The CareFusion Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Device Description

The Gold Tissue Marker is a sterile, single use device comprised of a gold marker and disposable delivery device. The delivery device has 1cm reference marks and echogenic marks on the distal tip to aid in ultrasound guided marker placement. The Gold Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the CareFusion Gold Tissue Marker. It demonstrates substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics for the device in the way one might expect for a diagnostic or AI-driven system. Instead, it lists the standards and tests performed to demonstrate safety and performance for a physical implantable device. The "acceptance criteria" are implied to be meeting the requirements of these standards.

Characteristic / Test Category	Standard/Test/FDA Guidance	Reported Device Performance (Implied)
Biocompatibility	AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing	Meets standard requirements
Biocompatibility	AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices - Part 6 Tests for Local Effects After Implantation	Meets standard requirements
Residuals (Ethylene Oxide Sterilization)	AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals	Meets standard requirements
Biocompatibility (Systemic Toxicity)	AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11 Tests for Systemic Toxicity	Meets standard requirements
Biocompatibility (Chemical Characterization)	AAMI/ANSI/ISO 10993-18: 2006 Biological Evaluation of Medical Devices - Part 18 Chemical Characterization of Materials	Meets standard requirements
Performance (General Requirements for Non-active Implants)	ISO 14630: 2012: Non-active Surgical Implants - General Requirements	Meets standard requirements
Performance (Gold Wire for Semiconductor Lead Bonding)	ASTM F72: 2006 Section 4: Standard Specification for Gold Wire for Semiconductor Lead Bonding	Meets standard requirements (relevance is for the gold marker material)
Performance (Magnetically Induced Displacement Force in MR Environment)	ASTM F2052: 2006: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment	Meets standard requirements (safe for MRI)
Performance (MR Image Artifacts from Passive Implants)	ASTM F2119: 2007: Standard Test Method for the Evaluation of MR Image Artifacts from Passive Implants	Meets standard requirements (minimal artifacts in MRI)
Performance (Radiofrequency Induced Heating in MRI)	ASTM F2182: 2011A: Standard Test Method for the Measurement of Radio frequency Induced Heating on or Near Passive Implants During MRI	Meets standard requirements (safe for MRI heating)
Performance (Magnetically Induced Torque in MR Environment)	ASTM F2213: 2006, RA 2011: Standard Test Method for the Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment	Meets standard requirements (safe for MRI torque)
Performance (Stainless Steel Needle Tubing)	BS EN ISO 9626:1995: Stainless Steel Needle Tubing for the Manufacture of Medical Devices	Meets standard requirements (relevance for delivery device)
Sterilization (Microbiological Methods)	ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1 & 2	Meets standard requirements
Sterilization (Ethylene Oxide Validation)	ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization	Meets standard requirements
Sterilization (Ethylene Oxide Process Equivalency)	AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization	Meets standard requirements
Performance (Bench Top Testing)	Marker securement, force to deploy, dimensional verification, and strength of connections	Meets design specifications/requirements
Performance (Simulated Use)	Implantation, visualization under ultrasound, MRI and radiograph, marker integrity after repeated compression	Meets design specifications/requirements

The general conclusion states: "The results of the non-clinical tests show that the CareFusion Gold Tissue Marker meets or exceed all performance requirements, and is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not involve a "test set" in the context of diagnostic performance evaluation using patient data. The studies are non-clinical, primarily bench-top and simulated use testing. Therefore, information on sample size for a "test set" of patient data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical tissue marker, not an AI or diagnostic system requiring expert-established ground truth from images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no "test set" requiring adjudication in the context of diagnostic interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a submission for a physical medical device (tissue marker), not an AI-assisted diagnostic tool. Therefore, a multi-reader, multi-case comparative effectiveness study or analysis of human reader improvement with AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is not an algorithm or software. It is a physical implantable marker.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the objective metrics and criteria established in the referenced industry standards (e.g., ISO, ASTM) and internal design specifications. For example, for biocompatibility, the ground truth is that the device material does not elicit an adverse biological response when tested according to the specified ISO standards. For MRI compatibility, the ground truth is that the device meets safety thresholds for displacement, torque, and heating, and produces acceptable artifact levels as defined by ASTM standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2015

CareFusion Ms. Joy Greidanus Manager, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061

Re: K141722

Trade/Device Name: CareFusion Gold Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: December 11, 2014 Received: December 15, 2014

Dear Ms. Greidanus:

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.

