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K Number
K033320
Device Name
SCOUT PRO
Manufacturer
BIOTRONIK, INC.
Date Cleared
2003-11-19

(35 days)

Product Code
DQY,DOY,SCO
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
K020821
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the ScoutPro is for introducing leads into the vessels of the left heart via the coronary sinus.

Device Description

The ScoutPro is designed to assist with introducing leads into the vessels of the left heart via the coronary sinus. It facilitates access to the coronary sinus venous system as well as probing of the coronary sinus. The ScoutPro has been expanded and modified from BIOTRONIK's currently legally marketed SCOUT (K020821, 06-03-02). The following ScoutPro accessories are the subjects of this 510(K);

ScoutPro 8F that contains the following components:

  • . 1 hemostatic valve
  • . 2 guiding catheters BIO 1 and BIO 2
  • 1 dilator for the quiding catheter .
  • 1 peel-away sheath 11F
  • 1 guide wire ●
  • 1 needle .
  • 1 svringe
  • 2 slitter tools 4.9 F and 6.3 F for different lead sizes ●

ScoutPro Sheath "Hook" that contains the following components:

  • . 1 quiding catheter "Hook"
  • 1 dilator for the guiding catheter .

ScoutPro Sheath "Multi-Purpose Hook" that contains the following components:

  • 1 guiding catheter "Multi-Purpose Hook" .
  • 1 dilator for the guiding catheter .

ScoutPro Sheath "Amplatz 6.0" contains the following components:

  • . 1 quiding catheter "Amplatz 6.0"
  • . 1 dilator for the guiding catheter
AI/ML Overview

This 510(k) Premarket Notification for the ScoutPro Percutaneous Catheter does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.

The document is a summary of the 510(k) application, focusing on:

  • Device Identification: Name, sponsor, classification, product code.
  • General Description: What the device is and its components.
  • Intended Use/Indications for Use: What the device is designed to do.
  • Regulatory Correspondence: FDA's notification of substantial equivalence.

It explicitly states that the ScoutPro is an "expanded and modified" version of a "currently legally marketed predicate device," the SCOUT (K020821). The basis for this 510(k) is substantial equivalence to that predicate device, not primary performance data from a new study meeting specific acceptance criteria as would be presented for a novel device or a significantly modified device requiring new clinical evidence.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert ground truthing, or MRMC studies, as this information is not present in the provided text. The FDA's letter (pages 2-3) confirms the substantial equivalence determination.

§ 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).