SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL

K131978 · Biotronik, Inc. · DQY · Aug 23, 2013 · Cardiovascular

Device Facts

• Record ID: K131978
• Device Name: SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
• Applicant: Biotronik, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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 Story

The Selectra Accessory Kit and Selectra Slitter Tool are accessories for the Selectra CS lead introducer system used during coronary sinus lead implantation. The kit includes a guide wire, Transvalvular Insertion (TVI) tools, a slitter tool, torquer, check-valves, stop-cocks, sealing caps, and a syringe. The TVI tool facilitates lead placement; the slitter tool allows for lead removal or adjustment. These devices are used in a clinical setting by physicians. Modifications include a redesigned TVI tool (PEBAX 7233), extended shelf life (2 years), and updated sterile packaging for the slitter tool. The device is sterilized via EtO. The system assists in the precise placement of cardiac leads, potentially improving procedural efficiency and patient outcomes during lead implantation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, EtO residual analysis, particulate matter, environmental preconditioning, transport/drop testing, and shelf-life validation (25 months) to confirm sterility and integrity.

Technological Characteristics

TVI Tool: PEBAX 7233, 4.8F OD, 1.26F ID. Slitter Tool: Acrylonitrile Butadiene body, Stainless Steel blade. Sterilization: EtO (single use). Shelf life: 2 years. Packaging: Sterile blister/pouch system.

Indications for Use

Indicated for use in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

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

• Selectra Accessory Kit (K111839)
• Selectra Slitter Tool (K112482)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] [e-mail] |

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:

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.

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

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K131978

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#### 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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)

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MA Hillman