(140 days)
No
The description focuses on the mechanical components and materials of a tissue marker system, with no mention of AI or ML capabilities for image analysis, diagnosis, or any other function.
No.
The device is intended to mark a surgical site, not to treat a disease or condition.
No
This device is a marker intended to mark a surgical site for later radiographic and radiological identification, not to diagnose a condition itself.
No
The device description clearly outlines physical components such as a marker, introducer cannula, and a plastic handheld applier with a deployment mechanism. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tumark® Professional and MRI Tumark® Professional are devices used to physically mark a surgical site within the body. They are implanted into soft tissue.
- Intended Use: The intended use is to "attach a marker to soft tissue at the surgical site" and "radiographically and radiologically mark the surgical location." This is a procedural aid for imaging and future surgical planning, not a diagnostic test performed on a sample outside the body.
The device is an implantable medical device used for marking purposes during and after surgical procedures.
N/A
Intended Use / Indications for Use
The Tumark® Professional and MRI Tumark® Professional are intended to attach a marker to soft tissue at the surgical site during an open or a perculancous procedure.
The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. Only the MRI Tumark® Professional is indicated to be used in Magnetic Resonance Imaging (MRI) procedures.
Product codes
NEU
Device Description
The Tumark® Professional and MRI Tumark® Professional 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 Tumark® Professional is not indicated to be used in Magnetic Resonance Imaging (MRI) procedures. The MRI Tumark® Professional is MRI Safe and indicated to be used during MRI procedures. The introducer cannula which will be available in stainless steel (Tumark® Professional) or cobalt-chrome alloy (MRI Tumark® Professional) for use with magnetic resonance imaging techniques is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. The cannulas will be available in different lengths. The handle is equipped with a slide-button which allows for a one handed placement. A safety catch system prevents the slide-button from inadvertently moving forward and therefore prevents a premature deployment of the marker. The Tumark® Professional will be available with a U-shaped or X-shaped marker. The MRI Tumark® Professional will only be available with a U-shaped marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI), radiographically, radiologically, ultrasound
Anatomical Site
soft tissue, breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for SOMATEX MEDICAL TECHNOLOGIES GMBH. Above the logo is the text "K093064 Page 1/4" in handwritten font. The SOMATEX logo is in a bold, sans-serif font, with the registered trademark symbol next to the "X".
— MADE IN GERMANY
Rheinstraße 7d | D-14513 Teltow Tel +49 (0) 3328 30 76-0 | Fax +49 (0) 3328 30 76-99 info@somatex.com | www.somatex.com
FEB 1 7 2010
510(k) SUMMARY
Tumark® Professional / MRI Tumark® Professional
| Submitter: | Somatex Medical Technologies' GmbH
Rheinstrasse 7d
14513 Teltow
Germany
Phone: +49 3328 3076 13
Fax: +49 3328 3076 99 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official
Correspondent: | Susanne Raab
Regulatory Affairs Consultant
1480 Cambridge Street
Cambridge, MA 02139
Phone: 617 547 0628
Fax: 617 520 2136
e-mail: sbraab@comcast.net |
| Trade Name: | Tumark® Professional / MRI 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® Professional and MRI Tumark® Professional 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 Tumark® Professional is not |
Page 1 of 4
1
Image /page/1/Picture/0 description: The image shows the logo for SOMATEX MEDICAL TECHNOLOGIES GMBH. Above the logo is the text "K093064 Page 2/4". The logo is in black and white and is a simple design.
MADE IN GERMANY
Rheinstraße 7d | D-14513 Teltow Tel +49 (0) 3328 30 76-0 | Fax +49 (0) 3328 30 76-99 info@somatex.com | www.somatex.com
indicated to be used in Magnetic Resonance Imaging (MRI) procedures. The MRI Tumark® Professional is MRI Safe and indicated to be used during MRI procedures. The introducer cannula which will be available in stainless steel (Tumark® Professional) or cobalt-chrome alloy (MRI Tumark® Professional) for use with magnetic resonance imaging techniques is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. The cannulas will be available in different lengths. The handle is equipped with a slide-button which allows for a one handed placement. A safety catch system prevents the slide-button from inadvertently moving forward and therefore prevents a premature deployment of the marker. The Tumark® Professional will be available with a U-shaped or X-shaped marker. The MRI Tumark® Professional will only be available with a U-shaped marker.
The Tumark® Professional and MRI Tumark® Professional Intended Use: are intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure.
The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. Only the MRI Tumark® Professional is indicated to be used in Magnetic Resonance Imaging (MRI) procedures.
2
Image /page/2/Picture/0 description: The image shows the logo for SOMATEX MEDICAL TECHNOLOGIES GMBH. Above the logo is the text "K093064 Page 3/4". The logo is in black and white and is a simple design.
MADE IN GERMANY
Rheinstraße 7d | D-14513 Teltow Tel +49 (0) 3328 30 76-0 | Fax +49 (0) 3328 30 76-99 info@somatex.com | www.somatex.com
Substantial Equivalence:
The Tumark® Professional and MRI Tumark® Professional are substantial equivalent to the Tumark® Professional, also manufactured by Somatex Medical Technologies GmbH, that has been cleared by FDA on March 19, 2008 (K073095), the ClipLoc Soft Tissue marker, manufactured by MRI Devices Corporation (K033447) and the UltraClip Tissue Marker, manufactured by Inrad Inc. The Tumark® Professional and MRI Tumark® Professional and each of their predicate devices are intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. All devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or 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. Furthermore, biocompatibility, sterility and packaging testing of the proposed devices demonstrate the safety and effectiveness of the system.
3
Image /page/3/Picture/0 description: The image shows the logo for SOMATEX Medical Technologies GmbH. Above the logo is the text "K093064 Page 4/4". The SOMATEX logo is in a bold, sans-serif font, with the registered trademark symbol to the right of the X.
MADE IN GERMANY
Rheinstraße 7d | D-14513 Teltow Tel +49 (0) 3328 30 76-0 | Fax +49 (0) 3328:30 76-99 info@somatex.com | www.somatex.com
Based on the same intended use and the similiarities in technology, design and materials the Turnark® Professional and MRI Tumark® Professional are substantially equivalent to their predicate devices. The minor technological differences between the proposed devices and the predicate devices do not raise new questions of safety and effectiveness.
Date Prepared:
January 18, 2010
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 7 2010
Somatex Medical Technologies, GmbH % Ms. Susanne Raab 1480 Cambridge Street Cambridge Massachusetts 02139
Re: K093064
Trade/Device Name: Tumark® Professional/MRI Tumark® Professional Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: January 20, 2010 Received: January 25, 2010
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Susanne Raab
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 100-1050. 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/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notfication" (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 the fire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
incerely yours,
Peter Romano
Mark N. Melkerson Director . Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
Device Name: Tumark® Professional / MRI Tumark® Proféssional
Indications for Use:
The Tumark® Professional and MRI Tumark® Professional are intended to attach a marker to soft tissue at the surgical site during an open or a perculancous procedure.
The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. Only the MRI Tumark® Professional is indicated to be used in Magnetic Resonance Imaging (MRI) procedures.
Prescription Use X (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)
Daniel Kime for MXM
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093064
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