(59 days)
Not Found
No
The description focuses on the physical properties and function of a simple medical tool (stylet) and does not mention any computational or data-driven capabilities.
No
The device, BIOTRONIK Stylets, is described as being used during the implantation procedure of leads to stiffen the flexible lead and facilitate its positioning. It does not exert a therapeutic effect itself but rather aids in the proper placement of other implantable systems (leads and pacemakers or ICD), which are the therapeutic devices.
No
The device description states that BIOTRONIK stylets "predominantly serve to stiffen the flexible lead during implantation in order to facilitate its positioning." This is an instrumental function, not a diagnostic one.
No
The device description explicitly states that the device consists of metal wires and a plastic handle, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the stylets are used in conjunction with implantable systems (leads and pacemakers or ICD) and are used during the implantation procedure. This indicates a surgical or procedural use, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description details a physical tool (metal wires with a handle) used to manipulate a lead during implantation. This aligns with a surgical accessory, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the BIOTRONIK Stylets are a surgical accessory used during the implantation of cardiac leads, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DRB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance was evaluated in the design validation.
The Stylets have undergone validation and verification testing to ensure functionality. The Stylets has passed all of the tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).
0
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
1
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,
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 |
| VP, Regulatory Affairs and | |
| Compliance | |
| BIOTRONIK, Inc. | |
| 6024 Jean Road | |
| Lake Oswego, OR 97035 | |
| Phone (888) 345-0374 | |
| jon.brumbaugh@biotronik.com |
-
BIOTRONIK SE & Co. KG Manufacturer Woermannkehre 1, 12359 Berlin, Germany
Registration number 9610139 -
- Subject Device
| Common or Usual
| Name | Stylet, Catheter |
|---|---|
| Classification Name | 21CFR870.1380 |
| Regulatory Class | II |
| Product Code | DRB |
-
- Predicate Device
Abbott stylets (K090163, cleared April 1, 2009).
- Predicate Device
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.
- 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 | ||||
| of Property | BIOTRONIK | |||
| Stylets | Abbott | |||
| Stylets | Difference to | |||
| Predecessor | ||||
| Device | Assessment and | |||
| Explanation of | ||||
| Relevance of | ||||
| Difference to | ||||
| Equivalence | ||||
| Stiffness | Soft | |||
| Medium | ||||
| Medium J | ||||
| Medium JL | ||||
| Firm | ||||
| Extra Firm | Soft | |||
| Firm | ||||
| Extra Firm | Yes | Non-relevant, additional | ||
| stiffness options within | ||||
| the same rigid-flex | ||||
| design and form factor | ||||
| Diameter | .36 -.40 | |||
| (mm) range | .33 - .40 | |||
| (mm) range | Yes | Non-relevant, diameter | ||
| options within the same | ||||
| range | ||||
| Length | 45-85(cm) | |||
| range | 34(cm) — 85 | |||
| (cm) range | Yes | Non-relevant, length | ||
| 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.