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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the "Tumark for Eviva" and "Tumark for Brevera" devices. This document summarizes the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, rather than a standalone study proving its performance against specific acceptance criteria for regulatory approval of a novel device. The primary goal of a 510(k) is to show substantial equivalence, not necessarily to prove efficacy/safety as an entirely new product.

Therefore, many of the requested details about a standalone study, multi-reader multi-case studies, expert adjudication methods, and explicit training set details are not present in this type of submission. The focus is on bench and in vitro testing relative to the predicate device.

Here's an analysis of the provided information, addressing what is available and noting what is not:

1. Table of Acceptance Criteria and the Reported Device Performance

Aspect	Test Method	Acceptance Criteria	Reported Device Performance
Biocompatibility	Testing per ISO-10993-1	Device met required biocompatibility requirements.	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.	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.	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.	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.	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.	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.	X-, Q-, and Vision markers could be deployed into the breast phantom. The device performs as intended. All acceptance criteria met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for each test (e.g., number of devices tested for sterility, shelf life, or blunt tip evaluation). The "Device Performance" test mentions "X-, Q-, and Vision markers" and deployment into a "breast phantom," implying a physical test, but the number of deployments or phantoms is not given.
Data Provenance: The document does not specify the country of origin of the data. The applicant is based in Germany.
Retrospective or Prospective: Not applicable as the studies described are bench and in vitro tests, not clinical studies involving patient data.

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

This information is not provided as the "studies" are bench and in vitro tests assessing physical and material properties, not diagnostic performance requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the "studies" are bench and in vitro tests, not diagnostic performance studies with a need for adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not applicable. The device is an implantable marker, not an AI-powered diagnostic tool for interpretation by human readers.

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

A standalone performance study in the context of an algorithm was not done and is not applicable. The device is a physical medical device (implantable marker). The performance studies listed are bench tests of its physical and material properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench and in vitro tests, the "ground truth" would be established physical measurements, material science standards (e.g., ISO for biocompatibility and sterility), and successful mechanical deployment into a phantom. There is no expert consensus, pathology, or outcomes data used for these types of tests.

8. The sample size for the training set

This information is not applicable/not provided. The device is an implantable marker, not an AI or algorithm-based system that requires a "training set." The tests conducted are to confirm the physical and biological properties of the device.

9. How the ground truth for the training set was established

This information is not applicable/not provided as there is no "training set" for this type of device.

Summary

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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

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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,

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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

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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)

K182082

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.
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510(k) Summary Tumark for Eviva and Tumark for Brevera

DATE PREPARED:	24.07.2018
APPLICANT:	SOMATEX Medical Technologies GmbHRheinstrasse 7d14513 TeltowGERMANYTel: +49 30 319 82 25 00Fax: +49 30 319 82 25 99E-Mail: service@somatex.com
CONTACT PERSON:	Burkhard Jakob, PhDRegulatory Affairs ManagerTel.: +49 30 319 82 25-51E-Mail: B.Jakob@somatex.com

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1 Device Name

Trade Name:	Tumark for EvivaTumark 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	RegulationDescription	RegulationMedicalSpecialty	ReviewPanel	ProductCode	RegulationNumber	DeviceClassification
Marker,Radiographic,Implantable	Implantableclip	General &PlasticSurgery	General &PlasticSurgery	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

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

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percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.

Description	SOMATEX MedicalTechnologiesTumark for Eviva andTumark for Brevera(New Device)	SOMATEX MedicalTechnologiesTumark Professional(Predicate Device)	SOMATEX MedicalTechnologiesTumark 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 sitemarking systemsconsisting of a non-absorbable nickel-titanium marker, anintroducer cannula and aplastic handheld applierwith deploymentmechanism.	Sterile, single use,preloaded tissue sitemarking systemsconsisting of a non-absorbable nickel-titanium marker, anintroducer cannula and aplastic handhetd applierwith deploymentmechanism.	Sterile, single use,preloaded tissue sitemarking systemsconsisting of a non-absorbable nickel-titanium marker, anintroducer cannula and aplastic handheld applierwith deploymentmechanism.
Marker	X-, Q- or sphere-shapeddesign which is visible inultrasound,mammography and MRI	Li-shaped or X-shapedvisible in ultrasound,mammography and MRI	Sphere-shaped designwhich is visible inultrasound,mammography and MRI
Marker Material	Nitinol	Nitinol	Nitinol
Cannula Design	Blunt, rounded tipno markings	Sharp tip withultrasound enhancementon the distal end,markings on the cannulaand puncture function	Sharp tip withultrasound enhancementon the distal end,markings on the cannulaand 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 applicationwith safety function toprevent prematuredeployment of themarker	One-handed applicationwith safety function toprevent prematuredeployment of themarker	One-handed applicationwith safety function toprevent prematuredeployment of themarker
Handle Material	stainless steel and plastic	stainless steel andplastic	stainless steel andplastic
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:

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Aspect	Test Method	Result
Biocompatibility	Testing per ISO-10993-1	Device met requiredbiocompatibility requirements.All acceptance criteria met.
Sterility	Testing per ISO 11737-1and ISO 11737-2	Device can be sterilized bythe sterilization process.All acceptance criteria met.
Shelf life	Confirm the function ofthe device afteraccelerated and real-timeaging	Device performance is maintainedafter simulated aging conditions.All acceptance criteria met.
Blunt cannula tip	Confirm that cannuladoes not damage wall ofintroducer sheath	The introducer sheath wasundamaged after placing themarker.The marker could be placed at theintended location.All acceptance criteria met.
Cannula is compatiblewith introducers ofrespective vacuum biopsysystems	Confirm that marker canbe deployed into thetarget region	The marker could be placed at theintended location.All acceptance criteria met.
Functionality of protectiontube	Confirm that cannula lieswithin removableprotection tube afterbeing removed out ofthe blister	The protection tube does not falloff by itself during handling butcan be removed manually fromthe cannula.All acceptance criteria met.
Device Performance	Confirm that marker canbe placed in the targetarea	X-, Q-, and Vision markers couldbe deployed into the breastphantom.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.

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.