(22 days)
No
The device description focuses on the physical components and materials of a tissue marker, and there is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are non-clinical tests related to the physical deployment and integrity of the marker.
No
The device is described as a marker for breast tissue during a biopsy procedure, which is a diagnostic and marking function, not a therapeutic one.
No
The device is a tissue marker used during a biopsy procedure, not to diagnose a condition. It helps mark a specific area of tissue for later identification, but it doesn't provide information about the presence or absence of a disease.
No
The device description clearly states it is comprised of a disposable applicator and an implantable marker, which are physical components, not software.
Based on the provided information, the SenoMark® Ultra Breast Tissue Marker is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure." This describes a device used in vivo (within the body) to mark a location for future imaging or procedures.
- Device Description: The description details an implantable marker and an applicator. This is consistent with a device used to be placed inside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. They typically involve reagents, assays, or instruments for analyzing biological samples like blood, urine, or tissue. The SenoMark® Ultra does not perform any such analysis.
Therefore, the SenoMark® Ultra Breast Tissue Marker is a medical device used in vivo for marking tissue, not an IVD.
N/A
Intended Use / Indications for Use
The SenoMark® Ultra Breast Tissue Marker is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The SenoMark® Ultra Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains three PGA pads which are visible via ultrasound imaging for approximately 3 weeks and are essentially resorbed by the body after approximately 12 weeks. The center PGA pad contains a metallic wireform interwoven with a PVA polymer. The non-resorbable PVA polymer enhances viewing under ultrasound. The wireform is made of Titanium or BioDur™ 108 in a ribbon or coil shape respectively. The wireform is visible radiographically on a permanent basis. The SenoMark® Ultra Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging, radiographically
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:
- Visual Inspection of Product for Pre-Deployment
- Inversion Test
- Deployment Force
- Read and Understand the IFU
The results demonstrate that the technological characteristics and performance criteria of the SenoMark® Ultra Breast Tissue Marker is comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
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.
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K123911 page 1/3.
Page 24 of 106
Special 510(k): Device Modification SenoMark® Ultra Breast Tissue Marker
510(k) Summary 21 CFR 807.92
JAN 1 0 2013
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based is as follows:
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|---------------------------------------------------------------------------------|
| Phone: | 480-638-2954 |
| Fax: | 480-449-2546 |
| Contact: | Sarah McCartney, Regulatory Affairs Associate |
| Date: | December 18, 2012 |
2. Subject Device:
| Device Trade Name: | SenoMark® Ultra Breast Tissue Marker |
|---|---|
| Common or Usual Name: | Tissue Marker |
| Classification: | Class II |
| Classification Name: | Marker, Radiographic, Implantable ( Product Code NEU) |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4300 (Implantable Clip) |
3. Predicate Device:
SenoMark® Breast Tissue Marker (K050090; cleared February 7, 2005)
4. Summary of Change:
A line extension to provide permanent ultrasound visibility and two unique shapes for use with each VAB probe.
5. Device Description:
The SenoMark® Ultra Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains three PGA pads which are visible via ultrasound imaging for approximately 3 weeks and are
Image /page/0/Picture/17 description: The image shows the word "BARD" in a stylized, bold font. The letters are outlined in black, giving them a distinct and modern appearance. The font choice is geometric, with sharp angles and clean lines, contributing to the overall visual impact of the word.
1
K123911 page 2/3
Special 510(k): Device Modificat SenoMark® Ultra Breast Tissue Marker
essentially resorbed by the body after approximately 12 weeks. The center PGA pad contains a metallic wireform interwoven with a PVA polymer. The non-resorbable PVA polymer enhances viewing under ultrasound. The wireform is made of Titanium or BioDur™ 108 in a ribbon or coil shape respectively. The wireform is visible radiographically on a permanent basis. The SenoMark® Ultra Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
6. Indications for Use of Device:
The SenoMark® Ultra Breast Tissue Marker is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.
7. Technological Comparison to Predicate Devices:
The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following:
- . Intended use
- Indications for use .
- Target population .
- Fundamental scientific technology .
- Operating principle .
- Resorbable implant design and materials .
- Packaging materials and configuration .
- Sterility .
The subject device is a modification of the predicate device the wireform in the center PGA pad with the wireform with PVA used in the referenced BPV devices (K042341 and K090547). The subject device and the predicate device are different in the following manner:
- Permanent implant design and materials .
- The subject device replaces the Titanium "O" or Stainless Steel "M" 0 wireform located in the center of the resorbable PGA pad with a titanium ribbon with a PVA insert or BioDur™ 108 coil wireform with a PVA insert (see Figure 1). These permanent implants are currently used on legally marketed BPV breast tissue markers (reference K042341 and K090547).
Image /page/1/Picture/20 description: The image shows the word "BARD" in a stylized, bold font. The letters are outlined in black, giving them a distinct and modern appearance. The font choice is sans-serif, contributing to the overall clean and contemporary design of the logo.
2
K123911 page 3/3
Special 510(k): Device Modification SenoMark® Ultra Breast Tissue Marker
Page 26 of 106
Image /page/2/Picture/3 description: The image shows a black silhouette of a person with their arms outstretched, resembling a ribbon. The person appears to be standing with one leg slightly forward. Below the silhouette, the text "Ribbon with PVA" is written in a simple, sans-serif font.
Image /page/2/Picture/4 description: The image shows a black ink drawing of a treble clef. The clef is drawn with thick lines and has a simple, slightly abstract design. The treble clef is isolated on a white background.
Coil with PVA
Figure 1: New Wireform Shapes of the Subject Device
- Performance specifications
- With the change to the legally marketed UltraClip II US wireforms, the O performance specifications for ultrasound imaging and MRI compatibility will now include permanent ultrasound visibility and scanning in up to a 3-Tesla MR system. These specifications are identical to the specifications provided in the reference devices.
8. Performance Testing Summary:
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:
- Visual Inspection of Product for Pre-Deployment �
- Inversion Test .
- Deployment Force .
- Read and Understand the IFU .
The results demonstrate that the technological characteristics and performance criteria of the SenoMark® Ultra Breast Tissue Marker is comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
9. Conclusion:
The SenoMark® Ultra Breast Tissue Marker is substantially equivalent to the legally marketed predicate device, the SenoMark® Breast Tissue Marker (K050090).
3
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 stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2013
C.R. Bard, Incorporated % Ms. Sarah McCartney Regulatory Affairs Associate 1625 West 3rd Street Tempe. Arizona 85281-1740
Re: K123911
Trade/Device Name: SenoMark® Ultra Breast Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: December 18, 2012 Received: December 19, 2012
Dear Ms. McCartney:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Sarah McCartney
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 for 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 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.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
SenoMark® Ultra Breast Tissue Marker
510(k) Number (if known):
Device Name:
Indications for Use:
The SenoMark® Ultra Breast Tissue Marker is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.
Prescription Use (Part 21 CFR B01 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123911