Who is the manufacturer of Tumark for Eviva, Tumark for Brevera?

Somatex Medical Technologies GmbH filed the 510(k) submission for Tumark for Eviva, Tumark for Brevera (K182082).

What is the FDA product code for Tumark for Eviva, Tumark for Brevera?

NEU. It is classified under 21 CFR 878.4300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Tumark for Eviva, Tumark for Brevera?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Tumark for Eviva, Tumark for Brevera?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Tumark for Eviva, Tumark for Brevera

K182082 · Somatex Medical Technologies GmbH · NEU · Oct 31, 2018 · General, Plastic Surgery

Device Facts

Record ID	K182082
Device Name	Tumark for Eviva, Tumark for Brevera
Applicant	Somatex Medical Technologies GmbH
Product Code	NEU · General, Plastic Surgery
Decision Date	Oct 31, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2

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

Device Story

Sterile, single-use tissue site marking system; consists of non-absorbable nickel-titanium (Nitinol) marker, introducer cannula, and handheld plastic applier with deployment mechanism. Used in clinical settings by physicians following percutaneous breast biopsy/procedure. Physician inserts blunt-tip cannula into biopsy site; uses slide-button on handle to deploy marker. Safety catch prevents premature deployment. Marker provides radiographic/radiological visibility for future surgical localization. Benefits include accurate identification of biopsy site for subsequent clinical decision-making or surgical intervention.

Clinical Evidence

Bench testing only. Evaluated biocompatibility (ISO 10993-1), sterility (ISO 11737), shelf-life, and mechanical functionality (cannula integrity, deployment accuracy, protection tube function). Testing confirmed markers were successfully deployed in breast phantoms and device performance met all acceptance criteria.

Technological Characteristics

Materials: Nitinol (marker), stainless steel (cannula), plastic (handle). Design: Preloaded, single-use, handheld applier with slide-button deployment and safety catch. Cannula: 1.2mm diameter, 18G, blunt tip. Sterilization: Ethylene oxide. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients undergoing percutaneous breast procedures requiring radiographic/radiological marking of the surgical site. Not indicated for use with MRI techniques.

Regulatory Classification

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 (K093064)

Reference Devices

Tumark Vision (K180443)

Related Devices

K073095 — TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 · Somatex Medical Technologies GmbH · Mar 19, 2008
K093064 — TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 · Somatex Medical Technologies GmbH · Feb 17, 2010
K102608 — SECURMARK BIOPSY SITE MARKING SYSTEM · Suros Surgical Systems, Inc. A Hologic Company · Oct 8, 2010
K240429 — Trilogy Tissue Marker · Inrad, Inc. · Nov 7, 2024
K180443 — Tumark Vision · Somatex Medical Technologies GmbH · Mar 22, 2018

Submission Summary (Full Text)

{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) 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) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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 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.