The Selectra accessory kit 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 Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package. The Selectra accessory kit includes the following components: 1 Selectra Slitter Tool, 1 Seldinger Guide Wire, 4 Transvalvular Insertion (TVI) Tools, 1 Syringe, 1 Torquer, 2 Stopcocks, 2 Check valves, 2 Sealing caps, 1 Technical Manual. The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies with specific acceptance criteria in the way a clinical trial would. Therefore, many of the requested elements pertaining to clinical performance, ground truth, expert opinions, and AI effect sizes are not applicable here.

Here's a breakdown of what can be extracted from the provided text:

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

Since this is a Special 510(k) for a device modification, the "acceptance criteria" are primarily based on ensuring the modified device maintains the same characteristics and performance as the predicate device. The document explicitly states:

Acceptance Criteria: The usage, indications for use, contraindications, and function of the Selectra accessory kit must remain unchanged compared to the predicate device (ScoutPro ACS accessory kit, K101776). The changes are "minor component modifications."
Reported Device Performance: The document implicitly states that the device meets these criteria by asserting, "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use, contraindications, and function, are the ScoutPro ACS accessory kit cleared on July 23, 2010 (K101776). Therefore, this previously cleared accessory kit will serve as the predicate device for the modified accessory kit included in this Special 510(k)."

Acceptance Criteria	Reported Device Performance
Usage remains unchanged.	"The usage of the Selectra accessory kit remains unchanged."
Indications for Use remain unchanged.	"The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use... are the ScoutPro ACS accessory kit cleared on July 23, 2010." (The indications listed for the current device are identical to the predicate's implied indications for assisting lead implantation in the left side of the heart via the coronary sinus.)
Contraindications remain unchanged.	"The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as... contraindications... are the ScoutPro ACS accessory kit cleared on July 23, 2010."
Function remains unchanged.	"The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as... function... are the ScoutPro ACS accessory kit cleared on July 23, 2010."
Changes are minor component modifications.	"The changes made to the Selectra accessory kit, as compared to the previously cleared ScoutPro ACS accessory kit, primarily include minor component modifications."

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

Not Applicable. This submission is for a device modification (Special 510(k)) and is based on maintaining substantial equivalence to a predicate device, not on specific clinical trial data with a test set in the traditional sense. The evidence provided typically involves engineering and bench testing to demonstrate that the minor component modifications do not alter the safety or effectiveness of the device. There's no mention of a clinical "test set" from patients.

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. As noted above, this is not a study requiring expert-established ground truth on patient data.

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

Not Applicable. No test set or human adjudication process for clinical data is described.

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 component kit for a lead introducer system; it does not involve AI or human readers for diagnostic interpretation.

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

Not Applicable. This device is a physical medical accessory kit, not an algorithm.

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

Not Applicable. The "ground truth" for this type of submission is the documented performance and characteristics of the legally marketed predicate device. The new device is compared against the predicate's established performance through engineering and design verification.

8. The sample size for the training set

Not Applicable. There is no training set in the context of device modification for substantial equivalence.

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

Not Applicable. There is no training set.

Summary

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Selectra Accessory Kit Special 510(k) Premarket Notification

SEP 2 6 2011

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:

Selectra Accessory Kit Class II (21 CFR 870.1330; 870.1340; 870.4500; 880.5860) Classification Name: Cardiovascular surgical instruments, catheter guide wire, catheter introducer, piston syringe DWS, DQX, DYB, FMF

General Description:

The Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package.

The Selectra accessory kit includes the following components:

Product Code:

1 Selectra Slitter Tool .
. 1 Seldinger Guide Wire
. 4 Transvalvular Insertion (TVI) Tools
1 Syringe .
. 1 Torquer
2 Stopcocks .
2 Check valves ●
. 2 Sealing caps
. 1 Technical Manual

The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads. The Selectra accessory kit is the subject of this Special 510(k).

Device Modification:

The changes made to the Selectra accessory kit, as compared to the previously cleared ScoutPro ACS accessory kit, primarily include minor component modifications.

The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use, contraindications, and function, are the ScoutPro ACS accessory kit cleared on July 23, 2010 (K101776). Therefore, this previously cleared accessory kit will serve as the predicate device for the modified accessory kit included in this Special 510(k).

Predicate Device:

BIOTRONIK's ScoutPro ACS Accessory Kit (K101776)

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BIOTRONIK, Selectra Accessory Kit, Special 510(k)

Indication for Use:

The Selectra accessory kit 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.

・

Phone (888) 345-0374 Fax (503) 635-9936

jon.brumbaugh@biotronik.com

・

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 (reg. 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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W()66-G609 Silver Spring, MD 20993-0002

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

ុទ្ធសាសនា 6 201

. Re: K111839

Trade/Device Name: Selectra Accessory Kit Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide wire Regulatory Class: Class II Product Code: DQY. DQX Dated: June 28, 2011 Received: June 29, 2011

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.

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Page 2 - Mr. Jon Brumbaugh

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 vour 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 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,

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): TBD

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

The Selectra accessory kit 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.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division St., OR

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K ///839

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).