(294 days)
Not Found
No
The device description focuses on physical components and their function in delivering other devices. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a delivery system and guide catheter intended for introducing other transvenous devices into the left heart, not for providing therapy itself.
No
Explanation: The document states the device's purpose is "introducing transvenous devices and leads into vessels of the left heart via the coronary sinus," indicating an interventional or delivery function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including guide catheters, a guide catheter dilator, a guide wire, a valve, and a slitter.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "introducing transvenous devices and leads into vessels of the left heart via the coronary sinus." This describes a procedure performed within the body (in vivo) to deliver other medical devices.
- Device Description: The description details components like guide catheters, guidewires, valves, and slitters, all used for accessing and navigating blood vessels and heart chambers for device delivery. This is consistent with an interventional medical device used in a surgical or procedural setting.
- 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 screening.
Therefore, the Medtronic Attain Command™ 6250 Left Heart Delivery Systems and the Medtronic Attain Command™ 6250 Guide Catheters for Left Heart Delivery are not IVD devices. They are devices used for facilitating the delivery of other medical devices within the body.
N/A
Intended Use / Indications for Use
The Medtronic Attain Command™ 6250 Left Heart Delivery Systems and the Medtronic Attain Command™ 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Attain Command™ Left Heart Delivery Systems contain two guide catheters, one guide catheter dilator, one guide wire, one valve and one slitter. It is designed to access the coronary sinus and the chambers of the heart using the guidewire to access the vein, the valve to reduce blood loss during the implant procedure, the guide catheter to introduce a transvenous device, the guide catheter dilator to facilitate catheter passage and the slitter to remove the guide catheter.
The Attain Command™ Left Heart Delivery Systems are available in two models:
• Attain Command™ 6250C Left Heart Delivery System
• Attain Command™ 6250S Left Heart Delivery System.
All components with the exception of the two guide catheters are identical in both models. The guide catheters are different in each model with respect to the guide catheter shape and length.
The Attain Command™ Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. It is also designed to access the coronary sinus and the chambers of the heart using the guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.
The Attain Command™ Guide Catheters for Left Heart Delivery are available in eleven models as follows:
- · Attain Command ™ 6250-45S Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-50S Guide Catheter for Left Heart Delivery
- · Attain Command " 6250-57S Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-AM Guide Catheter for Left Heart Delivery
- · Attain Command " 6250-EH Guide Catheter for Left Heart Delivery
- TH 6250-EHXL Guide Catheter for Left Heart Delivery · Attain Command
- ти 6250-MB2 Guide Catheter for Left Heart Delivery · Attain Command
- · Attain Command ™ 6250-MB2X Guide Catheter for Left Heart Delivery
- 6250-MP Guide Catheter for Left Heart Delivery · Attain Command T
- · Attain Command ™ 6250-MPR Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-MPX Guide Catheter for Left Heart Delivery
Each model is different with respect to the guide catheter shape and length and the dilator length
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the left heart via the coronary sinus
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 Command™ product family to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Command™ product family 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.
K053431, K021589, K021587, K024035, K024032
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, sans-serif font on the right. The graphic appears to depict a human figure within a circle. The text is in black.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | February 14, 2008 |
|---|---|
| Applicant: | Medtronic Ireland |
| Parkmore Business Park West | |
| Galway | |
| Ireland | |
| Submission Correspondent: | Marlene Peterson |
| Principal Regulatory Affairs Specialist | |
| Medtronic, Inc. | |
| 8200 Coral Sea Street | |
| MS MVS11 | |
| Mounds View MN 55112 | |
| USA | |
| Telephone: | (763) 526 2355 |
| Fax: | (651) 367 0603 |
| E-Mail: | marlene.v.peterson@medtronic.com |
| Proprietary Name: | Attain Command™ 6250 Left Heart Delivery Systems |
| Attain Command™ 6250 Guide Catheters for Left Heart Delivery | |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Description: | The Attain Command™ Left Heart Delivery Systems contain two guide |
| catheters, one guide catheter dilator, one guide wire, one valve and one slitter. It is | |
| designed to access the coronary sinus and the chambers of the heart using the | |
| guidewire to access the vein, the valve to reduce blood loss during the implant | |
| procedure, the guide catheter to introduce a transvenous device, the guide catheter | |
| dilator to facilitate catheter passage and the slitter to remove the guide catheter. |
The Attain Command™ Left Heart Delivery Systems are available in two models :
• Attain Command™ 6250C Left Heart Delivery System
• Attain Command™ 6250S Left Heart Delivery System.
