(138 days)
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.
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.
The HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird shape) does not involve AI. The provided text describes a medical device, a breast biopsy site marker, and its substantial equivalence to a predicate device. None of the listed points (acceptance criteria, device performance, sample size, ground truth, experts, adjudication, MRMC study, standalone performance, training set, or ground truth for training) are relevant to this type of device submission, especially concerning AI/ML aspects.
The submission focuses on establishing substantial equivalence to a legally marketed predicate device (HydroMARK™ Plus Breast Biopsy Site Marker with a Dragonfly shape, K221961) based on similar design, functionality, performance, and materials.
The key acceptance criteria and performance data for this device are related to its physical characteristics and biological compatibility, rather than AI model performance metrics.
Here's a summary of the relevant information provided, structured to respond to the prompt as closely as possible, even though AI/ML specific information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General for device type) | Reported Device Performance (Summary from submission) |
|---|---|
| Indications for Use: | |
| - Mark tissue during percutaneous breast biopsy (including axillary lymph nodes) | "Test Results: PASSED" - Device meets all system requirements as confirmed by performance testing. |
| - Visible under ultrasound for at least 6 weeks | "Test Results: PASSED" - Device meets all system requirements as confirmed by performance testing. |
| - Permanently visible by x-ray and MRI | "Test Results: PASSED" - Device meets all system requirements as confirmed by performance testing. |
| Material/Design/Biocompatibility: | |
| - Marker Material: Titanium and hydrogel | "Test Results: PASSED" - Biocompatibility testing met acceptance criteria. |
| - Sterility | "Test Results: PASSED" - Device is sterile. |
| - Single-Use | "Test Results: PASSED" - Device is single-use. |
| - Biocompatibility (Chemical characterization, Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Subacute/Chronic Toxicity, Implantation, Genotoxicity, Carcinogenicity) | "Test Results: PASSED" - Comprehensive biocompatibility testing confirmed safety. |
| - MR Conditional Status (for marker) | "Test Results: PASSED" - Marker is MR Conditional. |
| - MR Unsafe Status (for applicator) | "Test Results: PASSED" - Applicator is MR Unsafe. |
| Performance Evaluations: | |
| - Marker Size | "Test Results: PASSED" |
| - Deployment Force | "Test Results: PASSED" |
| - Visibility | "Test Results: PASSED" |
| Risk Management: | "Results: All risks have been reduced as far as possible through allowed controls." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for performance testing. It states that "Performance Testing was conducted" and "The results of all performance testing met acceptance criteria." The provenance is not explicitly mentioned but is implied to be from the manufacturer's internal testing as part of their ISO 13485:2016 compliant Quality Management System. This type of device does not typically involve clinical data from patients or diverse populations for basic substantial equivalence claims like this.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical marker and its performance evaluation involves objective physical, chemical, and biological tests rather than interpretation by human experts to establish ground truth for a test set in the context of AI/ML.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for human interpretation or multi-reader studies, which are not described for this device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-powered diagnostic tool, and therefore, no MRMC study was conducted in relation to AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software requiring standalone performance evaluation in the context of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be derived from objective engineering, material, and biocompatibility testing standards. For instance:
- Visibility: Confirmed through imaging techniques (ultrasound, X-ray, MRI) in a controlled setting or phantom, comparing against known visual properties.
- Biocompatibility: Determined by adherence to ISO 10993 standards through laboratory assays and in-vivo animal studies.
- Deployment Force, Marker Size: Measured quantitatively using calibrated instruments.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a training set for an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set for an AI/ML model.
Conclusion stated in the document: The applicant concluded that the HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird shape) is substantially equivalent to the predicate device (HydroMARK™ Plus Breast Biopsy Site Marker, K221961, Dragonfly shape) based on "similar functional and performance characteristics" and "substantially equivalent design, functionality, and performance characteristics." The "minor differences between the subject device and predicate device regarding marker shape do not raise concerns of safety and effectiveness."
