The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

Device Description

The Attain Select 6238TEL Guide catheter set for left-heart delivery consists of a set of 3 catheters, one straight catheter; one catheter with a 90° curved tip and one catheter with a 180°curved tip. The Attain Select 6238TEL guide catheters are designed to facilitate access to the coronary sinus and left-heart venotomy. The catheters provide a pathway for the delivery of contrast medium and transvenous devices such as guide wires and guide catheters. The Attain Select 6238TEL guide catheters are provided sterile and are intended for single use only.

The catheters, which have a working length of 70cm, also have radiopaque, flexible tips. The catheter functions as an inner catheter and, when used with an outer guide catheter, forms a dual-catheter assembly. The Attai.1 Select 6238TEL guide catheters feature a lumen that allows for the passage of guide wires up to 0.89 mm (0.035 in) in diameter. The guide catheters have a maximum outer diameter of 7 French (2.4 mm) and may be used with delivery systems that accept a 7 French (2.4 mm) transvenous device. Medtronic recommends using the guide catheters with Medtronic Attain Fixed Shape catheters or the Medtronic Attain Deflectable catheter.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or a clinical trial with human subjects.

Instead, the summary focuses on device integrity testing, biocompatibility, and sterilization validation to demonstrate that the new device is as safe and effective as its predicate devices, which is the basis for 510(k) clearance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to the type of information presented in this regulatory submission.

Here's a breakdown of the available information:

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

Acceptance Criteria Category	Reported Device Performance (Summary)
Mechanical Testing	Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery met all specified design and performance requirements.
Functional Testing	Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery met all specified design and performance requirements.
Biocompatibility Testing	Consistent with International Standard ISO 10993-1: 2003 ("Biological Evaluation of Medical devices- Part 1: Evaluation and Testing"). Device classified as external communicating with limited exposure (<24 hours) to circulating blood.
Sterilization Validation	Sterilized using a validated Ethylene Oxide (EtO) sterilization process.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for diagnostic performance. The "test set" here refers to the actual physical devices subjected to various engineering and biological tests. The document does not specify sample sizes for these tests, nor does it provide details on the data provenance in terms of patient data. These were laboratory and manufacturing tests performed by Medtronic Ireland.

3. 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 applicable. This information pertains to studies where expert consensus is needed to establish ground truth for diagnostic or clinical outcomes. The provided document describes engineering and biocompatibility testing, not clinical studies for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This refers to methods for resolving discrepancies in expert opinions for ground truth establishment in clinical studies. It's not relevant for device integrity or biocompatibility testing.

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 for a medical device (catheter) and not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant here.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical and functional testing: Ground truth would be defined by engineering specifications and performance standards established for such devices, against which the physical device performance is measured.
For biocompatibility: Ground truth is established by the accepted standards and protocols defined in ISO 10993-1, using biological assays and tests.
For sterilization: Ground truth is established by adherence to validated sterilization protocols and acceptable sterility assurance levels.

8. The sample size for the training set

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of device integrity tests (mechanical, functional), biocompatibility testing, and sterilization validation.

Device Integrity Testing: This involved subjecting the Attain Select™ 6238TEL Guide Catheter Set to various mechanical and functional challenges to ensure it performs as intended and meets its design specifications. The document states that the device "met all specified design and performance requirements." These tests are typically performed in a laboratory setting.
Biocompatibility Testing: The materials used in the catheter were tested for biocompatibility in accordance with International Standard ISO 10993-1: 2003 ("Biological Evaluation of Medical devices- Part 1: Evaluation and Testing"). This standard dictates methods for evaluating the biological response to medical devices. The device was classified as an "external communicating device with limited exposure (<24 hours) to circulating blood," and the testing confirmed its compliance with the standard for this classification.
Sterilization Validation: The Ethylene Oxide (EtO) sterilization process used for the device was "validated." This means that the sterilization cycle was rigorously tested and proven to consistently achieve the required sterility assurance level, ensuring the device is sterile when packaged and ready for use.

These studies collectively support the manufacturer's claim of substantial equivalence to legally marketed predicate devices, forming the basis for its 510(k) clearance by the FDA.

Summary

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SEP 1 5 2004

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

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Date Prepared:	August 11, 2004
Submitter:	Medtronic IrelandParkmore Business Park WestGalwayIreland
Contact:	Lynn JensenSr. Regulatory Affairs Specialist
Telephone:	(763) 514 4459
Fax:	(763) 514 6424
E-Mail	lynn.a.jensen@medtronic.com
Proprietary Name:	Attain Select™ 6238TEL Guide Catheter Set forLeft-heart Delivery
Common Name:	Catheter, Percutaneous
Device Classification:	Class II, 21 CFR 870.1250
Product Code:	DOY

Device Description

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used with delivery systems that accept a 7 French (2.4 mm) transvenous device. Medtronic recommends using the guide catheters with Medtronic Attain Fixed Shape catheters or the Medtronic Attain Deflectable catheter.

Indications for Use

Substantially Equivalent Devices:

The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices:

Medtronic AttainTM Access 6218A Left-Heart Delivery System (K#021589, . cleared May 30, 2002)
Attain™ Prevail® Steerable Catheter Set, Model 6228CTH (K031211, cleared . July 17, 2003)
Guidant RAPIDOTM Guiding Catheter (K#021455, cleared August 2, 2002) .

Summary of Studies:

Device integrity testing was performed to support the equivalency of the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery met all specified design and performance requirements.

Biocompatibility Information

Medtronic has tested the materials used to fabricate the Attain Select™ 6238TEL. Guide Catheter Set for Left-Heart Delivery for biocompatibility. The testing performed by Medtronic is consistent with International Standard ISO 10993-1: 2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the devices included in the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery are external communicating devices with limited exposure (<24 hours) to circulating blood.

Sterilization Validation

The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.

Conclusion

Through the data and information presented, Medtronic Ireland considers the Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery to be substantially equivalent to legally marketed predicate devices.

022 94

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2004

Medtronic, Inc. c/o Ms. Lynn Jensen Sr. Regulatory Affairs Specialist Parkmore Business Park West Galway IRELAND

Re: K042194

K042194
Medtronic Attain Select™ 6238 TEL Guide Catheter Set for Left-Heart Delivery: Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: August 11, 2004 Received: August 12, 2004

Dear Ms. Jensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 tose stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to comments that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices mat have been roomsonial of a premarket approval of a premarket approval application (PMA). allo Costience Act (71ct) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general oonly of over in the 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 If your device is classified (600 a00 roy als. Existing major regulations affecting your device can thay be subject to suell additional conserver , 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. 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 (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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blimmima for
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):_____________________________________________________________________________________________________________________________________________________

Device Name: Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery

X042194

Indications For Use: The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

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)

Page 1 of

Bhumima
(Division Sign-Off)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number KOH2144

Medtronic Ireland Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery Traditional 510(k)

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).