyperGlide™ and HyperForm™ Occlusion Balloon Catheters | K091458 |
| HyperGlide™ Occlusion Balloon Catheter | K090728 |
| HyperGlide™ Occlusion Balloon Catheter | K021066 |
| HyperForm™ Occlusion Balloon Catheter | K011656 |
Description of the Device Subject to Premarket Notification
The Occlusion Balloon Catheter is a single lumen balloon catheter that requires the insertion of the 0.010" guidewire to occlude the central lumen to allow inflation of the balloon. When the distal 10 cm platinum coil tip of the guidewire is advanced to or past the catheter tip, it occludes the inflation holes allowing the balloon to inflate through catheter sideholes. The Occlusion Balloon Catheters are marketed as the HyperForm™ and HyperGlide™ Occlusion Balloon Systems which include a quidewire.
Indications for Use
The Occlusion Balloon Catheter is designed for the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.
FEB - 2 2010
100063 page 1 of 2
January 08, 2010
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K100063 page 2 of 2
Special 510K ev3 Occlusion Balloon Catheters
January 08, 2010
Performance Data
The Occlusion Balloon Catheter devices have not changed; therefore there is no performance data included in this submission. The Instructions for Use have been revised to remove the pediatric and neonatal contraindication.
Substantial Equivalence
The devices have not changed and no new risks have been identified. The indications for use demonstrate the ev3 Occlusion Balloon Catheters are substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three wing segments, positioned to the right of a circular emblem. The emblem contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
EB - 2 2010
EV3 Neurovascular c/o Laura Heaton Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618
Re: K100063
Trade/Device Name: Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: MJN Dated: January 8, 2010 Received: January 15, 2010
Dear Ms. Heaton:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are 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 devices comply with other requirements of the Act
3
Page 2 - Ms. Laura Heaton
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 devices on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.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 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.
Sincerely yours,
Sincerely yours,
Bram D. Zyokerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510K ev3 Occlusion Balloon Catheters
January 08, 2010
2. STATEMENT OF INDICATIONS FOR USE
Indications for Use
510(k) Number (if known):
Device Name: HyperForm TM Occlusion Balloon Catheters
Indications for Use: The HyperForm™ Occlusion Balloon Catheters are indicated for the use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurvsms.
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)
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Num K100063
CONFIDENTIAL
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