CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM

• K Number: K120804
• Device Name: CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
• Manufacturer: CIANNA MEDICAL
• Date Cleared: 2013-02-04 ( 325 days)
• Product Code: PBY
• Regulation Number: 878.4300

Intended Use

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.

Predicate Devices

K102506, K111692, K090501

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a physical tissue marker and delivery system, with no mention of software, algorithms, or AI/ML capabilities. The imaging modalities are used for guidance during placement and removal, not for analysis or processing by the device itself.

Therapeutic

No
The device is intended to mark a lumpectomy site for surgical removal, not to treat a disease or condition.

Diagnostic

No
The device is a tissue marker used to mark a lumpectomy site for surgical removal, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is comprised of an implantable marker (hardware) and a delivery system (hardware), and performance studies include testing of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to mark a lumpectomy site within the breast for surgical removal. This is a surgical aid or implantable marker, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
• Device Description: The device is an implantable marker made of titanium and nitinol, designed to be placed in vivo (within the body). IVDs typically involve analyzing samples in vitro (outside the body).
• Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.), chemical reactions, or diagnostic assays.

Therefore, the Cianna Medical Tissue Marker is a medical device used during a surgical procedure, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (

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.

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 Medical
6 Journey # 125
Aliso Viejo, CA 92656 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | 2-3-2013 |
| CONTACT PERSON: | Gary Mocnik
Cianna Medical
6 Journey
Aliso Viejo, CA 92656
Phone: [phone] x134
Fax: [phone]
Email: [e-mail] |
| 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- K102506
TuMark Flex Tissue Marking System- K111692
Hydromark (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.

1

Section 6

K120804 page 2/3

510(k) Summary

K120804 Page 2 of 3

Indication for Use:

The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (