The Attain™ Prevail® Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Device Description

The Medtronic Attain™ Prevail® Steerable Catheter Set features a steerable catheter and accessories to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The Prevail Steerable Catheter has a single lumen for passage of devices up to 0.035" (0.89 mm) diameter or injection of contrast solutions. Transvenous devices with an inner diameter of 7 French (2.3 mm) or larger can be loaded on and delivered with the Prevail catheter. The catheter features a steerable distal section controlled by the catheter handle. The catheter is radiopaque for visibility under fluoroscopy.

The Prevail Steerable Catheter Set features a guide wire and guide wire torque tool to assist in cannulating the coronary sinus ostium and coronary vasculature. Fluid management components include a Y-connector with an adjustable hemostasis valve. extension tube and 3-way stopcock. The adjustable hemostasis valve is used to reduce blood loss during the procedure. The Y-connector with side port and stopcock are used to aspirate air or inject solutions during the procedure.

The Prevail Steerable Catheter Set is provided STERILE and is intended for single use only.

AI/ML Overview

The provided text describes the 510(k) submission for the Medtronic Attain™ Prevail® Steerable Catheter Set. This device is a catheter and, as such, is subject to performance testing rather than studies involving interpretation of medical images or data by experts. Therefore, many of the requested categories are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "The Attain Prevail Steerable Catheter Set met all specified design and performance requirements." However, specific numerical acceptance criteria or performance metrics (e.g., tensile strength, steerability angles, flow rates) are not detailed in this summary document. The studies were focused on device integrity, biocompatibility, and sterilization validation.

Acceptance Criteria Category	Reported Device Performance
Mechanical Testing	All specified design and performance requirements were met.
Functional Testing	All specified design and performance requirements were met.
Packaging Testing	All specified design and performance requirements were met.
Biocompatibility	All specified biocompatibility requirements (consistent with ISO-10993 Part 1) were met.
Sterilization Validation	Ethylene Oxide (EtO) sterilization process was validated.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the various mechanical, functional, packaging, or biocompatibility tests. The data provenance is internal to Medtronic, Inc. as these are laboratory and validation tests. These studies are prospective in nature, as they involve testing newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the device is a catheter and its performance is evaluated through engineering tests, not by expert interpretation of medical data. The "ground truth" is established by the test methods and specifications themselves, which are typically developed by engineers and quality assurance personnel.

4. Adjudication method for the test set

This is not applicable for this type of device and testing. Test results are typically compared against pre-defined specifications without an adjudication process involving multiple experts.

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

This is not applicable. The device is a physical catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical catheter.

7. The type of ground truth used

The "ground truth" for the device's performance is established by engineering specifications and recognized standards (e.g., ISO-10993 for biocompatibility). For mechanical and functional tests, the ground truth would be the pre-defined performance limits or acceptable ranges for each parameter.

8. The sample size for the training set

This is not applicable. The device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This is not applicable.

Summary

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510(k) Attachments JUL 17 2003 Attain™ Prevail® Steerable Catheter Set

510(k) Summary of Substantial Equivalence

Date Prepared:	April 14, 2003
Submitter:	Medtronic, Inc.7000 Central Avenue N.E.Minneapolis, MN 55432
Contact:	Lynn JensenSr. Regulatory Affairs Specialist
Telephone:	(763) 514-4459
Fax:	(763) 514-6424
E-Mail:	lynn.a.jensen@medtronic.com
Proprietary Name:	Attain™ Prevail® Steerable Catheter Set
Common Name:	Catheter, Percutaneous
Device Classification:	Class II, 21 CFR § 870.1250
Product Code:	74DOY

Device Description

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510(k) Attachments

The Prevail Steerable Catheter Set is provided STERILE and is intended for single use only.

Indications for Use

The Attain Prevail Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Substantially Equivalent Devices
	Predicate Device	Predicate DeviceManufacturer	Predicate 510(k)
Percutaneous Catheter	Medtronic Model10600 DeflectableCatheter System	Medtronic	K013517
	Medtronic Attain LDSModel 6216A Left-Heart DeliverySystem	Medtronic	K021587
	Medtronic AttainAccess Model 6218ALeft-Heart DeliverySystem	Medtronic	K021589
	Medtronic MarinrSeries EP DiagnosticCatheters	Medtronic	K931794
	Cardima NaviportDeflectable GuidingCatheter	Cardima Inc.	K974683
Stainless SteelGuidewire	Medtronic AVESteerable Guidewires	Medtronic AVE	Approved 10/7/86with P790017/S8prior to down-classing of PTCAguide wires.
Y Connector withAdjustableHemostasis Valve	Interventional VascularY-Adapter	Medtronic AVE	K945461
	Angeion Y-Adaptorwith Touhy-BorstValve	Angeion	K895580
Extension Tubing	Smallbore ExtensionSet	B Braun	K760385
Stopcock	Medex Stopcock andLuer Lock PlugModel MX531-1L	Medex, Inc.	Pre-amendmentdevice.
Guide Wire Torque Tool	Pinvise / Torque Tool	Merit Medical	K921702 (Accessory toGuide Wire)
Guide Wire Clip	Class I device, exempt from premarket notification.

Substantially Equivalent Devices

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510(k) Attachments

The Attain Prevail Steerable Catheter Set uses similar technology and has similar intended uses, materials and dimensional characteristics to the predicate devices.

Summary of Studies

Device integrity testing was performed to support the equivalency of the Attain Prevail Steerable Catheter Set to the predicate devices. Testing included mechanical, functional, and packaging testing. The Attain Prevail Steerable Catheter Set met all specified design and performance requirements.

Biocompatibility Information

Biocompatibility was performed on all blood and tissue contacting materials of the Prevail catheter. Testing performed was consistent with ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". All specified biocompatibility requirements were met.

Sterilization Validation

The Attain Prevail Steerable Catheter Set will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.

Conclusion

Through the data and information presented, Medtronic, Inc. considers the Attain Prevail Steerable Catheter Set to be substantially equivalent to legally marketed predicate devices.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

Medtronic, Inc. c/o Lynn Jensen Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K031211

Attain Prevail Steerable Catheter Set, Model 6228CTH Regulation Number: 870.1250 Regulation Name: Catheter Percutaneous Regulatory Class: Class II Product Code: DQY Dated: May 14, 2003 Received: May 15, 2003

Dear Ms. Jensen:

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 - Lynn Jensen

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 (OS) 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

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

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510(k) Indications for Use Attain™ Prevail® Steerable Catheter Set

INDICATIONS FOR USE

Page I of 1

510(k) Number (if known): _ _ KU31211

Device Name: Attain™ Prevail® Steerable Catheter Set

Indications for Use: The Attain™ Prevail® Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

(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)

510(K

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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).