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

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 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.

Device Description

BIOTRONIK's Selectra lead introducer system is a combination of quiding 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 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 510(k) premarket notification for a medical device, the "Selectra Lead Implantation System." This document is NOT about an AI/ML device, but rather a traditional medical device (a percutaneous catheter system). Therefore, most of the requested information about acceptance criteria, study design for AI/ML models (e.g., sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment), and AI-specific performance metrics is not applicable or present in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's what can be extracted from the document regarding acceptance criteria and performance data, re-framing it for a traditional medical device:

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

Since this is a 510(k) for minor modifications to an existing device, the performance data provided are primarily non-clinical bench testing to confirm that the modifications do not negatively impact safety and effectiveness and that the device continues to meet established performance criteria. The document states: "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."

The specific values or detailed acceptance criteria for each test (e.g., "burst pressure > X psi" for functional testing) are not detailed in this summary document. Regulatory summaries typically only list the types of tests performed and the conclusion that they were "successfully performed."

Acceptance Criteria Category	Reported Device Performance
Compatibility Testing	Successfully performed.
Functional Testing	Successfully performed.
Biocompatibility	Successfully performed.
Packaging Testing	Successfully performed.

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

Sample Size: Not specified for the non-clinical tests. For bench testing, sample sizes are typically determined by engineering standards and statistical confidence limits, but these specifics are not in the provided summary.
Data Provenance: Non-clinical test data, likely generated in a laboratory setting by the manufacturer (Biotronik, Inc.). This is retrospective as it was conducted prior to the 510(k) submission. No patient data or geographical provenance is applicable here.

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

Not Applicable. This is a traditional medical device (catheter system) and not an AI/ML device. There is no concept of "ground truth" established by experts in the context of image interpretation or diagnosis for this specific device. Performance is assessed through engineering and biocompatibility testing.

4. Adjudication method for the test set:

Not Applicable. As above, no expert adjudication is involved for this type of device's performance 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 is not an AI/ML diagnostic aid. No MRMC study was performed as it's not relevant to this device's function.

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

Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

Not Applicable directly for "ground truth" as typically defined for AI/ML. For this device, the "ground truth" or reference for performance is established by engineering specifications, material standards, and successful function as an introducer system (e.g., ability to facilitate lead implantation without breakage, material non-toxicity, appropriate dimensions). The "ground truth" is adherence to pre-defined technical specifications.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set.

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

Not Applicable. As above, no AI/ML training set.

Summary

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July 19, 2022

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

Re: K222037

Trade/Device Name: Selectra Lead Implantation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 8, 2022 Received: July 11, 2022

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. 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

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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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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,

Hetal Odobasic Assistant 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

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Indications for Use

510(k) Number (if known) K222037

Device Name Selectra Catheters, Accessory Kit and Slitter Tool

Indications for Use (Describe)

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

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

X 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: July 19, 2022

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 Catheters, Selectra Accessory Kit and Selectra Slitter Tool (K192996, cleared November 21, 2019 and K193474, cleared October 16, 2020).

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 (K192996, cleared November 21, 2019 and K193474, cleared October 16, 2020).

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:

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 to add stabilizers to the polyamide (PA) and polyether block amide (PEBAX) components in the Selectra catheters and qualify alternative or replacement materials to ensure continuous supply of the components.
The technological updates do not raise questions reqarding 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. 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
Packaging Testing ●

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

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510(k) Summary

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

8. Conclusions

The subject devices result from minor modifications to the predicate devices. The performance testing demonstrates that the subject devices 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).