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 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.

AI/ML Overview

The Equinox™ Occlusion Balloon Catheter (K990487) did not present specific acceptance criteria in the provided 510(k) summary. Instead, it relied on demonstrating conformance to established international standards for medical devices and establishing substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Conformance to ISO 10993-1	Test results confirmed biocompatibility of the Equinox catheter when tested as an external communicating, blood contact, short duration (<24 hrs.) device.
Device Performance: Conformance to ISO 10555 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.
Substantial Equivalence to Predicate Device	The Equinox™ Occlusion Balloon Catheter is substantially equivalent to the Target Therapeutics, Inc (BSC). Endeavor Coaxial Catheter in intended use and principles of operation.

Study Details:

Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for the performance and biocompatibility testing. The data provenance is not explicitly mentioned in terms of country of origin or retrospective/prospective nature, but the testing was conducted by the manufacturer, Micro Therapeutics, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the 510(k) summary. The testing conducted was for device performance and biocompatibility, not clinical efficacy or diagnostic accuracy requiring expert interpretation of results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. The testing involves standardized engineering and laboratory evaluations against predefined performance parameters, not subjective clinical assessments.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. This an occlusion balloon catheter, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance testing was adherence to the specifications outlined in ISO 10555 (e.g., dimensional tolerances, tensile strength values, balloon inflation pressures). For biocompatibility, the ground truth was conformance to ISO 10993-1, which involves specific biological endpoints (e.g., cytotoxicity, irritation).
The sample size for the training set:
This information is not applicable as there is no training set in the context of this device. The device is a physical medical instrument, not a learned algorithm.
How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.

Summary

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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.2 GoodyearIrvine, CA 92618	CONTACT:	Tom DaughtersRegulatory Affairs(949) 837-3700

PREDICATE DEVICES

Target Therapeutics, Inc (BSC). Endeavor Coaxial Catheter

DEVICE DESCRIPTION

INDICATIONS FOR USE

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

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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

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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

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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

Regulation Number and Section

§ 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).