The deflectable catheter delivery system is indicated to provide a pathway through 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 6226DEF system features a percutaneous needle and syringe to access the venous insertion site, a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a deflectable catheter dilator to facilitate deflectable catheter passage, and a slitter to remove the deflectable catheter.

The Attain 6226DEF Deflectable Catheter Delivery System combines devices that are either pre-amendment devices, devices that are cleared for market distribution via 510(k), or are exempt from premarket notification because of Class I designation.

The key changes being made to the system versus the predicate 10600 device are a decrease in the length of the deflectable catheter, a reduction in the stiffness of the deflectable catheter tip, and a change in the articulated shape of the catheter. The dilator length is also decreased in line with the catheter. In addition the slitters are replaced by a Universal Slitter and the adjustable hemostasis valve is replaced by an introducer valve. The entire system is packaged in a revised packaging configuration.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the ATTAIN™ 6226DEF Deflectable Catheter Delivery System. It establishes substantial equivalence to existing predicate devices based on design, technology, features, functions, intended use, and in vitro testing, as well as biocompatibility and sterilization validation.

However, the document does not contain specific acceptance criteria tables nor detailed study results that would typically be used to "prove" the device meets such criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device, or specific success rates for a therapeutic device). This type of information is not typically presented in a 510(k) summary focused on substantial equivalence to a predicate device.

Instead, the document states that:"In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain 6226DEF meets all of its design and performance requirements."

Without access to the full submission, which would include the detailed testing reports, it's impossible to extract the specific acceptance criteria and detailed performance data.

Therefore, for the information requested, I can only provide what is explicitly stated or inferable from the document:

A table of acceptance criteria and the reported device performance:
The document states: "The results of this testing indicates that the Attain 6226DEF meets all of its design and performance requirements." However, specific numerical acceptance criteria (e.g., tensile strength > X, deflection angle > Y) and the corresponding measured performance values are not provided in this summary. The summary refers to in vitro testing and biocompatibility/sterilization testing.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions in vitro testing and biocompatibility/sterilization testing. It does not specify sample sizes, data provenance, or whether the tests were retrospective or prospective. In vitro tests generally refer to laboratory-based experiments rather than human data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable or provided. The testing described is in vitro (laboratory) and biocompatibility/sterilization, which does not involve human subjects or expert assessment of "ground truth" in a clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. Adjudication methods are typically used in clinical studies with human assessors, which is not described here.
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:
This information is not applicable or provided. The device is a "Deflectable Catheter Delivery System," a medical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable or provided. The device is a physical catheter delivery system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For in vitro and biocompatibility/sterilization testing, "ground truth" would typically refer to established engineering specifications, material standards, and validated sterilization protocols. The document does not specify the exact "ground truth" used for each specific test, but implies adherence to "design and performance requirements" and ISO10993 for biocompatibility.
The sample size for the training set:
This information is not applicable or provided. The device is a physical medical instrument, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
This information is not applicable or provided for the same reason as point 8.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which features three stylized human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2003 NOV 3

Medtronic, Inc. c/o Ms. Kristina Mollner Sr. Regulatory Affairs Specialist Cardiac Rhythm Management 7000 Central Avenue, NE Minneapolis, MN 55432

Re: K032312

Trade Name: ATTAIN™ 6226DEF Deflectable Catheter Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: September 19, 2003 Received: September 22, 2003

Dear Ms. Mollner:

This letter corrects our substantially equivalent letter of October 21, 2003 regarding the designation as class III (three) in the letter. The correct class for the device is class II (two).

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

{1}------------------------------------------------

Page 2 - Ms. Kristina Mollner

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

O. Malla

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

OCT 2 1 2003

510(K) Summary of Substantial Equivalence

Date prepared	25 July, 2003
Submitter:	Medtronic IrelandParkmore Business Park WestGalwayIreland
Submission Correspondent:	Kristina MollnerSr. Regulatory Affairs Specialist7000 Central Avenue, N.E.Minneapolis, MN 55432
Telephone:	(763) 514-3914
Fax:	(763) 514-6424
E-Mail:	kristina.mollner@medtronic.com
Proprietary Name:	Attain™ 6226DEF Deflectable Catheter DeliverySystem
Common Name:	Catheter, Percutaneous
Device Classification:	Class II, 21 CFR § 870.1250
Product Code:	74 DQY

Performance Standard

Performance standards do not currently exist for these devices. None established under Section 514.

{3}------------------------------------------------

Device Description

Indications for Use

{4}------------------------------------------------

Substantially Equivalent Devices

Attain 6226DEF Deflectable catheter delivery system predicate devices

The design, technology, features, functions and intended use of the 6226DEF Deflectable Catheter Delivery System are substantially equivalent to the following predicate devices currently in interstate commerce.

Attain 6226DEFDeflectableCatheter DeliverySystem	Predicate Device	Predicate DeviceManufacturer	Predicate 510(k)
Deflectablecatheter	Medtronic 10600Deflectable catheter system	Medtronic, Inc.Minneapolis, MN 55432	K013517
Guide CatheterDilator	Medtronic 10600Deflectable catheter system	Medtronic, Inc.Minneapolis, MN 55432	K013517
Guide Wire	Medtronic 10600Deflectable catheter system	Medtronic, Inc.Minneapolis, MN 55432	K013517
Introducer valve	Cook 6228VAL IntroducerValve	Cook Vascular IncorporatedLeechburg, PA 15656 USA	K010128
Universal Slitter	Medtronic 6228SLTUniversal Slitter	Medtronic, Inc.Minneapolis, MN 55432	Class I device, exemptfrom premarketnotification
Needle	Medtronic 10600Deflectable catheter system	Medtronic, Inc.Minneapolis, MN 55432	K013517
Syringe	Medtronic 10600Deflectable catheter system	Medtronic, Inc.Minneapolis, MN 55432	K013517

Additionally, the biocompatibility of the Attain 6226DEF Deflectable Catheter Delivery System is substantially equivalent to the following device.

Attain 6226DEFDeflectableCatheter DeliverySystem	Predicate Device	Predicate DeviceManufacturer	Predicate 510(k)
Deflectablecatheter	Medtronic Attain Access6218 Left-Heart DeliverySystem	Medtronic, Inc.Minneapolis, MN 55432	K012083

{5}------------------------------------------------

CONFIDENTIAL

May not be reproduced without written permission from Medtronic, Inc.

Summary of Studies

In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain 6226DEF meets all of its design and performance requirements.

Biocompatibility Information

Materials/components of the Attain 6226DEF kit were evaluated for compliance to ISO10993. All materials were found to be biocompatible and in compliance to ISO10993.

Sterilization Validation

The Attain 6226DEF Deflectable catheter delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated.

Conclusion (Statement of Equivalence)

Through the data and information presented, as well as similarities to legally marketed devices, Medtronic, Inc. considers the Attain 6226DEF deflectable catheter delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices.

{6}------------------------------------------------

CONFIDENTIAL May not be reproduced without written permission from Medtronic, Inc.

Indications for Use Statement

510(k) Number (if known):	N/A
Device Name:	Attain™ 6226DEF Deflectable catheter delivery system
Indications For Use:	The deflectable catheter delivery system is indicated to provide a pathway through 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	X
------------------------------------------	---

(Division Sign-Off)
Division of Cardiovascular Devices

Over-The-Counter Use
----------------------	--

510(k) Number	K032312
---------------	---------

Special 510(k): Device Modification Premarket Notification Attain™ 6226DEF Deflectable Catheter Delivery System

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).