(30 days)
Not Found
No
The description focuses on a physical tissue marker and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's stated intended use is to mark a surgical location for radiological follow-up, not to treat a disease or condition.
No
Explanation: The device is used to mark the surgical location for radiological follow-up and does not provide any diagnostic information itself. It is a marking system, not a system that diagnoses a condition.
No
The device description explicitly states it consists of a marker, introducer cannula, and plastic handle, which are physical hardware components.
Based on the provided information, the Tumark Vision is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Tumark Vision's Function: The Tumark Vision is a device that is implanted into the body to mark a surgical site. It is used during or after a surgical procedure to provide a physical marker for future imaging. It does not analyze or test any bodily fluids or tissues in vitro.
The description clearly states its purpose is to "attach a marker to soft tissue at the surgical site" and "radiologically mark the surgical location." This is an in-vivo (within the body) application, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The Tumark Vision is a sterile, sinqle use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handle. It 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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human figures, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below.
March 22, 2018
SOMATEX Medical Technologies GmbH Burkhard Jakob, M.D. Regulatory Affairs Manager Rheinstr. 7d Teltow, Brandenburg 14513 Germany
Re: K180443
Trade/Device Name: Tumark Vision Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: February 13, 2018 Received: February 20, 2018
Dear Dr. Jakob:
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
1
801); medical device 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Expiration Date: 06/30/2020
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180443
Device Name Tumark Vision
Indications for Use (Describe)
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 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.
| 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) |
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3
510(k) SUMMARY Tumark Vision
DATE PREPARED:
02.03.2018
APPLICANT:
SOMATEX Medical Technologies GmbH Rheinstr. 7d 14513 Teltow Germany Tel: +49 30 319 82 25 00 Fax: +49 30 319 82 25 99 E-Mail: info@somatex.com
CONTACT PERSON:
Dr. Burkhard Jakob Regulatory Affairs Manager Tel.: +49 30 319 82 25-51 E-Mail: B.Jakob@somatex.com
4
1 Device Name
Trade Name: Common Name: Device Classification Name: Tumark Vision Tissue Site Marking System Marker, Radiographic, Implantable
Classification / Product Code 2
The Tumark Vision 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 |
က Predicate Device / Reference Device
| Device | Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|---|
| Tumark Vision | Tumark Professional | K093064 | SOMATEX Medical |
| Technologies GmbH |
4 Device Description
The Tumark Vision is a sterile, sinqle use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handle. It 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.
5 Intended Use
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.
Technological Characteristics ર
| Description | SOMATEX Medical Technologies
Tumark Vision
(New Device) | SOMATEX Medical Technologies
Tumark Professional
(Predicate Device) |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 878.4300 | 878.4300 |
| Class | 2 | 2 |
| Product Code | NEU | NEU |
| Design | A sterile, single use, preloaded
tissue site marking system
consisting of a non-absorbable
nickel-titanium marker, an
introducer cannula and a plastic
handle | A sterile, single use, preloaded
tissue site marking system
consisting of a non-absorbable
nickel-titanium marker, an
introducer cannula and a plastic
handle |
5
| Description | SOMATEX Medical Technologies
Tumark Vision
(New Device) | SOMATEX Medical Technologies
Tumark Professional
(Predicate Device) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Marker | Sphere-shaped design which is
visible in ultrasound, mammography
and MRI | U-shaped or X-shaped visible in
ultrasound, mammography and MRI |
| Marker Material | Nitinol | Nitinol |
| Cannula Design | Sharp tip with ultrasound
enhancement on the distal end,
markings on the cannula and
puncture function | Sharp tip with ultrasound
enhancement on the distal end,
markings on the cannula and
puncture function |
| Cannula length [mm] | 100 / 120 | 100 / 120 |
| Cannula Diameter [mm] | 1.2 | 1.2 |
| Gauge [G] | 18 | 18 |
| Cannula Material | stainless steel | stainless steel |
| 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 |
| Handle Material | stainless steel and plastic | stainless steel and plastic |
| Sterilization Method | Ethylene oxide | Ethylene oxide |
7 Design Control Activities
A risk analysis was performed to identify new risk based on the device modification. Risks are mitigated as far as possible. All verification and validation activities identified as necessary were performed by designated individuals and results demonstrate that predetermined acceptance criteria were met. The manufacturing facility fulfills design procedure requirements.
Substantial Equivalence Summary / Conclusion 8
In summary, the proposed changes do not raise any new questions regarding safety and effectiveness of the Tumark Vision. The Tumark Vision is substantially equivalent to the predicate device Tumark Professional.