The Attain Clarity™ 6225 Venogram Balloon Catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging.

Device Description

The Attain Clarity™ 6225 Venogram Balloon Catheter contains one non-latex occlusion balloon catheter, one stopcock and one controlled stroke syringe. It is indicated for use within the coronary sinus and is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging. This device is available in one model, the Attain Clarity™ 6225 Venogram Balloon Catheter.
The Attain Clarity™ 6225 Venogram Balloon Catheter is a non-latex occlusion balloon catheter designed for use within the coronary sinus for infusing contrast solution for occlusive venogram imaging.
The balloon catheter consists of polymeric tubing with an infusion port and an inflation port in the main body of the catheter.
The inflation port features a luer lock at the proximal end. Inflation is achieved through the use of a controlled stroke fixed volume syringe attached to a stopcock. The stopcock is manually attached to the balloon catheter. Both the stopcock and the syringe are supplied with the device.
A silicone balloon is located near the distal end; a marker band is located proximally to the balloon to help with visualizing the location of the balloon under fluoroscopy.
The infusion port has a luer lock at the proximal end.

AI/ML Overview

The Medtronic Attain Clarity™ 6225 Venogram Balloon Catheter is indicated for use within the coronary sinus and is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Device Integrity	All specified design and performance requirements.	"The Attain Clarity™ 6225 Venogram Balloon Catheter met all specified design and performance requirements."
Dimensional Testing	Not explicitly stated, implied to meet design specifications.	Performed and met requirements.
Balloon Safety & Performance	Not explicitly stated, implied to meet safety and function standards.	Performed and met requirements.
Catheter Safety & Performance	Not explicitly stated, implied to meet safety and function standards.	Performed and met requirements.
Compatibility Testing	Not explicitly stated, implied for proper function with associated components/fluids.	Performed and met requirements.
Packaging Testing	Not explicitly stated, implied to ensure device integrity during storage/transport.	Performed and met requirements.
Biocompatibility	Meets ISO10993-1:2009 for external communicating devices with limited exposure (≤ 24 hours blood contact).	"The biocompatibility evaluation completed verifies that the Attain Clarity™ 6225 Venogram Balloon Catheter is biocompatible." (Specific tests include: Cytotoxicity, Maximisation Sensitization, Acute Intracutaneous Reactivity, Acute Systemic Toxicity, USP Material Mediated Pyrogen, In-vitro Hemolysis, PTT Coagulation, C3a Complement Activation, SC5b-9 Complement Activation, In Vivo Thromboresistance, USP Physicochemical Tests).
Sterilization Assurance Level	Minimum Sterility Assurance Level (SAL) of 10^-6.	"The Attain Clarity™ 6225 Venogram Balloon Catheter will be sterilized using a validated Ethylene Oxide (EtO) to a minimum Sterility Assurance Level of 10-6 in compliance with ANSI/AAMI/ISO 11135-1."

2. Sample Size Used for the Test Set and Data Provenance

The study primarily relied on in-vitro bench tests. The document does not specify a numerical sample size for individual tests, but implies sufficient samples were used to demonstrate compliance. The data provenance is from in-vitro bench testing conducted by the manufacturer, Medtronic Ireland. These are not clinical studies, so the concept of country of origin of patient data or retrospective/prospective does not apply.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission relies on bench testing and established international standards (e.g., ISO, ASTM, USP), rather than expert evaluation of clinical data for ground truth. The "ground truth" for these tests is defined by the parameters and pass/fail criteria of the specified engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation was based on meeting pre-defined criteria of objective bench tests and international standards, not expert adjudication of qualitative data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this is not an AI-based device that requires human interpretation. The device is a medical catheter and its effectiveness is determined by its physical and biological performance characteristics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of an algorithm or AI performance was not done. This is a physical medical device (catheter), not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation was based on:

Pre-defined design specifications and performance requirements for dimensional, safety, performance, and compatibility testing.
Internationally recognized biocompatibility standards (e.g., ISO 10993-1), with specific tests having their own established pass/fail criteria.
Internationally recognized sterilization standards (e.g., ANSI/AAMI/ISO 11135-1) for sterility assurance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical catheter, not an AI or machine learning model that requires a training set. The concept of a "training set" is irrelevant to this device's evaluation.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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K121219

5 2012

510(k) Summary

Date Prepared:

April 20, 2012

Applicant:

Medtronic Ireland Parkmore Business Park West Galway Ireland

Official Correspondent:

