HydroMARK Breast Biopsy Site Marker
Device Facts
| Record ID | K210752 |
|---|---|
| Device Name | HydroMARK Breast Biopsy Site Marker |
| Applicant | Devicor Medical Products, Inc. |
| Product Code | NEU · General, Plastic Surgery |
| Decision Date | Apr 14, 2021 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
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.
Device Story
HydroMARK Breast Biopsy Site Marker is a two-component implantable device for marking breast biopsy sites. Components include a resorbable, highly expandable solid cylinder of polymerized/desiccated hydrogel and an embedded metallic wire coil (Titanium or Stainless Steel). The device is supplied pre-loaded in a sterile, disposable applicator compatible with biopsy devices. During percutaneous biopsy, the marker is deployed into the cored-out space; the hydrogel expands upon fluid contact to conform to the site, providing ultrasound visibility for at least 6 weeks. The metallic coil provides permanent identification under X-ray and MRI. The device is used in clinical settings by physicians. It remains in the body unless the marked tissue is surgically removed. The device aids in long-term localization of biopsy sites for clinical follow-up.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is supported by document analysis of labeling modifications and verification of design/functional requirements.
Technological Characteristics
Implantable radiographic marker. Materials: polymerized/desiccated hydrogel, Titanium or Stainless Steel wire coil. Delivery: sterile, disposable applicator (flexible or rigid cannula). Sterilization: ETO. Standards: ISO 13485:2016, ISO 14971:2007. No software or electronic components.
Indications for Use
Indicated for marking tissue during percutaneous breast biopsy procedures in patients 12 years of age and older. Contraindicated for use in infected areas, patients with known nickel allergies (for stainless steel markers), and patients with known allergies to poly (ethylene glycol), poly (trimethylene carbonate), and acrylate-capped poly (L-lactide).
Regulatory Classification
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Predicate Devices
- HydroMARK Breast Biopsy Site Marker (K121113)
Reference Devices
Submission Summary (Full Text)
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April 14, 2021
Devicor Medical Products, Inc. Diane Sung Senior Regulatory Affairs Associate 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241
Re: K210752
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: March 12, 2021 Received: March 15, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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,
# Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. 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
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# Indications for Use
510(k) Number (if known) K210752
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, 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) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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Image /page/3/Picture/1 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue graphic element resembling two crescent shapes facing each other, flanking the word "DEVICOR" in bold, black sans-serif font. Below "DEVICOR" are the words "MEDICAL PRODUCTS, INC." in a smaller, lighter font. A registered trademark symbol appears next to the "R" in "DEVICOR".
#### 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
March 12, 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 | Special 510(k) Premarket Notification |
| Classification Panel | General & Plastic Surgery |
| Premarket Review | Surgical and Infection Control Devices (OHT4)<br>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:
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| Predicate<br>Device | • Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker<br>(K121113) [predicate device]<br>• Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker<br>(K130537) [reference device]<br>• Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker<br>(K161021) [reference device] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject<br>device] is substantially equivalent (SE) to the Devicor Medical Products Inc.<br>HydroMARK Breast Biopsy Site Marker (K121113) [predicate devices] and the Devicor<br>Medical Products, Inc. HydroMARK Breast Biopsy Site Marker (K130537 and K161021)<br>[reference devices] in terms of the identical indications for use / intended use to mark<br>tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for<br>at least 6 weeks, and be permanently visible by x-ray and MRI. |
| | • Substantial equivalency (SE) of the subject device has also been based on<br>substantially equivalent design, functionality, and performance characteristics<br>as the predicate device and reference devices. |
#### 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 is 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 Special 510(k) is being submitted for modifications to the labeling of the cleared devices, HydroMARK Breast Biopsy Site Marker (K12113) [predicate device] and HydroMARK Breast Biopsy Site Marker (K130537 and K161021) [reference devices]. The fundamental scientific technology of the HydroMARK Breast Biopsy Site Markers has not changed. 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 and method, no changes to packaging, no changes to shelf-life, and no changes to indications for use or intended use.
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Changes to the labeling include the modifications to the User Instructions & Operations Guide, Deployment Guide, Safety and Precautions Booklet, and packaging labels mentioned below:
- . Modifying the predicate User Instructions & Operations Guide from 1 summative to 7 productbased User Instructions & Operations Guides;
- . Creating a Safety and Precautions Booklet, and label modifications to transition the predicate User Instructions & Operations Guide to an electronic version;
- . Updating translations and symbols in the deployment guide;
- . Updating labels to be more descriptive with marker shape names to match how each device is marketed, adding the manufacturing date, and changing from a barcode to a data matrix Unique Device Identifier (UDI);
- . Combining package and variable labels for cost savings;
- . Adding a contraindication to the predicate User Instructions & Operations Guide that the marker should not be implanted in infected areas;
- . Adding a contraindication to the predicate User Instructions & Operations Guide that the physician should not use the Stainless Steel markers on patients with known nickel allergies.
