The Selectra CS lead introducer system is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The Selectra Guiding Catheter is packaged with the following components: 1 Selectra CS guiding catheter (sterile), 1 dilator for the guiding catheter (sterile), 1 technical manual or web-card (non-sterile).

AI/ML Overview

This document describes a Special 510(k) premarket notification for the BIOTRONIK Selectra 7F Guiding Catheters. The core of this notification is a device modification (reduction of Tungsten concentration and shelf-life extension) rather than a new device with novel performance claims. As such, the study design and acceptance criteria differ significantly from what would be expected for a device making claims based on algorithm performance.

Here's the breakdown of the information requested, based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Mechanical Properties	Not explicitly detailed as numerical criteria or performance. However, the reason for the Tungsten reduction was "to improve the mechanical properties of the X-ray marker after aging," implying a positive outcome compared to the predicate.
Packaging Integrity	Not explicitly detailed as numerical criteria or performance.
Sterilization Efficacy	Not explicitly detailed as numerical criteria or performance.
Shelf-life Extension	Extended shelf-life from 6 months. (Acceptance criteria would be that the device maintains its specified properties and safety over the extended period.)
Product Characteristics (Indications for Use, Contraindications, Functions)	"unchanged and ... identical to the previously cleared Selectra 7F guiding catheters" (K110461). This implicitly means the modified device performs equivalently for its intended use.
Substantial Equivalence to Predicate	Claimed based on comparison of attributes, specifications, intended use, material composition, and validation testing.

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

The document does not specify a "test set" in the context of an algorithm or human performance study. Instead, it describes general "validation testing" for mechanical, packaging, sterilization, and shelf-life properties. Therefore, information on sample sizes for a clinical test set or data provenance (country, retrospective/prospective) is not applicable to this type of device modification submission. The studies were likely bench-top or accelerated aging tests.

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

This is not applicable. The submission is for a material and shelf-life change to a guiding catheter, not for a diagnostic or AI device requiring expert-established ground truth on patient data.

4. Adjudication method for the test set

This is not applicable. As there is no clinical test set requiring expert interpretation or consensus, there's no adjudication method.

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. This is not an AI-powered device, nor does it involve human readers interpreting clinical cases.

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

This is not applicable. This is not an algorithm or AI device.

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

For the specific modifications (Tungsten concentration and shelf-life extension), the "ground truth" would be established through:

Engineering specifications and material science: For the Tungsten concentration, the "truth" is its measured concentration and the resulting mechanical properties.
Accelerated aging studies and real-time aging studies: For shelf-life, the "truth" is the device's ability to maintain its sterile barrier, material integrity, and functional performance over time, typically verified against pre-defined stability protocols and standards.
Sterilization validation standards: For sterilization, the "truth" is achieving a specified sterility assurance level (SAL).

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a training set.

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

This is not applicable. There is no training set for this device modification.

Summary

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BIOTRONIK, Additional Information Selectra 7F Special 510(k)

December 13, 2012

Selectra MPH-55

Selectra Right-45

Selectra Right-55

Selectra 7F JAN 1 1 2013 Extended Shelf Life Special 510(k) Premarket Notification

1. 510(K) SUMMARY

Name and Address of Sponsor:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 1028232

Establishment Registration Number: Device Name:

Proprietary Name: Classification: Classification Name: Product Code:

Selectra 7F Guiding Catheters Class II (21 CFR 870.1250) Percutaneous Catheter DQY

General Description:

The Selectra CS lead introducer system is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The following legally marketed Selectra 7F guiding catheters (K110461, 20-Apr-2011) are the subjects of this Special 510(k);

Selectra Amplatz 6.0-45 Selectra Extended Hook-Selectra MPEP-45 . . . 45 Selectra Amplatz 6.0-55 Selectra MPEP-55 . . . Selectra Extended Hook-· Selectra Straight-45 Selectra MPH-45 . રક
Selectra Straight-55 . Selectra BIO2-45
Selectra Hook-45 . ●
. Selectra Hook-55
Selectra BIO2-55 .
The Selectra Guiding Catheter is packaged with the following components:
- . 1 Selectra CS guiding catheter (sterile)
- 1 dilator for the guiding catheter (sterile) .
- 1 technical manual or web-card (non-sterile) .

Predicate Device:

BIOTRONIK's Selectra 7F Guiding Catheters (K110461, 20-Apr-2011)

Indication for Use:

The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Device Modification:

The changes made to the Selectra 7F compared to the previously cleared Selectra 7F quiding catheters is a reduction in the concentration of Tungsten in the X-ray marker band (from 80% to 60%) and a shelflife extension from 6 months. The reason for the reduction in Tungsten concentration between the current and proposed catheters is to improve the mechanical properties of the X-ray marker after aging.

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BIOTRONIK, Additional Information Selectra 7F Special 510(k) K123324

December 13, 2012

The usage of the Selectra 7F catheters remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared Selectra 7F guiding catheters in submission K110461, cleared on April 20, 2011. Therefore, this previously cleared version will serve as the predicate device for the modified product family included in this Special 510(k).

Summary of Non-Clinical Testing:

The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following:

Comparison of attributes and specifications of the subject and predicate devices -
-Subject device risk analysis
Subject device validation testing which includes the following testing: -
- Mechanical o
- Packaging o
- Sterilization and Shelf life ಂ

Substantial Equivalence:

The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following information:

Description of the subject and predicate devices -
-Intended use of the subject and predicate devices
Material composition of the subject and predicate devices .
Validation testing

Name and Address of Manufacturer:

BIOTRONIK SE & Co. KG (reg. no. 9610139) Woermannkehre 1. 12359 Berlin, Germany 011-49-30-689-05-1210

Name and Address of Contract Manufacturer: BIOTRONIK AG (reg. no. 8043892)

Ackerstrasse 6 8180 Bülach, Switzerland 011-41-44-864-5169

Name and Address of Contract Sterilizer:

Sterigenics Germany GmbH (req. no. 3002807090) Kasteler Straße 45 (Rheingaustrasse 190 - 196) D-65203 Wiesbaden, Germany

Contact Person(s) and Phone Number:

Jon Brumbaugh VP, Regulatory Affairs and Compliance Phone (888) 345-0374 Fax (800) 913-6993 jon.brumbaugh@biotronik.com

Page 20 of 330

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle or other bird with its wings spread, suggesting a sense of protection and care. The logo is black and white.

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

Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Rd. Lake Oswego, OR 97035

Re: K123324

Trade/Device Name: Selectra 7F Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 13, 2012 Received: December 14, 2012

Dear Mr. Brumbaugh:

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 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

JAN 1 1 2013

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Page 2 - Mr. Jon Brumbaugh

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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

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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Appendix 1

Indications for Use

510(k) Number (if known): TBD K12 3314-

Device Name: Selectra CS Lead Introducer System Indications for Use:

The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Prescription Use イ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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 1

C.M.S. Wilhelm

Division of Cardiovascular Devices

510(k) Number K123324

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).