The Tumark® Vision, the Tumark® Professional, the Tumark® Professional Q-Shape are intended to attach a marker to soft breast tissue and axillary lymph nodes, following an open or a percutaneous procedure to radiographically mark the location of the surgical site. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.

Device Description

The Tumark® Vision, Tumark® Professional, Tumark® Q, and Tumark® Professional Q-Shape are sterile products for single use only. Each consists of a non-absorbable nickel-titanium clip marker, an introducer cannula, and a plastic handle. The clip marker is contained within the cannula when new and unopened. The cannula tip is bevelled, has markings 1 cm apart for measuring depth, and a textured surface behind the tip. The handle has a slide button for one-handed marker placement and a safety catch system to prevent premature deployment. The clip markers have different shapes: spherical (Tumark Vision), U-shape (Tumark Professional), Q-shape (Tumark Q), and Q-shaped (Tumark Professional Q Shape). The symbol of the clip marker shape is depicted on the handle.

AI/ML Overview

Based on the provided text, the device in question is a tissue site marking system, specifically the Tumark Vision, Tumark Professional, Tumark Q, and Tumark Professional Q-Shape. These devices are intended to attach a marker to soft breast tissue and axillary lymph nodes to radiographically mark the location of a surgical site.

It's important to note that this document is a 510(k) premarket notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving safety and effectiveness through extensive new clinical trials like a PMA (Premarket Approval) application would. Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical and limited clinical data submitted for substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Aspect	Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets requirements of ISO 10993-1; absence of toxic leachables and contaminants; acceptable EO residual values.	Components and manufacturing processes similar to predicate and reference devices. Made from standard materials. EO residual values far below acceptable limits. Cytotoxicity testing and toxicological review confirmed absence of toxic leachables and contaminants. All requirements met.
Sterilization & Shelf Life	All acceptance criteria met during sterility testing; defined shelf-life proven based on packaging and device testing after real-time aging; all defined acceptance criteria met.	Sterility testing confirmed all acceptance criteria were met. Shelf-life proven after real-time aging, with all defined acceptance criteria met during shelf life testing. All acceptance criteria met.
Device Function	Marker can be placed in the target area.	U-, Q- and Vision markers could be deployed. The device performs as intended. All acceptance criteria met.
Device Performance	Clip marker and cannula are recognized in ultrasound, mammography, and MR imaging.	Clip markers and cannulas are recognized in ultrasound, mammography, and MR imaging. All acceptance criteria are met.
Device Stability during transport	Devices are not damaged during transport.	Drop tests performed. Devices were not damaged. All acceptance criteria are met.
Clinical Equivalence	Clinical support for the use of markers inside axillary lymph nodes; support for the defined indication for use.	A literature review was performed to clinically support the use of the markers inside axillary lymph nodes. Physician statements were obtained to support the indication for use. This supports the substantial equivalence to predicate devices with similar indications. Claim of substantial equivalence made.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a quantitative "sample size" in terms of number of patients or cases for the in vitro (bench) testing. The "test set" for the non-clinical evaluations appears to be the devices themselves.

Sample Size for Bench Testing: Not explicitly stated as a numerical count of devices tested. The text says "Bench testing was performed to validate the device design" and lists aspects like "Device Function," "Device Performance," and "Device Stability during transport."
Data Provenance: The studies are described as "in vitro testing" and "bench testing." There is also a "Clinical Analysis" which involved a "literature review" and "physician statements."
- Country of Origin: Not explicitly stated, but the applicant (SOMATEX Medical Technologies GmbH) is based in Berlin, Germany.
- Retrospective or Prospective: The bench testing is presumably prospective (planned tests). The literature review is retrospective. The physician statements are likely prospective or current.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The "Clinical Analysis" mentions "physician statements," implying medical professionals.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified for the presented bench testing. The evaluation is based on meeting pre-defined acceptance criteria for the physical and functional characteristics of the device. For the clinical analysis, "physician statements" were obtained, but no multi-reader adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No MRMC comparative effectiveness study was done or reported. This device is a physical marker, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.

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

Standalone Performance: Not applicable. This is a physical medical device (implantable clip), not an algorithm or software.

7. The Type of Ground Truth Used

For Bench Testing: The "ground truth" is based on engineered specifications and the physical performance of the device against those specifications (e.g., successful deployment, visibility under imaging modalities, structural integrity). This is a technical and objective validation against design requirements.
For Clinical Analysis (Supporting Indications): The "ground truth" for the expanded indication (axillary lymph nodes) relies on a literature review and physician statements, suggesting a consensus of existing medical knowledge and expert opinion. It is not based on direct patient outcomes data from a new clinical study.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set." The development of the device would involve engineering design and iterative testing, not AI model training.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set Establishment: Not applicable as there is no "training set" in the context of an AI/ML model for this device. The design and validation of this device follow traditional medical device engineering and testing methodologies.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

February 18, 2021

SOMATEX Medical Technologies GmbH David Vasmer Regulatory Affairs Manager Hohenzollerndamm 150/151 Berlin, Berlin 14199 Germany

