(138 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 used to mark tissue post-biopsy, not to treat a disease or condition.
No
Explanation: The device is a site marker used to permanently mark tissue after a breast biopsy procedure. It does not perform any diagnostic function.
No
The device description clearly states it is a "two-component marker" with an "implantable marker" made of hydrogel and a "permanent titanium marker embedded," which are physical components, not software.
Based on the provided information, this device 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. This is a procedural device used in vivo (within the body) to mark a specific location.
- Device Description: The device is described as an implantable marker that is deployed into the biopsy cavity. It is a physical object placed within the body.
- Lack of In Vitro Activity: IVD devices are used to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device does not analyze or test any biological samples in a laboratory setting.
The device's function is to provide a visible marker within the body for subsequent imaging, not to diagnose or provide information about a disease state based on the analysis of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, x-ray, MRI
Anatomical Site
breast biopsy, 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)
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 results of all performance testing met acceptance criteria and are provided in support of the substantial equivalence determination.
HydroMARK™ Plus Risk Management: All risks have been reduced as far as possible through allowed controls: Inherent safety by design, information for safety, and/or preventative measures.
Biocompatibility Testing: The results of these Non-Clinical Bench Performance Data are provided in support of the substantial equivalence determination.
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] is as safe, as effective, and performs as well as, the legally marketed 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). 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 513-919-8842 Email: katy.austin@mammotome.com
Date Prepared
July 8, 2024
DEVICE
| Device Trade/Proprietary Name: | HydroMARK ™ Plus Breast Biopsy Site Marker
(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)
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
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. |
|---|
| Substantial equivalence (SE) of the subject device is based on substantially |
| equivalent design, functionality, and performance characteristics as the |
| 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 | |||
| 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 | ||
| De Mexico S De RL De CV | Devicor Medical Products | ||
| De Mexico S De RL De CV | Same | ||
| Device Trade or | |||
| Proprietary Name | HydroMARK™ Plus Breast Biopsy Site Marker | HydroMARK™ Plus Breast Biopsy Site Marker | Same |
| Device Class | Class II | Class II | Same |
| Device Classification | |||
| Name | Marker, Radiographic, Implantable | Marker, Radiographic, Implantable | Same |
| Device Common | |||
| Name | Implantable Marker | Implantable Marker | 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, 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 | |||
| Over-the-Counter (OTC) | |||
| 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 | |||
| Material | Stainless Steel | Same | |
| Plunger Rod | |||
| Material | Stainless Steel | Same | |
| Plastic Handle | Plastic Polymer | Same | |
| Plunger Lock | Plastic Polymer | Same | |
| Plastic Plunger | |||
| Button | Plastic Polymer | Same | |
| Shelf Life | 1.5 years/18 months | Same | |
| Biocompatibility | |||
| results | Chemical |
- Characterization
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic
- Toxicity
- Pyrogenicity
- Subacute/ Chronic/
- Subchronic Toxicity
- Implantation
- Genotoxicity
- Carcinogenicity | Chemical
- Characterization
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic
- Toxicity
- Pyrogenicity
- Subacute/ Chronic/
- Subchronic Toxicity
- Implantation
- Genotoxicity
- Carcinogenicity | Same |
| Performance
evaluation
testing | Marker Size - Deployment Force
- Visibility | Marker Size
- Deployment Force
- Visibility | Substantially Equivalent |
| MR Testing Results | | | |
| MR Status for
Marker | MR Conditional | Same | |
| MR Status for
Applicator | MR Unsafe | Same | |
6
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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 | |
| HydroMARK™ Plus | Test Results: PASSED |
| The results of all performance testing met acceptance criteria and are provided in support of the substantial equivalence determination. | |
| HydroMARK™ Plus Risk | |
| 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 | |
| Standards: ISO 13485:2016 | |
| Certification – Medical | |
| Devices - Quality | |
| Management Systems – | |
| Requirements for | |
| Regulatory Purposes | |
| process for medical | |
| devices ISO 14971:2019 (Ed.3.0) | |
| – Medical Devices - | |
| Application of Risk | |
| Management to Medical | |
| 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 | |
| Pyrogenicity Subacute/Subchronic/ Chronic | |
| Toxicity Implantation Effects Genotoxicity Carcinogenicity | Test Results: PASSED |
| 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 | |
| Evaluation of Medical Devices - Part 1: | |
| Evaluation and Testing Within a Risk | |
| Management Process ISO 10993-3:2014 Biological | |
| Evaluation of Medical Devices - Part 3: | |
| Tests for Genotoxicity, carcinogenicity | |
| and reproductive toxicity 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 10993-17:2002 Biological | |
| Evaluation of Medical Devices - Part | |
| 17: Establishment of allowable limits | |
| for leachable substances ISO 10993-18:2020 Biological | |
| Evaluation of Medical Devices - Part | |
| 18: Chemical characterization of | |
| medical device materials within a risk | |
| management process ISO 10993-23:2021 Biological | |
| Evaluation of Medical Devices - Part | |
| 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].