(254 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and deployment of a tissue marker, with no mention of AI or ML.
No
The device is used to mark the surgical site for radiographic purposes and does not provide any therapeutic benefit or treatment.
No
The device is a tissue marker used to radiographically mark a biopsy site, not to diagnose a condition or disease. Its function is to mark the location for future reference, not to provide diagnostic information itself.
No
The device description clearly states it consists of a disposable beveled needle applicator containing a Nitinol radiographic ring marker, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark the biopsy procedure" by attaching to soft breast tissue. This is a surgical/interventional procedure performed on the patient's body, not a test performed on a sample outside the body.
- Device Description: The device is a needle applicator containing a marker that is deployed into tissue. This is consistent with a device used in vivo (within a living organism).
- Lack of IVD Characteristics: IVDs typically involve analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment. This device does not perform any such analysis. It is a physical marker placed within the body.
Therefore, the UltraCor Twirl Breast Tissue Marker is a medical device used in a surgical or interventional setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UltraCor Twirl Breast Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
The UltraCor® Twirl™ Breast Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The UltraCor® Twirl™ Breast Tissue Marker consists of a disposable beveled needle applicator containing a Nitinol radiographic ring marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17q x 10cm needle with 1 cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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)
Bench testing was performed to verify that the modifications to the subject device do not impact safety or effectiveness of the device. Design verification testing included: marker shape distinguishability, ultrasound visibility, marker deployment accuracy, marker deployment force, marker deployment, marker retention, marker dimensional testing, applicator dimensional testing, applicator tensile testing, visual inspection of the product, visual integrity of the packaging, pouch seal strength of the packaging, MRI testing (magnetic field interactions, MRIrelated heating, artifact testing), as well as biocompatibility testing on the applicator and the marker implant.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
Bard Peripheral Vascular, Inc. Ms. Kristen Dejeu Regulatory Affairs Associate 1625 West 3rd Street Tempe, Arizona 85281
Re: K152510
Trade/Device Name: Ultracore Twirl Breast Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: April 12, 2016 Received: April 13, 2016
Dear Ms. Dejeu:
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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.
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
2
Indications for Use
510(k) Number (if known) K152510
Device Name UltraCor Twirl Breast Tissue Marker
Indications for Use (Describe)
The UltraCor Twirl Breast Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary [As required by 21 CFR 807.92(c)]
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:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|--------------------------------------------------------------------------------|
| Phone: | 480-350-6067 |
| Fax: | 480-449-2546 |
| Contact: | Kristen DeJeu, Regulatory Affairs Associate |
| Date: | May 11, 2016 |
Subject Device:
| Device Trade Name: | UltraCor® Twirl™ Breast Tissue Marker |
|---|---|
| Common or Usual Name: | Breast Tissue Marker |
| Classification: | Class 2 |
| Classification Name: | Marker, Radiographic, Implantable ( Product Code NEU) |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4300 (Implantable Clip) |
Predicate Device:
UltraClip® II US Wing and Coil (K090547, Cleared March 18, 2009)
Summary of Change:
The modifications from the predicate device, the UltraClip® II US Wing and Coil Breast Tissue Marker, to the subject device, the UltraCor® Twirl™ Breast Tissue Marker, include differences in marker design and material, applicator design and material, packaging material, and labeling.
4
Device Description:
The UltraCor® Twirl™ Breast Tissue Marker consists of a disposable beveled needle applicator containing a Nitinol radiographic ring marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17q x 10cm needle with 1 cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.
Indications for Use of Device:
The UltraCor® Twirl™ Breast Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Technological Characteristics:
The UltraCor® Twirl™ has the following similarities to the predicate device:
- . Same intended use / indications for use
- . Similar technological characteristics
- . Same fundamental scientific technology
- . Same target population
- . Same operating principle
- . Same sterility assurance level
- . Same method of sterilization
- . Same packaging configuration
Performance Testing Summary:
Bench testing was performed to verify that the modifications to the subject device do not impact safety or effectiveness of the device. Design verification testing included: marker shape distinguishability, ultrasound visibility, marker deployment accuracy, marker deployment force, marker deployment, marker retention, marker dimensional testing, applicator dimensional testing, applicator tensile testing, visual inspection of the product, visual integrity of the packaging, pouch seal strength of the packaging, MRI testing (magnetic field interactions, MRIrelated heating, artifact testing), as well as biocompatibility testing on the applicator and the marker implant.
5
Conclusion:
The subject device, the UltraCor® Twirl™ Breast Tissue Marker, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. Therefore, the UltraCor® Twirl™ Breast Tissue Marker is substantially equivalent to the legally marketed predicate device, the UltraClip II US Wing and Coil Breast Tissue Marker (K090547).