· Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
· To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
· The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

Device Description

The GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in coronary saphenous bypass grafts. The system is used to contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures and is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal® Adapter and the Export® Aspiration Catheter and the EZ Flator Inflation Device. The GuardWire may also be used during these procedures alone or in conjunction with the Export Catheter to locally infuse diagnostic or therapeutic agents with or without vessel occlusion. The modification to the GuardWire system addressed with this submission entails the introduction of the EZ-Adapter as a replacement for the MicroSeal Adapter (MSA), as the device that actuates the MicroSeal of the GuardWire device. Both the EZ Adapter and the MicroSeal Adapter provide the same mechanical functions: hold the GuardWire in a static fixed position, actuate, through linear movement, the MicroSeal plug system of the GuardWire, and provide direct communication from the EZ Flator inflation device to the GuardWire balloon to facilitate inflation or deflation of the GuardWire balloon.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GuardWire Temporary Occlusion and Aspiration System, focusing on the EZ-Adapter modification:

This submission (K023878) concerns a modification to an existing device, the GuardWire Temporary Occlusion and Aspiration System. The core of this submission is the replacement of the MicroSeal Adapter (MSA) with a new component called the EZ-Adapter.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the EZ-Adapter. Instead, the basis for clearance is substantial equivalence to the predicate device's component (MicroSeal Adapter). The primary "acceptance criteria" appear to be functional equivalence and equivalent manufacturing.

Acceptance Criteria Category	Specific Criteria (Implicit from text)	Reported Device Performance (EZ-Adapter)
Functional Equivalence	- Hold GuardWire in a static fixed position	"EZ Adapter... provide the same mechanical functions: hold the GuardWire in a static fixed position"
	- Actuate MicroSeal plug system (linear movement)	"EZ Adapter... provide the same mechanical functions: actuate, through linear movement, the MicroSeal plug system of the . GuardWire"
	- Provide direct communication to GuardWire balloon for inflation/deflation	"EZ Adapter... provide the same mechanical functions: provide direct communication from the EZ Flator inflation device to the . GuardWire balloon to facilitate inflation or deflation of the GuardWire balloon."
Material Equivalence	- Made from equivalent materials	"EZ Adapter is manufactured... using the similar processes and equivalent materials, as the MicroSeal Adapter"
Process Equivalence	- Manufactured under similar conditions/processes	"EZ Adapter is manufactured under the same conditions, using the similar processes... as the MicroSeal Adapter"
Indications for Use	- No change in intended use	"the indications for use have not changed."
Performance Testing	- Determination of substantial equivalence	"The EZ Adapter has been subjected to performance testing and it has been determined that the EZ Adapter is substantially equivalent to the MicroSeal Adapter."

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The EZ Adapter has been subjected to performance testing and it has been determined that the EZ Adapter is substantially equivalent to the MicroSeal Adapter." However, no specific details regarding the sample size used for this testing are provided. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. Given the nature of a component replacement and the focus on functional equivalence, this testing would likely be bench testing rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a 510(k) submission based on substantial equivalence of a component, the "ground truth" is primarily established through engineering and performance testing against defined specifications and comparison to the predicate component's known performance. Expert clinical input might be involved in defining the functional requirements, but there's no mention of a formal expert panel to establish ground truth for a test set in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Since the "test set" and "ground truth" in the typical sense of clinical trials or AI/diagnostic device evaluation are not explicitly described, an adjudication method is not mentioned and is likely not applicable in this context. The evaluation would have been based on direct measurement and engineering comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving human interpretation) to assess the impact of a device on reader performance. The GuardWire system and its EZ-Adapter component are interventional medical devices, and the submission focuses on functional equivalence of a mechanical component, not human interpretational effectiveness.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" (usually for an algorithm) also does not apply here. The EZ-Adapter is a physical component of a medical device intended for use in an interventional procedure by a clinician. Its "performance" is inherent to its mechanical function, not an algorithm's output. The performance testing would have evaluated the physical attributes and operational capabilities of the EZ-Adapter.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications, functional requirements, and direct comparison to the performance of the predicate MicroSeal Adapter. The document emphasizes "functional equivalence," "similar processes and equivalent materials," and "performance testing" to determine substantial equivalence. This is not derived from expert consensus, pathology, or outcomes data in the way a diagnostic device's ground truth would be.

8. The Sample Size for the Training Set

No training set is mentioned or applicable for this type of device modification. Training sets are relevant for machine learning or AI algorithms, which are not involved in the EZ-Adapter.

9. How the Ground Truth for the Training Set Was Established

As there is no training set and no AI component, this question is not applicable.

Summary

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K023878

JAN 2 4 2003

Section 6 Summary of Safety and Effectiveness

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)

1. ldentifying Information: Submitters Name: Medtronic AVE, Inc. 1.1. 37A Cherry Hill Drive Danvers, MA 01923 1.2. Contact Person: Fred L. Boucher R.A.C. (978) 777-0042 2. Classification Name: Device, Coronary Saphenous Vein Graft, Temporary, for Embolization Protection (21 CFR Part 870.1250) 3. Proprietary Name: GuardWire Temporary Occlusion and Aspiration System 4. Name of Predicate Devices: GuardWire Temporary Occlusion and

5. Description:

Aspiration System

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The modification to the GuardWire system addressed with this submission entails the introduction of the EZ-Adapter as a replacement for the MicroSeal Adapter (MSA), as the device that actuates the MicroSeal of the GuardWire device.

Both the EZ Adapter and the MicroSeal Adapter provide the same mechanical functions:

hold the GuardWire in a static fixed position, ●
actuate, through linear movement, the MicroSeal plug system of the . GuardWire, and
provide direct communication from the EZ Flator inflation device to the . GuardWire balloon to facilitate inflation or deflation of the GuardWire balloon.

Intended-Use:

The GuardWire 3-6 Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

· Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
· To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
· The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

Technology:

The EZ Adapter is manufactured under the same conditions, using the similar processes and equivalent materials, as the MicroSeal Adapter that is contained in the GuardWire Temporary Occlusion and Aspiration System; the leqally marketed predicate device. In addition to being technologically equivalent, the indications for use have not changed.

The EZ Adapter has been subjected to performance testing and it has been determined that the EZ Adapter is substantially equivalent to the MicroSeal Adapter.

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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a bold, sans-serif font. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line. The text is black against a white background.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fred L. Boucher, R.A.C. Sr. Regulatory Affairs Manager Medtronic AVE 37A Cherry Hill Drive Danvers, MA 01923

Re: K023878

Trade/Device Name: GuardWire 3-6 Temporary Occlusion and Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NFA Dated: December 24, 2002 Received: December 26, 2002

Dear Mr. Boucher:

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, listing 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 such 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); good manufacturing practice requirements as set

Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle image.

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Page 2 -- Mr. Fred Boucher

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 procéed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K023878

Device Name: GuardWire Temporary Occlusion and aspiration System

Indications for Use:

The GuardWire 3-6 Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

· Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
· To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
· The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter -

Noleth

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K023878

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).