Christine Fazentieux Senior Regulatory Affairs Specialist Medtronic Ireland Parkmore Business Park West . Galway Ireland Phone: (011-353-91) 708958 Fax: (011-353-91) 708672 Email: christine.fazentieux(@medtronic.com

Proprietary Name:

Medtronic Attain Clarity™ Venogram Balloon Catheter

Model:

6225

Device Classification Name: Product Code:

DQY

Catheter, Percutaneous

Class II, 21 CFR 870.1250

Device Description:

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KI2I2I9

Indications For Use:	The Attain Clarity™ 6225 Venogram Balloon Catheter isindicated for use within the coronary sinus; it is intended forinfusing contrast solutions into the coronary vasculature forocclusive venogram imaging.
Substantially EquivalentDevices:	The Attain Clarity™ 6225 Venogram Balloon Catheter issimilar to the following predicates with respect to intendeduse, design and technology:Attain™ 6215 Venogram Balloon Catheter (K012225,cleared August 28, 2001) Oscor Occlusion Balloon Catheter, Model Venos™(K081052, cleared June 18, 2008)
Summary of TechnologicalCharacteristics:	The Attain Clarity™ 6225 Venogram Balloon Catheter is anon-latex occlusion balloon catheter designed for use withinthe coronary sinus for infusing contrast solution for occlusivevenogram imaging.The balloon catheter consists of polymeric tubing with aninfusion port and an inflation port in the main body of thecatheter.The inflation port features a luer lock at the proximal end.Inflation is achieved through the use of a controlled strokefixed volume syringe attached to a stopcock. The stopcock ismanually attached to the balloon catheter. Both the stopcockand the syringe are supplied with the device.A silicone balloon is located near the distal end; a markerband is located proximally to the balloon to help withvisualizing the location of the balloon under fluoroscopy.The infusion port has a luer lock at the proximal end.
Summary of Studies:	Device integrity testing was performed to support theequivalency of the Attain Clarity™ 6225 Venogram BalloonCatheter to the predicates.The following in-vitro bench tests were completed on thedevice:Dimensional testing Balloon safety & performance testing Catheter safety & performance testing Compatibility testing Packaging testing The Attain Clarity™ 6225 Venogram Balloon Catheter metall specified design and performance requirements.

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Summary of Clinical Data:

No clinical investigation has been performed for this device.

Biocompatibility Information:

Biocompatibility testing for the Attain Clarity™ 6225 Venogram Balloon Catheter has been completed in accordance with the International Standard ISO10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing" for an external communicating devices with limited exposure i.e. whose contact with circulating blood is ≤ 24 hours.

The following Biocompatibility tests were performed:

Cytotoxicity Study using ISO MEM Elution method: .
ISO Maximisation Sensitisation Study .
. ISO Acute Intracutaneous Reactivity
ISO Acute Systemic Toxicity ●
USP Material Mediated Pyrogen Study in Rabbits .
ASTM In-vitro Hemolysis ●
ASTM Partial Thromboplastin Time (PTT) . Coagulation Testing
C3a Complement Activation Assay Study .
SC5b-9Complement Activation Assay Study .
In Vivo Thromboresistance Study in the Dog, Jugular . Vein
. USP Physicochemical Tests for Plastic (Aqueous)

The biocompatibility evaluation completed verifies that the Attain Clarity™ 6225 Venogram Balloon Catheter is biocompatible.

The Attain Clarity™ 6225 Venogram Balloon Catheter will be sterilized using a validated Ethylene Oxide (EtO) to a minimum Sterility Assurance Level of 10-6 in compliance with ANSI/AAMI/ISO 11135-1.

Through the data and information presented, Medtronic Ireland considers the Attain Clarity™ 6225 Venogram Balloon Catheter to be substantially equivalent to the predicate devices.

Sterilization Validation:

Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP
25 2012

Wendy A. Saunders Medtronic, Inc CRDM 8200 Coral Sea Street, MS MVS11 Mounds View, MN 55112

Re: K121219

Attain Clarity 6225 Venogram Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: September 14, 2012 Received: September 17, 2012

Dear Ms. Saunders:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, MD

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):

Medtronic Attain Clarity™ 6225 Venogram Balloon Catheter Device Name:

The Attain Clarity™ 6225 Venogram Balloon Catheter is indicated for Indications for Use: use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging.

Prescription Use

AND/OR

(Part 21 CFR 801 Subpart D)

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)

മ്യേടിon Sign-Only
Division of Cardiovascular Devices

. 510(k) Number K12121

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).