The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 30 days) mark a lumpectomy site intended for surgical removal. Using ultrasound or radiography imaging guidance, the Cianna Tissue Marker is located and surgically removed with the target tissue.

Device Description

The Cianna Medical Tissue Marker and Delivery System is comprised of an implantable marker and a delivery system. The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) in the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging.. The Cianna Medical Tissue Marker and Delivery System is provided sterile, and is for single use only.

AI/ML Overview

The provided text describes the Cianna Medical Tissue Marker and Delivery System and its 510(k) submission (K120804). However, it does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic performance or clinical effectiveness.

Instead, the document focuses on:

Substantial Equivalence: Comparing the device's technological characteristics, intended use, and principle of operation to predicate devices (K102506, K111692, K090501).
Non-Clinical Performance Data: This section details various biocompatibility and material safety tests performed on the device components (e.g., cytotoxicity, sensitization, systemic toxicity, pyrogenicity, mutagenicity, implantation). These are common tests for implantable medical devices to ensure safety and material compatibility.
Clinical Data: Explicitly states, "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."

Therefore, based on the provided text, I cannot provide the requested information about acceptance criteria for diagnostic performance or a study demonstrating the device meets such criteria because:

No acceptance criteria for diagnostic performance are listed. The "acceptance criteria" discussed are implicitly related to the "Pass" or "Fail" results of the non-clinical (biocompatibility) tests.
No study demonstrating the device meets diagnostic performance criteria is described. The document states that no clinical data was used for substantial equivalence.

If you are looking for information regarding the diagnostic performance of a device (e.g., sensitivity, specificity, AUC), that kind of data is not present in this 510(k) summary. This document primarily demonstrates the safety and material compatibility of the tissue marker and its substantial equivalence to existing markers based on design and intended use, not its diagnostic accuracy in identifying or characterizing a medical condition.

Summary

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Section 6 510(k) Summary

K120804 Page 1 of 3

510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Cianna Medical6 Journey # 125Aliso Viejo, CA 92656
DATE PREPARED:	2-3-2013
CONTACT PERSON:	Gary MocnikCianna Medical6 JourneyAliso Viejo, CA 92656Phone: (949)360.0059 x134Fax: (949) 297.4527Email: gmocnik@ciannamedical.com
TRADE NAME:	Cianna Medical Tissue Marker and Delivery System
COMMON NAME:	Temporary Tissue Marker
CLASSIFICATION NAME:	Implantable Clip, 21 CFR 878.4300
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE	PBY
PREDICATE DEVICES:	Mixed Media Marker- K102506TuMark Flex Tissue Marking System- K111692Hydromark (K090501)

Substantially Equivalent To:

The Cianna Medial Tissue Marker and Delivery System is substantially equivalent in intended use, principal of operation and technological characteristics to the Mixed Media Marker (K102506), TuMark Flex Tissue Marking System (K111692), and the Hydromark (K090501). The Cianna Medical Tissue Marker differs from the predicates only in its intended implant duration. The predicates are intended to be long term implants while the Cianna Medical Tissue Marker is intended for implant duration of less than 30 days and is removed with the target tissue.

Description of the Device Subject to Premarket Notification:

The Cianna Medical Tissue Marker and Delivery System is comprised of an implantable marker and a delivery system.

The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) in the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging.. The Cianna Medical Tissue Marker and Delivery System is provided sterile, and is for single use only.

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Section 6

K120804 page 2/3

510(k) Summary

K120804 Page 2 of 3

Indication for Use:

Discuss of Technological Characteristics:

The Cianna Medical Tissue Marker and Delivery System has the same technological characteristics and is similar in overall design, materials and configuration compared to the predicates. The Cianna Medical Tissue Marker and Delivery System and the identified predicates are all radiographically visible marker elements positioned into tissue for visualization of the tissue site. The technical designs of the Cianna Medical Tissue Marker and the predicate devices are very similar, being composed of an array of biocompatible, radiopaque metals which are delivered into tissue via a needle delivery system.

