(62 days)
No
The summary describes a physical medical device (guiding catheters) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a lead introducer system, which is an accessory used to facilitate the implantation of leads. It does not perform a direct therapeutic action on the patient.
No
The device is described as a lead introducer system used to facilitate lead implantation and access to the coronary sinus, which are interventional or procedural functions, not diagnostic ones.
No
The device description explicitly states it is a "family of guiding catheters," which are physical hardware components used in medical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used to facilitate lead implantation in the heart. This is a procedural device used in vivo (within the living body) during a medical procedure.
- Device Description: The description confirms it's a "guiding catheter" used for "placement of coronary sinus leads" and "access to the coronary sinus venous system." These are all actions performed directly on the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, tissue, etc.) in vitro (outside the living body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly a surgical/interventional tool used during a 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
DQY, DRE, DQX
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 Selectra guiding catheters are the subject of this Special 510(k):
- . Selectra Amplatz 6.0-45
- ♥ Selectra Amplatz 6.0-55
- Selectra Straight-45
- Selectra Straight-55
- Selectra BIO2-45
- Selectra BIO2-55
- . Selectra Extended Hook-45
- . Selectra Extended Hook-55
- . Selectra Hook-45
- . Selectra Hook-55
- Selectra MPEP-45 .
- Selectra MPEP-55 .
- . Selectra MPH-45
- Selectra MPH-55
- Selectra Right-45 .
- Selectra Right-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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Selectra Lead Introducer System
APR 2 0 2011
Additional Information for Special 510(k) #K110461
510(K) SUMMARY 1.
Name and Address of Applicant:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
1028232
Establishment Registration Number:
Device Name:
.
.
.
.
.
Proprietary Name: Classification:
Product Code:
Classification Name:
Selectra Class II (21 CFR 870.1250; 870.1310; 870.1330) Wire, Guide, Catheters, Percutaneous DQY, DRE, DQX
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 Selectra guiding catheters are the subject of this Special 510(k):
- . Selectra Amplatz 6.0-45
- ♥ Selectra Amplatz 6.0-55
Selectra Straight-55
Selectra BIO2-45
Selectra BIO2-55
- Selectra Straight-45
- . Selectra Extended Hook-45
- . Selectra Extended Hook-રક
- . Selectra Hook-45
- . Selectra Hook-55
- Selectra MPEP-45 .
- Selectra MPEP-55 .
- . Selectra MPH-45
- Selectra MPH-55
- Selectra Right-45 .
- Selectra Right-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)
Device Modification:
The changes made to the Selectra compared to the previously cleared ScoutPro ACS are mainly minor changes in design.
The usage of the Selectra remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro ACS quiding catheters in submission K101776, cleared on July 23, 2010. Therefore, this previously cleared version will serve as the predicate device for the modified product family included in this Special 510(k). Predicate Device:
BIOTRONIK's ScoutPro ACS Catheters (K101776, 23-Jul-2010)
- ScoutPro ACS Amplatz 6.0 (45cm) .
- . ScoutPro ACS Amplatz 6.0 L (50cm)
ScoutPro ACS Straight L (50cm)
- ScoutPro ACS BIO2 (45cm) . . ScoutPro ACS BIO2 L (50cm)
- . ScoutPro ACS Straight (45cm)
- . ScoutPro ACS Extended Hook (45cm)
- ScoutPro ACS Extended Hook L (50cm) .
1
BIOTRONIK, Inc., Selectra, Additional Information for Special 510(k) #K110461.
- ScoutPro ACS Hook (45cm) .
- . ScoutPro ACS Hook L (50cm)
- ScoutPro ACS MPEP (45cm) .
- . ScoutPro ACS MPEP L (50cm)
- ScoutPro ACS MPH (45cm) .
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.
Name and Address of Manufacturing Site:
BIOTRONIK SE & Co. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-1210
Name and Address of Manufacturing Site:
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
510(k) Contact Person and Phone Number:
Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone (888) 345-0374 Fax (503) 635-9936 jon.brumbaugh@biotronik.com
- . ScoutPro ACS MPH L (50cm)
- . ScoutPro ACS Right (45cm)
- ScoutPro ACS Right L (50cm) .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 0 2011
Biotronik, Inc. c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035
Re: K110461
Trade/Device Name: Selectra Lead Introducer System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: February 17, 2011 Received: April 13, 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.
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.
3
Page 2 -- Mr. Jon Brumbaugh
Please be advised that ITDA '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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.
Prescription Use V (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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| Page 1 of 1 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K110461 |