(118 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a tissue marker, with no mention of AI or ML.
No.
The device's intended use is to mark tissue for visualization, not to treat a disease or condition.
No
The device is intended to mark tissue permanently after a biopsy procedure for future radiographic visibility and short-term ultrasound visibility, not to diagnose a condition.
No
The device description clearly states it consists of an implantable marker (hardware) and a delivery system (hardware). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Cianna Medical Permanent Tissue Marker is an implantable device used within the body during a percutaneous breast biopsy procedure. Its purpose is to mark tissue in situ for later visualization via imaging modalities (radiography and ultrasound). It does not analyze or test a sample taken from the body.
The device description and intended use clearly indicate that it is a surgical/implantable device used for marking tissue within the body, not for in vitro diagnostic testing of a specimen.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, radiography
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Tests performed and results:
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cianna Tissue Marker K120804, Mixed Media Marker- K102506, TuMark Flex Tissue Marking System- K111692
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
6 Journey # 125
Aliso Viejo, CA 92656 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | 10-28-2013 |
| CONTACT PERSON: | Gary Mocnik
Cianna Medical
6 Journey
Aliso Viejo, CA 92656
Phone: (949)360.0059 x134
Fax: (949) 297.4527
Email: gmocnik@ciannamedical.com |
| TRADE NAME: | Cianna Medical Permanent Tissue Marker and
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
Mixed Media Marker- K102506
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
1
K132463 Page 2/4
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- | ||
| 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 |
2
K132463 Page 3/4
Section 6
510(k) Summary
| Test Performed | Standard | Test Result/Conclusion |
|---|---|---|
| 13 Week Rabbit Implantation with | ||
| Subchronic Toxicity | ISO 10993-6 | |
| ISO10993-11 | Passed | |
| 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
Operation | Overall
Technological
Characteristics |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------|
| Cianna
Medical
Permanent
Tissue Marker
and Delivery
System | 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. | Marker is
implanted into
tissue site for
visualization of
tissue site | Radiographically
visible marker
element(s) |
| Cianna
Medical Tissue
Marker and
Delivery
System
K120804 | The Cianna Medical Tissue Marker is intended
to be placed percutaneously in the breast to
temporarily (