All components with the exception of the two guide catheters are identical in both
models. The guide catheters are different in each model with respect to the guide
catheter shape and length.
The Attain Command™ Guide Catheters for Left Heart Delivery are individual
packs, each containing one guide catheter and one guide catheter dilator. It is also
designed to access the coronary sinus and the chambers of the heart using the |
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" in bold, black letters on the right. The circular symbol appears to depict a stylized human figure within a circle.
guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.
The Attain Command™ Guide Catheters for Left Heart Delivery are available in eleven models as follows:
- · Attain Command ™ 6250-45S Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-50S Guide Catheter for Left Heart Delivery
- · Attain Command " 6250-57S Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-AM Guide Catheter for Left Heart Delivery
- · Attain Command " 6250-EH Guide Catheter for Left Heart Delivery
- TH 6250-EHXL Guide Catheter for Left Heart Delivery · Attain Command
- ти 6250-MB2 Guide Catheter for Left Heart Delivery · Attain Command
- · Attain Command ™ 6250-MB2X Guide Catheter for Left Heart Delivery
- 6250-MP Guide Catheter for Left Heart Delivery · Attain Command T
- · Attain Command ™ 6250-MPR Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-MPX Guide Catheter for Left Heart Delivery
Each model is different with respect to the guide catheter shape and length and the dilator length
The Attain Command™ 6250 Left Heart Delivery Systems and the Medtronic Indications For Use: Attain Command™ 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus
Substantially Equivalent Devices:
Attain Command™ 6250 Left Heart Delivery Systems and the Attain Command™ 6250 Guide Catheters for Left Heart Delivery uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices:
- · Attain Select™ II 6248DEL Delivery Catheter System (510(k) K053431).
- · Attain™ Access 6218A Left Heart Delivery System (510(k) K021589). Also commercialized under this 510(k) number is the Attain™ 6218A-45S, 6218A-50S, 6218A-57S and 6218A-EH Guide Catheters for Left-Heart Delivery individual packs.
- · Attain™ LDS 6216A Left Heart Delivery System (510(k) K021587). Also commercialized under this 510(k) number is the Attain™ 6216A-MB2 Guide Catheter for Left-Heart Delivery.
- · Attain™ 6218A-AM Guide Catheter for Left-Heart Delivery (510(k) K024035). Also commercialized under this 510(k) number is the Attain™ 6218A-EH Guide Catheter for Left-Heart Delivery individual pack.
· Attain™ 6218A-MP Guide Catheter for Left-Heart Delivery (510(k) K024032)
2
Image /page/2/Picture/0 description: The image shows the Medtronic logo. On the left is a circular symbol with a stylized human figure inside. To the right of the symbol is the word "Medtronic" in a bold, sans-serif font.
| Summary of Studies: | Device integrity testing was performed to support the equivalency of the Attain Command™ product family to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Command™ product family met all specified design and performance requirements. |
|---|---|
| Biocompatibility Information: | The biocompatibility evaluation completed for the Attain Command™ product family verifies that the Attain Command™ Left Heart Delivery Systems and the Attain Command™ Guide Catheters for Left Heart Delivery are biocompatible. |
| The testing which supports the biocompatibility of the Attain Command™ Left Heart Delivery Systems and the Attain Command™ Guide Catheters for Left Heart Delivery is consistent with International Standard ISO10993-1:2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." | |
| When classified according to this standard, the catheter and dilator included in the Attain Command™ product family are categorized as external communicating devices with limited exposure i.e. whose contact with circulating blood is (less than) |