(90 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
No
The device is used to mark the surgical site, not to treat a condition.
No
This device is used to mark a surgical site for future radiological procedures, not to diagnose a condition itself.
No
The device description explicitly states it consists of physical components: a marker, an introducer cannula, and a plastic handheld applier with a deployment mechanism. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "attach a marker to soft tissue at the surgical site during a percutaneous procedure" and "radiologically mark the surgical location in breasts." This is a surgical marking device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical marker, cannula, and applier. It does not involve reagents, calibrators, or other components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical accessory or implantable marker, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Tumark for Eviva and Tumark for Brevera are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. The devices are indicated for use to radiologically mark the surgical location in breasts following a percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.
Product codes
NEU
Device Description
Tumark for Eviva and Tumark for Brevera are sterile, single use, preloaded tissue site marking systems consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism.
The introducer cannula has a blunt tip and can only be used together with an introducer. The handle is equipped with a slide-button which allows for a one handed placement of the marker by pressing it forward. A safety catch system prevents the slide-button to inadvertently move forward and therefore prevents a premature deployment of the marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, breasts
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
Bench and in vitro testing were performed to evaluate technological characteristics and performance criteria.
Aspects tested included: Biocompatibility (per ISO-10993-1), Sterility (per ISO 11737-1 and ISO 11737-2), Shelf life (accelerated and real-time aging), blunt cannula tip impact on introducer sheath, cannula compatibility with introducers of respective vacuum biopsy systems, functionality of protection tube, and device performance (marker placement in target area).
Results: All acceptance criteria were met for all tests, demonstrating that the device met required biocompatibility requirements, could be sterilized, maintained performance after simulated aging, did not damage the introducer sheath, allowed marker placement at the intended location, had a protection tube that could be removed manually, and could deploy markers into the breast phantom.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
October 31, 2018
SOMATEX Medical Technologies GmbH Burkhard Jakob Regulatory Affairs Manager Rheinstrasse 7d, Teltow, DE 14513 Brandenburg GERMANY
Re: K182082
Trade/Device Name: Tumark for Eviva, Tumark for Brevera Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: July 24, 2018 Received: August 2, 2018
Dear Dr. Jakob:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Joseph Nielsen" stacked on top of each other. The text is written in a simple, sans-serif font, and the letters are black. The background is white, and there is a faint, light blue watermark in the background.
gitally signed by Joseph Nielsen -S
N: c=US, o=U.S. Government,
=HHS, ou=FDA, ou=People,
=Joseph Nielsen -S,
9.2342.19200300.100.1.1=200036750
te: 2018.10.31 09:43:45-04'00'
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Turnark for Eviva Tumark for Brevera
Indications for Use (Describe)
inutedins for Eviva and Turnark for Brevera are intended to attach a marker to soft tissue at the surgical site during a recount to a procedure. The devices are indicated for use to radiologically mark the surgical location in breasts following a percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
510(k) Summary Tumark for Eviva and Tumark for Brevera
| DATE PREPARED: | 24.07.2018 |
|---|---|
| APPLICANT: | SOMATEX Medical Technologies GmbH |
| Rheinstrasse 7d | |
| 14513 Teltow | |
| GERMANY | |
| Tel: +49 30 319 82 25 00 | |
| Fax: +49 30 319 82 25 99 | |
| E-Mail: service@somatex.com | |
| CONTACT PERSON: | Burkhard Jakob, PhD |
| Regulatory Affairs Manager | |
| Tel.: +49 30 319 82 25-51 | |
| E-Mail: B.Jakob@somatex.com |
4
1 Device Name
| Trade Name: | Tumark for Eviva
Tumark for Brevera |
|-----------------------------|----------------------------------------|
| Common Name: | Tissue Site Marking System |
| Device Classification Name: | Marker, Radiographic, Implantable |
2 Classification / Product Code
The Tumark for Eviva and Tumark for Brevera can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classification |
|-----------------------------------------|---------------------------|------------------------------------|---------------------------------|-----------------|----------------------|--------------------------|
| Marker,
Radiographic,
Implantable | Implantable
clip | General &
Plastic
Surgery | General &
Plastic
Surgery | NEU | 878.4300 | 2 |
Predicate Device/ Reference Device 3
| Device | Predicate Device
(Reference Device) | 510(k) Number | SIO(k) Holder |
|--------------------|----------------------------------------|---------------|-------------------|
| Tumark for Eviva | Tumark Professional | K093064 | SOMATEX Medical |
| Tumark for Brevera | (Tumark Vision) | (K180443) | Technologies GmbH |
Device Description ব
Tumark for Eviva and Tumark for Brevera are sterile, single use, preloaded tissue site marking systems consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism.
