(305 days)
No
The summary describes a system of physical catheters and accessories for lead implantation, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No
The device is used to facilitate lead implantation in the heart, but it does not directly treat a disease or medical condition. It is an accessory device used during a therapeutic procedure.
No
The device is described as a lead introducer system (guiding catheters and implantation accessories) used to facilitate lead implantation in the heart. Its intended use is to aid in a therapeutic procedure (lead implantation), not to diagnose a condition.
No
The device description explicitly states it is a "combination of guiding catheters and implantation accessories" and describes physical components like inner and outer catheters.
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 lead implantation in the heart chambers or in the coronary veins via the coronary sinus." This is a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as a "lead introducer system" consisting of "guiding catheters and implantation accessories." These are tools used for a surgical or interventional procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural, assisting in the delivery of leads to the heart.
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 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.
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
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
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.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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 (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)
Page 1 of 1
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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.