- O Adding "Contains Nickel" symbols to the labels of the Stainless Steel markers.
- O Adding "Does Not Contain Nickel" symbols to the labels of the Titanium markers.
- . Adding a contraindication to the predicate User Instructions & Operations Guide that the marker is not intended for the pediatric population under twelve years of age;
- . Adding a contraindication to the predicate User Instructions & Operations Guide that the marker should not be used on patients with known allergies to poly (ethylene glycol), poly (trimethylene carbonate), and acrylate-capped poly (L-lactide);
- . Adding an Adverse Reactions section to the predicate User Instructions & Operations Guide;
- . Removing the Caution section from the predicate User Instructions & Operations Guide and transferring all the information to a new Warnings Section.
- . Updating the MR Safety Information section of the predicate User Instructions & Operations Guide to include MR Image Artifact.
# 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 (K121113) [predicate device] and the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K130537 and K161021) [reference devices].
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)]
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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 (K12113) [predicate device] and the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K130537 and K161021) [reference devices] based on the identical indication for use / intended use and the same functional and performance characteristics of the subject device when compared to the predicate device and the reference devices. The minor differences between the subject device and predicate device/reference devices User Instructions & Operation Guides and labeling do not raise new or different issues 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 devices, as well as, the minor differences in the User Instructions & Operation Guide and labels which do not raise new or different issues of safety and effectiveness, support a determination of substantial equivalency (SE) is provided below.
| Regulatory<br>Information | HydroMARK Breast Biopsy<br>Site Marker<br>[Subject Device] | HydroMARK Breast<br>Biopsy Site Marker<br>(K121113)<br>[Predicate Device]<br>HydroMARK Breast<br>Biopsy Site Marker<br>(K130537 and K161021)<br>[Reference Devices] | Similarities /<br>Differences |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Manufacturer | Devicor Medical Products<br>De Mexico S De RL De CV | Devicor Medical<br>Products De Mexico S De<br>RL De CV | Same |
| Device Trade or<br>Proprietary<br>Name | HydroMARK Breast Biopsy<br>Site Marker | HydroMARK Breast<br>Biopsy Site Marker | Same |
| 510(k) Number | N/A | K121113<br>K130537<br>K161021 | N/A |
| Device Class | Class II | Class II | Same |
| Device<br>Classification<br>Name | Marker, Radiographic,<br>Implantable | Marker, Radiographic,<br>Implantable | Same |
| Device Common<br>Name | Implantable Clip | Implantable Clip | Same |
| Product Code | (NEU) - Marker,<br>Radiographic, Implantable | (NEU) - Marker,<br>Radiographic,<br>Implantable | Same |
| Regulation<br>Number | 21 CFR §878.4300 | 21 CFR §878.4300 | Same |
| Indications for<br>Use | To mark tissue during a<br>percutaneous breast<br>biopsy<br>procedure, be visible under<br>ultrasound for at least 6<br>weeks, and be<br>permanently visible by x-<br>ray and MRI. | To mark tissue during a<br>percutaneous breast<br>biopsy<br>procedure, be visible<br>under<br>ultrasound for at least 6<br>weeks, and be<br>permanently visible by x-<br>ray and MRI. | Same |
| Prescription or<br>Over-the-<br>Counter (OTC)<br>Use | Prescription | Prescription | Same |
| | Use Environment | | |
| Sterile | Yes | Yes | Same |
| Single-Use | Yes | Yes | Same |
| | Design Features | | |
| Marker<br>Composition | Polymerized and<br>desiccated<br>hydrogel | Polymerized and<br>desiccated<br>hydrogel | Same |
| Coil (Marker)<br>Composition | Titanium or Stainless Steel | Titanium or Stainless<br>Steel | Same |
| Coil (Marker)<br>Shapes | Barrel (T1, S1)<br>Butterfly (T4)<br>Open Coil (T3, S3) | Barrel (T1, S1)<br>Butterfly (T4)<br>Open Coil (T3, S3) | Same |
| | Cannula Type | | |
| 4010-01-08 | Flexible | Flexible | Same |
| 4010-03-09 | Rigid | Rigid | Same |
| 4010-04-09 | Rigid | Rigid | Same |
| 4010-01-11 | Rigid | Rigid | Same |
| 4010-02-15 | Rigid | Rigid | Same |
| 4010-03-15 | Rigid | Rigid | Same |
| 4010-02-18 | Rigid | Rigid | Same |
| | Cannula Material | | |
| 4010-01-08 | Polyether-b-amide | Polyether-b-amide | Same |
| 4010-03-09 | Stainless Steel | Stainless Steel | Same |
| 4010-04-09 | Stainless Steel | Stainless Steel | Same |
| 4010-01-11 | Polyether-b-amide | Polyether-b-amide | Same |
| 4010-02-15 | Stainless Steel | Stainless Steel | Same |
| 4010-03-15 | Stainless Steel | Stainless Steel | Same |
