Tumark Vision

K180443 · Somatex Medical Technologies GmbH · NEU · Mar 22, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180443
• Device Name: Tumark Vision
• Applicant: Somatex Medical Technologies GmbH
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Mar 22, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

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.

Device Story

Tumark Vision is a sterile, single-use, preloaded tissue site marking system; consists of a non-absorbable nickel-titanium (Nitinol) sphere-shaped marker, introducer cannula, and plastic handle. Used in clinical settings by physicians during open or percutaneous breast procedures to mark surgical locations. The device is manually operated; the physician uses the cannula to place the marker into soft tissue. The marker provides radiologic visibility for post-procedure localization. The system features a one-handed application mechanism with a safety lock to prevent premature deployment. The device is not MRI compatible. Benefits include precise identification of surgical sites for follow-up imaging.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to confirm that the device met predetermined acceptance criteria following the design modification.

Technological Characteristics

Materials: Nitinol (marker), stainless steel (cannula), plastic/stainless steel (handle). Design: 18G, 1.2mm diameter, 100/120mm length cannula with ultrasound-enhanced distal tip. Sterilization: Ethylene oxide. Operation: Manual, one-handed deployment with safety lock. Connectivity: None.

Indications for Use

Indicated for patients undergoing open or percutaneous breast procedures requiring radiological marking of the surgical site. Not for use with MRI.

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)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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)

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) SUMMARY Tumark Vision

DATE PREPARED:

02.03.2018

### APPLICANT:

SOMATEX Medical Technologies GmbH Rheinstr. 7d 14513 Teltow Germany Tel: [phone] Fax: [phone] E-Mail: [e-mail]

# CONTACT PERSON:

Dr. Burkhard Jakob Regulatory Affairs Manager Tel.: [phone] E-Mail: [e-mail]

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#### 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 | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review<br>Panel | Product<br>Code | Regulation<br>Number | Device<br>Classification |
|-----------------------------------------|---------------------------|------------------------------------|---------------------------------|-----------------|----------------------|--------------------------|
| Marker,<br>Radiographic,<br>Implantable | Implantable<br>clip | General &<br>Plastic<br>Surgery | General &<br>Plastic<br>Surgery | NEU | 2 | 878.4300 |

#### က Predicate Device / Reference Device

| Device | Predicate Device | 510(k) Number | 510(k) Holder |
|---------------|---------------------|---------------|--------------------------------------|
| Tumark Vision | Tumark Professional | K093064 | SOMATEX Medical<br>Technologies GmbH |

#### 4 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.

#### 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<br>---<br>Tumark Vision<br>(New Device) | SOMATEX Medical Technologies<br>---<br>Tumark Professional<br>(Predicate Device) |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 878.4300 | 878.4300 |
| Class | 2 | 2 |
| Product Code | NEU | NEU |
| Design | A sterile, single use, preloaded<br>tissue site marking system<br>consisting of a non-absorbable<br>nickel-titanium marker, an<br>introducer cannula and a plastic<br>handle | A sterile, single use, preloaded<br>tissue site marking system<br>consisting of a non-absorbable<br>nickel-titanium marker, an<br>introducer cannula and a plastic<br>handle |

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| Description | SOMATEX Medical Technologies<br>Tumark Vision<br>(New Device) | SOMATEX Medical Technologies<br>Tumark Professional<br>(Predicate Device) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Marker | Sphere-shaped design which is<br>visible in ultrasound, mammography<br>and MRI | U-shaped or X-shaped visible in<br>ultrasound, mammography and MRI |
| Marker Material | Nitinol | Nitinol |
| Cannula Design | Sharp tip with ultrasound<br>enhancement on the distal end,<br>markings on the cannula and<br>puncture function | Sharp tip with ultrasound<br>enhancement on the distal end,<br>markings on the cannula and<br>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<br>function to prevent premature<br>deployment of the marker | One-handed application with safety<br>function to prevent premature<br>deployment 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.