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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).
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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
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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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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. |
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| The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during apercutaneous breast biopsy procedure, including axillary lymph nodes, be visible underultrasound 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 substantiallyequivalent design, functionality, and performance characteristics as thepredicate 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.
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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) | |||
|---|---|---|---|
| RegulatoryInformation | HydroMARK™ Plus Breast Biopsy Site Marker [Hummingbird, Subject Device] K240527 | HydroMARK™ Plus Breast Biopsy Site Marker [Dragonfly, Predicate Device] K212158 | Comparison |
| Manufacturer | Devicor Medical ProductsDe Mexico S De RL De CV | Devicor Medical ProductsDe Mexico S De RL De CV | Same |
| Device Trade orProprietary Name | HydroMARK™ Plus Breast Biopsy Site Marker | HydroMARK™ Plus Breast Biopsy Site Marker | Same |
| Device Class | Class II | Class II | Same |
| Device ClassificationName | Marker, Radiographic, Implantable | Marker, Radiographic, Implantable | Same |
| Device CommonName | Implantable Marker | Implantable Marker | Same |
| Product Code | (NEU) – Marker, Radiographic, Implantable | (NEU) – Marker, Radiographic, Implantable | Same |
| RegulationNumber | 21 CFR §878.4300 | 21 CFR §878.4300 | Same |
| Design Features and Capabilities of the Device | |||
| Indications forUse | 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 orOver-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 | |
| CannulaMaterial | Stainless Steel | Same | |
| Plunger RodMaterial | Stainless Steel | Same | |
| Plastic Handle | Plastic Polymer | Same | |
| Plunger Lock | Plastic Polymer | Same | |
| Plastic PlungerButton | Plastic Polymer | Same | |
| Shelf Life | 1.5 years/18 months | Same | |
| Biocompatibilityresults | 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 |
| Performanceevaluationtesting | Marker Size- Deployment Force- Visibility | Marker Size- Deployment Force- Visibility | Substantially Equivalent |
| MR Testing Results | |||
| MR Status forMarker | MR Conditional | Same | |
| MR Status forApplicator | MR Unsafe | Same |
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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 TestingHydroMARK™ Plus | Test Results: PASSEDThe results of all performance testing met acceptance criteria and are provided in support of the substantial equivalence determination. |
| HydroMARK™ Plus RiskManagement | 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 TestingStandards: ISO 13485:2016Certification – MedicalDevices - QualityManagement Systems –Requirements forRegulatory Purposesprocess for medicaldevices ISO 14971:2019 (Ed.3.0)– Medical Devices -Application of RiskManagement to MedicalDevices | 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-MediatedPyrogenicity Subacute/Subchronic/ ChronicToxicity Implantation Effects Genotoxicity Carcinogenicity | Test Results: PASSEDThe 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-BiologicalEvaluation of Medical Devices - Part 1:Evaluation and Testing Within a RiskManagement Process ISO 10993-3:2014 BiologicalEvaluation of Medical Devices - Part 3:Tests for Genotoxicity, carcinogenicityand reproductive toxicity ISO 10993-5:2009-BiologicalEvaluation of Medical Devices - Part 5:Tests for In Vitro Cytotoxicity ISO 10993-6:2016-BiologicalEvaluation of Medical Devices - Part 6:Tests for local effects afterimplantation ISO 10993-10:2010-BiologicalEvaluation of Medical Devices - Part10: Tests for Irritation and SkinSensitization ISO 10993-11:2017-BiologicalEvaluation of Medical Devices - Part11: Tests for Systemic Toxicity ISO 10993-17:2002 BiologicalEvaluation of Medical Devices - Part17: Establishment of allowable limitsfor leachable substances ISO 10993-18:2020 BiologicalEvaluation of Medical Devices - Part18: Chemical characterization ofmedical device materials within a riskmanagement process ISO 10993-23:2021 BiologicalEvaluation of Medical Devices - Part23: 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] |
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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].
§ 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.