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K Number
K171767
Device Name
Cianna Medical SAVI Scout Reflector and SAVI Scout System
Manufacturer
Cianna Medical, Inc.
Date Cleared
2017-10-31

(139 days)

Product Code
NEU
Regulation Number
878.4300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.

Device Description

Not Found

AI/ML Overview

The provided documentation is an FDA 510(k) clearance letter for the Cianna Medical SAVI Scout Reflector and SAVI Scout System. It confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive submission summary.

Therefore, I cannot provide a complete answer to your request, as the critical information regarding acceptance criteria, reported device performance, study details (sample size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment for training and test sets) is not present in the provided text.

The document only states the "Indications for Use" for the device:

  • SAVI Scout Reflector: Intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System), the Reflector is located and surgically removed with the target tissue.
  • SAVI Scout System: Intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.

To answer your questions, I would need access to the actual clinical study report or a more detailed summary of the performance testing that was submitted to the FDA for this device.

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.