Biotronik Stylets

K191469 · Biotronik, Inc. · DRB · Aug 1, 2019 · Cardiovascular

Device Facts

• Record ID: K191469
• Device Name: Biotronik Stylets
• Applicant: Biotronik, Inc.
• Product Code: DRB · Cardiovascular
• Decision Date: Aug 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1380
• Device Class: Class 2

Intended Use

The BIOTRONIK Stylets are used in conjunction with the implantable systems (leads and pacemakers or ICD). Therefore, the same indications that apply for the designated active implant and leads, also apply for stylets.

Device Story

Biotronik Stylets are manual surgical instruments used during lead implantation procedures for pacemakers or ICDs. Device consists of metal wire of varying stiffness, length, and shape, attached to a proximal plastic handle. Handle features color-coding and printed specifications to assist clinician in selection. Primary function is to stiffen flexible leads to facilitate navigation and positioning within the patient's vasculature during implantation. Operated by physicians in clinical settings (e.g., OR or EP lab). Device provides mechanical support; no electronic or automated output. Benefits include improved maneuverability and placement accuracy of cardiac leads.

Clinical Evidence

No clinical data provided. Bench testing and design validation were performed to ensure functionality. Particulate matter testing was deemed unnecessary per DIN EN 45502-2-1 as the device has no body or blood contact.

Technological Characteristics

Metal wire stylets with plastic handles. Features include color-coded handles for stiffness/length identification. Dimensions: 0.36-0.40 mm diameter range; 45-85 cm length range. Stiffness levels: Soft, Medium, Medium J, Medium JL, Firm, Extra Firm. Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for use in conjunction with the implantation of implantable systems (leads and pacemakers or ICD). Patient population and contraindications are identical to those of the specific active implant and leads being used.

Regulatory Classification

Identification

A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

Predicate Devices

• Abbott stylets (K090163)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, while the Department of Health & Human Services logo is in black.

August 1. 2019 Biotronik, Inc Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035

## Re: K191469

Trade/Device Name: Biotronik Stylets Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II Product Code: DRB Dated: May 31, 2019 Received: June 3, 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. 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Jessica Paulsen Implantable Electrophysiology Devices Team 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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## Appendix 2

# Indications for Use

510(k) Number (if known): _K191469

Device Name: Stylets Indications for Use:

The BIOTRONIK Stylets are used in conjunction with the implantable systems (leads and pacemakers or ICD). Therefore, the same indications that apply for the designated active implant and leads, also apply for stylets.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

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510(k) Summary BIOTRONIK Stylets Traditional 510(k) Premarket Notification

Image /page/3/Picture/2 description: The image contains the logo for BIOTRONIK. The logo features the BIOTRONIK name in bold, dark blue letters. Below the name is the tagline "excellence for life" in a smaller, lighter font. To the left of the name is a circular emblem with the letters "BIO" inside.

| | 1. Submission Information |
|--|---------------------------|
| | |

| Date prepared | May 31, 2019 |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jon Brumbaugh<br>VP, Regulatory Affairs and<br>Compliance<br>BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035<br>Phone [phone]<br>[e-mail] |

- BIOTRONIK SE & Co. KG Manufacturer Woermannkehre 1, 12359 Berlin, Germany
Registration number 9610139

- 2. Subject Device

| Common or Usual<br>Name | Stylet, Catheter |
|-------------------------|------------------|
| Classification Name | 21CFR870.1380 |
| Regulatory Class | II |
| Product Code | DRB |

- 3. Predicate Device
Abbott stylets (K090163, cleared April 1, 2009).

#### 4. Device Description

BIOTRONIK stylets are intended for use with long-term implantable BIOTRONIK leads and are used during the implantation procedure of these leads. Stylets predominantly serve to stiffen the flexible lead during implantation in order to facilitate its positioning.

BIOTRONIK stylets consist of metal wires of different stiffness, lengths and shapes that are attached to a small plastic handle on their proximal end to simplify the manipulation of the stylet during lead implantation. The plastic handle carries a color-code that indicates the stylet length and the stiffness. In addition, the wire diameter and the length of the stylet are printed on the handle.

#### 5. Indications for Use

Stylets are used in conjunction with the implantation of implantable systems (leads and pacemakers or ICD). Therefore, the same indications and contraindications that apply for the designated active implant and leads, also apply for stylets.

6. Comparison of Technological Characteristics with the Predicate Device

The similarities and differences between the predicate and proposed stylets are summarized

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Image /page/4/Picture/1 description: The image shows the logo for BIOTRONIK. The logo consists of a circular emblem with the letters "BO" inside, followed by the word "BIOTRONIK" in bold, dark blue letters. Below the word "BIOTRONIK" is the tagline "excellence for life" in a smaller, lighter font.

510(k) Summary BIOTRONIK Stylets Traditional 510(k) Premarket Notification below.

| Comparison of BIOTRONIK Stylets to the Predicate Device, Abbott Stylets | | | | |
|-------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------|
| Description<br>of Property | BIOTRONIK<br>Stylets | Abbott<br>Stylets | Difference to<br>Predecessor<br>Device | Assessment and<br>Explanation of<br>Relevance of<br>Difference to<br>Equivalence |
| Stiffness | Soft<br>Medium<br>Medium J<br>Medium JL<br>Firm<br>Extra Firm | Soft<br>Firm<br>Extra Firm | Yes | Non-relevant, additional<br>stiffness options within<br>the same rigid-flex<br>design and form factor |
| Diameter | .36 -.40<br>(mm) range | .33 - .40<br>(mm) range | Yes | Non-relevant, diameter<br>options within the same<br>range |
| Length | 45-85(cm)<br>range | 34(cm) — 85<br>(cm) range | Yes | Non-relevant, length<br>within the same range |

#### 7. Performance Data

Performance was evaluated in the design validation.

#### 8. Pre-Clinical Study

This submission does not contain a preclinical study.

#### 9. Usability Testing

This submission does not require usability testing due to the expected training and experience of the user.

#### 10. Verification and Validation Testing

The Stylets have undergone validation and verification testing to ensure functionality. The Stylets has passed all of the tests. Particulate matter testing was not conducted for the stylets because the stylets have no body or blood contact and therefore no testing was required according to DIN EN 45502-2-1.

#### 11. Conclusion

The information presented supports a determination of substantial equivalence and therefore clearance of the BIOTRONIK stylet models through this 510k Premarket Notification. The subject and predicate devices use the same principles of operation, have similar device features, and there are no new issues.