(283 days)
Not Found
No
The device description and performance studies focus on the physical properties and visibility of the marker under different imaging modalities, with no mention of AI or ML for image analysis, diagnosis, or any other function.
No.
The device is a marker used during a biopsy procedure to mark tissue and does not treat or cure any medical condition.
No.
The device is a marker used to identify the location of a percutaneous breast biopsy procedure for future imaging and potential surgical removal; it does not diagnose a condition.
No
The device description clearly states it is a two-component marker with a resorbable hydrogel component and a metallic component, supplied in a sterile, disposable applicator. This indicates a physical medical device, not a software-only one.
Based on the provided information, the HydroMARK Breast Biopsy Site Marker is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mark tissue during a percutaneous breast biopsy procedure and for subsequent imaging. This is a procedural and imaging aid, not a test performed on a sample of tissue or body fluid outside the body to diagnose a condition.
- Device Description: The device is a physical marker implanted into the tissue. It doesn't analyze biological samples.
- Function: Its function is to provide a visible landmark for imaging, not to provide diagnostic information based on the analysis of biological material.
IVD devices are typically used to examine samples like blood, urine, tissue biopsies (after removal from the body), etc., to detect diseases, conditions, or infections. The HydroMARK marker is used in vivo (within the body) to facilitate future imaging and potential surgical removal of the marked tissue.
N/A
Intended Use / Indications for Use
The HydroMARK Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, 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 [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component, and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices.
The HydroMARK Breast Biopsy Site Marker has a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogel material expands with fluid contact and is then resorbed by the body over time. Since the hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium or Stainless Steel. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray, and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, X-ray, MRI
Anatomical Site
Breast, 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)
Non-Clinical Bench Performance Testing:
Test type: Design Verification Analysis by Document Review of Labeling Changes
Test Results: PASSED
Conclusion: The results of this Design Verification Analysis by Document Review were provided in support of the substantial equivalence (SE) determination.
Test type: Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Subchronic Toxicity, Implantation, Genotoxicity, Carcinogenicity)
Test Results: PASSED
Conclusion: The results of these Non-Clinical Bench Performance Data are provided in support of the substantial equivalence determination.
Summary of Design Validation:
Test type: Literature Search
Test Results: The results of this Literature Search are provided in support of the substantial equivalence (SE) determination.
Conclusion: The results of the Literature Search conducted on the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] demonstrates that placement of the subject device in axillary lymph nodes is substantially equivalent to the predicate. All identified risks were found to be similar to risks associated with breast tissue marking and residual risks were determined to be acceptable. This Literature Search supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device].
Further details: Nineteen (19) scientific articles (2015 to 2021) were evaluated, including 16 specifically mentioning HydroMARK Breast Biopsy Site Markers. A total of 787 HydroMARK Breast Biopsy Site Markers were used across the 16 articles, with 297 used in axillary lymph nodes. Adverse events identified were similar to those in breast tissue marking and did not raise new questions of safety or effectiveness.
Test type: Clinician Survey
Test Results: Five (5) physicians were surveyed to gain insight on current practices. They provided information to support that use of the HydroMARK Breast biopsy Site Marker [subject device] in axillary lymph nodes does not raise a concern of safety or effectiveness.
Conclusion: The Design Validation results for the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] demonstrate that the subject device is as safe, and as effective as the predicate device and support a determination of substantial equivalence (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device]. Furthermore, the Design Validation results support that using the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] to mark axillary lymph nodes demonstrates substantial equivalence.
Overall conclusion: The results of the Verification Testing support the safety of the device and demonstrate that the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] meets all design and functional requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device].
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2022
Devicor Medical Products, Inc. Diane Sung Senior Regulatory Affairs Associate 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241
Re: K212158
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: July 9, 2021 Received: July 12, 2021
Dear Diane Sung:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Deborah Fellhauer, RN, BSN, CQIA Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212158
Device Name HydroMARK Breast Biopsy Site Marker
Indications for Use (Describe)
The HydroMARK Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
Image /page/3/Picture/1 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue symbol on the left, resembling two crescent shapes facing each other. To the right of the symbol is the company name, "DEVICOR," in bold, black letters. Below "DEVICOR" is the text "MEDICAL PRODUCTS, INC." in a smaller, light blue font.
