EQUINOX OCCLUSION BALLOON SYSTEM

K990487 · Micro Therapeutics, Inc. · MJN · Aug 31, 1999 · Cardiovascular

Device Facts

• Record ID: K990487
• Device Name: EQUINOX OCCLUSION BALLOON SYSTEM
• Applicant: Micro Therapeutics, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Aug 31, 1999
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Equinox Occlusion Balloon System is a single-lumen catheter (2.8F to 2.2F) with a non-detachable, low-inflation-pressure compliant balloon. Used by physicians for temporary vascular occlusion to control blood flow. Operates by tracking over a 0.010" guidewire; guidewire insertion into the catheter lumen is required to enable balloon inflation. Features two platinum markers for angiographic visualization and a hydrophilically coated shaft for navigation. Supplied as a sterile, single-use system including the guidewire and a rotating hemostatic valve. Clinical benefit includes precise, selective flow control during endovascular procedures.

Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993-1. Performance testing conducted per ISO 10555, including dimensional verification, balloon compliance and integrity, tensile strength, torque strength, flexibility, and coating integrity.

Technological Characteristics

Single-lumen catheter; 2.8F to 2.2F diameter; non-detachable compliant balloon; platinum markers; hydrophilic coating. Complies with ISO 10555 (sterile, single-use intravascular catheters) and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for use in blood vessels where temporary occlusion is desired to selectively stop or control blood flow.

Regulatory Classification

Identification

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

Predicate Devices

• Target Therapeutics, Inc (BSC). Endeavor Coaxial Catheter

Submission Summary (Full Text)

{0}------------------------------------------------

K990487

## 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.<br>2 Goodyear<br>Irvine, CA 92618 | CONTACT: | Tom Daughters<br>Regulatory Affairs<br>[phone] |

#### 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 (<24 hrs.) device.

Performance testing of the Equinox catheter was conducted in accordance with ISO 10555 Sterile, single use intravascular catheters - Parts 1 and 4. Tests included dimensional verification, balloon compliance and integrity, catheter tensile strength, torque strength, flexibility, and coating integrity. Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device.

#### SUMMARY OF SUBSTANTIAL EQUIVALENCE

The Equinox™ Occlusion Balloon Catheter, is substantially equivalent to the predicate device in intended use and principles of operation.

> 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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