TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC

K111692 · Somatex Medical Technologies GmbH · NEU · Nov 8, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111692
• Device Name: TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
• Applicant: Somatex Medical Technologies GmbH
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Nov 8, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The TUMARK® Flex is intended for radiographically and radiologically percutaneous marking of soft tissue, especially breast tissue, via a clip marker. The TUMARK® Flex is not indicated to be used with magnetic resonance imaging (MRI) techniques.

Device Story

TUMARK® Flex is a sterile, single-use tissue site marking system. It consists of a non-absorbable Nitinol clip-marker, a guide wire or tube, and a handle with an ejection mechanism. The device is used by clinicians during percutaneous procedures to mark surgical locations in soft tissue, particularly the breast. The clinician uses the handle slider to release the clip marker from the distal ramp of the guide wire/tube into the target tissue. The marker is visible via ultrasound and stereotactic X-ray imaging, allowing healthcare providers to identify the site for follow-up or surgical planning. While the device itself is not indicated for use with MRI, the placed clip is compatible with magnetic fields up to 3.0 Tesla.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-absorbable Nitinol clip-marker; surgical high-grade steel distal ramp; flexible tube guide wire; handle with mechanical slider ejection; sterile, single-use. No electronic components or software.

Indications for Use

Indicated for percutaneous radiographic and radiological marking of soft tissue, specifically breast tissue, using a clip marker. 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 Tissue Site Marking System (K073095)
• TUMARK® Professional / MRI TUMARK® Professional Tissue Site Marking System (K093064)

Submission Summary (Full Text)

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NOV - 8 2011 K111692

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SOMATEX® Medical Technologies GmbH Rheinstrasse 7 d D-14513 Teltow / Germany

## Summary of Safety and Effectiveness

・.

## Titel: TUMARK® Flex

May 30 , 2011

| Submitter | SOMATEX®<br>Medical Technologies GMBH<br>Rheinstrasse 7 d<br>D-14513 Teltow<br>Germany<br>Frank Kniep<br>General Manager<br>Telefon: ++49 3328 / 30 76 0<br>FAX: ++49 3328 / 30 76 99<br>E-mail: [e-mail] |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application correspondent<br>(consultant) | Harald Jung<br>General Manager<br>JUNG Consulting<br>Unterer Winkel 3<br>D-78573 Wurmlingen<br>Germany<br>Telefon [phone]<br>FAX [phone]<br>E-mail: [e-mail] |
| Trade Name | TUMARK® Flex |
| Common Name | Tissue Site Marking System |
| Classification Name | Radiographic Implantable Marker,<br>21 C.F.R. 878.4300 |
| Regulatory Class: | II |
| Product Code : | NEU |
| Performance Standards | No performance standards have been<br>established under Section 514 of the Food, Drug<br>and Cosmetic Act for Tissue Site Marking<br>Systems. |

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SOMATEX® Medical Technologies GmbH Rheinstrasse 7 d D-14513 Teltow / Germany

#### Legally marketed (unmodified) device:

The predicate device is the TUMARK® Professional Tissue Site Marking System, [K073095, March 19, 2008] and the TUMARK® Professional / MRJ TUMARK® Professional Tissue Site Marking System, [K093064, February 17, 2010]

#### Device Description (new devices):

The TUMARK® Flex is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable Nitinol clip-marker, a guide wire or tube and a handle with ejection mechanism. The guide wire is composed of a flexible tube, a distal ramp made of surgical high-grade steel with an opening for releasing the clip marker and a depth stopper with snap-in tip. The guide tube is composed of a tube section, a distal ramp made of surgical steel with an opening for releasing the clip marker, and a marking line, which shows the orientation of the ejection port for the clip marker. The handle is provided with a slider by means of which the clip can be released. The clip marker is situated in the distal ramp. TUMARK® Flex can be used together with, e.g. ultrasound and stereotactic X-ray imaging procedures.

The TUMARK® Flex is not indicated to be used in Magnetic Resonance Tomography (MRT). However, the clip marker placed in the patient can be exposed to a magnetic field of up to 3.0 Tesla, for instance in follow-up examinations.

#### Indications for Use:

The TUMARK® Flex is intended for radiographically and radiologically percutaneous marking of soft tissue, especially breast tissue, via a clip marker.

The TUMARK® Flex is not indicated to be used with magnetic resonance imaging (MRI) techniques.

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Summary of Safety and Effectiveness

SOMATEX® Medical Technologies GmbH Rheinstrasse 7 d D-14513 Teltow / Germany

#### Comparison to cleared devices (Substantial Equivalence):

The TUMARK® Flex is substantial equivalent to the TUMARK® Professional and MRI TUMARK® Professional, also manufactured by Somatex® Medical Technologies GmbH that have been cleared by FDA (K093064 and K073095). The TUMARK® Flex and TUMARK® Professional and MRI TUMARK® Professional are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. All devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following a percutaneous procedure.

In addition, both the proposed devices and the predicate devices are identical or similar in technology, design and material. In particular, the proposed devices and the predicate devices consist of the same primary components and the component materials of the proposed devices and the predicate devices are substantially equivalent and/or standard materials for invasive medical techniques. The minor technological differences between the proposed device and the predicate devices raise no new questions of safety and effectiveness.

K111692

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and a wavy base.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

S9OMATEX® Medical Technologies GmbH % JUNG Consulting Mr. Harald Jung Unterer Winkel 3 Wurmlingen 78573 Germany

Re: K111692

Trade/Device Name: TUMARK® Flex Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: September 30, 2011 Received: October 17, 2011

Dear Mr. Jung:

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

NOV - 8 2011

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Page 2 - Mr. Harald Jung

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 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm far the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree mobile [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

R

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: TUMARK® Flex

Indications for Use:

The TUMARK® Flex is intended for radiographically and radiologically percutaneous marking of soft tissue, especially breast tissue, via a clip marker.

The TUMARK® Flex is not indicated to be used with magnetic resonance imaging (MRI) techniques.

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kune for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111692
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