(91 days)
Not Found
No
The description focuses on the physical components and function of a biopsy site marker, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a marker used for visualization during and after a biopsy, not for treating a disease or condition.
No
The device is a site marker used to mark tissue during a breast biopsy procedure, making it a therapeutic or interventional device rather than a diagnostic one. It does not diagnose any condition but rather facilitates a procedure.
No
The device description clearly states it is a physical device containing a resorbable hydrogel component and a metallic component, delivered via a sterile, disposable applicator. It is a physical marker, not software.
Based on the provided information, 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 HydroMark Breast Biopsy Site Marker is a physical device implanted into the body to mark a biopsy site. It is used during a procedure to leave a visible marker, not to analyze a sample outside the body.
- Intended Use: The intended use is to "mark tissue during a percutaneous breast biopsy procedure," and to be visible under various imaging modalities. This is a procedural aid, not a diagnostic test performed on a sample.
- Device Description: The description details a physical implant with a hydrogel and metallic component. It does not describe a test kit, reagent, or analytical instrument used to analyze a biological sample.
Therefore, the HydroMark Breast Biopsy Site Marker falls under the category of a medical device, specifically an implantable marker, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
Product codes
NEU
Device Description
The HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking.
The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure.
The Biopsy Sciences HydroMark Breast Biopsy Site Markers will have a change in vendor for the supplier of the hydrogel material. The change in the supplier of the hydrogel has no effect on the finished product specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, x-ray, MRI
Anatomical Site
breast
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
Non-clinical testing included physical, functional and biocompatibility of the finished products manufactured in a newly qualified facility, using hydrogel material from a new supplier. The devices performed as intended according to the original specifications established for the finished device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logo for Biopsy Sciences. The word "Biopsy" is split into two parts, with "Bio" in white letters on a black background and "psy" in black letters on a white background. Below the word "Biopsy" is the word "Sciences" in a smaller font.
JUL 12 2012
510(K) SUMMARY (21 CFR 807.92)
HYDROMARK BIOPSY SITE MARKER
510(k) Owner: Biopsy Sciences, Inc. 4900 Creekside Drive, Suite C Clearwater, FL 33760 Tel: 727-290-9825 Fax: 727-290-9828
- Sharon Rockwell Contact Person: Tel: 714-695-9269 E-mail: srockwell(@writeme.com
- July, 2012 Date Prepared:
- HydroMark Biopsy Site Marker Trade Name:
- Biopsy site marker Common Name:
- Classification Name: Implantable clip per 21 CFR 878.4300, NEU
- Predicate Devices: Biopsy Sciences HydroMark Breast Biopsy Site Marker, K060769 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K083006 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K090501
- The HydroMark Breast Biopsy Site Marker contains a resorbable Device Description: hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking.
The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure.
The Biopsy Sciences HydroMark Breast Biopsy Site Markers will have a change in vendor for the supplier of the hydrogel material. The change in the supplier of the hydrogel has no effect on the finished product specifications.
1
- To mark tissue during a percutaneous breast biopsy procedure, be Intended Use: visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
Technological Characteristics:
The hydrogel component expands on fluid contact to fill the track of the biopsy needle anchoring the HydroMark at the exact location of biopsy. Because the hydrogel is hydrophilic, it is clearly distinct from normal breast structure under ultrasound imaging. The hydrogel material degrades via hydrolysis over time leaving the internal stainless steel or titanium coil which provides permanent visibility under x-ray and MRI.
Non-Clinical
- Performance Data: Non-clinical testing included physical, functional and biocompatibility of the finished products manufactured in a newly qualified facility, using hydrogel material from a new supplier. The devices performed as intended according to the original specifications established for the finished device.
The testing supports a determination of substantial equivalence to Conclusions: predicate devices cleared by FDA.
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Image /page/2/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 mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biopsy Sciences, LLC % Ms. Sharon Rockwell Consultant 5582 Chalon Road Yorba Linda, Florida 33760
JUL 12 2012
Re: K121113
Trade/Device Name: Biopsy Sciences HydroMark Breast Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: April 09, 2012 Received: April 12, 2012
Dear Ms. Rockwell:
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
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Page 2 - Ms. Sharon Rockwell
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Or ice-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 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _
Device Name: Biopsy Sciences HydroMark Breast Biopsy Site Marker
Indications for Use:
To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
Prescription Use X (Part 21 CFR 801 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)
Daniel Kronefu MXM
(Division Sign-Off)
Page of
Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K121113