(30 days)
Not Found
No
The device description focuses on the mechanical components and design of a lead introducer system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a lead introducer system designed to facilitate the implantation of leads, not to provide therapy itself.
No
This device is a lead introducer system designed to facilitate the implantation of leads in the heart, not to diagnose a condition.
No
The device description clearly outlines physical components like guiding catheters and dilators, indicating it is a hardware-based medical device, not software-only.
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 describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The device is described as a "delivery system for coronary sinus leads" and "guiding catheters." These are instruments used to physically access and navigate within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly used in vivo (inside the body) for a procedural purpose.
N/A
Intended Use / Indications for Use
The ScoutPro 7F long catheters are used in coniunction with the ScoutPro 7F 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)
DQY, DRE
Device Description
ScoutPro 7F is a delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of 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 system contains guiding catheters with seven distal arc shapes and accessories to facilitate the lead implantation. This Special 510(k) introduces additional catheters as shown below, which have the same distal arc shapes but are 5 cm longer in length: :
ScoutPro 7F Sheath Hook L
ScoutPro 7F Sheath Multipurpose Hook L
ScoutPro 7F Sheath Amplatz 6.0 L
ScoutPro 7F Sheath BIO2 L
ScoutPro 7F Sheath MPEP L
ScoutPro 7F Sheath Extended Hook L
ScoutPro 7F Sheath Extended Hook Right L
Each of these catheters is separately available from the ScoutPro 7F kit and contains the following components:
- · 1 quiding catheter
• 1 (long) dilator for the guiding catheter
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
5093303
BIOTRONIK, ScoutPro 7F Long Catheters, Special 510(k)
October 20, 2009
ScoutPro 7F Long Guiding Catheters Special 510(k) Premarket Notification
1028232
NOV 2 0 2009
1. 510(k) SUMMARY
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
Device Name:
Proprietary Name:
ScoutPro 7F Sheath Multipurpose Hook L
ScoutPro 7F Sheath Amplatz 6.0 L
... ScoutPro 7F Sheath BIO2 L
ScoutPro 7F Sheath MPEP L
ScoutPro 7F Sheath Hook L
ScoutPro 7F Sheath Extended Hook L
ScoutPro 7F Sheath Extended Hook Right L
Class II (21 CFR 870.1250; 870.1310; 870.1330) Classification: Guide, Catheters, Percutaneous Classification Name: DQY, DRE Product Code:
General Description:
ScoutPro 7F is a delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of 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 system contains guiding catheters with seven distal arc shapes and accessories to facilitate the lead implantation. This Special 510(k) introduces additional catheters as shown below, which have the same distal arc shapes but are 5 cm longer in length: :
ScoutPro 7F Sheath Hook L
ScoutPro 7F Sheath Multipurpose Hook L
ScoutPro 7F Sheath Amplatz 6.0 L
ScoutPro 7F Sheath BIO2 L
ScoutPro 7F Sheath MPEP L
ScoutPro 7F Sheath Extended Hook L
ScoutPro 7F Sheath Extended Hook Right L
Each of these catheters is separately available from the ScoutPro 7F kit and contains the following components:
- · 1 quiding catheter
• 1 (long) dilator for the guiding catheter
36
1
Device Modification: .
The main difference between the predicate device ScoutPro 7F catheters and the ScoutPro 7F long catheters described in this documentation is the long catheters also utilize a modified X-ray marker which is described in this document; however the patient contacting materials remain identical to the predicate. Additionally, a new dilator which is identical to the predicate but differs in length is also described.
Predicate Device:
BIOTRONK's ScoutPro 7F (#K060807, 24-Apr-2006)
- ScoutPro 7F Sheath Amplatz 6.0 .
- ScoutPro 7F Sheath Hook .
- ScoutPro 7F Sheath Multipurpose Hook .
BIOTRONIK's ScoutPro 7F (#K072329, 25-Mar-2008)
- ScoutPro 7F Sheath BIO2 .
- . ScoutPro 7F Sheath Extended Hook
- ScoutPro 7F Sheath Extended Hook Right .
- ScoutPro 7F Sheath MPEP | i .
Indication for Use:
The ScoutPro 7F long catheters are used in coniunction with the ScoutPro 7F CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus.
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)
Contact Person(s) and Phone Number:
Ackerstrasse 6 8180 Bülach, Switzerland 011-41-44-864-5169
Jon Brumbaugh VP, Regulatory Affairs and Compliance Phone (888) 345-0374 Fax (503) 635-9936 jon brumbaugh@biotronik.com
2
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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Biotronik, Inc. c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035
NOV 2 0 2009
Re: K093303
Trade/Device Name: ScoutPro 7F Long Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY, DRE Dated: October 20, 2009 Received: October 21, 2009
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.
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 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/ReportalProblem/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):
Device Name:
ScoutPro 7F Long Catheters
Indications For Use:
The ScoutPro CS lead introducer system and its separately available accessories are used to facilitate lead implantation in the left side of the heart via the coronary sinus.
Prescription Use × (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 e of Device Evaluation (ODE)
W.M.
on Sian-Off Division of Cardiovascular Devices
510(k) Number K093303
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