(139 days)
Not Found
No
The 510(k) summary describes a mechanical tissue marker and delivery system with no mention of software, algorithms, or any features that would suggest the use of AI or ML.
No
The device is described as a "tissue site marking system" used to attach a marker to soft tissue for radiological marking, not for treating a condition or disease.
No
The device is described as a marker intended to mark the surgical location in breasts for future radiographic and radiologic imaging. It does not perform any diagnostic analysis itself.
No
The device description clearly outlines physical components such as a marker, introducer cannula, and a plastic handheld applier, indicating it is a hardware device, not software-only.
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 outside of the body (in vitro) to provide information about a person's health.
- Tumark® Professional Function: The Tumark® Professional is a device used to mark a surgical site within the body (in vivo). It is a physical marker placed in soft tissue.
- Intended Use: The intended use clearly states it's for attaching a marker to soft tissue at the surgical site during a procedure. This is an interventional procedure, not a diagnostic test performed on a sample.
Therefore, the Tumark® Professional falls under the category of a surgical or interventional device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The Tumark® is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism. The introducer cannula which consists of stainless steel is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KU73095 ソン
MAR 1 9 2008
510(k) SUMMARY
Tumark Professional
| Submitter: | Somatex Medical Technolgies 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 |
| 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
marking system consisting of a non-absorbable nickel-
titanium marker, an introducer cannula and a plastic
handheld applier with deployment mechanism. The
introducer cannula which consists of stainless steel is
designed with 1 cm depth marks, a beveled tip and an
ultrasound enhancement on the distal end. 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. |
| 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. |
| Substantial
Equivalence: | The Tumark Professional is substantial equivalent to the
ClipLoc Soft Tissue marker (the "ClipLoc") manufactured
by MRI Devices Corporation (K033447) and the UltraClip
Tissue Marker (the "UltraClip") manufactured by Inrad Inc.
The Tumark and each of its predicate devices are intended to
attach a marker to soft tissue at the surgical site during an
open or a percutaneous procedure. All three 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 Tumark Professional and the predicate
devices are similar in technology, design and material. Both
the Tumark Professional and the predicate devices consist of
the same primary components and the component materials
of the proposed device and the predicate devices are
substantially equivalent. |
| | Based on the same intended Use and the similarities in
technolgy, design and materials the Tumark Professional is
substantially equivalent to its predicate devices. The minor
technological differences between the proposed device and
the predicate devices do not raise new questions of safety
and effectiveness. |
| Date Prepared: | February 19, 2008 |
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Image /page/2/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 three stripes extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
3
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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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