The Selectra lead introducer system is used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Device Description

BIOTRONIK's Selectra lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various different curve shapes and the Selectra accessory kit.

The Selectra Accessory Kit includes the following components in a single sterile package:

1 Selectra Slitter Tool
1 quide wire
2 7F Transvalvular Insertion Tools (TVI)
1 syringe
1 torque tool
2 check valves
2 stopcocks
1 Tuohy Borst Adapter (TBA)

The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system, and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

AI/ML Overview

The provided text describes a medical device clearance (K192996) for Biotronik's Selectra Catheters, Accessory Kit, and Slitter Tool. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel effectiveness. Therefore, the information provided is not a study proving de novo performance against specific acceptance criteria for a new AI/software-as-a-medical-device (SaMD) product.

The document states: "No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence." This indicates that extensive clinical studies, including those typically associated with AI/SaMD performance validation (like MRMC studies, standalone AI performance, expert ground truth establishment for AI training/testing), were not performed or required for this particular device clearance.

Instead, the performance data provided supports the substantial equivalence to a previously cleared predicate device (BIOTRONIK's Selectra 5F and 7F Catheters, Selectra Accessory Kit and Selectra Slitter Tool - K183265). The tests conducted were primarily engineering and quality control tests to confirm that minor modifications to the device and manufacturing processes did not negatively impact its performance or safety compared to the predicate.

Therefore, many of the requested criteria for AI/SaMD performance studies cannot be extracted from this document because they are not applicable to the type of device and clearance pathway described.

However, I can extract the available information as it pertains to the "acceptance criteria" and "study" for this specific device clearance, acknowledging that it's about substantial equivalence and not AI performance.

Acceptance Criteria and Device Performance (as reported for K192996 clearance)

Since this is a 510(k) for minor modifications to an existing device, the "acceptance criteria" and "performance" are implicitly defined by demonstrating that the modified device performs equivalently to the predicate device and meets established safety and functionality standards for a percutaneous catheter system.

1. Table of Acceptance Criteria & Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance / Assessment Method
Compatibility	Tests were conducted to demonstrate the modified Selectra system meets the same compatibility criteria as the predicate devices. (Specific results not detailed, but implied to be successful.)
Functional Performance	Tests were conducted to demonstrate the modified Selectra system meets the same functional performance criteria as the predicate devices. This includes testing for aspects like in-line luer lock, catheter handle, PEBAX-7233 segment, TVI, Tuohy-Borst Adapter, and updated outer diameter tolerance. (Specific results not detailed, but implied to be successful.)
Biocompatibility	Assessments were conducted to ensure the device remains biocompatible, meeting the same standards as the predicate. (Specific results/tests not detailed, but implied to be successful.)
Microbiology & Sterilization	Tests were conducted to confirm the effectiveness of the sterilization process and maintain microbiological safety, including the new sterilization process and altered packaging (single Tyvek pouch for accessory kit and catheters). (Specific results/tests not detailed, but implied to be successful.)
Manufacturing Changes	Manufacturing changes were assessed to have "no effect on performance criteria." Quality control testing on final products "remains unchanged." (Demonstrated through internal testing and quality processes.)
Quality Control	"Quality control testing on the final products remains unchanged." (Implied consistent performance with predicate.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in terms of number of devices tested for each category. These types of tests are typically done on a representative sample size determined by engineering and quality assurance protocols (e.g., ISO standards, internal validation plans) to ensure statistical confidence, but the specific numbers are not public in a 510(k) summary.
Data Provenance: The tests were conducted by Biotronik, presumably at their facilities or certified labs. The location of the company is Lake Oswego, Oregon, USA. The data would be prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence of the modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable / Not Mentioned. This type of "expert ground truth" for a test set is typically relevant for interpretative devices (e.g., AI for diagnostics). For a percutaneous catheter system, "ground truth" relates to quantifiable physical and material properties and functional performance, verified through engineering and bench testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set:

Not Applicable / None. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, particularly for AI validation. This device's testing involves objective measurements and standards, not subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence." MRMC studies are clinical studies involving human readers, and none were performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not Applicable / No. This device is a physical medical instrument (catheter system), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance validation is based on engineering specifications, material science standards, established functional parameters, and safety benchmarks (e.g., biocompatibility standards, sterility assurance levels). It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be. The performance of the modified device was compared against the known, established performance of the predicate device.