| 4010-02-18 | Stainless Steel | Stainless Steel | Same |
| | Plunger Rod Type | | |
| 4010-01-08 | Continuous Flexible Nylon<br>Rod | Continuous Flexible Nylon<br>Rod | Same |
| 4010-03-09 | Rigid Stainless Steel Rod with<br>welded Flexible Spring Tip | Rigid Stainless Steel Rod<br>with welded Flexible Spring<br>Tip | Same |
| 4010-04-09 | Rigid Stainless Steel Rod | Rigid Stainless Steel Rod | Same |
| 4010-01-11 | Continuous Flexible Nylon<br>Rod | Continuous Flexible Nylon<br>Rod | Same |
| 4010-02-15 | Rigid Stainless Steel Rod | Rigid Stainless Steel Rod | Same |
| 4010-03-15 | Rigid Stainless Steel Rod | Rigid Stainless Steel Rod | Same |
| 4010-02-18 | Rigid Stainless Steel Rod | Rigid Stainless Steel Rod | Same |
| Plunger Rod Material | | | |
| 4010-01-08 | Nylon | Nylon | Same |
| 4010-03-09 | Stainless Steel Rod + Stainless<br>Steel Tension Spring Flexible<br>Tip | Stainless Steel Rod +<br>Stainless Steel Tension<br>Spring Flexible Tip | Same |
| 4010-04-09 | Stainless Steel | Stainless Steel | Same |
| 4010-01-11 | Nylon | Nylon | Same |
| 4010-02-15 | Stainless Steel | Stainless Steel | Same |
| 4010-03-15 | Stainless Steel | Stainless Steel | Same |
| 4010-02-18 | Stainless Steel | Stainless Steel | Same |
| Packaging and Sterilization | | | |
| Packaging | Foil pouch with Tyvek vent | Foil pouch with Tyvek<br>vent | Same |
| Sterilization<br>Method | ETO | ETO | Same |
| Shelf Life | 3 years/36 months | 3 years/36 months | Same |
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# VII. SUMMARY OF VERIFICATION DATA AND VERIFICATION TEST CONCLUSIONS [Per 807.92(b)(1)(2)(3)]
Verification Testing by document analysis of the labeling modifications was conducted on the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] to confirm that the device meets all system labeling requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K12113) [predicate device] and the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K130537 and K161021) [reference devices]. The following Verification Data was provided in support of the substantial equivalence (SE) determination.
#### Verification Testing
- Verification Testing including: .
- o Document Analysis of Labeling Changes
| Summary of Non-Clinical Bench Performance Testing | | |
|---------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------|
| • | Design Verification by Document | Test Results: PASSED |
| | Analysis of Labeling Changes | The results of these Verification Data are provided in support of the<br>substantial equivalence (SE) determination. |
| FDA Recognized Testing Standards: | | |
| | • ISO 13485:2016 Certification | |
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| | Medical Devices – Quality | Conclusion Supporting Substantial Equivalence: The results of the |
|---|-----------------------------------|---------------------------------------------------------------------|
| | Management Systems – | Design Verification Testing by Document Analysis of Labeling |
| | Requirements for Regulatory | Changes conducted on the Devicor Medical Products, Inc. |
| | Purposes process for medical | HydroMARK Breast Biopsy Site Marker [subject device] |
| | devices | demonstrates that the subject device is as safe and as effective as |
| ○ | ISO 14971:2007 (Ed.2.0) - Medical | the legally marketed predicate device and reference devices. This |
| | Devices - Application of Risk | testing supports a determination of substantial equivalence of the |
| | Management to Medical Devices | Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site |
| | | Marker [subject device] when compared to the Devicor Medical |
| | | Products Inc. HydroMARK Breast Biopsy Site Marker (K121113) |
| | | [predicate device] and the Devicor Medical Products Inc. |
| | | HydroMARK Breast Biopsy Site Marker (K130537 and K161021) |
| | | [reference devices]. |
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 (K12113) [predicate device] and the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K130537 and K161021) [reference devices].
#### VIII. CONCLUSIONS
The data generated from the results of the Verification Testing 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/reference devices 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 (K12113) [predicate device] and the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K130537 and K161021) [reference devices].
The similar indications for use, intended use, technological characteristics, 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/reference devices, and any differences in labeling do not raise different issues of safety and effectiveness when compared to the predicate and reference devices. Therefore, the Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject device] is substantially equivalent to the predicate and reference devices.
