The Attain 6215 Venogram balloon catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.

Device Description

The Medtronic Attain 6215 Venogram balloon catheter is designed for use within the coronary sinus for infusing contrast solutions for venogram imaging. It consists of extruded polymeric tubing with two lumens (inflation and infusion) in the main body of the catheter and a 1.25 cc controlled stroke volume syringe. The inflation lumen features a luer lock and stopcock at the proximal hub. Its distal end opens into a latex balloon, which is located near the catheter tip. The infusion lumen has a luer lock at its proximal hub.

AI/ML Overview

The provided text describes the Medtronic Attain™ 6215 Venogram Balloon Catheter and its 510(k) submission. However, it does not contain the specific information required to complete the requested table and details about a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices, device description, indications for use, and regulatory clearance. It mentions "compatibility testing and incoming inspection of final packaged device" and "clinical use experience" but does not provide the detailed acceptance criteria or a formal study report with specific performance metrics.

Here's a breakdown of what CANNOT be extracted from the provided text based on your request:

A table of acceptance criteria and the reported device performance: The document states that the catheter "passed all of the in vitro specified requirements" but does not list these specific requirements or their corresponding performance results.
Sample sized used for the test set and the data provenance: Not mentioned.
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): Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device (catheter), not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for specific performance criteria. The "clinical use experience" suggests real-world performance, but details are lacking.
The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance is:

"The Attain 6215 Venogram balloon catheter passed all of the in vitro specified requirements, and ensures that the Attain 6215 Venogram balloon catheter meets all of its design and performance requirements."
"The Attain 6215 Venogram balloon catheter has been used in two Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain 6215 Venogram balloon catheter has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus."

This suggests that some performance evaluation was conducted, but the specifics required to fill out your detailed request are absent from this 510(k) summary. A 510(k) often focuses on demonstrating substantial equivalence rather than presenting a full, detailed performance study report with explicit acceptance criteria and corresponding results in the manner you've requested for an AI device.

Summary

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

510(K) Summary of Substantial Equivalence

Date prepared	July 13, 2001
Submitter:	Medtronic, Inc.7000 Central Avenue N.E.Minneapolis, MN 55432
Contact:	Karen Reidt, RACSr. Product Regulation Manager
Telephone:	(763) 514-3914
Fax:	(763) 514-6424
E-Mail:	karen.reidt@medtronic.com
Proprietary Name:	Attain™ 6215 Venogram Balloon Catheter
Common Name:	Catheter, Flow Directed
Device Classification:	Class II, 21 CFR § 870.1240
Product Code:	74 DYG

Device Description

Indications for Use

The Attain™ 6215 Venogram balloon catheter is intended for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.

Medtronic COMMERCIAL

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

Substantially Equivalent Device

The predicate device for the Attain™ 6215 Venogram balloon catheter is outlined in the following table.

Predicate Device	Predicate DeviceManufacturer	Predicate 510(k)
Balloon Wedge Pressure, Angiographic	B. Braun Medical, Inc.*Allentown, PA 18103	K822806cleared 11/1/82
Accent DG ™ Balloon AngioplastyCatheter	Cook, IncBloomington, IN 47402	K900677cleared 02/22/91
Vueport ™ Coronary Sinus BalloonOcclusion Guiding Catheter	Cardima, IncFreemont, CA 94538	K973298cleared 06/26/98

Summary of Studies

Compatibility testing and incoming inspection of final packaged device was performed to support substantial equivalence to the predicate device. The Attain 6215 Venogram balloon catheter passed all of the in vitro specified requirements, and ensures that the Attain 6215 Venogram balloon catheter meets all of its design and performance requirements.

Clinical Use Experience

The Attain 6215 Venogram balloon catheter has been used in two Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain 6215 Venogram balloon catheter has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.

Biocompatibility Information

Because there are no new materials or material composition changes made to the Attain 6215 Venogram balloon catheter from those used in the predicate Model WP balloon catheter manufactured by B. Braun Medical, Inc., biocompatibility testing was not repeated for the Attain 6215 Venogram balloon catheter.

Sterilization Validation

The Attain 6215 Venogram balloon catheter is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Processes appropriate for sterilizing the devices were validated.

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

Conclusion

Through the data and information presented, as well as similarities to legally marketed devices, Medtronic Inc, considers the Attain 6215 Venogram balloon catheter to be substantially equivalent to the previously discussed legally marketed predicate devices.

Medtronic CONFIDENTIAL

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2001

Ms. Karen Reidt Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K012225

Trade Name: Attain 6215 Venogram Balloon Catheter Regulation Number: 21 CFR 870.1240 Regulatory Class: Class II (two) Product Code: 74 DYG Dated: July 13, 2001 Received: July 16, 2001

Dear Ms. Reidt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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

Page 2 - Ms. Karen Reidt

response to your premarket notification submission does not affect any obligation you might It spoulse to your promations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premater notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The I Dri imanig of easing 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 and If you desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, (201) 594-4640. Raditionally, For quice at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsibility and 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,

Dak Tiller

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):	N/A K012225
Device Name:	Medtronic® Attain™ 6215 Venogram balloon catheter
Indications For Use:	The Attain 6215 Venogram balloon catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.

(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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012225

CONNOCHTAL

Regulation Number and Section

§ 870.1240 Flow-directed catheter.

(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).