8. Sample Size for the Training Set:

Not Applicable. This is a hardware device, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As explained above, there is no AI training set for this device.

Summary

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November 21, 2019

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

Re: K192996

Trade/Device Name: Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 25, 2019 Received: October 28, 2019

Dear Jon 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192996

Device Name

Selectra Catheters, Accessory Kit and Slitter Tool

Indications for Use (Describe)

The Selectra lead introducer system is used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Type of Use (Select one or both, as applicable)

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

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510(k) Summary

BIOTRONIK Selectra Lead Introducer System Selectra Catheters, Accessory Kit and Slitter Tool

1. Submitter

BIOTRONIK 6024 SW Jean Road Lake Oswego, OR 97035 Phone: (888) 345-0374 Fax: 503-451-8519

Contact Person: Jon Brumbaugh Date Prepared: October 21, 2019

2. Device

Name of Device	Selectra Lead Introducer System, includingSelectra Catheters, Selectra Accessory Kit andSelectra Slitter Tool
Common or Usual Name	Lead Introducer System
Classification Name	Percutaneous Catheter (21 CFR 870.1250)
Regulatory Class	II
Product Code	DQY

3. Predicate Devices

BIOTRONIK's Selectra 5F and 7F Catheters, Selectra Accessory Kit and Selectra Slitter Tool ● (K183265, cleared December 13, 2018)

4. Device Description

The Selectra Accessory Kit includes the following components in a single sterile package:

. 1 Selectra Slitter Tool
1 quide wire
2 7F Transvalvular Insertion Tools (TVI) ●
1 syringe ●
1 torque tool ●
2 check valves ●
2 stopcocks ●
1 Tuohy Borst Adapter (TBA) ●

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510(k) Summary

BIOTRONIK Selectra Lead Introducer System Selectra Catheters, Accessory Kit and Slitter Tool

5. Indications for Use

The Indications for Use statements are unchanged from prior clearance (K183265, cleared December 13, 2018).

The Selectra lead introducer system is used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Selectra Guiding Catheter:

In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Selectra Accessory Kit:

The Selectra accessory kit is used in conjunction with the lead introducer system to facilitate lead implantation in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Selectra Slitter Tool:

Selectra accessories are used in conjunction with the lead introducer system to facilitate lead implantation in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

6. Comparison of Technological Characteristics with the Predicate Device

The technological principles of the subject and predicate devices are the same. The differences represent minor modifications to the currently marketed Selectra lead introducer system as follows:

Minor modifications to the Selectra Lead Introducer System and packaging
- In-line luer lock added to the outer catheter handle o
- Additional supplier for catheter handle O
- Additional PEBAX-7233 seqment added to the shaft segment for the outer and O inner catheters
- Modified half-shelf Transvalvular Insertion Tool (TVI) and new Tuohy-Borst O Adapter were introduced to the Selectra Accessory Kit
- The single pouch as sterile barrier of Selectra Accessory kit was changed to a o Tyvek pouch. Also, the double Tyvek pouch system of Selectra catheters was changed to single Tyvek pouch.
- Additional sterilization process introduced O
- Updated outer diameter tolerance for all Selectra outer catheters O
- O Updated product boxes for all Selectra products
. Manufacturing changes with no effect on performance criteria

The technological updates do not raise questions regarding safety and effectiveness based on the verification/validation testing that has been successfully performed and the conclusion that clinical benefit outweighs the residual risk according to the risk analysis.

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510(k) Summary

BIOTRONIK Selectra Lead Introducer System Selectra Catheters, Accessory Kit and Slitter Tool

Quality control testing on the final products remains unchanged.

7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

To demonstrate that the modified Selectra lead introducer system meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria for the predicate devices.

. Compatibility Testing
Functional Testing .
. Biocompatibility
. Microbiology and sterilization

No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence.

8. Conclusions

The subject devices result from minor modifications to the predicate devices. The performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.

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).