← Product Code [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU) · K201863 # Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape (K201863) _Somatex Medical Technologies GmbH · NEU · Feb 18, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K201863 ## Device Facts - **Applicant:** Somatex Medical Technologies GmbH - **Product Code:** [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU.md) - **Decision Date:** Feb 18, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use 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 Story Tumark Vision, Professional, Q, and Professional Q-Shape are sterile, single-use tissue site marking systems. Each consists of a non-absorbable nickel-titanium (Nitinol) clip marker preloaded in a stainless steel introducer cannula with a plastic handle. The device is used by physicians in clinical settings to mark surgical sites in breast tissue or axillary lymph nodes. The operator uses a one-handed slide button mechanism on the handle to deploy the marker from the cannula into the target tissue. A safety catch prevents premature deployment. The cannula features a bevelled tip and depth markings. Once implanted, the marker provides a permanent radiographic reference point for the surgical site, aiding in follow-up imaging and clinical decision-making. The device is not MRI-compatible. ## Clinical Evidence No clinical trials were conducted. Evidence consists of bench testing (device function, performance, and stability) and a literature review supporting the use of markers in axillary lymph nodes. Physician statements were also provided to support the indication for use. ## Technological Characteristics Sterile, single-use, preloaded marking system. Marker: Nitinol. Cannula: Stainless steel, 18G, lengths 70-150mm. Handle: Plastic with one-handed deployment mechanism and safety catch. Biocompatibility per ISO 10993-1. Sterilization: EO. Non-MRI compatible. ## Regulatory Identification An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - Tumark Professional ([K073095](/device/K073095.md)) ## Reference Devices - Tumark Vision ([K180443](/device/K180443.md)) - UltraCor Twirl Breast Tissue Marker ([K180061](/device/K180061.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) 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. | 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 | 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 | 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 Medical
Technologies GmbH | | Tumark Professional
Tumark Q
Tumark Professional Q-Shape | --- | Tumark Vision | K180443 | SOMATEX Medical
Technologies GmbH | | | --- | UltraCor Twirl Breast
Tissue 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 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. #### 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 Medical
Technologies GmbH
--
Tumark Vision,
Tumark Professional
Tumark Q
Tumark Professional
Q-Shape
(New Device) | SOMATEX Medical
Technologies GmbH
--
Tumark Professional
(Predicate Device) | SOMATEX Medical
Technologies GmbH
--
Tumark Vision
(Reference Device) | Bard Peripheral
Vascular, Inc.
--
UltraCor Twirl Breast
Tissue Marker
(Reference Device) | Result | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Device Name | Tumark Vision,
Tumark Professional
Tumark Q
Tumark Professional
Q-Shape | Tumark Professional | Tumark Vision | UltraCor Twirl Breast
Tissue Marker | --- | | Regulation
Number | 878.4300 | 878.4300 | 878.4300 | 878.4300 | Substantially
Equivalent | | Class | 2 | 2 | 2 | 2 | Substantially
Equivalent | | Code | NEU | NEU | NEU | NEU | Substantially
Equivalent | | 510(k) number | --- | K073095 | K180443 | K180061 | --- | | Company | SOMATEX Medical
Technologies GmbH
---
Tumark Vision,
Tumark Professional
Tumark Q
Tumark Professional
Q-Shape
(New Device) | SOMATEX Medical
Technologies GmbH
---
Tumark Professional
(Predicate Device) | SOMATEX Medical
Technologies GmbH
Tumark Vision
(Reference Device) | Bard Peripheral
Vascular, Inc.
UltraCor Twirl Breast
Tissue Marker
(Reference Device) | Result | | Indication for Use | The Tumark® Vision,
the Tumark®
Professional, the
Tumark® Q and 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. | The Tumark
Professional 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. | 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. | The UltraCor® Twirl®
Breast Tissue Marker
is intended for use to
attach to soft breast
tissue, including
axillary lymph nodes,
to radiographically
mark the location of
the biopsy procedure. | Substantially
Equivalent | | Design | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, a
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, a
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, a
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, a
cannula and a plastic
handheld applier with
deployment
mechanism. | Substantially
Equivalent | | Marker Design | Sphere-shaped; U-
shaped, Q-shaped | U-shaped | Sphere-shaped | Ring-shaped | Substantially
Equivalent | | Marker Material | Nitinol | Nitinol | Nitinol | Nitinol | Substantially
Equivalent | | Cannula Design | Sharp tip, markings on
the cannula and
puncture function | Sharp tip, markings on
the cannula and
puncture function | Sharp tip, markings on
the cannula and
puncture function | Sharp tip, markings on
the cannula and
puncture function | Substantially
Equivalent | | Cannula length
[mm] | 70 / 100 / 120 / 150 | 70 / 100 / 120 | 100 / 120 | 100 | Substantially
Equivalent | | Gauge [G] | 18 | 18 | 18 | 17 | Substantially
Equivalent | | Cannula Material | stainless steel | stainless steel | stainless steel | stainless steel | Substantially
Equivalent | | 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 | One-handed
application with safety
function to prevent
premature
deployment of the
marker | Substantially
Equivalent | | Handle Material | stainless steel
plastic material | stainless steel
plastic material | stainless steel
plastic material | plastic material | Substantially
Equivalent | #### 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 the
target 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 are
recognized | Clip markers and cannulas are recognized in
ultrasound, 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K201863](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K201863) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com