Selectra Catheters, Selectra Accessory Kit

K183265 · Biotronik, Inc. · DQY · Dec 13, 2018 · Cardiovascular

Device Facts

• Record ID: K183265
• Device Name: Selectra Catheters, Selectra Accessory Kit
• Applicant: Biotronik, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 13, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Selectra lead introducer system comprises guiding catheters and accessory kit; facilitates access to heart for lead/catheter implantation. System includes inner (5F) and outer (7F) catheters forming telescopic arrangement; accessory kit contains slitter tool, guide wire, transvalvular insertion (TVI) tools, syringe, torque tool, check valves, stopcocks, and sealing caps. Used by clinicians in clinical settings to navigate leads into coronary sinus or heart chambers. Device provides mechanical guidance for lead placement; no electronic or software components involved. Benefits include facilitated lead delivery during cardiac procedures.

Clinical Evidence

No clinical data or performance testing required as no design changes were made.

Technological Characteristics

Percutaneous guiding catheters and accessory kit. Telescopic 5F/7F catheter system. Mechanical guidance principle. Sterile, single-use components. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring lead implantation in the coronary veins via the coronary sinus or heart chambers.

Regulatory Classification

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.

Predicate Devices

• BIOTRONIK Selectra 7F Catheters (K123324)
• BIOTRONIK Selectra 5F Catheters (K151409)
• BIOTRONIK Selectra Accessory Kit (K131978)
• BIOTRONIK Selectra Slitter Tool (K112482)

Reference Devices

• Medtronic's C315 Delivery Catheter (K101885)

Submission Summary (Full Text)

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December 13, 2018

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

Re: K183265

Trade/Device Name: Selectra Catheters, Selectra Accessory Kit Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 21, 2018 Received: November 23, 2018

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hetal B. Patel -S 2018.12.13 14:54:42 -05'00'

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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### Indications for Use

510(k) Number (if known) K183265

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 sinus or to facilitate lead implantation into the heart chambers.

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

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| <div> <object data="data:image/svg+xml,%3Csvg xmlns='http://www.w3.org/2000/svg' viewBox='0 0 24 24'%3E%3Cpath d='M19 3H5c-1.11 0-2 .9-2 2v14c0 1.1.89 2 2 2h14c1.1 0 2-.9 2-2V5c0-1.1-.9-2-2-2zm0 16H5V5h14v14z'/%3E%3C/svg%3E" height="20" type="image/svg+xml" width="20"></object> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### K183265

### 510(k) Summary

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

# 1. Submitter

BIOTRONIK 6024 SW Jean Road Lake Oswego, OR 97035 Phone: [phone] Fax: [phone]

Contact Person: Jon Brumbaugh Date Prepared: November 13, 2018

# 2. Device

| Name of Device | Selectra Lead Introducer System, including<br>Selectra Catheters, Selectra Accessory Kit and<br>Selectra 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 Selectra 7F Catheters (K123324, cleared January 11, 2013) ●
- BIOTRONIK Selectra 5F Catheters (K151409, cleared August 7, 2015) ●
- o BIOTRONIK Selectra Accessory Kit (K131978, cleared August 23, 2013)
- o BIOTRONIK Selectra Slitter Tool (K112482, cleared September 26, 2011)

#### ৰ্ Reference Device

The reference device for this submission is:

- Medtronic's C315 Delivery Catheter (K101885, cleared September 9, 2010) ●
# 5. 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 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 ●
- 4 transvalvular insertion (TVI) tools
- 1 syringe
- 1 torque tool ●
- 2 check valves .
- 2 stopcocks ●
- 2 sealing caps

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### K183265

### 510(k) Summary

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

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.

# 6. Indications for Use

The Indications for Use statements have been updated to reflect industry standard.

### 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 coniunction with the lead introducer system to faciliate 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.

## 7. Comparison of Technological Characteristics with the Predicate Device

The technological principles of the subject and predicate devices are identical because no design changes have been made.

#### Performance Data క్

Performance data was not required to support this submission because no design change has been made.

# 9. Conclusions

The subject devices result from minor labeling modifications to the predicate devices. The new Indications for Use statements fall within the same Intended Use for all devices.