HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)

K240527 · Devicor Medical Products, Inc. · NEU · Jul 10, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K240527
• Device Name: HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
• Applicant: Devicor Medical Products, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Jul 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.

Device Story

Implantable marker for breast biopsy or axillary lymph node site identification; consists of titanium marker embedded in highly expandable polymerized/desiccated hydrogel cylinder. Upon fluid contact, hydrogel expands to equilibrium point, providing ultrasound visibility; hydrogel resorbed by body over time. Titanium wire remains permanently visible under x-ray and MRI. Supplied pre-loaded in sterile, disposable applicator; deployed via compatible introducer or direct puncture into biopsy cavity. Used in clinical settings by physicians; permanent implant not intended for removal unless tissue is surgically excised. Benefits include long-term site localization for follow-up imaging and surgical planning.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included marker size, deployment force, and visibility assessments. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, subacute/subchronic/chronic toxicity, implantation, genotoxicity, carcinogenicity). All tests passed.

Technological Characteristics

Materials: Titanium marker, polymerized/desiccated hydrogel, stainless steel cannula/plunger, plastic handle. Form factor: Implantable marker in disposable applicator. Connectivity: None. Sterilization: Sterile. Standards: ISO 13485:2016, ISO 14971:2019, ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2016, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-17:2002, ISO 10993-18:2020, ISO 10993-23:2021.

Indications for Use

Indicated for marking tissue during percutaneous breast biopsy procedures, including axillary lymph nodes, in patients requiring biopsy site localization. Marker remains visible under ultrasound for at least 6 weeks and permanently visible via x-ray and MRI.

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™ Plus Breast Biopsy Site Marker (K221961)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 10, 2024

Devicor Medical Products, Inc. Katy Austin Senior Regulatory Affairs Specialist 300 E-Business Way, Fifth Floor Cincinnati. Ohio 45241

# Re: K240527

Trade/Device Name: HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) Regulation Number: 21 CFR 878.4300 Regulation Name: Marker, Radiographic, Implantable Regulatory Class: Class II Product Code: NEU Dated: June 10, 2024 Received: June 11, 2024

# Dear Katy Austin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

#### Sincerely, Digitally signed by Tek N Tek N. Lamichhane -S Lamichhane -s Date: 2024.07.10 20:36:18 -04'00 Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

Center for Devices and Radiological Health

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K240527

Device Name

HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)

Indications for Use (Describe)

The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary K240527

### SUBMITTER

#### Sponsor/Manufacturer

Devicor Medical Products, Inc. 300 E. Business Way, Fifth Floor Cincinnati, OH 45241 U.S.A.

# Establishment Registration Number

3008492462

#### Official Correspondent for Devicor Medical Products, Inc.

Katy Austin, Senior Regulatory Affairs Specialist Phone: [phone] Email: [e-mail]

#### Date Prepared

July 8, 2024

### DEVICE

| Device Trade/Proprietary Name: | HydroMARK ™ Plus Breast Biopsy Site Marker<br>(Hummingbird shape) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------|
| Regulation Description | Implantable Marker |
| 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)<br>Infection Control and Plastic Surgery Devices (DHT4B) |

## PREDICATE DEVICE

| | The Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Sponsor's own predicate devices: |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Devicor Medical Products Inc. HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly, predicate device] |
| Predicate Device | The Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker [Hummingbird, subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly, predicate device] in terms of identical Indications for Use / Intended Use. |

{4}------------------------------------------------

| The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a<br>percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under<br>ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial equivalence (SE) of the subject device is based on substantially<br>equivalent design, functionality, and performance characteristics as the<br>predicate device |

### DEVICE DESCRIPTION

The HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird, subject device) is a two-component marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed.

The HydroMARK™ Plus Breast Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue requires surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer or by direct puncture into the biopsy cavity created by the breast biopsy device.

| Model Number | Material | Shape type | Shape |
|---------------|----------|-------------|--------------------------|
| 4010-02-15-T6 | Titanium | Hummingbird | Image: Hummingbird shape |

This Traditional 510(k) is being submitted to introduce HydroMARK™ Plus Breast Biopsy Siter Markers to the marketplace as part of the Mammotome brand, and the fundamental scientific technology when compared to the HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly, predicate device] has not changed. HydroMARK™ Plus Breast Biopsy Siter Marker [Hummingbird, subject device] will have an 18 month shelf life at launch.

