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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Medtronic Attain® 6227DEF Deflectable Catheter Delivery System. It describes a medical device and its substantial equivalence to a predicate device, as well as testing performed to support this equivalence.

However, this document does not contain information about the acceptance criteria or a study that uses AI/algorithm performance metrics such as sensitivity, specificity, or AUC, nor does it involve human readers, ground truth consensus, or training sets typical of a study proving a device meets acceptance criteria in an AI context.

Instead, this is a regulatory submission for a physical medical catheter delivery system, and the "study" referred to is device integrity testing and biocompatibility testing. The "acceptance criteria" generally refer to the design and performance requirements for the physical device, not a classification or diagnostic performance of an AI algorithm.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/algorithm performance studies based on the provided text. The document describes a traditional medical device clearance process, not one involving an AI component.

Here's an explanation of what the document does describe in terms of "acceptance criteria" and "studies":

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied): The device is expected to meet "all specified design and performance requirements" for a catheter delivery system. These would typically include:
- Mechanical integrity (e.g., tensile strength, resistance to kinking, pushability, torqueability, deflection capabilities).
- Functional performance (e.g., ability to introduce diagnostic/therapeutic transvenous devices and balloon catheters/leads effectively).
- Biocompatibility (meeting ISO 10993-1 standards for limited exposure to circulating blood).
- Sterility (achieving sterility through a validated EtO sterilization process).
Reported Device Performance:
- "The Attain® 6227DEF Deflectable Catheter Delivery System met all specified design and performance requirements."
- "The biocompatibility evaluation... verifies that the Attain® 6227DEF Deflectable Catheter Delivery System is biocompatible."
- "The Attain® 6227DEF Deflectable Catheter Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process."

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not a data-driven AI test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This relates to expert review of data, not physical device testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI sense. For the physical device, the "ground truth" is adherence to engineering specifications and biological safety standards.

8. The sample size for the training set: Not applicable. This is not an AI model.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a medical device's compliance with safety and performance standards for regulatory clearance, not an AI-powered system's performance metrics.

Summary

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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 IrelandParkmore Business Park WestGalwayIreland
Submission Correspondent:	Michelle NivalaRegulatory Affairs SpecialistMedtronic, Inc.1015 Gramsie RoadShoreviewMN 55126-3082USA
Telephone:	(763) 505 7863
Fax:	(763) 505 7877
E-Mail	michelle.d.nivala@medtronic.com
Proprietary Name:	Attain® 6227DEF Deflectable CatheterDelivery System
Common Name:	Catheter, Percutaneous
Device Classification:	Class II, 21 CFR 870.1250
Product Code:	DOY

Device Description

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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

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 (<24 hours) to circulating blood.

Sterilization Validation

The Attain® 6227DEF Deflectable Catheter Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.

Conclusion

Through the data and information presented, Medtronic Ireland considers the Attain® 6227DEF Deflectable Catheter Delivery System to be substantially equivalent to legally marketed predicate devices.

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Image /page/2/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", which is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2006

Medtronic Ireland c/o Ms. Clare Higgins Regulatory Affairs Specialist 1015 Gramsie Road Shoreview, MN 55126

Re: K061480

Attain 6227DEF Deflectable Catheter Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: August 11, 2006 Received: August 14, 2006

Dear Ms. Higgins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Clare Higgins

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR. 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mezayler
Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): KO6 l 4 BO

Device Name: Attain® 6227DEF Deflectable Catheter Delivery System

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Me May
Division of Cardiovascular Devices
510(k) Number K061480

Regulation Number and Section

§ 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).