The Selectra Accessory Kit / Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

Device Description

The legally marketed Selectra Accessory Kit and Selectra Slitter Tool are accessories to the Selectra lead introducer system, which is specifically used for the placement of coronary sinus leads. The modifications made to the legally marketed devices include a newly designed TVI tool, shelf life extension for the Selectra Accessory Kit/Selectra Slitter Tool, and new sterile packaging for the Selectra Slitter Tool.

AI/ML Overview

The provided document describes modifications to medical devices—the Selectra Accessory Kit and Selectra Slitter Tool—and their clearance through a Special 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove efficacy against specific acceptance criteria.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance through clinical studies.
Sample sizes used for test sets, data provenance, or details about training sets.
The number or qualifications of experts used to establish ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or associated effect sizes.
Standalone (algorithm-only) performance.
The type of ground truth used in a new clinical study.
How ground truth for a training set was established.

Instead, the submission demonstrates substantial equivalence primarily through non-clinical testing and a comparison of technological characteristics between the modified devices and their predicate devices.

Here's the information that is available:

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

The document provides a table outlining the technical specifications of the predicate and proposed devices, demonstrating that the proposed device maintains similar functionality, or improvements that do not raise new questions of safety or effectiveness. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.

Technical Data	Selectra Accessory Kit (Predicate)	Selectra Accessory Kit (Proposed)
Configuration	1 Accessory Kit Including: - 1 Guide Wire - 4 Transvalvular Insertion (TVI) Tools - 1 Selectra Slitter Tool - 1 Torquer - 2 Check-valves - 2 Stop-cocks - 2 Sealing Caps - 1 Syringe - Technical Manual	1 Accessory Kit Including: - 1 Guide Wire - 4 Transvalvular Insertion (TVI) Tools (subject of this Special 510(k)) - 1 Selectra Slitter Tool - 1 Torquer - 2 Check-valves - 2 Stop-cocks - 2 Sealing Caps - 1 Syringe - Technical Manual
TVI Tool Design	Image: TVI Tool Design Predicate (visual)	Image: TVI Tool Design Proposed (visual)
Dimensions	Outer Diameter: 5 F Inner Diameter: 3 F	Outer diameter: 4.8 F Inner diameter: 1.26 F
Materials	PTFE, PP	PEBAX 7233
Manufacturer	Galt Medical Corp.	BIOTRONIK SE & Co. KG
Product Packaging	The products are packaged in a sterile blister within a sterile pouch. The blister and pouch are placed in an outer cardboard box with label and a quality seal.	(Same as predicate for Accessory Kit)
EtO Sterilization	EtO sterilization for single use only. The sterilization process is validated at least bi-annually.	(Same as predicate for Accessory Kit)
Shelf Life	6 months	2 years
Technical Data	Selectra Slitter Tool (Predicate)	Selectra Slitter Tool (Proposed)
Selectra Slitter Tool Design	Image: Selectra Slitter Tool Predicate (visual)	Image: Selectra Slitter Tool Proposed (visual)
Compatibility	Can be used with all coronary sinus leads with a diameter of 4.6F to 5.8 F.	(Same as predicate for Slitter Tool)
Materials	Body Material - Acrylonitrile Butadiene Blade Material - Stainless Steel	(Same as predicate for Slitter Tool)
Manufacturer	Creganna	(Same as predicate for Slitter Tool)
Product Packaging	The products are packaged in a sterile blister within a sterile pouch. The blister and pouch are placed in an outer cardboard box with label and a quality seal.	The products are packaged in two sterile pouches. Both pouches are placed in an outer cardboard box with label and a quality seal.
EtO Sterilization	EtO sterilization for single use only. Sterilization process is validated at least bi-annually.	(Same as predicate for Slitter Tool)
Shelf Life	6 months	2 years

Study that proves the device meets the acceptance criteria:

The "study" conducted for this 510(k) submission is a series of non-clinical tests designed to validate the safety and performance of the modified devices and to justify the shelf-life extension and new packaging. These tests implicitly serve as "acceptance criteria" for demonstrating substantial equivalence. The document states:

