(24 days)
Not Found
No
The device description and performance studies focus on physical components and functional testing, with no mention of AI/ML algorithms or data processing.
No
The device is used to facilitate the implantation of leads into the heart, which are then used for therapeutic purposes (e.g., pacemakers), but the introducer system itself does not directly provide therapy. It is an accessory used for lead delivery.
No
The device is an introducer system designed to facilitate the implantation of leads into the heart, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components such as guiding catheters, a slitter tool, guide wire, insertion tools, syringe, torque tool, check valves, stopcocks, and a Tuohy Borst Adapter. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The device consists of guiding catheters and implantation accessories used to access the heart. These are tools used during a medical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY
Device Description
BIOTRONIK's Selectra lead introducer system is a combination of guiding 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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary veins via the coronary sinus or ... heart chambers.
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)
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
- Microbiology and sterilization
No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence.
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
§ 870.1250 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2019
Biotronik, Inc Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035
Re: K192996
Trade/Device Name: Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 25, 2019 Received: October 28, 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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K192996
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 veins via the coronary sinus or to facilitate lead implantation into the heart chambers.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: October 21, 2019
2. Device
| Name of Device | Selectra Lead Introducer System, including
Selectra Catheters, Selectra Accessory Kit and
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's Selectra 5F and 7F Catheters, Selectra Accessory Kit and Selectra Slitter Tool ● (K183265, cleared December 13, 2018)
4. Device Description
BIOTRONIK's Selectra lead introducer system is a combination of guiding 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
- 2 7F Transvalvular Insertion Tools (TVI) ●
- 1 syringe ●
- 1 torque tool ●
- 2 check valves ●
- 2 stopcocks ●
- 1 Tuohy Borst Adapter (TBA) ●
4
510(k) Summary
BIOTRONIK Selectra Lead Introducer System Selectra Catheters, Accessory Kit and 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.
5. Indications for Use
The Indications for Use statements are unchanged from prior clearance (K183265, cleared December 13, 2018).
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:
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.
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 and packaging
- In-line luer lock added to the outer catheter handle o
- Additional supplier for catheter handle O
- Additional PEBAX-7233 seqment added to the shaft segment for the outer and O inner catheters
- Modified half-shelf Transvalvular Insertion Tool (TVI) and new Tuohy-Borst O Adapter were introduced to the Selectra Accessory Kit
- The single pouch as sterile barrier of Selectra Accessory kit was changed to a o Tyvek pouch. Also, the double Tyvek pouch system of Selectra catheters was changed to single Tyvek pouch.
- Additional sterilization process introduced O
- Updated outer diameter tolerance for all Selectra outer catheters O
- O Updated product boxes for all Selectra products
- . Manufacturing changes with no effect on performance criteria
The technological updates do not raise questions regarding 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.
5
510(k) Summary
BIOTRONIK Selectra Lead Introducer System Selectra Catheters, Accessory Kit and Slitter Tool
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
- . Microbiology and sterilization
No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence.
8. Conclusions
The subject devices result from minor modifications to the predicate devices. The performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.