510(k) Summary
I. SUBMITTER [Per 807.92(a)(1)]
Sponsor/Manufacturer
Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Establishment Registration Number: 3008492462
Contact Person
Diane Sung Senior Regulatory Affairs Associate Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Ph: 513-894-2931 Fax: 513-864-9011 E-mail: Diane.Sung@mammotome.com
Date Prepared
July 9, 2021
II. DEVICE [Per 807.92(a)(2)]
| Device Trade/Proprietary Name | HydroMARK Breast Biopsy Site Marker |
|---|---|
| Regulation Description | Implantable Clip |
| Device Common or Usual Name | Marker, Radiographic, Implantable |
| Device Regulatory Classification | Class II |
| Device Classification Regulation | 21 CFR §878.4300 |
| Product Code | (NEU) – Marker, Radiographic, Implantable |
| Submission Type | Traditional 510(k) Premarket Notification |
| Classification Panel | General & Plastic Surgery |
| Premarket Review | Surgical and Infection Control Devices (OHT4) |
| Infection Control and Plastic Surgery Devices (DHT4B) |
III. PREDICATE DEVICE [Per 807.92(a)(3)]
The Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Sponsor's own predicate devices:
4
Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker ● (K210752) [predicate device] Predicate The Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject
Device device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device] in terms of similar Indications for Use / Intended 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. The Devicor Medical Product, Inc. HydroMARK Breast Biopsy Site Marker (subject device) is including axillary lymph nodes to the previous Indications for Use/Intended Use statement for the direct puncture devices (4010-02-15-T1, 4010-02-15-T3, 4010-02-15-T4, 4010-02-15-S1, 4010-02-15-S3, 4010-02-18-T3).
- Substantial equivalency (SE) of the subject device has also been based on substantially equivalent design, functionality, and performance characteristics as the predicate device.
IV. DEVICE DESCRIPTION [Per 807.92(a)(4)]
The HydroMARK Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component, and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices.
The HydroMARK Breast Biopsy Site Marker has a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogel material expands with fluid contact and is then resorbed by the body over time. Since the hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium or Stainless Steel. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray, and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI.
This Traditional 510(k) is being submitted for modifications for Use/Intended Use of the cleared device, HydroMARK Breast Biopsy Site Marker (K210752) [predicate device]. The fundamental scientific technology of the HydroMARK Breast Biopsy Site Markers has not changed. There are no changes to the supplier of the hydrogel 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, and no changes to shelf life.
Changes to the Indications for Use/Intended Use include modifications to the User Instructions & Operations Guide, and the Safety Information Booklet mentioned below:
5
- . Modifying the predicate User Instructions & Operations Guide for direct puncture devices to include axillary lymph nodes in the Indications for Use statement;
- . Creating a Safety Information Booklet for direct puncture devices to include axillary lymph nodes in the Indications for Use statement.
IV. INTENDED USE / INDICATIONS FOR USE [Per 807.92(a)(5)]
The Intended Use and the Indications for Use are the same for the HydroMARK Breast Biopsy Site Marker [subject device] and the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device] with the exception of the addition of axillary lymph nodes to the HydroMARK Breast Biopsy Site Marker [subject device].
[subject device]:
The HydroMARK Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
[predicate device]:
The 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.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]
The Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device] based on the same functional and performance characteristics of the subject device when compared to the predicate device. The minor differences between the subject device and predicate device User Instructions & Operation Guides, Safety Information Booklet and Intended Use/Indications for Use do not raise concerns of safety and effectiveness.
A side-by-side comparison of the technological characteristics of design, components and materials of construction between the subject device and the predicate device, as well as the minor differences in the Intended Use/Indications for Use, do not raise concerns of safety and effectiveness. The comparisons supporting a determination of substantial equivalency (SE) are provided below.
| Regulatory
Information | HydroMARK Breast Biopsy
