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K Number
K042555
Device Name
SURGICHIP TAG SURGICAL MARKER
Manufacturer
SURGICHIP, INC.
Date Cleared
2004-11-09

(50 days)

Product Code
FZZ
Regulation Number
878.4660
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SURGICHIP Tag is intended to mark an anatomical site for surgery.

The SURGICHIP Tag surgical marker is indicated to mark an anatomical site for surgery.

Device Description

The SURGICHIP™ Tag smart label and procedure that uses Radio Frequency Identification technology to mark an anatomical site prior to surgery. It is designed to be used in addition to the usual safeguards so that the correct procedure is performed on the correct site and on the intended patient.

AI/ML Overview

The provided text describes a 510(k) submission for the SURGICHIP™ Tag Surgical Marker. However, it does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study with the specific parameters requested.

The document primarily focuses on:

  • Device Description: The SURGICHIP™ Tag uses Radio Frequency Identification (RFID) to mark an anatomical site prior to surgery, supplementing existing safeguards to ensure correct procedure, site, and patient.
  • Intended Use/Indications for Use: To mark an anatomical site for surgery.
  • Substantial Equivalence: The device is deemed substantially equivalent to a Skin Marker, an Adhesive Surgical Site Marker, and a RFID Hospital Identification Wristband. The document states, "Testing of the subject device demonstrated that the SURGICHIP Tag is an effective method of marking a surgical site prior to surgery and is equivalent to the predicate devices."

Missing Information:

The document does not provide:

  • Specific acceptance criteria (e.g., quantitative performance metrics, thresholds for accuracy, reliability, etc.).
  • Any details about the "testing" mentioned, such as study design, methodology, sample sizes, data provenance, ground truth establishment, expert involvement, or statistical analysis.
  • Results in a format suitable for a "reported device performance" section with specific metrics.
  • Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • Details about training sets if an AI/algorithm-based device were involved (which, based on the description, is not the primary function of this RFID tag).

Conclusion:

Based on the provided text, it's not possible to generate the requested table or describe the study in detail because the document is a 510(k) summary focused on substantial equivalence rather than a detailed report of a performance study with specific acceptance criteria and results. The "testing" mentioned is referred to only in a broad statement, without any supporting data or methodology.

§ 878.4660 Skin marker.

(a)
Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.