Re: K201863

Trade/Device Name: Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: July 3, 2020 Received: July 6, 2020

Dear Dr. Vasmer:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201863

Device Name

Tumark Vision, Tumark Professional, Tumark Professional Q-Shape

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)

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

DATE OF APPLICATION:

18.02.2021

APPLICANT:

SOMATEX Medical Technologies GmbH Hohenzollerndamm 150/151 14199 Berlin Germany Tel: + 49 (0) 30 319 82 25 00 Fax: +49 (0) 30 319 82 25 99 E-Mail: info@somatex.com

CONTACT PERSON:

David Vasmer, PhD Regulatory Affairs Manager Tel.: +49 (0) 30 319 82 25-49 E-Mail: D.Vasmer@somatex.com

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

1 Device Name

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

Classification / Product Code 2

The subjected devices can be classified according to following device name and product code:

Device	RegulationDescription	RegulationMedicalSpecialty	Review Panel	Product Code	RegulationNumber	DeviceClassification
Marker,Radiographic,Implantable	Implantable clip	General & PlasticSurgery	General & PlasticSurgery	NEU	2	878.4300

3 Predicate Device / Reference Device

New Device	Predicate Device	Reference Device	510(k) Number	510(k) Holder
Tumark Vision	Tumark Professional	---	K073095	SOMATEX MedicalTechnologies GmbH
Tumark ProfessionalTumark QTumark Professional Q-Shape	---	Tumark Vision	K180443	SOMATEX MedicalTechnologies GmbH
	---	UltraCor Twirl BreastTissue Marker	K180061	Bard Peripheral Vascular, Inc.

4 Device Description

4.1 Tumark Vision

The Tumark" Vision is a sterile product for single use only and consists of a non-absorbable nickeltitanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the marker has a spherical shape. The symbol of the clip marker shape is depicted on the handle.

4.2 Tumark Professional

The Tumark® Professional is a sterile product for single use only and consists of a non-absorbable nickel-titanium clip marker, an introducer cannula, and a plastic handle. When new and unopened, the clip marker is contained within the cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore premature deployment of the marker. The clip marker has a U-shape. The symbol of the clip marker shape is depicted on the handle.

4.3 Tumark Q

The Tumark® Q is a sterile product for single use only and consists of a non-absorbable nickel-titanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the

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

cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The clip marker can be placed using one hand by pushing the slide button on the plastic handle forward once the fixing clip has been removed. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the clip marker. The clip marker has a Q-shape.

4.4 Tumark Professional Q Shape

The Tumark® Professional Q Shape is a sterile product for single use only and consists of a non-absorbable nickelttanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the clip markers for the Tumark® Professional are Q-shaped. The symbol of the clip marker shape is depicted on the handle.

5 Indication for Use

6 Duration of Use

The clip marker is a permanent implant (> 30 days).

7 Technological Characteristics

The technological characteristics of Tumark "Professional, Tumark" Q and Tumark" Professional Q-Shape are the same as the technological characteristics of the predicate device.

