The Tumark Vision is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

Device Description

The Tumark Vision is a sterile, sinqle use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handle. It is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

AI/ML Overview

This document is from a 510(k) premarket notification for a medical device called "Tumark Vision." It asserts substantial equivalence to a predicate device, "Tumark Professional." Because this is a 510(k) submission, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical study data outlining acceptance criteria and detailed device performance metrics in the way one might expect for a novel device or a Post-Market Approval (PMA).

Therefore, the requested information, particularly regarding acceptance criteria (beyond general safety and efficacy) and a rigorous standalone study proving device performance against those criteria, is not explicitly available in this type of submission. The document relies on similarity to the predicate device to establish safety and effectiveness.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed performance results in the format of a clinical study. The "acceptance criteria" for a 510(k) are generally around demonstrating that the new device performs as intended and is as safe and effective as the predicate. The comparison table (page 5) highlights technological characteristics and shows that the "Tumark Vision" (new device) and "Tumark Professional" (predicate device) are functionally equivalent in most aspects, with the primary difference being the "Sphere-shaped design" of the marker in the new device compared to "U-shaped or X-shaped" in the predicate.

Characteristic	Acceptance Criteria (Implied based on Predicate Equivalence)	Reported Device Performance (Table on Page 5) - Tumark Vision
Regulatory Class	Class II	Class II
Product Code	NEU	NEU
Design	Sterile, single use, preloaded tissue site marking system with non-absorbable nickel-titanium marker, introducer cannula, plastic handle	Sterile, single use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handle
Marker Material	Nitinol	Nitinol
Cannula Design	Sharp tip with ultrasound enhancement, markings, puncture function	Sharp tip with ultrasound enhancement on the distal end, markings on the cannula and puncture function
Cannula Length [mm]	100 / 120	100 / 120
Cannula Diameter [mm]	1.2	1.2
Gauge [G]	18	18
Cannula Material	stainless steel	stainless steel
Handle	One-handed application with safety function to prevent premature deployment	One-handed application with safety function to prevent premature deployment of the marker
Handle Material	stainless steel and plastic	stainless steel and plastic
Sterilization Method	Ethylene oxide	Ethylene oxide
Marker Visibility	Visible in ultrasound, mammography, and MRI	Sphere-shaped design which is visible in ultrasound, mammography and MRI

Specific "acceptance criteria" linked to a study are not provided. The document states: "All verification and validation activities identified as necessary were performed by designated individuals and results demonstrate that predetermined acceptance criteria were met." However, it does not detail what those criteria were or the specific results.

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

This information is not provided in the document. A 510(k) summary primarily focuses on technical and performance characteristics comparison to a predicate device, rather than detailed clinical trial data. The document mentions "verification and validation activities" but doesn't elaborate on the type or scope of data used for these activities (e.g., patient data, in-vitro testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The submission does not describe a clinical study where expert ground truth was established for a test set.

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

This information is not provided. As no clinical study with a test set requiring adjudication is described, this detail is absent.

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

This information is not provided. The "Tumark Vision" is a physical medical device (implantable marker system), not an AI/software device. Therefore, an MRMC study related to AI assistance for human readers would not be applicable or expected for this submission.

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

This information is not provided. This question is relevant for AI or software-as-a-medical-device (SaMD) products. The Tumark Vision is a physical implantable marker.

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

This information is not provided. Since there's no described clinical study involving a test set, the concept of "ground truth" for patient data in that context isn't detailed. For a device like this, the ground truth would typically relate to the physical properties of the marker (e.g., visibility in imaging modalities, biocompatibility, deployment success), which were likely evaluated through non-clinical (e.g., bench, animal) testing rather than patient-level ground truth established by experts.

8. The sample size for the training set

This information is not provided. "Training set" is a concept typically associated with machine learning or AI algorithms, which is not applicable to this physical device.

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

This information is not provided. As explained above, this concept is not applicable here.

Summary

{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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human figures, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below.

March 22, 2018

SOMATEX Medical Technologies GmbH Burkhard Jakob, M.D. Regulatory Affairs Manager Rheinstr. 7d Teltow, Brandenburg 14513 Germany

Re: K180443

Trade/Device Name: Tumark Vision Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: February 13, 2018 Received: February 20, 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. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

David Krause -S

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}------------------------------------------------

Expiration Date: 06/30/2020

See PRA Statement below.

Form Approved: OMB No. 0910-0120

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180443

Device Name Tumark Vision

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"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 Vision

DATE PREPARED:

02.03.2018

APPLICANT:

SOMATEX Medical Technologies GmbH Rheinstr. 7d 14513 Teltow Germany Tel: +49 30 319 82 25 00 Fax: +49 30 319 82 25 99 E-Mail: info@somatex.com

CONTACT PERSON:

Dr. Burkhard Jakob Regulatory Affairs Manager Tel.: +49 30 319 82 25-51 E-Mail: B.Jakob@somatex.com

{4}------------------------------------------------

1 Device Name

Trade Name: Common Name: Device Classification Name: Tumark Vision Tissue Site Marking System Marker, Radiographic, Implantable

Classification / Product Code 2

The Tumark Vision 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	2	878.4300

က Predicate Device / Reference Device

Device	Predicate Device	510(k) Number	510(k) Holder
Tumark Vision	Tumark Professional	K093064	SOMATEX MedicalTechnologies GmbH

4 Device Description

5 Intended Use

The Tumark Vision is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

Technological Characteristics ર

Description	SOMATEX Medical Technologies---Tumark Vision(New Device)	SOMATEX Medical Technologies---Tumark Professional(Predicate Device)
Regulation Number	878.4300	878.4300
Class	2	2
Product Code	NEU	NEU
Design	A sterile, single use, preloadedtissue site marking systemconsisting of a non-absorbablenickel-titanium marker, anintroducer cannula and a plastichandle	A sterile, single use, preloadedtissue site marking systemconsisting of a non-absorbablenickel-titanium marker, anintroducer cannula and a plastichandle

{5}------------------------------------------------

Description	SOMATEX Medical TechnologiesTumark Vision(New Device)	SOMATEX Medical TechnologiesTumark Professional(Predicate Device)
Marker	Sphere-shaped design which isvisible in ultrasound, mammographyand MRI	U-shaped or X-shaped visible inultrasound, mammography and MRI
Marker Material	Nitinol	Nitinol
Cannula Design	Sharp tip with ultrasoundenhancement on the distal end,markings on the cannula andpuncture function	Sharp tip with ultrasoundenhancement on the distal end,markings on the cannula andpuncture function
Cannula length [mm]	100 / 120	100 / 120
Cannula Diameter [mm]	1.2	1.2
Gauge [G]	18	18
Cannula Material	stainless steel	stainless steel
Handle	One-handed application with safetyfunction to prevent prematuredeployment of the marker	One-handed application with safetyfunction to prevent prematuredeployment of the marker
Handle Material	stainless steel and plastic	stainless steel and plastic
Sterilization Method	Ethylene oxide	Ethylene oxide

7 Design Control Activities

A risk analysis was performed to identify new risk based on the device modification. Risks are mitigated as far as possible. All verification and validation activities identified as necessary were performed by designated individuals and results demonstrate that predetermined acceptance criteria were met. The manufacturing facility fulfills design procedure requirements.

Substantial Equivalence Summary / Conclusion 8

In summary, the proposed changes do not raise any new questions regarding safety and effectiveness of the Tumark Vision. The Tumark Vision is 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.