Non-Clinical Performance Data

Performance testing was conducted to evaluate and characterize the performance of the Cianna Medical Tissue Marker System. Preclinical testing conducted included dimensional conformance evaluation, visual inspections, and design verification to confirm imaging equivalency, MRI compatibility testing, and biocompatibility testing based on the applicable elements of ISO 10993-1 shown below.

Test Performed	Standard	Test Result/Conclusion
ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells	ISO 10993-5	Passed.Non-cytotoxic
ISO Intracutaneous Reactivity Test	ISO 10993-10	Passed.The test requirements were met
Sensitization: Guinea PigMaximization	ISO 10993-10	PassedNegative for evidence ofsensitization
ISO Acute Systemic Injection Test	ISO 10993-11	PassedThe test requirements were met
Material Mediated Rabbit PyrogenTest	ISO 10993-10	PassedNon-Pyrogenic
Bacterial Mutagenicity Test-AmesAssay	ISO 10993-3	PassedNon-Mutagenic
In Vitro Mouse Lymphoma Assay	ISO 10993-3	PassedNon-Mutagenic (non-genotoxic andnon-clastogenic)
In Vivo Mouse MicronucleusAssay	ISO 10993-3	PassedNon-Mutagenic
30 Day Rabbit Implantation withSubchronic Toxicity	ISO 10993-6ISO10993-11	PassedNo local or systemic signs of toxicity

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Section 6

K120504 Page 3/3

510(k) Summary

K120804 Page 3 of 3

Clinical Data

This submission does not rely on clinical data to determine substantial equivalency to the predicate devices.

Basis for Determination of Substantial Equivalence:

Product	Intended Use	Principle of Operation	Overall Technological Characteristics
CiannaMedical TissueMarker andDeliverySystem	The Cianna Medical Tissue Marker is intendedto be placed percutaneously in the breast totemporarily (<30 days) mark a lumpectomysite intended for surgical removal. Usingultrasound or radiography imaging guidance,the Cianna Tissue Marker is located andsurgically removed with the target tissue.	Marker isimplanted intotissue site forvisualization oftissue site	Radiographicallyvisible markerelement(s)
Mixed MediaMarkerK102506	The Mixed Media Markers (MMM) areintended to be implanted into the body insituations where the location of specificanatomy, normal or diseased, needs to bemarked for a future medical procedure. TheMMM can be visualized using medical imagingdevices; the MMM provides a reference fromwhich treatment can be guided. MMM's notintended for use with ultrasonography.	SAME	SAME
TuMark FlexTissuemarkingSystemK111692	The TuMark Flex is intended forradiographically and radiologicallypercutaneous marking of soft tissue, especiallybreast tissue, via a clip marker. The TuMarkFlex is not indicated to be used with magneticresonance imaging (MRI) techniques.	SAME	SAME
HydroMarkBiopsy SiteMarkerK090501	The Biopsy Science LLC, HydroMark BiopsySite Marker is intended to mark tissue during apercutaneous breast biopsy procedure, bevisible under ultrasound for at least 6 weeksand be permanently visible by x-ray and MRI	SAME	SAME

Conclusions Drawn:

As shown, the Cianna Medical Tissue Marker has the following similarities to the predicate devices:

Similar intended use .
Similar design characteristics .
. Same operating principal
. Same mechanism of action
Similar technological characteristics .

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Cianna Medical Tissue Marker System is determined by Cianna Medical, to be substantially equivalent to existing legally marketed devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that create a sense of movement and flow.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Cianna Medical % Mr. Gary Mocnik Vice President, Regulatory Affairs and Quality Systems 6 Journey, Suite 125 Aliso Viejo, California 92656

Re: K120804

Trade/Device Name: Cianna Medical Tissue Marker System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PBY Dated: January 18, 2013 Received: January 30, 2013

Dear Mr. Mocnik:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

February 4, 2013

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Page 2 - Mr. Gary Mocnik

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/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 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,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K120804

Device Name: Cianna Medical Tissue Marker System

Indications for Use:

The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 30 days) mark a lumpectorny site intended for surgical removal. Using ultrasound or radiography imaging guidance, the Cianna Tissue Marker is located and surgically removed with the target tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801 Subpart D)

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

Page 1 of 1

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K120804

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.