(60 days)
Not Found
No
The summary describes a physical tissue marker and applicator, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a tissue marker used to radiographically mark the location of a biopsy procedure, not to treat a disease or condition.
No
This device is a marker used to identify a location in the breast tissue after a biopsy procedure. It does not diagnose any condition but rather marks the site for future reference.
No
The device description clearly states it consists of a disposable beveled needle applicator containing a nitinol radiographic ring wireform, which are physical hardware components.
No, 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 UltraCor® Twirl® Breast Tissue Marker is a physical device that is implanted into the body to mark a location for future radiographic imaging. It does not analyze a sample taken from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it is for "radiographically mark the location of the biopsy procedure," not for analyzing a sample to diagnose a condition.
- Device Description: The description details a needle and a wireform, which are physical components for implantation, not reagents or equipment for analyzing biological samples.
This device is a medical device used in a procedure, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
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 wireform. The wireform is intended for longterm radiographic marking of the tissue site. The applicator has a beveled 17G x 10cm needle with 1cm 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
radiographic
Anatomical Site
soft breast tissue, including axillary lymph nodes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted.
The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements. A comprehensive literature review was conducted to collect and assess relevant clinical literature related to the use of clips (breast tissue markers) in axillary lymph nodes in metastatic breast cancer patients. To further reinforce the clinical use of a breast tissue marker in the axillary lymph node region, Bard consulted with physicians to gain further insight on current practices.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
March 9, 2018
Bard Peripheral Vascular, Inc. Meghan McKelvey Regulatory Affairs Associate 1625 W. 3rd Street Tempe, Arizona 85281
Re: K180061
Trade/Device Name: UltraCor Twirl Breast Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: January 5, 2018 Received: January 8, 2018
Dear Ms. McKelvey:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K180061
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, including axillary lymph nodes, to radiographically mark the location of 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) |
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ULTRACOR®Twirl® Breast Tissue Marker 510(k) Summary 21 CFR 807.92
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 510(k) summary 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) 350-6153 |
| Fax: | (480) 966-7062 |
| Contact: | Meghan McKelvey, Regulatory Affairs Associate |
| Date: | January 5, 2018 |
2. Subject Device Names:
| Device Trade Name: | ULTRACOR® TWIRL® Breast Tissue Marker |
|---|---|
| Common or Usual Name: | Breast Tissue Marker |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4300 (FDA Product Code NEU) |
3. Predicate Devices:
| Predicate 510(k) Number | Subject Device |
|---|---|
| K152510; cleared May 13, 2016 | ULTRACOR® TWIRL® |
Summary of Change 4.
The Indications for Use statement is being updated to include the axillary lymph nodes. Subject device labeling updates including updates to the Instructions for Use and Potential Complications, are being implemented through this submission.
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5. Device Description:
The ULTRACOR® Twirl® Breast Tissue Marker consists of a disposable beveled needle applicator containing a nitinol radiographic ring wireform. The wireform is intended for longterm radiographic marking of the tissue site. The applicator has a beveled 17G x 10cm needle with 1cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.
6. Indications for Use of Device:
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.
7. Technological Comparison to Predicate Devices:
The ULTRACOR® Twirl® Breast Tissue Marker has the following similarities to the predicate device:
- . Same Intended Use
- Same Target Population .
- . Same Technological Characteristics
- Same Fundamental Scientific Technology .
- Same Operating Principal .
- . Same Implant Design and Materials
- . Same Applicator Design and Materials
- . Same Performance Specifications
- . Same Packaging Materials and Configurations
- . Same Sterility Assurance Level and Method of Sterilization
The subject device and the predicate device are different in the following manner:
- Modifications to Indications for Use .
There are no changes to the implants or delivery systems. The subject device labeling has been updated to include the updated Indications for Use language.
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8. Performance Data:
The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted.
9. Clinical Analysis:
The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements. A comprehensive literature review was conducted to collect and assess relevant clinical literature related to the use of clips (breast tissue markers) in axillary lymph nodes in metastatic breast cancer patients. To further reinforce the clinical use of a breast tissue marker in the axillary lymph node region, Bard consulted with physicians to gain further insight on current practices.
10. Conclusions:
The subject device, ULTRACOR® Twirl® Breast Tissue Marker, is substantially equivalent to the legally marketed predicate device.