(23 days)
Not Found
No
The device description focuses on the physical components (hydrogel, metallic marker, applicator) and mechanical modifications. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are based on physical and usability testing, not algorithmic performance.
No.
The device's purpose is to mark tissue for visualization during and after a breast biopsy, not to treat a condition or disease.
No
Explanation: The device, HydroMARK® Breast Biopsy Site Marker, is described as an implantable marker used to tag biopsy sites in the breast. Its function is to mark tissue for later visualization under ultrasound, x-ray, and MRI, not to diagnose a condition itself. It's a marking tool, not a diagnostic one.
No
The device is a physical breast biopsy site marker with a hydrogel and metallic component, delivered via a physical applicator. The 510(k) describes modifications to the physical delivery system and compatibility with a physical biopsy system.
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 outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Function: The HydroMARK® Breast Biopsy Site Marker is a physical marker implanted within the body during a biopsy procedure. Its purpose is to mark the location of the biopsy site for future imaging and identification. It does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it is "indicated to mark tissue during a percutaneous breast biopsy procedure." This is an in-vivo (within the body) application.
- Device Description: The description details a physical implantable device with a hydrogel and metallic component, delivered via an applicator. This is consistent with an implantable medical device, not an IVD.
Therefore, the HydroMARK® Breast Biopsy Site Marker is a medical device used in an in-vivo procedure, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HydroMARK® Breast 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.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The HydroMARK® Breast Biopsy Site Marker contains a reabsorbable 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® Breast Biopsy Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMARK® Breast Biopsy Site Marker is deployed by the delivery system and is left in the track created during the biopsy procedure.
This Special 510(k) is being submitted for modifications to two models of the cleared device, HydroMARK® Breast Biopsy Site Marker. The fundamental scientific technology of the two models of the modified HydroMARK® Breast Biopsy Site Markers has not changed. This submission contains information to support:
-
- Modifications to the rigid delivery system of two models of the HydroMARK® Breast Biopsy Site Marker;
-
- Compatibility for use of those two models with the Mammotome revolve® biopsy system; and
-
- IFU updates related to the modifications noted for those two models.
There are no changes to the supplier of the hydrogel material, or other materials of construction. There are no changes to the finished product manufacturing site. There are no changes to the sterilization location and method, no changes to packaging, no changes to shelf-life, and no changes to indications for use or intended use.
Changes to labeling include rebranding and legal manufacturer name and address, as well as updates to the IFU to incorporate instructions for use related to the added compatibility with the Mammotome revolve® Biopsy System.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Non-clinical testing included the following:
- Visual and Dimensional Testing
- Deployment Testing
- Usability testing for ease of insertion and deployment ●
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.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
Devicor Medical Products, Inc. Ms. Shawna Rose Director, Regulatory Affairs 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241
Re: K161021
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: April 8, 2016 Received: April 12, 2016
Dear Ms. Rose:
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
1
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 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/Resourcesfor You/Industry/default.htm. 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 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
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Indications for Use
510(k) Number (if known) K161021
Device Name HydroMARK® Breast Biopsy Site Marker
Indications for Use (Describe)
The HydroMARK® Breast 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY (21 CFR 807.92)
HYDROMARK® BREAST BIOPSY SITE MARKER
- 510(k) Owner: Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241 Tel: 513-864-9000 Fax: 513-864-9011
- Contact Person: Shawna Rose Tel: 513-864-9178 E-mail: srose@mammotome.com
Date Prepared: April 8, 2016
HydroMARK® Breast Biopsy Site Marker Trade Name:
Common Name: Biopsy Site Marker
Classification: Class II
Implantable clip per 21 CFR 878.4300, NEU Classification Name:
- Predicate Devices: Biopsy Sciences HydroMark Breast Biopsy Site Marker, K121113 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K130537
- Device Description: The HydroMARK® Breast Biopsy Site Marker contains a reabsorbable 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® Breast Biopsy Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMARK® Breast Biopsy Site Marker is deployed by the delivery system and is left in the track created during the biopsy procedure.
This Special 510(k) is being submitted for modifications to two models of the cleared device, HydroMARK® Breast Biopsy Site Marker. The fundamental scientific technology of the two models of the modified
4
HydroMARK® Breast Biopsy Site Markers has not changed. This submission contains information to support:
-
- Modifications to the rigid delivery system of two models of the HydroMARK® Breast Biopsy Site Marker;
-
- Compatibility for use of those two models with the Mammotome revolve® biopsy system; and
-
- IFU updates related to the modifications noted for those two models.
There are no changes to the supplier of the hydrogel material, or other materials of construction. There are no changes to the finished product manufacturing site. There are no changes to the sterilization location and method, no changes to packaging, no changes to shelf-life, and no changes to indications for use or intended use.
Changes to labeling include rebranding and legal manufacturer name and address, as well as updates to the IFU to incorporate instructions for use related to the added compatibility with the Mammotome revolve® Biopsy System.
- The indications for use and the intended use are the same for the predicate Intended Use: and the modified devices.
The indications for use are:
"The HydroMARK® Breast 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 intended use is:
"The HydroMARK® Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, to be 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 marker at the exact location of biopsy.
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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 modifications to the HydroMARK® Breast Biopsy Site Markers delivery system for the two models, the device compatibility testing, and the associated IFU and label changes represent minor updates to the products. The changes do not raise new questions of safety or efficacy. The technological characteristics are identical to those of the predicate devices.
Non-Clinical Performance Data: Non-clinical testing included the following:
- Visual and Dimensional Testing
- Deployment Testing
- Usability testing for ease of insertion and deployment ●
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.
Summary of
Substantial Equivalence:
Side-by-Side Comparison to Legally Marketed Device
HydroMARK® Breast Biopsy Site Marker
| Device
Characteristics | Marketed Device HydroMARK®
Breast Biopsy Site Marker | Modified Device 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. | 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. |
| Device Composition | | |
| Marker Composition | Polymerized and desiccated
hydrogel | Polymerized and desiccated
hydrogel |
| Coil (Marker)
Composition | Titanium or Stainless Steel | Titanium or Stainless Steel |
| Coil (Marker) Shapes | Barrel (T1)
Open Coil (T3) | Barrel (T1)
Open Coil (T3) |
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| Device
Characteristics | Marketed Device HydroMARK®
Breast Biopsy Site Marker | Modified Device HydroMARK®
Breast Biopsy Site Marker |
|-----------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Cannula Type | Rigid Cannula | Rigid Cannula |
| Cannula Material | 304 Stainless Steel | 304 Stainless Steel |
| Plunger Rod Type | Rigid Plunger Rod | Rigid Plunger Rod |
| Plunger Rod Material | 302 Stainless Steel | 302 Stainless Steel |
| Plunger Rod Tip | Welded Flexible Tip | Welded Spring |
| Packaging and Sterilization | | |
| Sterile Packaging | Foil pouch with Tyvek® vent | Foil pouch with Tyvek® vent |
| Sterilization Method | ETO | ETO |
| Shelf Life | 3 years/36 months | 3 years/36 months |
- The comparison testing, including functionality, usability testing, as well as Conclusions: side-by-side comparison of technological characteristics of design, components and materials of construction, and clinical application, demonstrates that the two modified models of the HydroMARK® Breast Biopsy Site Markers perform as intended, accurately marking the biopsy site in the cavity of the breast biopsy. The two modified devices work in an identical manner to previously cleared HydroMARK® Breast Biopsy Site Markers. Thus, the two modified devices can be considered substantially equivalent.