CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM

K132463 · Cianna Medical, Inc. · NEU · Dec 3, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132463
• Device Name: CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
• Applicant: Cianna Medical, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Dec 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

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 Story

Device consists of implantable marker and delivery system; marker comprises titanium beads constrained on heat-shaped nitinol wire. Delivered percutaneously via needle delivery system; marker deploys into tissue, maintaining coiled shape (approx. 4.5mm diameter x 5mm length). Used in clinical setting during breast biopsy; operated by physician. Marker provides permanent radiographic visibility and ultrasound visibility for up to 30 days; assists healthcare providers in locating biopsy site for future medical procedures or surgical removal. Benefits patient by enabling accurate localization of tissue sites.

Clinical Evidence

No clinical data. Bench testing only: dimensional conformance, visual inspection, design verification, MRI compatibility, and biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, mutagenicity, and 13-week rabbit implantation study).

Technological Characteristics

Implantable marker: titanium beads on nitinol wire. Delivery system: needle-based. Radiopaque and echogenic. Biocompatible materials. Sterilized, single-use. No software or energy source.

Indications for Use

Indicated for marking tissue during percutaneous breast biopsy procedures in patients requiring permanent radiographic visualization and ultrasound visualization for up to 30 days.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Cianna Tissue Marker (K120804)
• Mixed Media Marker (K102506)
• TuMark Flex Tissue Marking System (K111692)

Submission Summary (Full Text)

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## Section 6

## 510(k) Summary

#### 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 Medical<br>6 Journey # 125<br>Aliso Viejo, CA 92656 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | 10-28-2013 |
| CONTACT PERSON: | Gary Mocnik<br>Cianna Medical<br>6 Journey<br>Aliso Viejo, CA 92656<br>Phone: [phone] x134<br>Fax: [phone]<br>Email: [e-mail] |
| TRADE NAME: | Cianna Medical Permanent Tissue Marker and<br>Delivery 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 K120804<br>Mixed Media Marker- K102506<br>TuMark 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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## Section 6

sterile, and is for single use only.

#### Indication for Use:

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.

## 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-<br>929 Mouse Fibroblast Cells | ISO 10993-5 | Passed.<br>Non-cytotoxic |
| ISO Intracutaneous Reactivity Test | ISO 10993-10 | Passed.<br>The test requirements were met |
| Sensitization: Guinea Pig<br>Maximization | ISO 10993-10 | Passed<br>Negative for evidence of<br>sensitization |
| ISO Acute Systemic Injection Test | ISO 10993-11 | Passed<br>The test requirements were met |
| Material Mediated Rabbit Pyrogen<br>Test | ISO 10993-10 | Passed<br>Non-Pyrogenic |
| Bacterial Mutagenicity Test-Ames<br>Assay | ISO 10993-3 | Passed<br>Non-Mutagenic |
| In Vitro Mouse Lymphoma Assay | ISO 10993-3 | Passed<br>Non-Mutagenic (non-genotoxic and<br>non-clastogenic) |
| In Vivo Mouse Micronucleus<br>Assay | ISO10993-3 | Passed<br>Non-Mutagenic |
| 30 Day Rabbit Implantation with<br>Subchronic Toxicity | ISO 10993-6<br>ISO10993-11 | Passed<br>No local or systemic signs of toxicity |

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## Section 6

## 510(k) Summary

| Test Performed | Standard | Test Result/Conclusion |
|---------------------------------------------------------|----------------------------|--------------------------------------------------|
| 13 Week Rabbit Implantation with<br>Subchronic Toxicity | ISO 10993-6<br>ISO10993-11 | Passed<br>No 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 of<br>Operation | Overall<br>Technological<br>Characteristics |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------|
| Cianna<br>Medical<br>Permanent<br>Tissue Marker<br>and Delivery<br>System | The Cianna Medical Permanent Tissue Marker<br>is intended to mark tissue during a<br>percutaneous breast biopsy procedure and be<br>permanently visible by radiography and visible<br>for up to thirty days by ultrasound. | Marker is<br>implanted into<br>tissue site for<br>visualization of<br>tissue site | Radiographically<br>visible marker<br>element(s) |
| Cianna<br>Medical Tissue<br>Marker and<br>Delivery<br>System<br>K120804 | The Cianna Medical Tissue Marker is intended<br>to be placed percutaneously in the breast to<br>temporarily (< 30 days) mark a lumpectomy<br>site intended for surgical removal. Using<br>ultrasound or radiography imaging guidance,<br>the Cianna Tissue Marker is located and<br>surgically removed with the target tissue. | SAME | SAME |
| Mixed Media<br>Marker<br>K102506 | The Mixed Media Markers (MMM) are<br>intended to be implanted into the body in<br>situations where the location of specific<br>anatomy, normal or diseased, needs to be<br>marked for a future medical procedure. The<br>MMM can be visualized using medical imaging<br>devices; the MMM provides a reference from<br>which treatment can be guided. MMM's not<br>intended for use with ultrasonography. | SAME | SAME |
| TuMark Flex<br>Tissue<br>marking<br>System<br>K111692 | The TuMark Flex is intended for<br>radiographically and radiologically<br>percutaneous marking of soft tissue, especially<br>breast tissue, via a clip marker. The TuMark<br>Flex is not indicated to be used with magnetic<br>resonance imaging (MRI) techniques. | SAME | SAME |

## Conclusions Drawn:

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

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

OR

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