TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560

K073095 · Somatex Medical Technologies GmbH · NEU · Mar 19, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073095
• Device Name: TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
• Applicant: Somatex Medical Technologies GmbH
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

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 indicated to be used with magnetic resonance imaging (MRI) techniques.

Device Story

Tumark Professional is a sterile, single-use tissue site marking system; consists of non-absorbable nickel-titanium marker, stainless steel introducer cannula, and plastic handheld applier. Cannula features 1 cm depth marks, beveled tip, and ultrasound enhancement at distal end. Handle includes slide-button for one-handed placement and safety catch to prevent premature deployment. Used in clinical settings by physicians during open or percutaneous breast procedures. Device enables radiographic and radiological localization of surgical sites; assists healthcare providers in identifying tissue locations for follow-up or subsequent procedures. Benefits patient by providing permanent, visible marker for post-surgical monitoring.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics, design, and material comparisons to predicate devices.

Technological Characteristics

Non-absorbable nickel-titanium marker; stainless steel introducer cannula with 1 cm depth markings and ultrasound-enhanced distal tip; plastic handheld applier with mechanical slide-button deployment and safety catch. Sterile, single-use device.

Indications for Use

Indicated for patients undergoing open or percutaneous breast procedures requiring radiographic/radiological marking of the surgical site. Contraindicated 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

• ClipLoc Soft Tissue marker (K033447)
• UltraClip Tissue Marker

Submission Summary (Full Text)

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KU73095 ソン

MAR 1 9 2008

## 510(k) SUMMARY

## Tumark Professional

| Submitter: | Somatex Medical Technolgies GmbH<br>Rheinstrasse 7d<br>14513 Teltow<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official<br>Correspondent: | Susanne Raab<br>Regulatory Affairs Consultant<br>1480 Cambridge Street<br>Cambridge, MA 02139<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Trade Name: | Tumark Professional |
| Common Name: | Tissue Site Marking System |
| Classification Name: | Radiographic Implantable Marker, 21 C.F.R. 878.4300 |
| Regulatory Class: | II |
| Product Code: | NEU |
| Device Description: | The Tumark® is a sterile, single use, preloaded tissue site<br>marking system consisting of a non-absorbable nickel-<br>titanium marker, an introducer cannula and a plastic<br>handheld applier with deployment mechanism. The<br>introducer cannula which consists of stainless steel is<br>designed with 1 cm depth marks, a beveled tip and an<br>ultrasound enhancement on the distal end. The handle is<br>equipped with a slide-button which allows for a one handed<br>placement. A safety catch system prevents the slide-button |
| | from inadvertently moving forward and therefore prevents a<br>premature deployment of the marker. |
| Intended Use: | The Tumark® Professional is intended to attach a marker to<br>soft tissue at the surgical site during an open or a<br>percutaneous procedure. It is indicated for use to<br>radiographically and radiologically mark the surgical<br>location in breasts following an open or percutaneous<br>procedure. It is not indicated to be used with magnetic<br>resonance imaging (MRI) techniques. |
| Substantial<br>Equivalence: | The Tumark Professional is substantial equivalent to the<br>ClipLoc Soft Tissue marker (the "ClipLoc") manufactured<br>by MRI Devices Corporation (K033447) and the UltraClip<br>Tissue Marker (the "UltraClip") manufactured by Inrad Inc.<br>The Tumark and each of its predicate devices are intended to<br>attach a marker to soft tissue at the surgical site during an<br>open or a percutaneous procedure. All three devices are<br>indicated for use to radiographically and radiologically mark<br>the surgical location in breasts following an open or<br>percutaneous procedure. |
| | In addition, both the Tumark Professional and the predicate<br>devices are similar in technology, design and material. Both<br>the Tumark Professional and the predicate devices consist of<br>the same primary components and the component materials<br>of the proposed device and the predicate devices are<br>substantially equivalent. |
| | Based on the same intended Use and the similarities in<br>technolgy, design and materials the Tumark Professional is<br>substantially equivalent to its predicate devices. The minor<br>technological differences between the proposed device and<br>the predicate devices do not raise new questions of safety<br>and effectiveness. |
| Date Prepared: | February 19, 2008 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2008

Somatex Medical Technologies GmbH % Ms. Susanne Raab 1480 Cambridge Street Cambridge, Massachusetts 02139

Re: K073095

Trade/Device Name: Tumark Professional Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 23, 2008 Received: February 27, 2008

Dear Ms. Raab:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.

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Page 2 - Ms. Susanne Raab

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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

Enclosure

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## Indication for Use

510(k) Number (if known): K073095

Device Name: Tumark Professional

Indications for Use:

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 indicated to be used with magnetic resonance imaging (MRI) techniques.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Sanita
Vision Sign-Co.

ision of General, Kestorative and Neurological Devices

510(k) Mr.

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