"Summary of Non-Clinical Testing: The substantial equivalence claim between the subject and the predicate devices is supported by the information included in this premarket notification. This includes the following:

Comparison of the attributes and specifications of the subject and predicate devices -
Subject device risk analysis
Subject device validation testing which includes the following testing:"

Non-Clinical Validation Testing Performed:

For the New TVI Tool:

Cytotoxicity
Sensitization Local Lymph Node Assay (LLNA)
Irritation or Intracutaneous Reactivity
Acute Systemic Toxicity in the Mouse with 4 Extracts
Material Mediated Pyrogenicity Rabbit Pyrogen Test
Hemocompatibility Evaluation
Compendium of Biological Evaluation
EtO Residual Gas Analysis
Environmental Preconditioning
Release of Particulate Matter
Tests After Environmental Preconditioning and Shelf Life (25 months)
Labeling on Sales / Sterile Package Accompanying Documentation

For the Extended Shelf-Life for the Selectra Accessory Kit and Selectra Slitter Tool:

Determination of Shelf Life (25 months) Transport Test, Drop Test, Completeness of Unit
Inspection of Seldinger Guide Wire
Inspection of Syringe
Inspection of Check Valve, Stop-Cock, and Sealing Caps
Inspection of TVI and slitter tool
Proof of Sterilization after Accelerated Aging of 25 Months

For the New Sterile Packaging for the Selectra Slitter Tool:

Labelling on Sales / Sterile Package Accompanying Documentation
Environmental Preconditioning
Determination of Shelf Life (25 months) and Integrity of Sterile Packaging
EtO Sterilization Cycle Product Adoption
Tests after Environmental Preconditioning and Accelerated Aging (25 Months)

2. Sample sized used for the test set and the data provenance: Not applicable. These are non-clinical (laboratory/mechanical/biological) tests, not human studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission for device modifications.

4. Adjudication method for the test set: Not applicable. See above.

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 device is a catheter accessory, not an AI or imaging device involving human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. See above.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests is based on established scientific and engineering standards, and documented test methods to verify material properties, sterility, mechanical integrity, and biological compatibility.

8. The sample size for the training set: Not applicable. No "training set" in the context of machine learning or AI is relevant here.

9. How the ground truth for the training set was established: Not applicable. See above.

Summary

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Selectra Accessory Kit and Selectra Slitter Tool Modifications

Special 510(k) Premarket Notification

1. 510(K) SUMMARY

Date Prepared:	August 22, 2013
Name and Address of Sponsor:	BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035

AUG 2 3 2013

Establishment Registration Number:	1028232
510(k) Contact Person and Phone Number:	Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone: (888) 345-0374 Fax: (800) 913-6993 jon.brumbaugh@biotronik.com

Device Name:

Proprietary Name:	Selectra Accessory Kit, Selectra Slitter Tool
Common Name:	Catheter Guide wire
Classification:	Class II (21 CFR 870.1330)
Product Code:	DQX, DQY

Predicate Devices:

. Selectra Accessory Kit (K111839, dated September 26, 2011)
Selectra Slitter Tool (K112482, dated September 26, 2011) .

Indications for Use:

The Selectra Accessory Kit/Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

Device Modifications:

Technological Characteristics and Substantial Equivalence:

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

-Description of the subject and predicate devices
Intended use of the subject and predicate devices -
Performance of the subject and predicate devices -
Technological characteristics of the subject and predicate devices -
Validation Testing -