A User Instructions & Operations Guide, and Safety Information Booklet will be provided for all HydroMARK™ Plus Breast Biopsy Siter Markers.

### INDICATIONS FOR USE

The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.

{5}------------------------------------------------

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Siter Marker [Hummingbird, subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly, predicate device] based on the similar functional and performance characteristics of the subject device when compared to the predicate device. The minor differences between the subject device and predicate device regarding marker shape do not raise concerns of safety and effectiveness.

A side-by-side comparison of the technological characteristics of the subject device and the predicate device, supports a determination of substantial equivalency (SE) per the table below.

| Subject HydroMARK™ Plus Comparison to Predicate HydroMARK™ Plus (K221961) | | | |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Regulatory<br>Information | HydroMARK™ Plus Breast Biopsy Site Marker [Hummingbird, Subject Device] K240527 | HydroMARK™ Plus Breast Biopsy Site Marker [Dragonfly, Predicate Device] K212158 | Comparison |
| Manufacturer | Devicor Medical Products<br>De Mexico S De RL De CV | Devicor Medical Products<br>De Mexico S De RL De CV | Same |
| Device Trade or<br>Proprietary Name | HydroMARK™ Plus Breast Biopsy Site Marker | HydroMARK™ Plus Breast Biopsy Site Marker | Same |
| Device Class | Class II | Class II | Same |
| Device Classification<br>Name | Marker, Radiographic, Implantable | Marker, Radiographic, Implantable | Same |
| Device Common<br>Name | Implantable Marker | Implantable Marker | Same |
| Product Code | (NEU) – Marker, Radiographic, Implantable | (NEU) – Marker, Radiographic, Implantable | Same |
| Regulation<br>Number | 21 CFR §878.4300 | 21 CFR §878.4300 | Same |
| Design Features and Capabilities of the Device | | | |
| Indications for<br>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, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI. | Same |
| Prescription or<br>Over-the-Counter (OTC)<br>Use | Prescription | Prescription | Same |
| Use Environment | | | |
| Sterile | Yes | Same | |
| Single-Use | Yes | Same | |
| Design Features | | | |
| Marker Material | Titanium marker, surrounded by hydrogel | Same | |
| Marker Shape | Hummingbird | Substantially Equivalent | |
| Cannula Type | Rigid | Same | |
| Cannula<br>Material | Stainless Steel | Same | |
| Plunger Rod<br>Material | Stainless Steel | Same | |
| Plastic Handle | Plastic Polymer | Same | |
| Plunger Lock | Plastic Polymer | Same | |
| Plastic Plunger<br>Button | Plastic Polymer | Same | |
| Shelf Life | 1.5 years/18 months | Same | |
| Biocompatibility<br>results | Chemical<br>- Characterization<br>- Cytotoxicity<br>- Sensitization<br>- Irritation<br>- Acute Systemic<br>- Toxicity<br>- Pyrogenicity<br>- Subacute/ Chronic/<br>- Subchronic Toxicity<br>- Implantation<br>- Genotoxicity<br>- Carcinogenicity | Chemical<br>- Characterization<br>- Cytotoxicity<br>- Sensitization<br>- Irritation<br>- Acute Systemic<br>- Toxicity<br>- Pyrogenicity<br>- Subacute/ Chronic/<br>- Subchronic Toxicity<br>- Implantation<br>- Genotoxicity<br>- Carcinogenicity | Same |
| Performance<br>evaluation<br>testing | Marker Size<br>- Deployment Force<br>- Visibility | Marker Size<br>- Deployment Force<br>- Visibility | Substantially Equivalent |
| MR Testing Results | | | |
| MR Status for<br>Marker | MR Conditional | Same | |
| MR Status for<br>Applicator | MR Unsafe | Same | |

