HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL

K100063 · Ev3, Inc. · MJN · Feb 2, 2010 · Cardiovascular

Device Facts

Record IDK100063
Device NameHYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
ApplicantEv3, Inc.
Product CodeMJN · Cardiovascular
Decision DateFeb 2, 2010
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 870.4450
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

Single lumen balloon catheter; requires 0.010" guidewire for operation. Guidewire distal 10 cm platinum coil tip advances to or past catheter tip to occlude central lumen; allows balloon inflation via catheter sideholes. Used in peripheral and neuro vasculature for temporary blood flow control or balloon-assisted embolization of intracranial aneurysms. Operated by physicians in clinical settings. Provides vessel-selective occlusion to assist in interventional procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single lumen balloon catheter; includes 0.010" guidewire with 10 cm platinum coil tip. Mechanical inflation mechanism via guidewire-controlled sidehole occlusion. Class II device (21 CFR 870.4450).

Indications for Use

Indicated for patients requiring temporary vascular occlusion in peripheral and neuro vasculature, including balloon-assisted embolization of intracranial aneurysms.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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 6 {1}------------------------------------------------ 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. {2}------------------------------------------------ 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}------------------------------------------------ K100063 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 4
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%