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Table 1: Substantial Equivalence of the Modified Selectra Accessory Kit andSelectra Slitter Tool
Technical Data	Selectra Accessory Kit(Predicate)	Selectra Accessory Kit(Proposed)
Configuration	1 Accessory Kit Including:- 1 Guide Wire- 4 Transvalvular Insertion(TVI) Tools- 1 Selectra Slitter Tool- 1 Torquer- 2 Check-valves- 2 Stop-cocks- 2 Sealing Caps- 1 Syringe- Technical Manual	1 Accessory Kit Including:- 1 Guide Wire- 4 Transvalvular Insertion(TVI) Tools (subject of thisSpecial 510(k))- 1 Selectra Slitter Tool- 1 Torquer- 2 Check-valves- 2 Stop-cocks- 2 Sealing Caps- 1 Syringe- Technical Manual
TVI Tool Design	Image: TVI Tool Design Predicate	Image: TVI Tool Design Proposed
DimensionsMaterials	Outer Diameter: 5 FInner Diameter: 3 FPTFE, PP	Outer diameter: 4.8 FInner diameter: 1.26 FPEBAX 7233
Manufacturer	Galt Medical Corp.	BIOTRONIK SE & Co. KG
Product Packaging	The products are packaged in a sterile blister within a sterilepouch. The blister and pouch are placed in an outercardboard box with label and a quality seal.
EtO Sterilization	EtO sterilization for single use only. The sterilization processis validated at least bi-annually.
Shelf Life	6 months	2 years
Technical Data	Selectra Slitter Tool(Predicate)	Selectra Slitter Tool(Proposed)
Selectra Slitter ToolDesign	Image: Selectra Slitter Tool Predicate	Image: Selectra Slitter Tool Proposed
Compatibility	Can be used with all coronary sinus leads with a diameter of4.6F to 5.8 F.
Materials	Body Material - Acrylonitrile ButadieneBlade Material - Stainless Steel
Manufacturer	Creganna
Product Packaging	The products are packagedin a sterile blister within asterile pouch. The blister andpouch are placed in an outercardboard box with label anda quality seal.	The products are packagedin two sterile pouches. Bothpouches are placed in anouter cardboard box withlabel and a quality seal.
EtO Sterilization	EtO sterilization for single use only. Sterilization process isvalidated at least bi-annually.
Shelf Life	6 months	2 years

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K131978

Page 3 of 3

Summary of Non-Clinical Testing:

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

Comparison of the attributes and specifications of the subject and predicate devices -
-Subject device risk analysis
Subject device validation testing which includes the following testing: -

New TVI Tool:

・ Cytotoxicity
Sensitization Local Lymph Node Assay (LLNA) -
Irritation or Intracutaneous Reactivity י
Acute Systemic Toxicity in the Mouse with 4 Extracts -
Material Mediated Pyrogenicity Rabbit Pyrogen Test -
Hemocompatibility Evaluation -
Compendium of Biological Evaluation -
-Eto Residual Gas Analysis
Environmental Preconditioning -
Release of Particulate Matter -
Tests After Environmental Preconditioning and Shelf Life (25 months) -
Labeling on Sales / Sterile Package Accompanying Documentation .

Extended Shelf-Life for the Selectra Accessory Kit and Selectra Slitter Tool:

Determination of Shelf Life (25 months) Transport Test, Drop Test, Completeness of -Unit
Inspection of Seldinger Guide Wire -
-Inspection of Syringe
Inspection of Check Valve, Stop-Cock, and Sealing Caps -
Inspection of TVI and slitter tool -
Proof of Sterilization after Accelerated Aging of 25 Months -

New Sterile Packaging for the Selectra Slitter Tool:

Labelling on Sales / Sterile Package Accompanying Documentation 1
Environmental Preconditioning -
Determination of Shelf Life (25 months) and Integrity of Sterile Packaging -
י EtO Sterilization Cycle Product Adoption
. Tests after Environmental Preconditioning and Accelerated Aging (25 Months)

Conclusion:

BIOTRONIK considers the modifications to the Selectra Accessory Kit and Selectra Slitter Tool to be substantially equivalent to the legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized emblem consisting of three curved shapes, which are meant to represent the department's mission of promoting health and well-being.

Public Health Service

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

August 23, 2013

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

Re: K131978

Trade/Device Name: Selectra Accessory Kit, Selectra Slitter Tool Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DQY Dated: July 24, 2013 Received: July 25, 2013

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 vour 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

M.A. Gilliland

for Bram D. Zuckerman, Ph.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): K131978

Device Name: Selectra Accessory Kit and Selectra Slitter Tool Indications for Use:

Prescription Use > (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

MA Hillman

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).