(182 days)
Not Found
No
The description focuses on the mechanical components and intended use for delivering devices and leads. There is no mention of AI, ML, or any computational analysis of data.
No
The device is described as a "Left Heart Delivery System" and "delivery catheter system" intended for "introducing transvenous devices and leads" or "delivery of contrast medium and transvenous devices." It facilitates the delivery of other devices or substances but is not itself performing a therapeutic function.
No
This device is intended for the delivery of other transvenous devices, leads, and contrast medium into the left heart, not for diagnostic purposes.
No
The device description explicitly lists multiple hardware components including guide catheters, valves, dilators, guide wires, and slitters.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "introducing transvenous devices and leads into vessels of the left heart via the coronary sinus" and for "delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy." This describes a device used in vivo (within the body) for delivering other medical devices and substances.
- Device Description: The description details catheters, guide wires, dilators, and slitters, all components used in interventional procedures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo to facilitate procedures within the cardiovascular system.
N/A
Intended Use / Indications for Use
Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery:
The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
Attain Select™ II + SureValve™ Delivery Catheter System:
The Attain Select™ II + SureValve™ 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 quide catheters.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
The Attain Command™ + SureValve™ Left-Heart Delivery System kits each contain two outer quide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + SureValve™ Left-Heart Delivery System is available in two models:
Attain Command TM + SureValve ™ 6250VC Left Heart Delivery System —
Attain Command™ + SureValve™ 6250VS Left Heart Delivery System -
With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length.
The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models:
- Attain Command™ + SureValve™ 6250V-45S Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-50S Guide Catheter for Left Heart Delivery ー
- Attain Command™ + SureValve™ 6250V-57S Guide Catheter for Left Heart Delivery —
- Attain Command™ + SureValve™ 6250V-AM Guide Catheter for Left Heart Delivery -
- ー Attain Command ™ + SureValve™ 6250V-EH Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-EHXL Guide Catheter for Left Heart -Delivery
- Attain Command™ + SureValve™ 6250V-MB2 Guide Catheter for Left Heart l Delivery
- Attain Command™ + SureValve™ 6250V-MB2X Guide Catheter for Left Heart -Delivery
- Attain Command ™ + SureValve ™ 6250V-MP Guide Catheter for Left Heart Delivery l
- Attain Command™ + SureValve™ 6250V-MPR Guide Catheter for Left Heart l Delivery
- Attain Command™ + SureValve™ 6250V-MPX Guide Catheter for Left Heart -Delivery
- Attain Command ™ + SureValve™ 6250V-3D Guide Catheter for Left Heart Delivery ー
Each model is different with respect to the guide catheter shape and length and dilator length.
The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate leftheart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ 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 guide catheters. Together, the catheters function as a telescoping system that can provide additional subselecting capabilities.
The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models:
- Attain Select™ 11 + SureValve™ 6248V-90 Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-90S Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-90L Delivery Catheter System ー
- Attain Select™ II + SureValve™ 6248V-130 Delivery Catheter System ー
- Attain Select™ II + SureValve™ 6248V-130L Delivery Catheter System l
- Attain Select™ II + SureValve™ 6248V-90P Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-90SP Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-130P Delivery Catheter System
The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left heart, coronary sinus, cardiac veins
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)
Summary of non-clinical performance data:
Testing was performed to support the equivalency of the Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices to their respective predicate devices. The following nonclinical test summaries are presented below:
- In Vitro Bench Testing .
- Biocompatibility .
- Sterilization .
In Vitro Bench Tests:
The following in vitro bench tests were performed:
- Dimensional Testing -
- | Catheter Safety & Performance Testing
- -Component/Accessory Safety & Performance Testing
- -Interface Safety & Performance Testing (compatibility with transvenous devices)
- Packaging Qualifications -
- -Shelf Life Testing
The Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices met all specified design and performance requirements.
Biocompatibility Validations:
Biocompatibility of the Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices was evaluated in accordance with ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, and testing was completed in accordance with FDA Good Laboratory Practice (GLP) requlations (21 CFR, Part 58).
Biocompatibility tests supporting biocompatibility of the Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices were appropriate for an implant device that is an externally communicating device in limited contact with circulating blood (
§ 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
| 510(k) Summary | APR 09 2013 | ||
|---|---|---|---|
| Applicant: | Medtronic Ireland | ||
| Parkmore Business Park West | |||
| Galway | |||
| Ireland | |||
| Submission Correspondent: | Deirdre McMahon | ||
| Senior Regulatory Affairs Specialist | |||
| Medtronic Ireland | |||
| Parkmore Business Park West | |||
| Galway | |||
| Ireland | |||
| Telephone: | +353-91-708968 | ||
| Fax: | +353-91-708672 | ||
| E-mail: | deirdre.mcmahon@medtronic.com | ||
| Date Prepared: | September 28, 2012 | ||
| Name of the device, including the trade or proprietary name, if applicable, the common or | |||
| usual name, and the classification name, if known | |||
| Proprietary Names: | - | Attain Command™ + SureValve™ Left Heart Delivery System | |
| - | Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery | ||
| - | Attain Select™ II + SureValve™ Delivery Catheter System | ||
| Common Names: | - | Left Heart Delivery System | |
| - | Guide Catheters for Left Heart Delivery | ||
| - | Delivery Catheter System | ||
| Device Classification Name: | Catheter, Percutaneous | ||
| Class II, 21 CFR 870.1250 |
1
Substantially Equivalent Device(s):
The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are similar to the following predicates with respect to intended use, design and technology:
- Attain Command™ 6250 Left Heart Delivery Systems . (K080428, K090659)
- . Attain Command™ 6250 Guide Catheters for Left Heart (K080428, K090659)
The Attain Select™ II + SureValve Delivery Catheter System is similar to the following predicate with respect to intended use, design and technology:
- Medtronic Attain Select™ II 6248DEL Delivery . Catheter System (K053431)
Device Description:
The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
The Attain Command™ + SureValve™ Left-Heart Delivery System kits each contain two outer quide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + SureValve™ Left-Heart Delivery System is available in two models:
Attain Command TM + SureValve ™ 6250VC Left Heart Delivery System —
Attain Command™ + SureValve™ 6250VS Left Heart Delivery System -
With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length.
