(150 days)
Not Found
No
The document describes a physical medical device (balloon catheter) and its intended use for temporary vascular occlusion. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as "Occlusion Balloon Catheters," which are used in medical procedures to temporarily stop or control blood flow, or for balloon-assisted embolization of intracranial aneurysms, all of which are therapeutic interventions.
No
The device description indicates that the catheters are used for "temporary occlusion" and "balloon-assisted embolization," which are therapeutic interventions rather than diagnostic procedures. The mention of "platinum markers provide angiographic" indicates visualization during a procedure, not a diagnostic function of the device itself.
No
The device description clearly describes a physical catheter with a balloon, which is a hardware component.
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, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a catheter with a balloon designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing diagnostic tests outside the body.
Therefore, this device falls under the category of an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The MTI HyperForm™ Occlusion Balloon Catheters are indicated for 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 balloonassisted embolization of intracranial aneurysms,
The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for 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 balloonassisted embolization of intracranial aneurysms.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The HyperForm™ Occlusion Balloon Catheter is a single lumen tapered catheter with a non-detachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No bench testing and biocompatibility testing was performed to support a determination of substantial equivalence. Results from submitters experience and literature review provides assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Equinox Occlusion Balloon Catheter (K001237), HyperForm Occlusion Balloon Catheter (K011656), and HyperGlide Occlusion Balloon Catheter (K011526, K090728).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
OCT 1 5 2009
HyperForm™ Occlusion Balloon Catheter HyperGlide™ Occlusion Balloon Catheter
A TO BALL A MARK A BALL A BALL A BALL A BALL A BALL A BALL A BALL A BALL A BALA BALA BALA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R § 807.92. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Micro Therapeutics, Inc. dba ev3 Neurovascular |
| Submitter | Micro Therapeutics, Inc.
9775 Toledo Way
Irvine, CA 92618
Tel: 949-680-1237
Fax: 949-465-1737 |
| Contact Person | Tom Daughters
Director, Regulatory Affairs |
| Date Prepared | May 8, 2009 |
| Device Trade Name | HyperForm™ Occlusion Balloon Catheter
HyperGlide™ Occlusion Balloon Catheter |
| Device Common Name | Occlusion Balloon Catheter |
| Classification Name | Catheter, Intravascular Occluding, Temporary (21 CFR 870.4450,
Product Code MJN |
| Classification Panel | Cardiovascular |
| Predicate Devices | Equinox Occlusion Balloon Catheter (K001237), HyperForm
Occlusion Balloon Catheter (K011656), and HyperGlide Occlusion
Balloon Catheter (K011526, K090728). |
| Intended use | The MTI HyperForm™ Occlusion Balloon Catheters are indicated for
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. |
| Intended use | The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for
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. |
| Device Description | The HyperForm™ Occlusion Balloon Catheter is a single lumen
tapered catheter with a non-detachable low inflation pressure
compliant balloon attached to the distal end of the catheter. The
catheter is designed to track over a 0.010" guidewire, and requires
insertion of the guidewire to occlude the catheter shaft lumen to allow
inflation of the balloon. Two platinum markers provide angiographic |
| Performance data | No bench testing and biocompatibility testing was performed to support a determination of substantial equivalence. Results from submitters experience and literature review provides assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. |
| Summary of Substantial
Equivalence | The proposed HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are identical to the predicate devices and use the same basic technology as the predicate devices. The proposed devices share the following similarities to the predicate devices:
Same intended use (all predicates) Same balloon technology and specifications (all predicates) Same catheter technology and characteristics (all predicates) Same other product technology and specifications (all predicates) |
| Conclusion | Based on the similar indications for use, technological characteristics and performance testing, ev3 believes the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are substantially equivalent to the Equinox Occlusion Balloon Catheter (K001237), the HyperForm™ Occlusion Balloon Catheter (K011656), and the HyperGlide™ Occlusion Balloon Catheter (K011526, K090728). |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. To the left of the eagle is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
ev3 Neurovascular ATTN: Tom Daughters Director, Regulatory Affairs 9775 Toledo Way Irvine, CA 92618
OCT 1 5 2009
Re: K091458
Trade/Device Name: Hyperform & Hyperglide Occlusion Balloon Catheters Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 18, 2009 Received: September 21, 2009
Dear Mr. Daughters:
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. Ilsting 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.
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
3
Page 2 - Mr. Daughters
forth in the quality systems (OS) 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 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,
Duna R. Hohner
Image /page/3/Picture/7 description: The image shows a black and white drawing of a signature. The signature is stylized and difficult to read, but it appears to have a loop at the top and a sharp angle at the bottom. The signature is on a white background.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use Statement
1091458 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: HyperForm™ Occlusion Balloon Catheters
HyperGlide™ Occlusion Balloon Catheters
Indications for Use:
The MTI HyperForm™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vesscl selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms,
The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for 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 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)
Duma R. Lielmes
Division Sign-Off)
ivision of Cardiovascular Devices
510(k) Number K091458