(493 days)
Not Found
No
The device description and performance studies focus on the physical properties and radiographic visibility of a tissue marker, with no mention of AI or ML for image analysis, diagnosis, or any other function.
No
The device is described as a tissue marker for radiographic marking of soft tissue, not for treating or preventing a disease or condition. Its purpose is to identify a location, not to provide therapy.
No
This device is a tissue marker used to radiographically mark soft tissue for future surgical procedures or during a surgical procedure, not to diagnose a condition or disease.
No
The device description clearly states it is a physical tissue marker consisting of a polymeric tube and a dessicated solution, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Breast-Med Tissue Marker is a physical marker placed into soft tissue during a surgical procedure. Its purpose is to be visible on imaging modalities to mark a location. It does not analyze or test a specimen taken from the body.
- Intended Use: The intended use is to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures." This is a procedural aid, not a diagnostic test performed on a sample.
The device is a surgical accessory used for localization, not for performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The Breast-Med Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The Breast-Med Tissue Marker is a sterile, nonpyrogenic, single use tissue marker consisting of a polymeric tube filled with a dessicated solution of sodium chloride with trace amounts of gadolinium chelate that is visible on standard radiographs (x-ray, mammography) as well as ultrasound and Magnetic Resonance Imaging (MRI). The tissue marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard radiographs (x-ray, mammography), ultrasound, Magnetic Resonance Imaging (MRI)
Anatomical Site
soft 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to verify that the subject device has equivalent radiographic visualization to the predicates under standard radiographs, ultrasound, and MRI in both tissue and phantom models. Safety testing of the device was performed utilizing the following standards: ASTM F2182, ASTM F2052, ASTM F2213 and ASTMF2119.
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.
BiomarC Tissue Marker, K032347, KDM-Mark1 Tissue Marker, K093473
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
Breast-Med Incorporated Dr. Michael Nelson President 1745 Bridgewater Road Golden Valley, MN 55422
Re: K133697
Trade/Device Name: Breast-Med Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: April 6, 2015 Received: April 8, 2015
Dear Dr. Nelson:
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K133697
Device Name Breast-Med Tissue Marker
Indications for Use (Describe)
The Breast-Med Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY - K133697
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Breast-Med Tissue Marker is provided below.
| Submitted by: | Breast-Med, Inc. |
|---|---|
| Contact Person: | Michael Nelson, M.D. |
| President | |
| Breast-Med, Inc. | |
| 1745 Bridgewater Road | |
| Golden Valley, MN 55422 | |
| Tel: 763-522-2121 | |
| Email: mtnelson@comcast.net | |
| Date of Summary: | April 10, 2015 |
| Device Trade Name: | Breast-Med Tissue Marker |
| 510(k) Number: | K133697 |
| Product Code: | NEU |
| Common or Usual Name: | Tissue Marker |
| Classification Name: | Implantable clip (21 CFR 878.4300) |
| Predicate Device(s): | BiomarC Tissue Marker, K032347 |
| KDM-Mark1 Tissue Marker, K093473 | |
| Device Description: | The Breast-Med Tissue Marker is a sterile, nonpyrogenic, single |
| use tissue marker consisting of a polymeric tube filled with a | |
| dessicated solution of sodium chloride with trace amounts of | |
| gadolinium chelate that is visible on standard radiographs (x- | |
| ray, mammography) as well as ultrasound and Magnetic | |
| Resonance Imaging (MRI). The tissue marker is placed into | |
| soft tissue during open, percutaneous, or endoscopic | |
| procedures to radiographically mark a surgical location. | |
| Indication for Use: | The Breast-Med Tissue Marker is indicated for use to |
| radiographically mark soft tissue during a surgical procedure or | |
| for future surgical procedures. |
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| Technological
Characteristics: | The technological characteristics of the Breast-Med Tissue
Marker are substantially equivalent to those of the predicates in
terms of the following:
Intended use Indications for use Target population Fundamental scientific technology Patient-contacting materials Method of delivery |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing
Summary: | Bench testing was performed to verify that the subject device
has equivalent radiographic visualization to the predicates under
standard radiographs, ultrasound, and MRI in both tissue and
phantom models.
Safety testing of the device was performed utilizing the following
standards: ASTM F2182, ASTM F2052, ASTM F2213 and
ASTMF2119. |
| Conclusion: | The Breast-Med Tissue Marker is substantially equivalent to the
named predicates based on technological comparison,
indications for use, and laboratory and other safety testing. It is
concluded that there are no new questions of safety and
effectiveness. |