(96 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and makes no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
The device is intended for temporary occlusion of large vessels and to expand vascular prostheses, which are therapeutic interventions.
No
The device is described as a balloon catheter intended for temporary occlusion or expansion of vascular prostheses, which are therapeutic actions, not diagnostic.
No
The device is described as a "Reliant Stent Graft Balloon Catheter," which is a physical medical device used for temporary occlusion and expansion of vascular prostheses. This description clearly indicates a hardware component, not a software-only device.
Based on the provided information, the Reliant Stent Graft Balloon Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary occlusion of large vessels, or to expand vascular prostheses." This describes a device used within the body for a therapeutic or procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Mentions image processing, AI, DNN, ML, Input Imaging Modality, Description of training/test sets, Summary of Performance Studies, Key Metrics: The absence of these elements, which are common in IVD submissions, further supports that this is not an IVD.
- Anatomical Site: "large vessels" refers to a location within the body.
- Intended User / Care Setting: "Prescription Use" is typical for medical devices used in a clinical setting, not necessarily specific to IVDs.
- Predicate Devices: The listed predicate devices (CODA Balloon Catheter, Iliac Balloon Catheter, Large Diameter Occlusion Balloon Catheter) are all devices used for vascular procedures within the body, consistent with the intended use of the Reliant Stent Graft Balloon Catheter.
In summary, the intended use and the nature of the predicate devices clearly indicate that the Reliant Stent Graft Balloon Catheter is a device used for interventional procedures within the vascular system, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Reliant Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large vessels
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)
Not Found
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.
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).
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510(k) Pre-Market Notification Reliant Stent Graft Balloon Catheter Medtronic, Inc.
510(k) Summary
| Submitter: | Medtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
USA |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Willie Mitchell
Associate Regulatory Affairs Specialist
(707) 591-2091
(707) 566-1432 - FAX
willie.mitchell@medtronic.com |
| Date Prepared: | January 6, 2005 |
| Trade Name: | Reliant Stent Graft Balloon Catheter |
| Common Name: | Balloon Catheter |
| Classification Name: | Percutaneous Catheter |
| Predicate Devices: | The CODA Balloon Catheter (K032869) manufactured by
Cook Incorporated (vessel occlusion and expansion of
vascular prosthesis, product code DQY), and was cleared by
FDA on November 19, 2003.
The Iliac Balloon Catheter (K003495) manufactured by
Guidant Corporation (prosthesis expansion, product code
DQY), and was cleared by FDA on February 7, 2001.
The Large Diameter Occlusion Balloon Catheter (K002286)
manufactured by Cook Incorporated (vessel occlusion,
product code MJN), and was cleared by FDA on March 22,
2001. |
| Substantial Equivalence: | The Reliant Stent Graft Balloon Catheter is substantially
equivalent to the predicate devices listed above, as it is
comparable with respect to their intended use, overall catheter
configuration, and performance characteristics. |
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
APR 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Vascular c/o Mr. Willie Mitchell Associate Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, CA 95403
Re: K050038
Reliant Stent Graft Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: January 6, 2005 Received: January 7, 2005
Dear Mr. Mitchell:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 3 ro(x) premainted in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interests for use stated in the enclosure) the aventified the aveces marketed in interstate for use stated in the cherosule) to regard manating to the Medical Device American be have a Frank Frank Drus commerce prior to May 20, 1970, the enational with the provisions of the Federal Food. Drug. devices mat have been reclassified in accerative mail as premarket approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a premarket approval a and Cosmelle Act (Act) that do not require appear al controls provisions of the Act. The You may, therefore, market the device, salyer to the genirements for annual registration, listing of the and general controls provisions of the Fieldes some in the measures misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) this. Existing major regulations affecting your device can may be subject to such additional controller Lifting of July 2011 - 11 addition, FDA may be found in the Oode of Proderal Loncerning your device in the Federal Register.
2
Page 2 - Mr. Willie Mitchell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backers complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that FDA has made a decermination that Jour as research agencies. You must or any Federal statures and regulations daminities, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercess, cannotacturing practice requirements as set CFR Part 607), labeling (21 CFR Part 820); go d if applicable, the electronic forin in the quality systems (QD) regalizations (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons 551 - 15 cm can bescribed in your Section 5 10(k)
This letter will allow you to begin marketing your device to logics to Jogal I his letter will anow you to oegin manxellig of substantial equivalence of your device to a legally premarket notification. THC PDA miding of backandal of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your de vice of other note the regulation entitled, the regulation entitled, the move abtain contact the Office of Complanee at (210) 276 of 807.97). You may obtain "Misbranding by reference to premainer noutheast in the Act from the Division of Small
on (800) of everal information on your responsibilities under the Act from the 1900 638 other getteral information on your responsible in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of Archives (demansion) by w Manufacturers, International and Octoberhers http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duma R. Vaitiner
Image /page/2/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is small and compact.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): not yet assigned KO5CC 3 E
Device Name: Reliant Stent Graft Balloon Catheter
Indications For Use:
The Reliant Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dams R. Vacher
Page 1 of L
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K650038