Site Marker
[Subject Device] | HydroMARK Breast
Biopsy Site Marker
(K210752)
[Predicate Device] | Similarities /
Differences |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Devicor Medical Products
De Mexico S De RL De CV | Devicor Medical
Products De Mexico S De
RL De CV | Same |
| Device Trade or
Proprietary
Name | HydroMARK Breast Biopsy
Site Marker | HydroMARK Breast
Biopsy Site Marker | Same |
| 510(k) Number | N/A | K210752 | N/A |
| Device Class | Class II | Class II | Same |
| Device
Classification
Name | Marker, Radiographic,
Implantable | Marker, Radiographic,
Implantable | Same |
| Device Common
Name | Implantable Clip | Implantable Clip | Same |
| Product Code | (NEU) - Marker,
Radiographic, Implantable | (NEU) - Marker,
Radiographic,
Implantable | Same |
| Regulation
Number | 21 CFR §878.4300 | 21 CFR §878.4300 | Same |
| Design Features and Capabilities of the Device | | | |
| Indications for
Use | To mark tissue during a
percutaneous breast
biopsy
procedure, including
axillary lymph nodes, 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. | Different. The
difference in
Indications for
Use (addition of
axillary lymph
nodes) does not
raise new or
different
questions of
safety and
effectiveness. A
literature
review and
clinician survey
have been
conducted to
demonstrate
safety and
effectiveness in
the axillary
lymph nodes. |
| Prescription or
Over-the-
Counter (OTC)
Use | Prescription | Prescription | Same |
| Use Environment | | | |
| Sterile | Yes | Yes | Same |
| Single-Use | Yes | Yes | Same |
| Design Features | | | |
| Marker
Composition | Polymerized and
desiccated | Polymerized and
desiccated | Same |
| | hydrogel | hydrogel | |
| Coil (Marker)
Composition | Titanium or Stainless Steel | Titanium or Stainless Steel | Same |
| Coil (Marker)
Shapes | Barrel (T1, S1)
Butterfly (T4)
Open Coil (T3, S3) | Barrel (T1, S1)
Butterfly (T4)
Open Coil (T3, S3) | Same |
| Cannula Type | | | |
| 4010-02-15 | Rigid | Rigid | Same |
| 4010-02-18 | Rigid | Rigid | Same |
| Cannula Material | | | |
| 4010-02-15 | Stainless Steel | Stainless Steel | Same |
| 4010-02-18 | Stainless Steel | Stainless Steel | Same |
| Plunger Rod Type | | | |
| 4010-02-15 | Rigid Stainless Steel Rod | Rigid Stainless Steel Rod | Same |
| 4010-02-18 | Rigid Stainless Steel Rod | Rigid Stainless Steel Rod | Same |
| Plunger Rod Material | | | |
| 4010-02-15 | Stainless Steel | Stainless Steel | Same |
| 4010-02-18 | Stainless Steel | Stainless Steel | Same |
| Packaging and Sterilization | | | |
| Packaging | Foil pouch | Foil pouch | Same |
| Sterilization
Method | ETO | ETO | Same |
| Shelf Life | 3 years/36 months | 3 years/36 months | Same |
6
7
VII. SUMMARY OF VERIFICATION DATA AND VERIFICATION TEST CONCLUSIONS [Per 807.92(b)(1)(2)(3)]
Non-Clinical Bench Performance Testing was conducted on the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] to confirm that the device meets all system requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device]. The following Verification Data was provided in support of the substantial equivalence (SE) determination.
Summary of Non-Clinical Bench Performance Testing Non-Clinical Bench Performance Testing was conducted on the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device]. The table below includes the list of the performance testing results submitted, referenced, or relied on in this premarket notification for a determination of substantial equivalence.
| Design Verification Analysis by Document Review | |
|---|---|
| Design Verification Analysis by | |
| Document Review of Labeling | |
| Changes | Test Results: PASSED |
| The results of this Design Verification Analysis by Document Review | |
| were provided in support of the substantial equivalence (SE) | |
| determination. | |
| Conclusion Supporting Substantial Equivalence (SE): The results of | |
| the Design Verification Analysis by Document Review conducted on | |
| the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site | |
| Marker [subject device] demonstrates that the subject device is as | |
| safe, as effective, and performs as well as, the legally marketed | |
| predicate device. This testing supports a determination of | |
| substantial equivalence (SE) of the Devicor Medical Products, Inc. | |
| HydroMARK Breast Biopsy Site Marker [subject device] when | |
| compared to the Devicor Medical Products, Inc. HydroMARK Breast | |
| Biopsy Site Marker (K210752) [predicate device]. | |
| Biocompatibility Testing | |
| Biocompatibility Testing including: |
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Subchronic Toxicity
- Implantation
- Genotoxicity
- Carcinogenicity | Test Results: PASSED
The results of these Non-Clinical Bench Performance Data are
provided in support of the substantial equivalence determination.
