(227 days)
No
The 510(k) summary describes a mechanical device for marking tissue. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies. The performance studies focus on biocompatibility, sterilization, shelf life, and mechanical function.
No
The device is described as a marker to radiographically mark the location of a surgical site after an open or percutaneous procedure. It is used for localization, not for treating a disease or condition.
No
The device is intended to attach a marker to surgically mark the location of a site. It is not used to diagnose a condition or disease.
No
The device description explicitly states it consists of a physical clip marker, introducer cannula, and plastic handle, which are hardware components.
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 devices are designed to physically mark a location within the body (soft breast tissue and axillary lymph nodes) for later radiographic identification. They are implanted devices, not devices that analyze samples taken from the body.
- Intended Use: The intended use is to "radiographically mark the location of the surgical site," which is an in-vivo (within the living body) function, not an in-vitro (in glass/outside the living body) function.
The device is a surgical marker used during or after a procedure to help locate a specific area for future imaging or surgery. This falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Tumark® Vision, the Tumark® Professional, the Tumark® Professional Q-Shape are intended to attach a marker to soft breast tissue and axillary lymph nodes, following an open or a percutaneous procedure to radiographically mark the location of the surgical site. 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
Tumark Vision
The Tumark" Vision is a sterile product for single use only and consists of a non-absorbable nickeltitanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the marker has a spherical shape. The symbol of the clip marker shape is depicted on the handle.
Tumark Professional
The Tumark® Professional is a sterile product for single use only and consists of a non-absorbable nickel-titanium clip marker, an introducer cannula, and a plastic handle. When new and unopened, the clip marker is contained within the cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore premature deployment of the marker. The clip marker has a U-shape. The symbol of the clip marker shape is depicted on the handle.
Tumark Q
The Tumark® Q is a sterile product for single use only and consists of a non-absorbable nickel-titanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The clip marker can be placed using one hand by pushing the slide button on the plastic handle forward once the fixing clip has been removed. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the clip marker. The clip marker has a Q-shape.
Tumark Professional Q Shape
The Tumark® Professional Q Shape is a sterile product for single use only and consists of a non-absorbable nickelttanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the clip markers for the Tumark® Professional are Q-shaped. The symbol of the clip marker shape is depicted on the handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft breast tissue and axillary lymph nodes
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)
The new devices were evaluated in vitro testing. Specific aspects included:
Biocompatibility
The components and manufacturing processes of the subjected devices are similar to the predicate device Tumark Professional (K073095) and the reference device Tumark Vision (K180443). The devices are made from standard materials. EO residual values are far below the acceptable limits. In addition, cytotoxicity testing and the toxicological review confirmed the absence of toxic leachables and contaminants. Therefore, the requirements of ISO 10993-1 are met and further testing is deemed not necessary.
Sterilization and Shelf Life
The devices are delivered in sterile state. All acceptance criteria are met during the sterility testing. Furthermore, the defined shelf-life could be proven based on packaging and device testing after real-time ageing. All defined acceptance criteria were met during shelf life testing.
Bench Testing
Bench testing was performed to validate the device design.
Device Function: U-, Q- and Vision markers could be deployed. The device performs as intended. All acceptance criteria are met.
Device Performance: Clip markers and cannulas are recognized in ultrasound, mammography and MR imaging. All acceptance criteria are met.
Device Stability during transport: Devices were not damaged. All acceptance criteria are met.
Clinical Analysis
A literature review was performed to clinically support the use of the markers inside axillary lymph nodes. This literature review confirms the defined indication for use. Furthermore, physician statements were obtained to support the indication for use.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
February 18, 2021
SOMATEX Medical Technologies GmbH David Vasmer Regulatory Affairs Manager Hohenzollerndamm 150/151 Berlin, Berlin 14199 Germany
Re: K201863
Trade/Device Name: Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: July 3, 2020 Received: July 6, 2020
Dear Dr. Vasmer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201863
Device Name
Tumark Vision, Tumark Professional, Tumark Professional Q-Shape
Indications for Use (Describe)
The Tumark® Vision, the Tumark® Professional, the Tumark® Professional Q-Shape are intended to attach a marker to soft breast tissue and axillary lymph nodes, following an open or a percutaneous procedure to radiographically mark the location of the surgical site. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
DATE OF APPLICATION:
18.02.2021
APPLICANT:
SOMATEX Medical Technologies GmbH Hohenzollerndamm 150/151 14199 Berlin Germany Tel: + 49 (0) 30 319 82 25 00 Fax: +49 (0) 30 319 82 25 99 E-Mail: info@somatex.com
CONTACT PERSON:
David Vasmer, PhD Regulatory Affairs Manager Tel.: +49 (0) 30 319 82 25-49 E-Mail: D.Vasmer@somatex.com
4
1 Device Name
| Trade Name: | Tumark Vision |
|---|---|
| Tumark Professional | |
| Tumark Q | |
| Tumark Professional Q-Shape | |
| Common Name: | Tissue Site Marking System |
| Device Classification Name: | Marker, Radiographic, Implantable |
Classification / Product Code 2
The subjected devices can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review Panel | Product Code | Regulation
Number | Device
Classification |
|-----------------------------------------|---------------------------|------------------------------------|------------------------------|--------------|----------------------|--------------------------|
| Marker,
Radiographic,
Implantable | Implantable clip | General & Plastic
Surgery | General & Plastic
Surgery | NEU | 2 | 878.4300 |
3 Predicate Device / Reference Device
| New Device | Predicate Device | Reference Device | 510(k) Number | 510(k) Holder |
|---|---|---|---|---|
| Tumark Vision | Tumark Professional | --- | K073095 | SOMATEX Medical |
| Technologies GmbH | ||||
| Tumark Professional | ||||
| Tumark Q | ||||
| Tumark Professional Q-Shape | --- | Tumark Vision | K180443 | SOMATEX Medical |
| Technologies GmbH | ||||
| --- | UltraCor Twirl Breast | |||
| Tissue Marker | K180061 | Bard Peripheral Vascular, Inc. |
4 Device Description
4.1 Tumark Vision
The Tumark" Vision is a sterile product for single use only and consists of a non-absorbable nickeltitanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the marker has a spherical shape. The symbol of the clip marker shape is depicted on the handle.
