(64 days)
GuardWire Temporary Occlusion and Aspiration System
Not Found
No
The description focuses on mechanical components and their function in a temporary occlusion and aspiration system, with no mention of AI or ML capabilities.
Yes.
The device is used to contain and aspirate embolic material and to infuse/deliver diagnostic or therapeutic agents, which are direct actions to treat a condition.
No
The device is primarily intended for containing and aspirating embolic material and delivering therapeutic agents, even though it can deliver "diagnostic agents," which does not make the device itself a diagnostic device. Its main function is interventional.
No
The device description clearly outlines multiple physical components (catheters, adapters, inflation device) that are part of the system, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The GuardWire 3-6 Temporary Occlusion & Aspiration System is a medical device used during interventional procedures (angioplasty or stenting) within the coronary saphenous vein bypass grafts. Its primary functions are:
- Containing and aspirating embolic material.
- Infusing diagnostic or therapeutic agents.
- Providing temporary vascular occlusion.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of specimens from the body to provide diagnostic information. It is a tool used directly within the patient's vasculature during a procedure.
Therefore, the device's intended use and description clearly indicate it is an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NFA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary saphenous vein bypass grafts
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GuardWire Temporary Occlusion and Aspiration System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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.
Aspiration System
1
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.
2
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.
3
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
4
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)
OR
Over-The-Counter -
Noleth
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K023878