(140 days)
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 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.
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.
This document is a 510(k) Summary for the Tumark® Professional / MRI Tumark® Professional tissue site marking systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study proving performance against specific acceptance criteria.
Therefore, many of the requested fields related to a comparative effectiveness study, standalone algorithm performance, or ground truth establishment for a test set, cannot be found in this document.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for device performance in the way an AI/ML device study would. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, focusing on:
- Intended Use: Identical or similar
- Technology, Design, and Material: Identical or similar
- Biocompatibility, Sterility, and Packaging: Demonstrated safety and effectiveness through testing.
Since no specific performance metrics are provided, a "Reported Device Performance" column cannot be filled with quantitative data from this document.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use: Attach a marker to soft tissue at the surgical site during an open or percutaneous procedure, to radiographically and radiologically mark the surgical location in breasts. (MRI Tumark® Professional also for MRI procedures). | The Tumark® Professional and MRI Tumark® Professional's intended use is identical or similar to their predicate devices. |
| Technology, Design & Material: Similar primary components and component materials. | The proposed devices and predicate devices are identical or similar in technology, design, and material, with substantially equivalent component materials. Minor technological differences do not raise new questions of safety and effectiveness. |
| Biocompatibility: Safe for use in the human body. | Biocompatibility testing of the proposed devices demonstrates safety and effectiveness of the system. |
| Sterility: Sterilized for single-use. | Sterility testing of the proposed devices demonstrates safety and effectiveness of the system. |
| Packaging: Maintains sterility and protects the device. | Packaging testing of the proposed devices demonstrates safety and effectiveness of the system. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical performance study with a test set of data. The document mentions tests for biocompatibility, sterility, and packaging but does not detail sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth is described in this document.
4. Adjudication method for the test set
Not applicable. No test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical device (tissue marker), not an AI/ML software. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an AI/ML study. For the device itself, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, and regulatory standards for medical devices (e.g., ISO standards for biocompatibility and sterility) and comparison to predicate devices that have already been considered safe and effective.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
In summary: This document is a 510(k) summary for a medical device (tissue marker) seeking clearance based on substantial equivalence to existing devices. It does not contain information related to software performance studies, AI/ML algorithms, or clinical trial data with acceptance criteria for such, but rather addresses the physical and functional characteristics of the device itself.
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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' GmbHRheinstrasse 7d14513 TeltowGermanyPhone: +49 3328 3076 13Fax: +49 3328 3076 99 |
|---|---|
| OfficialCorrespondent: | Susanne RaabRegulatory Affairs Consultant1480 Cambridge StreetCambridge, MA 02139Phone: 617 547 0628Fax: 617 520 2136e-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 aresterile, single use, preloaded tissue site marking systemsconsisting of a non-absorbable nickel-titanium marker, anintroducer cannula and a plastic handheld applier withdeployment mechanism. The Tumark® Professional is not |
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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.
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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.
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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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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
Page 1 of 1
§ 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.