4.2 Tumark Professional
The Tumark® Professional is a sterile product for single use only and consists of a non-absorbable nickel-titanium clip marker, an introducer cannula, and a plastic handle. When new and unopened, the clip marker is contained within the cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore premature deployment of the marker. The clip marker has a U-shape. The symbol of the clip marker shape is depicted on the handle.
4.3 Tumark Q
The Tumark® Q is a sterile product for single use only and consists of a non-absorbable nickel-titanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the
5
cannula. The cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The clip marker can be placed using one hand by pushing the slide button on the plastic handle forward once the fixing clip has been removed. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the clip marker. The clip marker has a Q-shape.
4.4 Tumark Professional Q Shape
The Tumark® Professional Q Shape is a sterile product for single use only and consists of a non-absorbable nickelttanium clip marker, an introducer cannula and a plastic handle. When new and unopened, the clip marker is contained within the cannula tip is bevelled to help insertion, has markings 1 cm apart for measuring the depth of penetration, and a textured surface behind the cannula tip. The handle is equipped with a slide button which allows one handed placement of the marker by pressing it forward. A safety catch system prevents the slide button from inadvertently moving forward and therefore prevents premature deployment of the clip markers for the Tumark® Professional are Q-shaped. The symbol of the clip marker shape is depicted on the handle.
5 Indication for Use
The Tumark® Vision, the Tumark® Professional, the Tumark® Professional Q-Shape are intended to attach a marker to soft breast tissue and axillary lymph nodes, following an open or a percutaneous procedure to radiographically mark the location of the surgical site. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.
6 Duration of Use
The clip marker is a permanent implant (> 30 days).
7 Technological Characteristics
The technological characteristics of Tumark "Professional, Tumark" Q and Tumark" Professional Q-Shape are the same as the technological characteristics of the predicate device.
| Company | SOMATEX Medical
Technologies GmbH
Tumark Vision,
Tumark Professional
Tumark Q
Tumark Professional
Q-Shape
(New Device) | SOMATEX Medical
Technologies GmbH
Tumark Professional
(Predicate Device) | SOMATEX Medical
Technologies GmbH
Tumark Vision
(Reference Device) | Bard Peripheral
Vascular, Inc.
UltraCor Twirl Breast
Tissue Marker
(Reference Device) | Result |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Tumark Vision,
Tumark Professional
Tumark Q
Tumark Professional
Q-Shape | Tumark Professional | Tumark Vision | UltraCor Twirl Breast
Tissue Marker | --- |
| Regulation
Number | 878.4300 | 878.4300 | 878.4300 | 878.4300 | Substantially
Equivalent |
| Class | 2 | 2 | 2 | 2 | Substantially
Equivalent |
| Code | NEU | NEU | NEU | NEU | Substantially
Equivalent |
| 510(k) number | --- | K073095 | K180443 | K180061 | --- |
| Company | SOMATEX Medical
Technologies GmbH
Tumark Vision,
Tumark Professional
Tumark Q
Tumark Professional
Q-Shape
(New Device) | SOMATEX Medical
Technologies GmbH
Tumark Professional
(Predicate Device) | SOMATEX Medical
Technologies GmbH
Tumark Vision
(Reference Device) | Bard Peripheral
Vascular, Inc.
