(305 days)
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.
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 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.
The provided text describes a 510(k) premarket notification for the BIOTRONIK Selectra 3D Outer Guiding Catheters (K193474). This device is a percutaneous catheter used to facilitate lead implantation in the heart. The submission asserts substantial equivalence to a predicate device (BIOTRONIK's Selectra 7F Guiding Outer Catheters, K192996).
Crucially, the provided document explicitly states that "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence." This means that the device's acceptance criteria and proven performance are based on non-clinical data.
Therefore, for aspects related to clinical performance, a multi-reader multi-case (MRMC) study, or human-in-the-loop performance, the information is not available in the given text. The "acceptance criteria" and "study proving the device meets the acceptance criteria" in this context refer to engineering and biocompatibility testing, not clinical effectiveness or human interpretability.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a detailed table with specific numerical acceptance criteria and corresponding reported performance for each test. Instead, it broadly states that the modified devices were tested against "the same test methods and acceptance criteria for the predicate devices" and that they "meet the same functional acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Compatibility Testing | Meets the same performance criteria as predicate devices. |
| Functional Testing | Meets the same performance criteria as predicate devices; "the subject device meet the same functional acceptance criteria for the same intended use." |
| Biocompatibility | Meets the same performance criteria as predicate devices. |
| Microbiology and Sterilization | Meets the same performance criteria as predicate devices. |
| Packaging Testing | Meets the same performance criteria as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices or test samples. The document states "the following tests were conducted."
- Data Provenance: Not explicitly stated, but given it's a submission to the U.S. FDA by BIOTRONIK, Inc. (Lake Oswego, Oregon), it's highly likely the testing was conducted in the US or in compliance with US standards. The data is retrospective in the sense that it's reported after the completion of the tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Applicability: Not applicable given that no clinical studies involving human interpretation or subjective 'ground truth' were performed. The testing described is engineering and laboratory-based.
4. Adjudication Method for the Test Set
- Applicability: Not applicable for the same reason as #3. Adjudication methods are relevant for studies involving human assessment where consensus or arbitration is needed to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Answer: No. The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence." Therefore, an MRMC study related to human reader improvement with AI assistance was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Answer: No. This device is a physical medical device (catheter), not an AI algorithm. "Standalone performance" in the context of AI refers to the algorithm's performance independent of a human. This concept does not apply to this device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is established by engineering specifications, material science standards, and biocompatibility requirements. For example, a "functional test" for catheter flexibility would have a predefined acceptable range of force or deflection, which serves as the "ground truth" for that test. Similarly, sterility testing has specific pass/fail criteria based on absence of microbial growth.
8. The Sample Size for the Training Set
- Applicability: Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for physical medical devices in this context.
9. How the Ground Truth for the Training Set Was Established
- Applicability: Not applicable for the same reason as #8.
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October 16, 2020
BIOTRONIK, Inc Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035
Re: K193474
Trade/Device Name: Selectra 3D Outer Guiding Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 15, 2020 Received: September 16, 2020
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 Actinclude 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.
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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 (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 https://www.fda.gov/medical-devices/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 (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
Hetal Odobasic 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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Indications for Use
510(k) Number: K193474
Device Name: Selectra 3D Outer Guiding Catheters 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.
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)
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510(k) Summary
BIOTRONIK Selectra 3D Outer Guiding Catheters
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: December 11, 2019
2. Device
| Name of Device | Selectra 3D Outer Guiding Catheters |
|---|---|
| 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 7F Guiding Outer Catheters, (K192996, cleared November 21, 2019) .
Device Description ৰ
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 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 submission (K192996, cleared November 21, 2019).
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.
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BIOTRONIK Selectra 3D Outer Guiding Catheters
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 outer guiding catheters as follows:
- The Selectra 3D outer catheters provide additional curve shapes with updated working lengths ● compared to the currently marketed Selectra outer guiding catheters. Updated packaging was also required to support the new curve shapes.
The technological updates do not raise questions regarding safety and effectiveness based on the verification/validation testing that has been successfully performed and the 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 outer catheters meet 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
- . Packaging Testing
No clinical testing was deemed necessary or completed in the premarket notification submission 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.
§ 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).