{6}------------------------------------------------

{7}------------------------------------------------

## SUMMARY OF VERIFICATION DATA AND VERIFICATION TEST CONCLUSIONS

#### Summary of Performance Testing

Performance Testing was conducted on the Devicor Medical Products, Inc. HydroMARK™ Plus 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 (K221961) [predicate device]. The following Verification Data was provided in support of the substantial equivalence (SE) determination.

| Performance Testing | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing<br>HydroMARK™ Plus | Test Results: PASSED<br>The results of all performance testing met acceptance criteria and are provided in support of the substantial equivalence determination. |
| HydroMARK™ Plus Risk<br>Management | Results: All risks have been reduced as far as possible through allowed controls: Inherent safety by design, information for safety, and/or preventative measures. |
| FDA Recognized Testing<br>Standards: ISO 13485:2016<br>Certification – Medical<br>Devices - Quality<br>Management Systems –<br>Requirements for<br>Regulatory Purposes<br>process for medical<br>devices ISO 14971:2019 (Ed.3.0)<br>– Medical Devices -<br>Application of Risk<br>Management to Medical<br>Devices | Conclusion Supporting Substantial Equivalence: The results of the design verification carried out within Devicor Medical Product's ISO 13485:2016 compliant Quality Management System conducted on the HydroMARK™ Plus Breast Biopsy Site Marker [subject device] demonstrates that the subject device is as safe and as effective as the legally marketed predicate device. This evidence in conjunction with the ISO 14971:2019 compliant Risk Management process supports a determination of substantial equivalence of the Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker [Hummingbird, subject device] when compared to the Devicor Medical Products Inc. HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly, predicate device]. |
| Biocompatibility Testing | |
| Biocompatibility Testing including: Chemical Characterization Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Material-Mediated<br>Pyrogenicity Subacute/Subchronic/ Chronic<br>Toxicity Implantation Effects Genotoxicity Carcinogenicity | Test Results: PASSED<br>The results of these Non-Clinical Bench Performance Data are provided in support of the substantial equivalence determination. |
| FDA Recognized Testing Standards: | Conclusion Supporting Substantial Equivalence: |
| ISO 10993-1:2018-Biological<br>Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk<br>Management Process ISO 10993-3:2014 Biological<br>Evaluation of Medical Devices - Part 3:<br>Tests for Genotoxicity, carcinogenicity<br>and reproductive toxicity ISO 10993-5:2009-Biological<br>Evaluation of Medical Devices - Part 5:<br>Tests for In Vitro Cytotoxicity ISO 10993-6:2016-Biological<br>Evaluation of Medical Devices - Part 6:<br>Tests for local effects after<br>implantation ISO 10993-10:2010-Biological<br>Evaluation of Medical Devices - Part<br>10: Tests for Irritation and Skin<br>Sensitization ISO 10993-11:2017-Biological<br>Evaluation of Medical Devices - Part<br>11: Tests for Systemic Toxicity ISO 10993-17:2002 Biological<br>Evaluation of Medical Devices - Part<br>17: Establishment of allowable limits<br>for leachable substances ISO 10993-18:2020 Biological<br>Evaluation of Medical Devices - Part<br>18: Chemical characterization of<br>medical device materials within a risk<br>management process ISO 10993-23:2021 Biological<br>Evaluation of Medical Devices - Part<br>23: Tests for Irritation | The results of the Biocompatibility Testing conducted on the Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker [Hummingbird, 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™ Plus Breast Biopsy Site Marker [Hummingbird, subject device] when compared to the Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly, predicate device]. |
| Conclusion: The results of the Verification Testing support the safety of the device and demonstrate that the Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker [Hummingbird, subject device] | |

{8}------------------------------------------------

### SUBSTANTIAL EQUIVALENCE SUMMARY / CONCLUSIONS

Based on the verification results and a side-by-side comparison of the technological characteristics of design, indication for use / intended use, components, and materials of construction, it is concluded that the Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker [Hummingbird, subject device] is substantially equivalent to the Devicor Medical Products Inc. HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly predicate devices].

Products Inc. HydroMARK™ Plus Breast Biopsy Site Marker (K221961) [Dragonfly, predicate device].