UltraCor Twirl Breast
Tissue Marker
(Reference Device) | Result |
| Indication for Use | The Tumark® Vision,
the Tumark®
Professional, the
Tumark® Q and the
Tumark® Professional
Q-Shape are intended
to attach a marker to
soft breast tissue and
axillary lymph nodes,
following an open or a
percutaneous
procedure to
radiographically mark
the location of the
surgical site. It is not
indicated to be used
with magnetic
resonance imaging
(MRI) techniques. | 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
intended to be used
with magnetic
resonance imaging
(MRI) techniques. | The Tumark Vision 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
intended to be used
with magnetic
resonance imaging
(MRI) techniques. | The UltraCor® Twirl®
Breast Tissue Marker
is intended for use to
attach to soft breast
tissue, including
axillary lymph nodes,
to radiographically
mark the location of
the biopsy procedure. | Substantially
Equivalent |
| Design | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, a
cannula and a plastic
handheld applier with
deployment
mechanism. | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, a
cannula and a plastic
handheld applier with
deployment
mechanism. | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, a
cannula and a plastic
handheld applier with
deployment
mechanism. | Sterile, single use,
preloaded tissue site
marking systems
consisting of a non-
absorbable nickel-
titanium marker, a
cannula and a plastic
handheld applier with
deployment
mechanism. | Substantially
Equivalent |
| Marker Design | Sphere-shaped; U-
shaped, Q-shaped | U-shaped | Sphere-shaped | Ring-shaped | Substantially
Equivalent |
| Marker Material | Nitinol | Nitinol | Nitinol | Nitinol | Substantially
Equivalent |
| Cannula Design | Sharp tip, markings on
the cannula and
puncture function | Sharp tip, markings on
the cannula and
puncture function | Sharp tip, markings on
the cannula and
puncture function | Sharp tip, markings on
the cannula and
puncture function | Substantially
Equivalent |
| Cannula length
[mm] | 70 / 100 / 120 / 150 | 70 / 100 / 120 | 100 / 120 | 100 | Substantially
Equivalent |
| Gauge [G] | 18 | 18 | 18 | 17 | Substantially
Equivalent |
| Cannula Material | stainless steel | stainless steel | stainless steel | stainless steel | Substantially
Equivalent |
| Handle | One-handed
application with safety
function to prevent
premature
deployment of the
marker | One-handed
application with safety
function to prevent
premature
deployment of the
marker | One-handed
application with safety
function to prevent
premature
deployment of the
marker | One-handed
application with safety
function to prevent
premature
deployment of the
marker | Substantially
Equivalent |
| Handle Material | stainless steel
plastic material | stainless steel
plastic material | stainless steel
plastic material | plastic material | Substantially
Equivalent |
7.1 Device Characteristics Table
6
Summary of Technological Characteristics 7.2
The proposed devices are similar in terms of design, indication for use and have similar technological characteristics as the predicate device and reference devices. It can be stated, that Tumark Vision, Tumark Q
7
and Tumark Professional Q-Shape are considered substantially equivalent to the predicate device/reference devices.
8 Performance Data
To demonstrate that Tumark Vision, Tumark Q and Tumark Professional Q-Shape are as safe and effective as the predicate and reference devices, their technological characteristics and performance criteria were evaluated. The new devices were evaluated in vitro testing. Specific aspects included:
8.1 Biocompatibility
The components and manufacturing processes of the subjected devices are similar to the predicate device Tumark Professional (K073095) and the reference device Tumark Vision (K180443). The devices are made from standard materials. EO residual values are far below the acceptable limits. In addition, cytotoxicity testing and the toxicological review confirmed the absence of toxic leachables and contaminants. Therefore, the requirements of ISO 10993-1 are met and further testing is deemed not necessary.
8.2 Sterilization and Shelf Life
The devices are delivered in sterile state. All acceptance criteria are met during the sterility testing. Furthermore, the defined shelf-life could be proven based on packaging and device testing after real-time ageing. All defined acceptance criteria were met during shelf life testing.
8.3 Bench Testing
Bench testing was performed to validate the device design. Specific aspects include:
| Aspect | Test Method | Results |
|---|---|---|
| Device Function | Confirm that the marker can be placed in the | |
| target area | U-, Q- and Vision markers could be deployed. | |
| The device performs as intended. | ||
| All acceptance criteria are met. | ||
| Device Performance | Confirm that the clip marker and cannula are | |
| recognized | Clip markers and cannulas are recognized in | |
| ultrasound, mammography and MR imaging. | ||
| All acceptance criteria are met. | ||
| Device Stability during transport | Drop tests | Devices were not damaged. |
| All acceptance criteria are met. |
All acceptance criteria were met during the bench testing. The devices perform as intended and are as safe and as effective as the predicate device.
8.4 Clinical Analysis
A literature review was performed to clinically support the use of the markers inside axillary lymph nodes. This literature review confirms the defined indication for use. Furthermore, physician statements were obtained to support the indication for use.
ਰੇ Substantial Equivalence Summary / Conclusion
Based on available 510(k) information herein provided, Tumark Professional, Tumark Q and Tumark Professional Q-Shape are considered substantially equivalent to the predicate devices in terms of intended use, technology and performance specifications. There are no differences between the devices which may raise new issues concerning safety or effectiveness.