Conclusion Supporting Substantial Equivalence: The results of the
Biocompatibility Testing conducted on the Devicor Medical Products,
Inc. HydroMARK Breast Biopsy Site Marker [subject device]
demonstrates that the subject device is as safe, as effective, and
performs as well as, the legally marketed predicate device. This
testing supports a determination of substantial equivalence (SE) of
the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site
Marker [subject device] when compared to the Devicor Medical
Products, Inc. HydroMARK Breast Biopsy Site Marker (K210752)
[predicate device]. |
| FDA Recognized Testing Standards:
○ ISO 10993-1:2018-Biological
Evaluation of Medical Devices –
Part 1: Evaluation and Testing
Within a Risk Management Process
○ ISO 10993-5:2009-Biological
Evaluation of Medical Devices –
Part 5: Tests for In Vitro
Cytotoxicity
○ ISO 10993-6:2016-Biological
Evaluation of Medical Devices –
Part 6: Tests for local effects after
implantation
○ ISO 10993-10:2010-Biological
Evaluation of Medical Devices –
Part 10: Tests for Irritation and Skin
Sensitization
○ ISO 10993-11:2017-Biological
Evaluation of Medical Devices –
Part 11: Tests for Systemic Toxicity
○ ISO 10993-12:2012-Biological
Evaluation of Medical Devices -
Part 12: Sample preparation and
reference materials. | |
| Conclusion: The results of the Verification Testing support the safety of the device and demonstrate that the
Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] meets all design and | |
| Summary of Design Validation | |
| • Literature Search | The results of this Literature Search are provided in support of the substantial equivalence (SE) determination. |
| | Conclusion Supporting Substantial Equivalence: The results of the Literature Search conducted on the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] demonstrates that placement of the subject device in axillary lymph nodes is substantially equivalent to the predicate. All identified risks were found to be similar to risks associated with breast tissue marking and residual risks were determined to be acceptable. This Literature Search supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device]. |
| • Clinician Survey | To further reinforce the clinical use of HydroMARK Breast Biopsy Site Marker [subject device] in axillary lymph nodes, Devicor Medical Products, Inc. conducted a clinician survey of five (5) physicians to gain further insight on current practices. The five (5) clinicians provided information to support that use of the HydroMARK Breast biopsy Site Marker [subject device] in axillary lymph nodes does not raise a concern of safety or effectiveness. |
| Conclusion: The Design Validation results for the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] demonstrate that the subject device is as safe, and as effective as the predicate device and support a determination of substantial equivalence (SE) to the Devicor Medical Products Inc. HydroMARK | |
8
9
functional requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device].
VIII. SUMMARY OF DESIGN VALIDATION AND CONCLUSIONS
A validation analysis was conducted on the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] to confirm the device is safe and effective for use with axillary lymph nodes and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device]. The following Design Validation results were provided in support of the substantial equivalence (SE) determination: Literature Search and Clinician Survey.
Breast Biopsy Site Marker (K210752) [predicate device]. Furthermore, the Design Validation results support that using the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] to mark axillary lymph nodes demonstrates substantial equivalence.
Summary of Literature Search:
A literature search was performed to identify, and review published scientific articles relating to the safety and effectiveness of the use of the HydroMARK Breast Biopsy Site Markers in axillary lymph nodes.
10
Medical journals (Google Scholar, ScienceDirect, PubMed) and the internet were searched using keywords listed below. Nineteen (19) scientific articles, with date ranges from 2015 to 2021, were found that included information about breast biopsy markers being used in the axillary lymph node area. Of these articles, sixteen (16) specifically included HydroMARK Breast Biopsy Site Markers while the other (3) three articles included other brands of markers. A total of 787 HydroMARK Breast Biopsy Site Markers were used across the 16 articles, of which 297 were used in axillary lymph nodes. Collectively, the 19 articles covered the aspects of axillary lymph node biopsy, marking, localization, surgical removal and associated risks. The adverse events identified in the literature search associated with utilizing the Biopsy Site Markers in axillary lymph nodes are similar to risks associated with using biopsy markers in breast tissue. These include clip migration and/or extrusion of the marker away from the positive lymph node, extrusion or displacement of the marker during surgical excision, difficulty in detection and visibility, ability to maintain sonographic detectability, formation of microcalcifications, failed deployment, and allergic reactions to biopsy markers. Based on the literature review, the types, severity, and frequency of adverse events as well as the performance of HydroMARK for use in axillary lymph nodes do not raise new questions of safety or effectiveness. These previously characterized risks are mitigated by the User Instructions Operations Guide. The HydroMARK product referenced in these articles is the same product as the HydroMARK Breast Biopsy Site Marker [subject device]. Therefore, the data demonstrate that the HydroMARK Breast Biopsy Site Marker [subject device] is substantially equivalent to the HydroMARK product referenced in the literature data. Therefore, these scientific literature articles support substantial equivalence of the HydroMARK Breast Biopsy Site Marker for placement in the axillary lymph nodes.
Key words:
Biopsy markers, biopsy clips, ultrasound visibility, breast ultrasound, axilla, breast cancer, contrast agents, sentinel lymph node, ultrasonography, ultrasound, clip, targeted axillary dissection, breast neoplasms, lymph nodes, magnetic resonance imaging, surgical instruments, axillary lymph node dissection, axillary staging, neoadjuvant chemotherapy, and ultrasound visibility clip.
IX. SUBSTANTIAL EQUIVALENCE SUMMARY / CONCLUSIONS
The data generated from the results of the Verification Testing, Design Validation, and clinical literature, along with a side-by-side comparison of the technological characteristics of design, components, and materials of construction between the subject device and the predicate device, demonstrate that the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] is as safe and effective and performs as well as the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device].
The similar technological and performance characteristics for the proposed Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] have been assessed to be substantially equivalent to the predicate device, and any differences in Intended Use/ Indications for Use do not raise concerns of safety and effectiveness when compared to the predicate device. Therefore, the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] is substantially equivalent to the predicate device.