(83 days)
#032312
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No
The description focuses on the mechanical components and function of a catheter delivery system and does not mention any AI or ML capabilities.
No
The device is described as a delivery system to introduce other diagnostic and therapeutic devices, not as a therapeutic device itself.
No
The device is a delivery system for introducing other diagnostic and therapeutic transvenous devices; it does not perform diagnosis itself.
No
The device description explicitly lists multiple physical components (catheter, dilator, slitter, valve, guidewire, needle, syringe) and performance studies focus on mechanical and functional testing of these physical components. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to introduce other diagnostic and therapeutic devices into the body (specifically the heart and its vasculature). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details components like catheters, dilators, guidewires, needles, and syringes, all of which are tools for accessing and navigating 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 diagnostic purposes. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
Therefore, the Attain® 6227DEF Deflectable Catheter Delivery System is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DQY
Device Description
The Attain® 6227DEF Deflectable Catheter Delivery System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The Attain® 6227DEF Deflectable Catheter Delivery System is designed to access the coronary sinus and the chambers of the heart using the percutaneous needle and syringe to access the venous insertion site, the guidewire to access the vein the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers and coronary vasculature of the heart, coronary sinus, 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® 6227DEF Deflectable Catheter Delivery System to the predicate devices. Testing included mechanical and functional testing. The Attain® 6227DEF Deflectable Catheter Delivery System met all specified design and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
#032312
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.
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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).
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§ 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 three figures in motion within the circle.
Image /page/0/Picture/1 description: The image shows the text "K061480" in a handwritten style, with the date "AUG 21 2006" printed below it. The text is in black ink and appears to be scanned or photographed. The date is printed in a simple, sans-serif font, while the handwritten text has a more stylized appearance.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | May 26, 2006 |
|---|---|
| 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.d.nivala@medtronic.com | |
| Proprietary Name: | Attain® 6227DEF Deflectable Catheter |
| Delivery System | |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DOY |
Device Description
The Attain® 6227DEF Deflectable Catheter Delivery System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The Attain® 6227DEF Deflectable Catheter Delivery System is designed to access the coronary sinus and the chambers of the heart using the percutaneous needle and syringe to access the venous insertion site, the guidewire to access the vein the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate
1
Image /page/1/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 features three stylized human figures arranged in a circular pattern.
deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter.
Indications for Use
The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Substantially Equivalent Devices:
The Attain® 6227DEF Deflectable Catheter Delivery System uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate device:
- Medtronic Attain 6226DEF Deflectable Catheter Delivery System (510(k) . #032312, cleared November 3, 2003)
Summary of Studies:
Device integrity testing was performed to support the equivalency of the Attain® 6227DEF Deflectable Catheter Delivery System to the predicate devices. Testing included mechanical and functional testing. The Attain® 6227DEF Deflectable Catheter Delivery System met all specified design and performance requirements.
Biocompatibility Information
The biocompatibility evaluation which has been completed for the Attain® 6227DEF Deflectable Catheter Delivery System verifies that the Attain® 6227DEF Deflectable Catheter Delivery System is biocompatible. The testing which supports the biocompatibility of the Attain® 6227DEF Deflectable Catheter Delivery System is consistent with International Standard ISO 10993-1:, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheter and dilator included in the Attain® 6227DEF Deflectable Catheter Delivery System are external communicating devices with limited exposure (