(20 days)
No
The document describes a mechanical lead introducer system and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is used to facilitate the implantation of leads, not to provide therapy itself.
No
The device is described as a lead introducer system designed to facilitate the implantation of leads, which is a procedural aid, not a diagnostic tool.
No
The device description explicitly lists physical components such as guiding catheters, a slitter tool, guide wire, TVI tools, syringe, torque tool, check valves, stopcocks, and sealing caps, indicating it is a hardware-based medical device system.
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 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 is a "lead introducer system" consisting of "guiding catheters and implantation accessories." These are tools used to physically access and navigate within the heart.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
Therefore, the Selectra lead introducer system is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DQY
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 guide wire
- 4 transvalvular insertion (TVI) tools
- 1 syringe
- 1 torque tool
- 2 check valves
- 2 stopcocks
- 2 sealing caps
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
Heart chambers, coronary sinus, coronary veins
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 data was not required to support this submission because no design change has been made.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K123324, K151409, K131978, K112482
Reference Device(s)
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).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (888) 345-0374 Fax: 503-451-8519
Contact Person: Jon Brumbaugh Date Prepared: November 13, 2018
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 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
4
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.