(89 days)
Not Found
No
The device description lists standard catheter accessories and the "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an accessory kit used to facilitate lead implantation in the heart, not to provide therapy itself. It contains tools and components but no therapeutic agents or mechanisms.
No
The device description states that the kit "is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation." It includes tools like guide wires, catheters, and stopcocks, which are used for procedural assistance, not for diagnosing a condition or disease.
No
The device description explicitly lists multiple physical components (Slitter Tool, Guide Wire, TVI Tools, Syringe, Torquer, Stopcocks, Check valves, Sealing caps, Technical Manual) which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate lead implantation in the left side of the heart via the coronary sinus." This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The components listed (slitter tool, guide wire, TVI tools, syringe, torquer, stopcocks, check valves, sealing caps) are all tools used for surgical or interventional procedures, not for testing samples outside the body.
- Anatomical Site: The anatomical site is the "left side of the heart via the coronary sinus," which is an internal part of the body.
IVD devices are used to examine specimens (like blood, urine, or tissue) that have been taken from the human body to provide information about a physiological state, a disease, or a congenital abnormality. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Selectra accessory kit is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
DWS, DQX, DYB, FMF
Device Description
The Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package.
The Selectra accessory kit includes the following components:
- 1 Selectra Slitter Tool .
- . 1 Seldinger Guide Wire
- . 4 Transvalvular Insertion (TVI) Tools
- 1 Syringe .
- . 1 Torquer
- 2 Stopcocks .
- 2 Check valves ●
- . 2 Sealing caps
- . 1 Technical Manual
The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads. The Selectra accessory kit is the subject of this Special 510(k).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left side of the heart 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Selectra Accessory Kit Special 510(k) Premarket Notification
SEP 2 6 2011
1. 510(K) SUMMARY
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
1028232 Establishment Registration Number:
Device Name:
Proprietary Name: Classification:
Selectra Accessory Kit Class II (21 CFR 870.1330; 870.1340; 870.4500; 880.5860) Classification Name: Cardiovascular surgical instruments, catheter guide wire, catheter introducer, piston syringe DWS, DQX, DYB, FMF
General Description:
The Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package.
The Selectra accessory kit includes the following components:
Product Code:
- 1 Selectra Slitter Tool .
- . 1 Seldinger Guide Wire
- . 4 Transvalvular Insertion (TVI) Tools
- 1 Syringe .
- . 1 Torquer
- 2 Stopcocks .
- 2 Check valves ●
- . 2 Sealing caps
- . 1 Technical Manual
The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads. The Selectra accessory kit is the subject of this Special 510(k).
Device Modification:
The changes made to the Selectra accessory kit, as compared to the previously cleared ScoutPro ACS accessory kit, primarily include minor component modifications.
The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use, contraindications, and function, are the ScoutPro ACS accessory kit cleared on July 23, 2010 (K101776). Therefore, this previously cleared accessory kit will serve as the predicate device for the modified accessory kit included in this Special 510(k).
Predicate Device:
BIOTRONIK's ScoutPro ACS Accessory Kit (K101776)
1
BIOTRONIK, Selectra Accessory Kit, Special 510(k)
Indication for Use:
The Selectra accessory kit is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
・
Phone (888) 345-0374 Fax (503) 635-9936
.
:
・
| Name and Address of Manufacturer: | BIOTRONIK SE & Co. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-1210 |
|---|---|
| Name and Address of Contract Manufacturer: | BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-44-864-5169 |
| Name and Address of Contract Sterilizer: | Sterigenics Germany GmbH (reg. no. 3002807090) Kasteler Straße 45 (Rheingaustrasse 190 - 196) D-65203 Wiesbaden, Germany |
| Contact Person(s) and Phone Number: | Jon Brumbaugh VP, Regulatory Affairs and Compliance |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W()66-G609 Silver Spring, MD 20993-0002
Jon Brumbaugh Vice President, Regulatory Affairs and Compliance Biotronik, Inc. 6024 Jean Road Lake Oswego, Oregon 97035
ុទ្ធសាសនា 6 201
. Re: K111839
Trade/Device Name: Selectra Accessory Kit Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide wire Regulatory Class: Class II Product Code: DQY. DQX Dated: June 28, 2011 Received: June 29, 2011
Dear Mr. 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. 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.
3
Page 2 - Mr. Jon Brumbaugh
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 vour 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): TBD
Device Name: Selectra CS Lead Introducer System Indications for Use:
The Selectra accessory kit is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division St., OR
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K ///839