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141722

Device Name CareFusion Gold Tissue Marker

Indications for Use (Describe)

The CareFusion Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K141722

SUBMITTER INFORMATION
Name	CareFusion
Address	75 North Fairway Drive, Vernon Hills, IL 60061 USA
Phone number	(847) 362-8103
Fax number	(312) 949-0583
Establishment RegistrationNumber	1423507
Name of contact person	Joy Greidanus
Date prepared	January 14, 2015
DESCRIPTION OF DEVICE
Trade or proprietary name	CareFusion Gold Tissue Marker
Common or usual name	Tissue Marker
Classification name	Implantable Clip
Classification panel	General & Plastic Surgery
Regulation	Class II per 21CFR §878.4300, Procode NEU
Product Code(s)	Multiple
Legally marketed device(s) towhich equivalence is claimed	K070436 Carbon Medical Technologies
Reason for 510(k) submission	New product.
Device description	The Gold Tissue Marker is a sterile, single use device comprised of a goldmarker and disposable delivery device. The delivery device has 1cmreference marks and echogenic marks on the distal tip to aid in ultrasoundguided marker placement. The Gold Tissue Marker is placed into softtissue during open, percutaneous, or endoscopic procedures toradiographically mark a surgical location.
Intended use of the device	The Gold Tissue Marker is indicated for use to radiographically mark softtissue during a surgical procedure or for future surgical procedures.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPAREDTO THE PREDICATE DEVICE
Characteristic	New Device	Predicates
Delivery device	Manual mechanism (plungeraction) with stylet andcannula	Same as predicate: K070436 CarbonMedical Technologies
Tissue marker	Implanted, gold	Same as predicate: K070436 CarbonMedical Technologies
Visualization	Visible on standardradiographs, MagneticResonance Imaging (MRI)and ultrasound	Same as predicate: K070436 CarbonMedical Technologies

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

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CONCLUSION OF DEVICE COMPARISON
The technological characteristics of the proposed devices are substantially equivalent to the predicate.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE
Characteristic	Standard/Test/FDA Guidance
Biocompatibility	AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1:Evaluation and Testing
Biocompatibility	AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices -Part 6 Tests for Local Effects After Implantation
Residuals	AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7:Ethylene Oxide Sterilization Residuals
Biocompatibility	AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11Tests for Systemic Toxicity
Biocompatibility	AAMI/ANSI/ISO 10993-18: 2006 Biological Evaluation of Medical Devices - Part 18Chemical Characterization of Materials
Performance	ISO 14630: 2012: Non-active Surgical Implants - General Requirements
Performance	ASTM F72: 2006 Section 4: Standard Specification for Gold Wire for SemiconductorLead Bonding
Performance	ASTM F2052: 2006: Standard Test Method for Measurement of Magnetically InducedDisplacement Force on Medical Devices in the MR Environment
Performance	ASTM F2119: 2007: Standard Test Method for the Evaluation of MR Image Artifactsfrom Passive Implants
Performance	ASTM F2182: 2011A: Standard Test Method for the Measurement of Radio frequencyInduced Heating on or Near Passive Implants During MRI
Performance	ASTM F2213: 2006, RA 2011: Standard Test Method for the Measurement ofMagnetically Induced Torque on Medical Devices in the MR Environment
Performance	BS EN ISO 9626:1995: Stainless Steel Needle Tubing for the Manufacture of MedicalDevices.
Performance	ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1& 2
Performance	ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene OxideSterilization
Performance	AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene OxideSterilization
Performance	Bench Top Testing – Marker securement, force to deploy, dimensional verification, andstrength of connections
Performance	Simulated Use - Implantation, visualization under ultrasound, MRI and radiograph,marker integrity after repeated compression
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of the non-clinical tests show that the CareFusion Gold Tissue Marker meets or exceed all performance requirements, and is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.