(28 days)
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.
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. This Special 510(k) addresses the addition of a smaller size HydroMark Breast Biopsy Site Marker which will be provided in a smaller, rigid, sharp delivery system for use under ultrasound deployment either directly or though a commercially available 16 gauge x 9 cm coaxial needle. This Special 510(k) also describes minor modifications to the delivery system used for the ATEC 9 Ga Biopsy System and the EnCore 10 Ga Directional Vacuum-Assisted Biopsy Devices, and includes compatibility testing to allow the existing Mammotome MR Targeting Set to be labeled for use with other commercial MRI biopsy devices. Associated changes to the IFU and labels are also provided.
The acceptance criteria regarding device performance and the study details for the HydroMark Biopsy Site Marker are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|---|
| Visibility under Ultrasound | Visible under ultrasound for at least 6 weeks. | "The Hydrogel component... is clearly distinct from normal breast structure under ultrasound imaging." The submission states the device "be visible under ultrasound for at least 6 weeks," implying successful demonstration. |
| Permanent Visibility by X-ray | Permanently visible by x-ray. | "The internal stainless steel or titanium coil which provides permanent visibility under x-ray." The submission states the device "be permanently visible by x-ray," implying successful demonstration. |
| Permanent Visibility by MRI | Permanently visible by MRI. | "The internal stainless steel or titanium coil which provides permanent visibility under... MRI." The submission states the device "be permanently visible by... MRI," implying successful demonstration. |
| Accurate Marking | Accurately mark the biopsy site by fixating in the track of the needle biopsy. | "accurately marking the biopsy site by fixating in the track of the needle biopsy." |
| Ease of Insertion and Deployment | Usability for ease of insertion and deployment. | Performed as intended. (Evaluated through "Usability testing for ease of insertion and deployment") |
| Delivery System Integrity | Withstand tensile forces. | Performed as intended. (Evaluated through "Tensile testing of delivery system") |
| Penetration Force | Meet specifications for penetration. | Performed as intended. (Evaluated through "Penetration force" testing) |
| Hydration/Moisture Characteristics | Meet specifications for hydration and moisture. | Performed as intended. (Evaluated through "Hydration testing and moisture analysis") |
| Biocompatibility | Meet ISO 10993-1 requirements for biocompatibility. | Device continues to meet the ISO 10993-1 requirements for biocompatibility. |
| Sterilization | Successfully sterilized. | Performed as intended. (Evaluated through "Sterilization validation") |
| Dimensional & Visual Integrity | Meet visual and dimensional specifications. | Performed as intended. (Evaluated through "Visual and Dimensional testing") |
| New 18 Ga Marker Performance | The 18 gauge HydroMark Breast Biopsy Site Marker for use with a 16 gauge x 9 cm coaxial needle performs as intended. | "The 18 gauge HydroMark Breast Biopsy Site Marker for use with a 16 gauge x 9 cm coaxial needle performs as intended, accurately marking the biopsy site by fixating in the track of the needle biopsy." "The device works in an identical manner to previously cleared 15 ga HydroMark Breast Biopsy Site Markers for use with 13 gauge x 9 cm coaxial needles or for direct puncture." |
| Delivery System Modifications | Minor modifications to the delivery system for the ATEC 9 Ga Biopsy System and the EnCore 10 Ga Directional Vacuum-Assisted Biopsy Devices and compatibility with the Mammotome MR Targeting Set do not raise new questions of safety or efficacy. | "All other modifications to the delivery systems, device compatibility and associated IFU and label changes represent minor updates to the products." The submission concluded substantial equivalence, implying these modifications met acceptance for safety and efficacy. |
2. Sample size used for the test set and the data provenance:
- The submission does not explicitly state the sample size for the test set for any of the non-clinical performance tests.
- The data provenance is non-clinical bench testing and simulated use testing. No human subject data (country of origin, retrospective/prospective) is reported for this 510(k). This is a Special 510(k) for minor device modifications and a new size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. Given that the testing was non-clinical bench and simulated use, it's unlikely that "experts" in the clinical sense (e.g., radiologists) were explicitly used to establish ground truth in the way they would for reading images. The ground truth for performance metrics (tensile strength, penetration force, hydration, visibility) would have been established by engineering specifications and objective measurements.
