(97 days)
K#021589, K#042194, K#031505
Not Found
No
The summary describes a mechanical catheter system for delivering contrast and devices, with no mention of AI/ML terms, image processing, or data analysis that would typically indicate AI/ML involvement.
No
This device is a delivery catheter system used to deliver contrast medium and transvenous devices, not to provide therapy itself.
No
The intended use of the Medtronic Attain Select™ II model 6248DEL delivery catheter system is for the delivery of contrast medium and transvenous devices, not for diagnosing a condition.
No
The device description clearly states it is a "Delivery Catheter System" containing physical components (delivery catheter and inner catheter) and is used in conjunction with other physical catheters. The performance studies also describe mechanical, functional, and biocompatibility testing, which are associated with hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Medtronic Attain Select™ II model 6248DEL delivery catheter system is a medical device used within the body to deliver substances (contrast medium) and other devices to specific anatomical locations (coronary sinus and left heart venous anatomy). It is an interventional device, not a diagnostic test performed on a sample outside the body.
The description clearly outlines its use in a clinical procedure for delivery within the patient's circulatory system, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy. The delivery catheter system is indicated for use with outer catheters.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Attain Select™ II 6248DEL Delivery Catheter System contains a delivery catheter and an inner catheter. The Delivery Catheter System is used in conjunction with a commercially available Medtronic Attain outer guide catheter. The outer guide catheter is used to gain coronary sinus access. Together, all three catheters function as a telescoping system that can provide additional sub-selecting capabilities. The 6248DEL Delivery Catheter System is available in two models each containing a straight inner catheter and a delivery catheter with either a 90° or 130° curved tip. The inner catheter in both kits is identical
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus and left heart venous anatomy
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)
Device integrity testing was performed to support the equivalency of the Attain Select™ II 6248DEL Delivery Catheter System to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ II 6248DEL Delivery Catheter System met all specified design and performance requirements.
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.
K#021589, K#042194, K#031505
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
Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, black letters on the right. The graphic appears to depict a human figure in motion, possibly related to medical or health-related activities.
MAR 16 2006
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| 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE |
|---|
| ------------------------------------------- |
| Date Prepared: | December 7, 2005 |
|---|---|
| Applicant: | Medtronic Ireland |
| Parkmore Business Park West | |
| Galway | |
| Ireland | |
| Submission Correspondent: | Michelle Nivala |
| Regulatory Affairs Specialist | |
| Medtronic, Inc. | |
| 1015 Gramsie Road | |
| Shoreview | |
| MN 55126-3082 | |
| USA | |
| Telephone: | (763) 505 7863 |
| Fax: | (763) 505 7877 |
| michelle.nivala@medtronic.com | |
| Proprietary Name: | Attain Select™ II 6248DEL Delivery Catheter |
| System | |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
Device Description
The Attain Select™ II 6248DEL Delivery Catheter System contains a delivery catheter and an inner catheter. The Delivery Catheter System is used in conjunction with a commercially available Medtronic Attain outer guide catheter. The outer guide catheter is used to gain coronary sinus access. Together, all three catheters function as a telescoping system that can provide additional sub-selecting capabilities. The 6248DEL Delivery Catheter System is available in two models each containing a straight inner catheter and a delivery catheter with either a 90° or 130° curved tip. The inner catheter in both kits is identical
1
Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" on the right. The circular symbol contains a stylized image of a person in motion. The word "Medtronic" is written in a bold, sans-serif font.
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page 2 of 2
Indications for Use
The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy. The delivery catheter system is indicated for use with outer catheters.
Substantially Equivalent Devices:
The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices:
- Medtronic Attain™ Access 6218A Left Heart Delivery System (K#021589, May . 30, 2002)
- Medtronic Attain™ Select™ Guide Catheter Set for Left-Heart Delivery . (K#042194, cleared September 15, 2004)
- Guidant RAPIDO™ Cut-Away Guiding Catheter (K#031505, cleared June 25, ● 2003)
Summary of Studies:
Device integrity testing was performed to support the equivalency of the Attain Select™ II 6248DEL Delivery Catheter System to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ II 6248DEL Delivery Catheter System met all specified design and performance requirements.
Biocompatibility Information
Medtronic has tested the materials used to fabricate the Attain Select™ II 6248DEL Delivery Catheter System for biocompatibility. The testing performed by Medtronic is consistent with International Standard ISO 10993-1: 2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheters included in the Attain Select™ II 6248DEL Delivery Catheter System are external communicating devices with limited exposure (