The MTI HyperForm™ Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature 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 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 the MTI 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 HyperForm catheter is supplied sterile for single use as a system, which includes the required 0.010" guidewire.

AI/ML Overview

The provided document describes the HyperForm™ Occlusion Balloon Catheter and its clearance through the FDA's 510(k) process, which relies on demonstrating substantial equivalence to a predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an already legally marketed device, rather than establishing absolute performance targets through a standalone clinical study with predefined acceptance criteria for a novel AI algorithm.

Therefore, many of the requested elements pertaining to acceptance criteria and detailed study design for AI devices (like sample sizes for test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this traditional medical device submission.

However, I can extract information related to the device's testing and substantial equivalence.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a catheter), the "acceptance criteria" are generally met by demonstrating compliance with recognized standards and substantial equivalence to a predicate device in terms of performance characteristics. There are no explicit quantitative "acceptance criteria" like sensitivity/specificity thresholds for an AI product.

Performance Characteristic/Test	Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 for external communicating, blood contact, short duration (<24 hrs.) device.	"Test results confirmed biocompatibility of the HyperForm catheter when tested as an external communicating, blood contact, short duration (<24 hrs.) device."
Dimensional Verification	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Balloon Compliance	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Balloon Integrity	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Catheter Tensile Strength	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Torque Strength	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Flexibility	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Trackability	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Coating Integrity	Compliance with ISO 10555 (Parts 1 & 4) requirements.	"Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device."
Substantial Equivalence	Device is substantially equivalent to predicate device in intended use and principle of operation.	"The MTI HyperForm™ Occlusion Balloon Catheter is substantially equivalent to the predicate device in intended use and principles of operation."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as this is not a study involving human data or image analysis where such details would be typically reported. The testing described is primarily bench and biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the clearance is not based on expert-adjudicated ground truth for a diagnostic or AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable.

5. 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

This information is not applicable as this is a physical medical device (catheter), not an AI diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical performance tests, the 'ground truth' is compliance with the specified ISO standards (e.g., ISO 10555). For biocompatibility, the 'ground truth' is compliance with ISO 10993-1. These are measurable physical or biological properties, not clinical ground truth derived from expert consensus or pathology in the context of AI.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/machine learning device.

Summary of the Study/Evidence:

The study proving the device meets its "acceptance criteria" (which in this context means demonstrating safety and effectiveness for a 510(k) submission) is a series of performance tests and biocompatibility assessments coupled with a declaration of substantial equivalence to an existing predicate device.

Biocompatibility Testing: Verified according to ISO 10993-1.
Performance Testing: Conducted in accordance with ISO 10555 (Sterile, single use intravascular catheters - Parts 1 and 4). This included:
- Dimensional verification
- Balloon compliance and integrity
- Catheter tensile strength
- Torque strength
- Flexibility
- Trackability
- Coating integrity
Substantial Equivalence: The manufacturer asserted, and the FDA agreed, that the HyperForm™ Occlusion Balloon Catheter is substantially equivalent to the MTI Equinox™ Occlusion Balloon Catheter in intended use and principles of operation, based on the testing and device description.

Summary

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JUN 2 0 2001

Micro Therapeutics, Inc.
Special 510(k):	HyperForm™ Occlusion Balloon Catheter

Attachment 6

	510(k) Summary
Prepared May 24, 2001
TRADE NAME	Unknown
GENERIC NAME	Occlusion Balloon Catheter
CLASSIFICATION	Class II (21 CFR 870.0)
SUBMITTED BY	Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618
CONTACT	Eben GordonRegulatory Affairs(949) 837-3700
PREDICATE DEVICE	MTI Equinox™ Occlusion Balloon Catheter
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 the MTI 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 HyperForm catheter is supplied sterile for single use as a system, which includes the required 0.010" guidewire.
INDICATIONS FOR USE	The MTI Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature 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 HyperForm catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the HyperForm catheter when tested as an external communicating, blood contact, short duration (<24 hrs.) device.Performance testing of the HyperForm 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, trackability, 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 MTI HyperForm™ Occlusion Balloon Catheter is substantially equivalent to the predicate device in intended use and principles of operation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around a symbol. The symbol consists of three stylized human profiles facing right, with three curved lines above them. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2001