The introducer cannula has a blunt tip and can only be used together with an introducer. The handle is equipped with a slide-button which allows for a one handed placement of the marker by pressing it forward. A safety catch system prevents the slide-button to inadvertently move forward and therefore prevents a premature deployment of the marker.
5 Intended Use
Tumark for Eviva and Tumark for Brevera are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following a
5
percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.
| Description | SOMATEX Medical
Technologies
Tumark for Eviva and
Tumark for Brevera
(New Device) | SOMATEX Medical
Technologies
Tumark Professional
(Predicate Device) | SOMATEX Medical
Technologies
Tumark Vision
(Reference Device) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 878.4300 | 878.4300 | 878.4300 |
| Class | 2 | 2 | 2 |
| Product Code | NEU | NEU | NEU |
| Design | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, an
introducer cannula and a
plastic handheld applier
with deployment
mechanism. | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, an
introducer cannula and a
plastic handhetd applier
with deployment
mechanism. | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, an
introducer cannula and a
plastic handheld applier
with deployment
mechanism. |
| Marker | X-, Q- or sphere-shaped
design which is visible in
ultrasound,
mammography and MRI | Li-shaped or X-shaped
visible in ultrasound,
mammography and MRI | Sphere-shaped design
which is visible in
ultrasound,
mammography and MRI |
| Marker Material | Nitinol | Nitinol | Nitinol |
| Cannula Design | Blunt, rounded tip
no markings | Sharp tip with
ultrasound enhancement
on the distal end,
markings on the cannula
and puncture function | Sharp tip with
ultrasound enhancement
on the distal end,
markings on the cannula
and puncture function |
| Cannula length [mm] | 123.5/125.5/127.5/
129.5/132.0/133.0/135. 5 | 100 / 120 | 100/ 120 |
| Cannula Diameter [mm] | 1.2 | 1.2 | 1.2 |
| Gauge [G] | 18 | 18 | 18 |
| Cannula Material | stainless steel | stainless steel | stainless steel |
| Handle | One-handed application
with safety function to
prevent premature
deployment of the
marker | One-handed application
with safety function to
prevent premature
deployment of the
marker | One-handed application
with safety function to
prevent premature
deployment of the
marker |
| Handle Material | stainless steel and plastic | stainless steel and
plastic | stainless steel and
plastic |
| Sterilization Method | Ethylene oxide | Ethylene oxide | Ethylene oxide |
6 Technological Characteristics
Performance Data 7
To demonstrate that the new devices are as safe and effective as the predicate device Tumark Professional, its technological characteristics and performance criteria were evaluated. The new devices were evaluated in bench and in vitro testing. Specific aspects included:
6
| Aspect | Test Method | Result |
|---|---|---|
| Biocompatibility | Testing per ISO-10993-1 | Device met required |
| biocompatibility requirements. | ||
| All acceptance criteria met. | ||
| Sterility | Testing per ISO 11737-1 | |
| and ISO 11737-2 | Device can be sterilized by | |
| the sterilization process. | ||
| All acceptance criteria met. | ||
| Shelf life | Confirm the function of | |
| the device after | ||
| accelerated and real-time | ||
| aging | Device performance is maintained | |
| after simulated aging conditions. | ||
| All acceptance criteria met. | ||
| Blunt cannula tip | Confirm that cannula | |
| does not damage wall of | ||
| introducer sheath | The introducer sheath was | |
| undamaged after placing the | ||
| marker. | ||
| The marker could be placed at the | ||
| intended location. | ||
| All acceptance criteria met. | ||
| Cannula is compatible | ||
| with introducers of | ||
| respective vacuum biopsy | ||
| systems | Confirm that marker can | |
| be deployed into the | ||
| target region | The marker could be placed at the | |
| intended location. | ||
| All acceptance criteria met. | ||
| Functionality of protection | ||
| tube | Confirm that cannula lies | |
| within removable | ||
| protection tube after | ||
| being removed out of | ||
| the blister | The protection tube does not fall | |
| off by itself during handling but | ||
| can be removed manually from | ||
| the cannula. | ||
| All acceptance criteria met. | ||
| Device Performance | Confirm that marker can | |
| be placed in the target | ||
| area | X-, Q-, and Vision markers could | |
| be deployed into the breast | ||
| phantom. | ||
| The device performs as intended. | ||
| All acceptance criteria met. |
The results from bench testing demonstrate that the different technological characteristics do not raise questions concerning safety and effectiveness. The new device can be used safely and effectively.
8 Substantial Equivalence Summary / Conclusion
The proposed changes do not raise any new questions regarding safety and effectiveness of the Tumark for Eviva and Tumark for Brevera. Tumark for Eviva and Tumark for Brevera are substantially equivalent to the predicate device Tumark Professional.