Company	SOMATEX MedicalTechnologies GmbH--Tumark Vision,Tumark ProfessionalTumark QTumark ProfessionalQ-Shape(New Device)	SOMATEX MedicalTechnologies GmbH--Tumark Professional(Predicate Device)	SOMATEX MedicalTechnologies GmbH--Tumark Vision(Reference Device)	Bard PeripheralVascular, Inc.--UltraCor Twirl BreastTissue Marker(Reference Device)	Result
Device Name	Tumark Vision,Tumark ProfessionalTumark QTumark ProfessionalQ-Shape	Tumark Professional	Tumark Vision	UltraCor Twirl BreastTissue Marker	---
RegulationNumber	878.4300	878.4300	878.4300	878.4300	SubstantiallyEquivalent
Class	2	2	2	2	SubstantiallyEquivalent
Code	NEU	NEU	NEU	NEU	SubstantiallyEquivalent
510(k) number	---	K073095	K180443	K180061	---
Company	SOMATEX MedicalTechnologies GmbH---Tumark Vision,Tumark ProfessionalTumark QTumark ProfessionalQ-Shape(New Device)	SOMATEX MedicalTechnologies GmbH---Tumark Professional(Predicate Device)	SOMATEX MedicalTechnologies GmbHTumark Vision(Reference Device)	Bard PeripheralVascular, Inc.UltraCor Twirl BreastTissue Marker(Reference Device)	Result
Indication for Use	The Tumark® Vision,the Tumark®Professional, theTumark® Q and theTumark® ProfessionalQ-Shape are intendedto attach a marker tosoft breast tissue andaxillary lymph nodes,following an open or apercutaneousprocedure toradiographically markthe location of thesurgical site. It is notindicated to be usedwith magneticresonance imaging(MRI) techniques.	The TumarkProfessional isintended to attach amarker to soft tissueat the surgical siteduring an open or apercutaneousprocedure. It isindicated for use toradiographically andradiologically mark thesurgical location inbreasts following anopen or percutaneousprocedure. It is notintended to be usedwith magneticresonance imaging(MRI) techniques.	The Tumark Vision isintended to attach amarker to soft tissueat the surgical siteduring an open or apercutaneousprocedure. It isindicated for use toradiographically andradiologically mark thesurgical location inbreasts following anopen or percutaneousprocedure. It is notintended to be usedwith magneticresonance imaging(MRI) techniques.	The UltraCor® Twirl®Breast Tissue Markeris intended for use toattach to soft breasttissue, includingaxillary lymph nodes,to radiographicallymark the location ofthe biopsy procedure.	SubstantiallyEquivalent
Design	Sterile, single use,preloaded tissue sitemarking systemsconsisting of a non-absorbable nickel-titanium marker, acannula and a plastichandheld applier withdeploymentmechanism.	Sterile, single use,preloaded tissue sitemarking systemsconsisting of a non-absorbable nickel-titanium marker, acannula and a plastichandheld applier withdeploymentmechanism.	Sterile, single use,preloaded tissue sitemarking systemsconsisting of a non-absorbable nickel-titanium marker, acannula and a plastichandheld applier withdeploymentmechanism.	Sterile, single use,preloaded tissue sitemarking systemsconsisting of a non-absorbable nickel-titanium marker, acannula and a plastichandheld applier withdeploymentmechanism.	SubstantiallyEquivalent
Marker Design	Sphere-shaped; U-shaped, Q-shaped	U-shaped	Sphere-shaped	Ring-shaped	SubstantiallyEquivalent
Marker Material	Nitinol	Nitinol	Nitinol	Nitinol	SubstantiallyEquivalent
Cannula Design	Sharp tip, markings onthe cannula andpuncture function	Sharp tip, markings onthe cannula andpuncture function	Sharp tip, markings onthe cannula andpuncture function	Sharp tip, markings onthe cannula andpuncture function	SubstantiallyEquivalent
Cannula length[mm]	70 / 100 / 120 / 150	70 / 100 / 120	100 / 120	100	SubstantiallyEquivalent
Gauge [G]	18	18	18	17	SubstantiallyEquivalent
Cannula Material	stainless steel	stainless steel	stainless steel	stainless steel	SubstantiallyEquivalent
Handle	One-handedapplication with safetyfunction to preventprematuredeployment of themarker	One-handedapplication with safetyfunction to preventprematuredeployment of themarker	One-handedapplication with safetyfunction to preventprematuredeployment of themarker	One-handedapplication with safetyfunction to preventprematuredeployment of themarker	SubstantiallyEquivalent
Handle Material	stainless steelplastic material	stainless steelplastic material	stainless steelplastic material	plastic material	SubstantiallyEquivalent

7.1 Device Characteristics Table

{6}------------------------------------------------

Summary of Technological Characteristics 7.2

The proposed devices are similar in terms of design, indication for use and have similar technological characteristics as the predicate device and reference devices. It can be stated, that Tumark Vision, Tumark Q

{7}------------------------------------------------

and Tumark Professional Q-Shape are considered substantially equivalent to the predicate device/reference devices.

8 Performance Data

To demonstrate that Tumark Vision, Tumark Q and Tumark Professional Q-Shape are as safe and effective as the predicate and reference devices, their technological characteristics and performance criteria were evaluated. The new devices were evaluated in vitro testing. Specific aspects included:

8.1 Biocompatibility

The components and manufacturing processes of the subjected devices are similar to the predicate device Tumark Professional (K073095) and the reference device Tumark Vision (K180443). The devices are made from standard materials. EO residual values are far below the acceptable limits. In addition, cytotoxicity testing and the toxicological review confirmed the absence of toxic leachables and contaminants. Therefore, the requirements of ISO 10993-1 are met and further testing is deemed not necessary.

8.2 Sterilization and Shelf Life

The devices are delivered in sterile state. All acceptance criteria are met during the sterility testing. Furthermore, the defined shelf-life could be proven based on packaging and device testing after real-time ageing. All defined acceptance criteria were met during shelf life testing.

8.3 Bench Testing

Bench testing was performed to validate the device design. Specific aspects include:

Aspect	Test Method	Results
Device Function	Confirm that the marker can be placed in thetarget area	U-, Q- and Vision markers could be deployed.The device performs as intended.All acceptance criteria are met.
Device Performance	Confirm that the clip marker and cannula arerecognized	Clip markers and cannulas are recognized inultrasound, mammography and MR imaging.All acceptance criteria are met.
Device Stability during transport	Drop tests	Devices were not damaged.All acceptance criteria are met.

All acceptance criteria were met during the bench testing. The devices perform as intended and are as safe and as effective as the predicate device.

8.4 Clinical Analysis

A literature review was performed to clinically support the use of the markers inside axillary lymph nodes. This literature review confirms the defined indication for use. Furthermore, physician statements were obtained to support the indication for use.

ਰੇ Substantial Equivalence Summary / Conclusion

Based on available 510(k) information herein provided, Tumark Professional, Tumark Q and Tumark Professional Q-Shape are considered substantially equivalent to the predicate devices in terms of intended use, technology and performance specifications. There are no differences between the devices which may raise new issues concerning safety or effectiveness.

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.