(196 days)
Not Found
Not Found
No
The summary describes a mechanical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is designed for "temporary occlusion" of blood vessels to "selectively stopping or controlling blood flow," which is a therapeutic action.
No
This device is described as an "Occlusion Balloon Catheter" designed for "temporary occlusion" and "selectively stopping or controlling blood flow." Its function is therapeutic (to block blood flow), not diagnostic (to identify or measure a condition). While it uses "angiographic visualization" for placement, this is a procedural aid, not a diagnostic output of the device itself.
No
The device description clearly details a physical catheter with a balloon, guidewire, and other hardware components. There is no mention of software as the primary or sole component 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 for temporary occlusion of blood vessels within the body during medical procedures. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is a catheter designed to be inserted into blood vessels. It uses a balloon to physically block blood flow. This is a therapeutic/interventional device, not a diagnostic one that analyzes samples.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (like blood, urine, tissue) to diagnose a condition or provide information about a patient's health status. Its function is purely mechanical and procedural.
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 Micro Therapeutics, Inc. Occlusion Balloon Catheter is designed for use in blood vessels where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The Equinox™ Occlusion Balloon Catheter is a single lumen balloon catheter with a maximum outer diameter of 2.8F tapering to 2.2F at the distal tip. The distal end of the catheter has a non-detachable low inflation pressure compliant balloon. The catheter is designed to track over the MTI SilverSpeed™ 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 visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The Equinox catheter is supplied sterile for single use as a system which includes the required SilverSpeed .010" Guidewire and a rotating hemostatic valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
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)
Biocompatibility of the Equinox catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the Equinox catheter when tested as an external communicating, blood contact, short duration (
§ 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 of Safety and Effectiveness Equinox™ Occlusion Balloon Catheter Prepared June 4, 1999
| TRADE NAME: | Equinox™ Occlusion Balloon System | ||
|---|---|---|---|
| GENERIC NAME: | Occlusion Balloon Catheter | CLASSIFICATION: | Class II |
| SUBMITTED BY: | Micro Therapeutics, Inc. | ||
| 2 Goodyear | |||
| Irvine, CA 92618 | CONTACT: | Tom Daughters | |
| Regulatory Affairs | |||
| (949) 837-3700 |
PREDICATE DEVICES
Target Therapeutics, Inc (BSC). Endeavor Coaxial Catheter
DEVICE DESCRIPTION
The Equinox™ Occlusion Balloon Catheter is a single lumen balloon catheter with a maximum outer diameter of 2.8F tapering to 2.2F at the distal tip. The distal end of the catheter has a non-detachable low inflation pressure compliant balloon. The catheter is designed to track over the MTI SilverSpeed™ 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 visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The Equinox catheter is supplied sterile for single use as a system which includes the required SilverSpeed .010" Guidewire and a rotating hemostatic valve.
INDICATIONS FOR USE
The Micro Therapeutics, Inc. Occlusion Balloon Catheter is designed for use in blood vessels where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.
TESTING
Biocompatibility of the Equinox catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the Equinox catheter when tested as an external communicating, blood contact, short duration ( Exhibit 1 Page 6 of 7
1
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 153
Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618
K990487 Re : Equinox™ Occlusion Balloon System Trade Name: Regulatory Class: II Product Code: MJN Dated: June 4, 1999 Received: June 9, 1999
Dear Mr. Daughters:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boose and we have determined the device is the device referenced above and indications for use stated in the substantially equivarence(201 che and 1970).
enclosure) to legally marketed predicate of the Modical enciosure) co regarly mainess in the enactment date of the Medical commerce prior co nay 20, 20, 20, 20, 20, 2017, 2017, 2017, and Device Amendits of co devices that and the Federal Food, prices to the accordance with the provideone and the device, subject to the Act (ACC). "You may, chererors, manufact . However, you are responsible general concrold provisions in the medical devices you use as components in the co decermine cho moulean determined as substantially equivalent.
[kit/tray] have either been determined as substantially of the ac [Kit/Cray] have ercher book assemments (Section 520(k) of the act),
under the premarket notification process (Section 520 (1976), the present day or were legally on the market prior to May 28, 1976, the enactment date of were regarly on the marked p=10 Please note: If you purchase your of the Medical Device Amendated, and further process (e.g.,
device components in bulk (i.e., unfinished) and further including these device componence in adily a new 510(k) before including these sceriffice) you mable basilly a The general controls provisions of the components in your kre/Lidy. The golders in annual registrations against Act incrude requirements for and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device ID class III (Premarket Approval) it may be subject to such Controls) of Class III (Fremantos regulations affecting your device
2
Page 2 - Mr. Tom Daughters
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, " Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christopher Thor
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Equinox Occlusion Balloon - 510(k) K990487 Additional Information Submission
510(k) Number (if known):
Device Name: Equinox™ Occlusion Balloon System
Indications for Use: The Micro Therapeutics, Inc. Occlusion Balloon Catheter is designed for use in blood vessels where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| Prescription Use | OR | Over the Counter Use | ||
| (Per 21 CFR 801.109) | ||||
| (Division Sign-Off) | ||||
| Division of Cardiovascular, Respiratory, and Neurological Devices | ||||
| 510(k) Number |
Exhibit 1 Page: 5 of 7