The Cianna Medical Permanent Tissue Marker is intended to mark tissue during a percutaneous breast biopsy procedure and be permanently visible by radiography and visible for up to thirty days by ultrasound.

Device Description

The Cianna Medical Permanent Tissue Marker and Delivery System consists 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) within the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging. The Cianna Medical Permanent Tissue Marker and Delivery System is provided sterile, and is for single use only.

AI/ML Overview

The provided text describes the non-clinical performance evaluation of the Cianna Medical Permanent Tissue Marker and Delivery System, focusing on biocompatibility. It explicitly states that no clinical data was used to determine substantial equivalence. Therefore, there is no information about acceptance criteria for device performance in a clinical setting, nor any study proving the device meets such criteria.

However, I can provide the acceptance criteria and results for the non-clinical performance data as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Test Performed	Acceptance Criteria (Standard)	Reported Device Performance (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 Pig Maximization	ISO 10993-10	Passed. Negative for evidence of sensitization
ISO Acute Systemic Injection Test	ISO 10993-11	Passed. The test requirements were met
Material Mediated Rabbit Pyrogen Test	ISO 10993-10	Passed. Non-Pyrogenic
Bacterial Mutagenicity Test-Ames Assay	ISO 10993-3	Passed. Non-Mutagenic
In Vitro Mouse Lymphoma Assay	ISO 10993-3	Passed. Non-Mutagenic (non-genotoxic and non-clastogenic)
In Vivo Mouse Micronucleus Assay	ISO10993-3	Passed. Non-Mutagenic
30 Day Rabbit Implantation with Subchronic Toxicity	ISO 10993-6, ISO10993-11	Passed. No local or systemic signs of toxicity
13 Week Rabbit Implantation with Subchronic Toxicity	ISO 10993-6, ISO10993-11	Passed. No local or systemic signs of toxicity

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. The document describes non-clinical, in-vitro, and in-vivo animal (mouse, guinea pig, rabbit) tests for biocompatibility, not human clinical test sets. The sample sizes for each specific biocompatibility test are not detailed in this summary.
Data Provenance: Not specified, but given the nature of the tests (ISO standards), these are laboratory-based studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth typically refers to clinical or pathological assessment in human studies. For these non-clinical tests, the "ground truth" is established by adherence to the specified ISO standards and validated laboratory methodologies, performed by qualified laboratory personnel.

4. Adjudication method for the test set:

Not applicable. These are not studies requiring adjudication by multiple experts in the sense of clinical image review. The results are based on standardized laboratory protocols and interpretations.

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. The document explicitly states: "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices." This is not an AI-assisted device, nor does it involve human readers interpreting images in a clinical setting.

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

No. This is a physical medical device (tissue marker), not an algorithm or AI system.

7. The type of ground truth used:

Non-Clinical Biocompatibility Standards: The "ground truth" for the non-clinical tests is based on the established safety thresholds and methodologies defined by the specific ISO 10993 series standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation and sensitization, ISO 10993-11 for systemic toxicity, ISO 10993-3 for genotoxicity, and ISO 10993-6 for local effects after implantation). These standards provide the basis for evaluating material safety.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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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Section 6 510(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:	10-28-2013
CONTACT PERSON:	Gary MocnikCianna Medical6 JourneyAliso Viejo, CA 92656Phone: (949)360.0059 x134Fax: (949) 297.4527Email: gmocnik@ciannamedical.com
TRADE NAME:	Cianna Medical Permanent Tissue Marker andDelivery System
COMMON NAME:	Tissue Marker
CLASSIFICATION NAME:	Implantable Clip, 21 CFR 878.4300
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE	NEU
PREDICATE DEVICES:	Cianna Tissue Marker K120804Mixed Media Marker- K102506TuMark Flex Tissue Marking System- K111692

Substantially Equivalent To:

The Cianna Medial Permanent Tissue Marker and Delivery System is identical to the company's' previously cleared marker and delivery system (K120804) that is intended for an implant duration of less than 30 days. Other devices that are substantially equivalent in intended use, principal of operation and technological characteristics are the Mixed Media Marker (K102506), and the TuMark Flex Tissue Marking System (K111692). These predicates are indicated for permanent implantation.

Description of the Device Subject to Premarket Notification:

The Cianna Medical Permanent Tissue Marker and Delivery System consists 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) within the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging. The Cianna Medical Permanent Tissue Marker and Delivery System is provided

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K132463 Page 2/4

Section 6

sterile, and is for single use only.

Indication for Use:

Discuss of Technological Characteristics:

The Cianna Medical Permanent 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 Permanent 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 Permanent 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 Permanent 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	ISO10993-3	PassedNon-Mutagenic
30 Day Rabbit Implantation withSubchronic Toxicity	ISO 10993-6ISO10993-11	PassedNo local or systemic signs of toxicity

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K132463 Page 3/4

Section 6 510(k) Summary

Test Performed	Standard	Test Result/Conclusion
13 Week Rabbit Implantation withSubchronic Toxicity	ISO 10993-6ISO10993-11	PassedNo local or systemic signs of toxicity

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 ofOperation	OverallTechnologicalCharacteristics
CiannaMedicalPermanentTissue Markerand DeliverySystem	The Cianna Medical Permanent Tissue Markeris intended to mark tissue during apercutaneous breast biopsy procedure and bepermanently visible by radiography and visiblefor up to thirty days by ultrasound.	Marker isimplanted intotissue site forvisualization oftissue site	Radiographicallyvisible markerelement(s)
CiannaMedical TissueMarker andDeliverySystemK120804	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.	SAME	SAME
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

Conclusions Drawn:

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

ﻟﻜ ﺴ

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Section 6

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

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 Permanent Tissue Marker System is determined by Cianna Medical, to be substantially equivalent to existing legally marketed devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, well-being, and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

December 3, 2013

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

Re: K132463

Trade/Device Name: Cianna Medical Tissue Marker System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: October 28, 2013 Received: November 6, 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 (reporting of medical

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Page 2 - Mr. Gary Mocnik

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. - For Acting Director

For
Division

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5

Indications For Use

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _K132463

Device Name: Cianna Medical Permanent Tissue Marker System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132463

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.