4. Adjudication method for the test set:
- This information is not applicable as the described studies are non-clinical bench and simulated use testing, not clinical studies requiring adjudicators for subjective outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (biopsy site marker), not an AI/software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.
7. The type of ground truth used:
- The ground truth for the non-clinical performance data was based on engineering specifications, objective measurements, and established industry standards (e.g., ISO 10993-1 for biocompatibility). For visibility, the ground truth was the objective observation of the marker under the specified imaging modalities (ultrasound, x-ray, MRI) as per the intended use.
8. The sample size for the training set:
- This information is not applicable. There is no "training set" in the context of an AI/algorithm for this physical medical device submission.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set for an AI/algorithm in this submission.
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K130537 Page 1/3
Image /page/0/Picture/1 description: The image shows the logo for Biopsy Sciences. The word "Biopsy" is written in a stylized font, with the "Bio" portion in a black box with white letters. The word "Sciences" is written in a smaller, simpler font below the word "Biopsy."
MAR 2 9 2013
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
- Contact Person: Sharon Rockwell Tel: 714-695-9269 E-mail: srockwell@writeme.com
Date Prepared: February, 2013
Trade Name: HydroMark Biopsy Site Marker
Common Name: Implantable clip
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 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K121113
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.
This Special 510(k) addresses the addition of a smaller size HydroMark Breast Biopsy Site Marker which will be provided in a smaller, rigid, sharp delivery system for use under ultrasound
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K 130537
deployment either directly or though a commercially available 16 gauge x 9 cm coaxial needle.
This Special 510(k) also describes minor modifications to the delivery system used for the ATEC 9 Ga Biopsy System and the EnCore 10 Ga Directional Vacuum-Assisted Biopsy Devices, and includes compatibility testing to allow the existing Mammotome MR Targeting Set to be labeled for use with other commercial MRI biopsy devices. Associated changes to the IFU and labels are also provided.
Intended Use:
The Biopsy Sciences, Inc. HydroMark Breast Biopsy Site Marker is intended 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.
The indications are identical to those of the predicate device, the Biopsy Sciences HydroMark Biopsy Site Marker, is indicated "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."
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.
The smaller size marker is a new model in the family of HydroMark Breast Biopsy Site Markers which will be provided with a rigid, sharp delivery system for use under ultrasound deployment either directly or through a 16 gauge x 9 cm coaxial needle. There are no technological differences between this site marker and the others in the family of HydroMark Breast Biopsy Site Markers; therefore the addition of the smaller size marker does not raise new questions of safety or efficacy. All other modifications to the delivery systems, device compatibility and associated IFU and label changes represent minor updates to the products.
Non-Clinical Performance Data:
Non-clinical testing included the following:
Visual and Dimensional testing .
Technological Characteristics:
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- Tensile testing of delivery system ●
- . Penetration force
- Usability testing for ease of insertion and deployment
- . Hydration testing and moisture analysis
- . Visibility under ultrasound, x-ray, and MRI
- . Sterilization validation
The devices performed as intended according to the specifications established for the finished device. The device continues to meet the ISO 10993-1 requirements for biocompatibility.
Conclusions:
The non-clinical bench testing, including simulated use testing, demonstrates that the 18 gauge HydroMark Breast Biopsy Site Marker for use with a 16 gauge x 9 cm coaxial needle performs as intended, accurately marking the biopsy site by fixating in the track of the needle biopsy. The device works in an identical manner to previously cleared 15 ga HydroMark Breast Biopsy Site Markers for use with 13 gauge x 9 cm coaxial needles or for direct puncture. The testing supports a determination of substantial equivalence to predicate HydroMark Breast Biopsy Site Markers cleared by FDA.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Letter dated: March 29, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biopsy Sciences, LLC % Ms. Sharon Rockwell Regulatory Affairs Consultant 5582 Chalon Road Yorba Linda, California 92886
Re: K130537
Trade/Device Name: Hydromark Breast Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: February 18, 2013 Received: March 1, 2013
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. Ilisting 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
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Page 2 - Ms. Sharon Rockwell
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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nijelkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _K130537
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)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130537
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§ 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.