(8 days)
Not Found
No
The document describes a system of physical catheters and accessories for lead implantation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is described as a "lead introducer system" consisting of guiding catheters and implantation accessories used to facilitate lead implantation. It is a tool used to assist in a medical procedure rather than a device intended to directly treat a medical condition or restore health.
No
The device is described as a system of catheters and accessories used to facilitate lead implantation in the heart, which is a procedural/therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including catheters, a slitter tool, guide wire, insertion tools, syringe, torque tool, check valves, stopcocks, and a Tuohy Borst Adapter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used to "facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus." This is a procedural device used in vivo (within the body) to aid in a surgical procedure.
- Device Description: The device description details guiding catheters and implantation accessories, which are physical tools used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) for diagnostic purposes. This device is used in vivo to assist in a therapeutic procedure.
N/A
Intended Use / Indications for Use
In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.
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 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
heart chambers, coronary veins via the coronary sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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
- Packaging Testing ●
No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence.
Key Metrics
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
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July 19, 2022
Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and New Product Development 6024 Jean Road Lake Oswego, Oregon 97035
Re: K222037
Trade/Device Name: Selectra Lead Implantation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 8, 2022 Received: July 11, 2022
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
1
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-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,
Hetal Odobasic Assistant 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
2
Indications for Use
510(k) Number (if known) K222037
Device Name Selectra Catheters, Accessory Kit and Slitter Tool
Indications for Use (Describe)
In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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: July 19, 2022
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 Catheters, Selectra Accessory Kit and Selectra Slitter Tool (K192996, cleared November 21, 2019 and K193474, cleared October 16, 2020).
4. 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 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.
4
510(k) Summary
BIOTRONIK Selectra Lead Introducer System Selectra Catheters. Accessory Kit and Slitter Tool
5. Indications for Use
The Indications for Use statements are unchanged from prior clearance (K192996, cleared November 21, 2019 and K193474, cleared October 16, 2020).
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 to add stabilizers to the polyamide (PA) and polyether block amide (PEBAX) components in the Selectra catheters and qualify alternative or replacement materials to ensure continuous supply of the components.
The technological updates do not raise questions reqarding 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. 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
- Packaging Testing ●
No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence.
5
510(k) Summary
BIOTRONIK Selectra Lead Introducer System Selectra Catheters, Accessory Kit and Slitter Tool
8. Conclusions
The subject devices result from minor modifications to the predicate devices. The performance testing demonstrates that the subject devices meet the same functional acceptance criteria for the same intended use.