2
The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models:
- Attain Command™ + SureValve™ 6250V-45S Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-50S Guide Catheter for Left Heart Delivery ー
- Attain Command™ + SureValve™ 6250V-57S Guide Catheter for Left Heart Delivery —
- Attain Command™ + SureValve™ 6250V-AM Guide Catheter for Left Heart Delivery -
- ー Attain Command ™ + SureValve™ 6250V-EH Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-EHXL Guide Catheter for Left Heart -Delivery
- Attain Command™ + SureValve™ 6250V-MB2 Guide Catheter for Left Heart l Delivery
- Attain Command™ + SureValve™ 6250V-MB2X Guide Catheter for Left Heart -Delivery
- Attain Command ™ + SureValve ™ 6250V-MP Guide Catheter for Left Heart Delivery l
- Attain Command™ + SureValve™ 6250V-MPR Guide Catheter for Left Heart l Delivery
- Attain Command™ + SureValve™ 6250V-MPX Guide Catheter for Left Heart -Delivery
- Attain Command ™ + SureValve™ 6250V-3D Guide Catheter for Left Heart Delivery ー
Each model is different with respect to the guide catheter shape and length and dilator length.
The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate leftheart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ 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 guide catheters. Together, the catheters function as a telescoping system that can provide additional subselecting capabilities.
The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models:
- Attain Select™ 11 + SureValve™ 6248V-90 Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-90S Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-90L Delivery Catheter System ー
- Attain Select™ II + SureValve™ 6248V-130 Delivery Catheter System ー
- Attain Select™ II + SureValve™ 6248V-130L Delivery Catheter System l
- Attain Select™ II + SureValve™ 6248V-90P Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-90SP Delivery Catheter System -
- Attain Select™ II + SureValve™ 6248V-130P Delivery Catheter System
3
The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.
Intended Use:
Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery:
The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
Attain Select™ II + SureValve™ Delivery Catheter System:
The Attain Select™ II + SureValve™ 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 quide catheters.
Summary of the technological characteristics of the device compared with the predicate device:
Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery:
The Attain Command ™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are designed to facilitate lead implantation in the left heart, via the coronary sinus. The left-heart delivery systems are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
The outer guide catheter is designed to gain and maintain access to the coronary sinus and facilitate passage of transvenous devices and placement of leads into the cardiac veins, while the dilator facilitates passage of the outer guide catheter into the venous system. Additional accessories packaged with the kits include the guide wire and slitter; the quide wire is intended to direct the outer guide catheter or dilator through a blood vessel, while the slitter is intended to remove the outer guide catheter following transvenous device implantation.
Attain Select™ II + SureValve™ Delivery Catheter System:
The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate left-heart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ 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 guide catheters. The delivery catheter aids in subselection and provides a pathway for the delivery of transvenous devices such as leads, inner catheters, and guide wires. It has a radiopaque flexible tip to facilitate viewing during fluoroscopy. The inner catheter supports the delivery catheter and aids in subselection. The inner catheter has a radiopague tip and allows delivery of a quide wire or contrast solution. The delivery catheter system is used with an outer quide catheter, which is the sheath used to gain coronary sinus access. Together, the catheters function as a telescoping system that can provide additional subselecting capabilities.
4
Summary of non-clinical performance data:
Testing was performed to support the equivalency of the Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices to their respective predicate devices. The following nonclinical test summaries are presented below:
- In Vitro Bench Testing .
- Biocompatibility .
- Sterilization .
In Vitro Bench Tests:
The following in vitro bench tests were performed:
- Dimensional Testing -
- | Catheter Safety & Performance Testing
- -Component/Accessory Safety & Performance Testing
- -Interface Safety & Performance Testing (compatibility with transvenous devices)
- Packaging Qualifications -
- -Shelf Life Testing
The Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices met all specified design and performance requirements.
Biocompatibility Validations:
Biocompatibility of the Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices was evaluated in accordance with ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, and testing was completed in accordance with FDA Good Laboratory Practice (GLP) requlations (21 CFR, Part 58).
Biocompatibility tests supporting biocompatibility of the Attain Command™ + SureValve™ and Attain Select™ II + SureValve devices were appropriate for an implant device that is an externally communicating device in limited contact with circulating blood (