(34 days)
K#021589, K031211, K#021455
Not Found
No
The summary describes a physical medical device (catheter set) and its intended use and performance testing. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML.
No
The device is a guide catheter designed to facilitate the delivery of other contrast media and transvenous devices; it does not directly provide a therapeutic effect itself.
No
The device is a guide catheter set intended for the delivery of contrast media and transvenous devices, providing a pathway for other tools. Its function is to facilitate the delivery of other substances or devices, not to diagnose a condition itself. Although it can deliver contrast media (used for imaging), the device's role is instrumental, not diagnostic.
No
The device description clearly states it is a set of physical catheters, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Attain Select™ 6238TEL Guide Catheter Set is a device used within the body (in vivo) to facilitate the delivery of other substances (contrast media) and devices (guide wires, guide catheters) to specific anatomical locations (coronary sinus and left heart venotomy). It is a tool for accessing and navigating within the cardiovascular system.
- Lack of Specimen Examination: The description does not mention the examination of any biological specimens outside of the body.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.
Product codes
DOY, DQY
Device Description
The Attain Select 6238TEL Guide catheter set for left-heart delivery consists of a set of 3 catheters, one straight catheter; one catheter with a 90° curved tip and one catheter with a 180°curved tip. The Attain Select 6238TEL guide catheters are designed to facilitate access to the coronary sinus and left-heart venotomy. The catheters provide a pathway for the delivery of contrast medium and transvenous devices such as guide wires and guide catheters. The Attain Select 6238TEL guide catheters are provided sterile and are intended for single use only.
The catheters, which have a working length of 70cm, also have radiopaque, flexible tips. The catheter functions as an inner catheter and, when used with an outer guide catheter, forms a dual-catheter assembly. The Attai.1 Select 6238TEL guide catheters feature a lumen that allows for the passage of guide wires up to 0.89 mm (0.035 in) in diameter. The guide catheters have a maximum outer diameter of 7 French (2.4 mm) and may be used with delivery systems that accept a 7 French (2.4 mm) transvenous device. Medtronic recommends using the guide catheters with Medtronic Attain Fixed Shape catheters or the Medtronic Attain Deflectable catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus and left heart venotomy
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
Device integrity testing was performed to support the equivalency of the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery met all specified design and performance requirements.
Key Metrics
Not Found
Predicate Device(s)
K#021589, K031211, K#021455
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 5 2004
CONFIDENTIAL May not be reproduced without written permission from Medtronic, Inc.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | August 11, 2004 |
|---|---|
| Submitter: | Medtronic Ireland |
| Parkmore Business Park West | |
| Galway | |
| Ireland | |
| Contact: | Lynn Jensen |
| Sr. Regulatory Affairs Specialist | |
| Telephone: | (763) 514 4459 |
| Fax: | (763) 514 6424 |
| lynn.a.jensen@medtronic.com | |
| Proprietary Name: | Attain Select™ 6238TEL Guide Catheter Set for |
| Left-heart Delivery | |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DOY |
Device Description
The Attain Select 6238TEL Guide catheter set for left-heart delivery consists of a set of 3 catheters, one straight catheter; one catheter with a 90° curved tip and one catheter with a 180°curved tip. The Attain Select 6238TEL guide catheters are designed to facilitate access to the coronary sinus and left-heart venotomy. The catheters provide a pathway for the delivery of contrast medium and transvenous devices such as guide wires and guide catheters. The Attain Select 6238TEL guide catheters are provided sterile and are intended for single use only.
The catheters, which have a working length of 70cm, also have radiopaque, flexible tips. The catheter functions as an inner catheter and, when used with an outer guide catheter, forms a dual-catheter assembly. The Attai.1 Select 6238TEL guide catheters feature a lumen that allows for the passage of guide wires up to 0.89 mm (0.035 in) in diameter. The guide catheters have a maximum outer diameter of 7 French (2.4 mm) and may be
1
used with delivery systems that accept a 7 French (2.4 mm) transvenous device. Medtronic recommends using the guide catheters with Medtronic Attain Fixed Shape catheters or the Medtronic Attain Deflectable catheter.
Indications for Use
The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.
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 AttainTM Access 6218A Left-Heart Delivery System (K#021589, . cleared May 30, 2002)
- Attain™ Prevail® Steerable Catheter Set, Model 6228CTH (K031211, cleared . July 17, 2003)
- Guidant RAPIDOTM Guiding Catheter (K#021455, cleared August 2, 2002) .
Summary of Studies:
Device integrity testing was performed to support the equivalency of the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery met all specified design and performance requirements.
Biocompatibility Information
Medtronic has tested the materials used to fabricate the Attain Select™ 6238TEL. Guide Catheter Set for Left-Heart Delivery 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 devices included in the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery are external communicating devices with limited exposure (