(145 days)
No
The device description focuses on the mechanical components and materials of a tissue marking system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device's purpose is to mark tissue for imaging, not to treat a disease or condition.
No
The TUMARK® Flex is a tissue site marking system used to place a clip marker in soft tissue for subsequent identification, rather than to diagnose a condition itself.
No
The device description clearly outlines physical components such as a clip-marker, guide wire/tube, and handle with ejection mechanism, indicating it is a hardware device.
Based on the provided information, the TUMARK® Flex is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- TUMARK® Flex Function: The TUMARK® Flex is a device used to mark soft tissue within the body. It is a percutaneous marking system used during imaging procedures (radiography, radiology, ultrasound, stereotactic X-ray) to identify a specific location. It does not analyze or test any bodily fluids or tissues in vitro.
The device's purpose is to facilitate the identification of a tissue site for future reference, not to perform a diagnostic test on a sample.
N/A
Intended Use / 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.
Product codes
NEU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound and stereotactic X-ray imaging procedures.
Anatomical Site
soft tissue, especially breast tissue
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
Not Found
Key Metrics
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.
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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®
Medical Technologies GMBH
Rheinstrasse 7 d
D-14513 Teltow
Germany
Frank Kniep
General Manager
Telefon: ++49 3328 / 30 76 0
FAX: ++49 3328 / 30 76 99
E-mail: info@somatex.com |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application correspondent
(consultant) | Harald Jung
General Manager
JUNG Consulting
Unterer Winkel 3
D-78573 Wurmlingen
Germany
Telefon +49 7461-96 92 36
FAX +49 7461-96 92 37
E-mail: hjung@harald-jung.de |
| Trade Name | TUMARK® Flex |
| Common Name | Tissue Site Marking System |
| Classification Name | Radiographic Implantable Marker,
21 C.F.R. 878.4300 |
| Regulatory Class: | II |
| Product Code : | NEU |
| Performance Standards | No performance standards have been
established under Section 514 of the Food, Drug
and Cosmetic Act for Tissue Site Marking
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.
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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 (800) 638-2041 or (301) 796-7100 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
5
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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