(77 days)
Not Found
No
The 510(k) summary describes a mechanical lead introducer system and does not mention any software, algorithms, or AI/ML capabilities.
No.
This device is an introducer system used to facilitate the implantation of leads, not a device that treats or diagnoses a condition itself.
No
The device is described as an introducer system and guiding catheter used to facilitate lead implantation and access the coronary sinus, which are interventional and procedural assistance functions, not diagnostic ones.
No
The device description explicitly lists physical components (guiding catheter, dilator) and mentions testing related to mechanical properties, packaging, sterilization, and shelf life, indicating it is a hardware device.
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 left side of the heart via the coronary sinus." This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device is a "guiding catheter" used for "placement of coronary sinus leads." This is a surgical or interventional tool used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool used in a medical procedure.
N/A
Intended Use / Indications for Use
The Selectra CS lead introducer system is used 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)
DQY
Device Description
The Selectra CS lead introducer system is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The following legally marketed Selectra 7F guiding catheters (K110461, 20-Apr-2011) are the subjects of this Special 510(k);
- Selectra Amplatz 6.0-45 Selectra Extended Hook-Selectra MPEP-45 . . . 45 Selectra Amplatz 6.0-55 Selectra MPEP-55 . . . Selectra Extended Hook-· Selectra Straight-45 Selectra MPH-45 . રક
- Selectra Straight-55 . Selectra BIO2-45
- Selectra Hook-45 . ●
- . Selectra Hook-55
- Selectra BIO2-55 .
The Selectra Guiding Catheter is packaged with the following components: - . 1 Selectra CS guiding catheter (sterile)
- 1 dilator for the guiding catheter (sterile) .
- 1 technical manual or web-card (non-sterile) .
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)
Summary of Non-Clinical Testing:
The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following:
- Comparison of attributes and specifications of the subject and predicate devices -
- -Subject device risk analysis
- Subject device validation testing which includes the following testing: -
- Mechanical o
- Packaging o
- Sterilization and Shelf life ಂ
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
BIOTRONIK, Additional Information Selectra 7F Special 510(k)
December 13, 2012
Selectra MPH-55
Selectra Right-45
Selectra Right-55
.
t
.
Selectra 7F JAN 1 1 2013 Extended Shelf Life Special 510(k) Premarket Notification
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: Classification Name: Product Code:
Selectra 7F Guiding Catheters Class II (21 CFR 870.1250) Percutaneous Catheter DQY
General Description:
The Selectra CS lead introducer system is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The following legally marketed Selectra 7F guiding catheters (K110461, 20-Apr-2011) are the subjects of this Special 510(k);
- Selectra Amplatz 6.0-45 Selectra Extended Hook-Selectra MPEP-45 . . . 45 Selectra Amplatz 6.0-55 Selectra MPEP-55 . . . Selectra Extended Hook-· Selectra Straight-45 Selectra MPH-45 . રક
- Selectra Straight-55 . Selectra BIO2-45
- Selectra Hook-45 . ●
- . Selectra Hook-55
- Selectra BIO2-55 .
- The Selectra Guiding Catheter is packaged with the following components:
- . 1 Selectra CS guiding catheter (sterile)
- 1 dilator for the guiding catheter (sterile) .
- 1 technical manual or web-card (non-sterile) .
Predicate Device:
.
BIOTRONIK's Selectra 7F Guiding Catheters (K110461, 20-Apr-2011)
Indication for Use:
The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.
Device Modification:
The changes made to the Selectra 7F compared to the previously cleared Selectra 7F quiding catheters is a reduction in the concentration of Tungsten in the X-ray marker band (from 80% to 60%) and a shelflife extension from 6 months. The reason for the reduction in Tungsten concentration between the current and proposed catheters is to improve the mechanical properties of the X-ray marker after aging.
1
BIOTRONIK, Additional Information Selectra 7F Special 510(k) K123324
December 13, 2012
The usage of the Selectra 7F catheters remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared Selectra 7F guiding catheters in submission K110461, cleared on April 20, 2011. Therefore, this previously cleared version will serve as the predicate device for the modified product family included in this Special 510(k).
Summary of Non-Clinical Testing:
The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following:
- Comparison of attributes and specifications of the subject and predicate devices -
- -Subject device risk analysis
- Subject device validation testing which includes the following testing: -
- Mechanical o
- Packaging o
- Sterilization and Shelf life ಂ
Substantial Equivalence:
The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following information:
- Description of the subject and predicate devices -
- -Intended use of the subject and predicate devices
- Material composition of the subject and predicate devices .
- Validation testing
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 (req. 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 Phone (888) 345-0374 Fax (800) 913-6993 jon.brumbaugh@biotronik.com
Page 20 of 330
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle or other bird with its wings spread, suggesting a sense of protection and care. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Rd. Lake Oswego, OR 97035
Re: K123324
Trade/Device Name: Selectra 7F Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 13, 2012 Received: December 14, 2012
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.
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
JAN 1 1 2013
3
Page 2 - Mr. Jon Brumbaugh
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,
Matthew G. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix 1
Indications for Use
510(k) Number (if known): TBD K12 3314-
Device Name: Selectra CS Lead Introducer System Indications for Use:
The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.
Prescription Use イ (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
C.M.S. Wilhelm
Division of Cardiovascular Devices
510(k) Number K123324