Mr Eben Gordon Mr Eben Gordon
Director of Regulatory Affairs and Quality Assurance Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618

Re: K011656

K011656
Trade Name: MTI HyperForm™ Occlusion Balloon Catheter
Trade Name: MTI HyperForm a Regulation Number: 870.4450 Regulation Class: II (two) Product Code: MJN Dated: May 24, 2001 Received: May 29, 2001

Dear Mr. Gordon:

We have reviewed your Section 510(k) notification of intent to market the device referenced
in the subscription of the layies is gubstentially equivalent (for the indication We have reviewed your Section 510(c) notification of the indications for use indications for use
above and we have determined the devices marked in interstate commerce above and we have determined the device is subsantany of an arter and stated in the enclosure) to legally marketed predical Device Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Federal Food. Drug and prior to May 28, 1976, the enatment uite the provisions of the Federal Food, Drug, and
have been reclassified in accordance with the provisions of the Federal contra have been reclassified in accordance with the provisions of a subject to the general controls
Cosmetic Act (Act). You may, therefore, market the Act include requirements fo Cosmetic Act (Act). You may, therefore, market incurrents and include requirements for annual
provisions of the Act. The general controls provisions of the Actively and pro provisions of the Act. The general controls provisions of the Ace 10 for and prohibitions against
registration, listing of devices, good manufacturing practice, labeling, an misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
) in the subscription of the stars of any as additional controls. Existing maj If your device is classified (see above) into entrely studions controls. Existing major regulations
(Premarket Approval), it may be subject to such additions Title 2 . Part (Premarket Approval), it may be subject to such adultions, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, Parts affecting your device can be lound in the counds compliance with the Current Good
A substantially equivalent determination assumes compliance with ( A substantially equivalent determination asstilles complains in System Regulation (QS) for
Manufacturing Practice requirements, as set forth in the Quality System Reciodic O Manufacturing Practice regulation (2) CFR Part 820) and that, through periodic QS
Medical Devices: General regulation (2) CFR Part 820) and that, through periodic of Medical Devices: General regulation (ZTCA) will verify such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assumptions, FDA may inspections, the Food and Drug Administration in Proxy Jonadition, FDA may publish
comply with the GMP regulation may resimination in the Forester this comply with the GMP regulation may result new Federal Register. Please note: this further announcements concerning your device in the reast affect any obligation you might
response to your premarket notification submission does not a Flectronic Product response to your premarket nothleadel studies under the Electronic Product
have under sections 531 through 542 of the Act for devices under the Electronic Product
Sales an have under sections 531 through 542 of the Federal laws or regulations.
Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr Eben Gordon

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin maneting your device of your device to a legally marketed .
notification. The FDA finding of substantial equivalence of your device to notification. The FDA inding of substantial equiveland thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your do rise contact the Office of Compliance at additionally 809.10 for in Vitto draghostions on the promotion and advertising of your device, (301) 394-4648. Addinonally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Wisoranding by relevelo to prema act may be obtained from the Division of Small
information on your responsibilities under the Act and 2011 - (201) 412 (6597 - at information on your responsibilities and its tool more (800) 638-2041 or (301) 443-6597 or at its Maindracturers / Issiblance as a catalog as a dsmamain.html".

Sincerely yours,

V. Dale Tell

James E. Dillard Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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	Attachment 2
--	--------------

	Indications for Use Statement
510(k) Number (if known):	KO11656

Device Name:

MTI HyperForm™ Occlusion Balloon Catheter

Indications for Use: The MTI HyperForm™ Occlusion Balloon Catheter issue The MIT Tryper of the blood vessels of the peripheral and Indicated for use in the semporary occlusion is desired. The MTI HyperForm™ Occlusion Balloon Catheter offers a MITI Hyperrorm---------------------------------------------------------------------------------------------------------------------------------------------------------------vesser selective technique vir 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)
		VICES	Page 18 of 100

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).