(373 days)
HydroMARK™ Plus Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI
The HydroMARK™ Plus Breast Biopsy Site Marker contains a two-component implantable 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 implantable component of the HydroMARK™ Plus Biopsy Site Marker is supplied preloaded 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 provided text is a 510(k) Summary for the HydroMARK™ Plus Breast Biopsy Site Marker, seeking to establish substantial equivalence to a predicate device (HydroMARK™ Breast Biopsy Site Marker). It details various performance and biocompatibility tests conducted to demonstrate this equivalence, rather than providing the kind of robust clinical study data typically associated with an AI/ML device approval that would include information on expert reader performance, ground truth establishment, and training/test set details as requested in the prompt.
Therefore, much of the requested information regarding AI/ML-specific study design (such as number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, and training/test set details for AI models) is not applicable to this submission, as it describes a physical medical device (a biopsy site marker) and its performance, not an AI/ML diagnostic or assistive tool.
However, I can extract the relevant acceptance criteria and reported device performance from the provided document, relating to the physical device itself.
Here's the breakdown based on the provided text, focusing on the device's performance characteristics as a physical marker:
1. A table of acceptance criteria and the reported device performance:
Since this is a physical device and not an AI/ML algorithm, the "acceptance criteria" are derived from the "Indications for Use" and various performance tests aiming to demonstrate substantial equivalence to the predicate device. The performance is reported as meeting these criteria, often by demonstrating equivalence or acceptable results compared to the predicate or relevant standards.
| Acceptance Criteria (Derived from Indications for Use / Bench Testing) | Reported Device Performance |
|---|---|
| Visibility under ultrasound for at least 6 weeks (from Indications for Use) | Verified. "Both immediate post-deployment testing and long-term migration performance of HydroMARK Plus Breast Biopsy Site Markers were confirmed." (While the specific "6 weeks" is not explicitly re-stated as a test result, the overall confirmation of long-term visibility supports this claim of equivalence to the predicate, which also states this.) Testing included "Time to Equilibrium" where "Testing proved both subject and predicate devices achieved hydrogel equilibrium within 24 hours, demonstrating substantial equivalence." |
| Permanently visible by x-ray and MRI (from Indications for Use) | Verified. The predicate device claims this, and the subject device uses the same titanium marker for permanent visibility, with "MRI Status (Marker)" being "Conditional" for both predicate and subject. "Both immediate post-deployment testing and long-term migration performance of HydroMARK Plus Breast Biopsy Site Markers were confirmed." (Again, specific "permanently visible" not numeric, but implied by equivalence and material.) |
| Safety and Effectiveness of Implantation | "Literature analysis was provided demonstrating product is safe and effective in both breast and lymph node." "HydroMARK™ Implantation Data: PASSED. All tests passed and no local tissue side effects were observed at both lymph node and intramuscular sites at 8 and 26 weeks. Applies only to implant portion of the device." "HydroMARK™ Plus Implantation Data: PASSED. All animals survived, and no abnormalities or adverse reactions were observed at necroscopy. Overall, the test article scored a relative score of '0' with a reactivity grade of 'minimal or no reaction' per Table E.3. of ISO 10993-6:2016 and met the requirements of the study." |
| Residual Moisture (Substantial Equivalence to Predicate) | "RESULTS: Testing provided no statistical difference with 95% confidence comparing predicate and subject devices, proving substantial equivalence." |
| Hydrogel Degradation (Substantial Equivalence to Predicate) | "RESULTS: Testing and existing clinical evidence of HydroMARK™ hydrogel was provided demonstrating substantial equivalence between predicate and subject devices." |
| Biocompatibility (Meeting ISO 10993-1:2020 and other specific ISO standards) | "All the biocompatibility testing conducted on the HydroMARK™ device is applicable to HydroMARK™ Plus devices as well since it is an extension of the existing HydroMARK™ product family... The materials utilized in the HydroMARK™ and HydroMARK™ Plus Biopsy Site Marker devices have been evaluated against all applicable biological endpoints and are considered biocompatible in accordance with EN ISO 10993-1:2020..." Specific tests: Acute Systemic Toxicity (PASSED), Cytotoxicity (PASSED), Irritation (PASSED), Sensitization (PASSED), Pyrogenicity (PASSED). |
| Sterilization (Meeting ISO 11135:2014) | "Sterilization: PASSED. Meets standard for ISO 11135:2014 Sterilization of Health Care Products; Ethylene Oxide Requirements for Development, Validation and Routine control of a sterilization process for medical devices." |
| Shelf Life (Device: 18 months; Packaging: 36 months) | "Shelf Life [Device]: The shelf life for the HydroMARK™ Plus Breast Biopsy Site Marker [subject device] is 1.5 years/18 months." "Shelf Life [Packaging]: HydroMARK™ Plus Breast Biopsy Site Marker [subject device] has been assessed and passed for up to 36 months." |
| Risk Management (Acceptable per ISO 14971:2019 and company policies) | "All risks have been reduced as far as possible through allowed controls. The product risk is acceptable in view of the benefits of the device." "Based on the clinical steps and failure modes tested on HydroMARK™ Plus vs. HydroMARK™, risks have been determined to be acceptable to risk management policies." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not directly specified in terms of "cases" like in an AI/ML study, but performance and biocompatibility tests were conducted. For instance:
- Implantation Data: Refers to "All animals survived" and "no abnormalities or adverse reactions were observed at necroscopy" for the HydroMARK Plus Implantation Data. The specific number of animals is not provided in this summary. It mentions "standard muscle implantation and lymph node sites" for HydroMARK device data and "additional implantation study" for HydroMARK Plus.
- Residual Moisture, Time to Equilibrium, Toxicity, Pyrogenicity, Irritation, Sensitization: These are laboratory bench tests and animal studies. Specific sample sizes (e.g., number of test articles or animals per test) are not detailed in this summary document, but results are reported as "PASSED."
- Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "Non-Clinical Bench Performance Data" and "Biological Evaluation Testing," which are typically laboratory or animal studies, not human clinical trials. They would be prospective in the sense of being planned tests on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a physical device submission, not an AI/ML diagnostic. "Ground truth" for this device relates to physical and biological properties (e.g., material composition, sterility, biocompatibility, physical expansion, visibility under imaging modalities) established through engineering specifications, laboratory tests, and animal studies, not human expert reader consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for human reader studies, typically in AI/ML performance evaluations. The presented data is from bench and animal testing.
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. No MRMC study was done, as this is not an AI/ML device for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device is established through:
- Physical and Chemical Benchmarking: Direct measurements of material properties, expansion rates, and stability.
- Biological/Toxicological Standards: Compliance with ISO 10993 series for biocompatibility, using laboratory assays and animal studies to assess absence of toxicity, irritation, sensitization, and pyrogenicity, and demonstration of acceptable local tissue effects upon implantation over time.
- Imaging Visibility: Demonstration of visibility under ultrasound (acute and long-term), x-ray, and MRI, likely through phantom studies or animal imaging.
- Engineering Specifications: Adherence to design requirements, manufacturing processes, and sterilization validation.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/ML system requiring a training set. The device was developed through traditional engineering and material science principles.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an AI model. "Ground truth" for manufacturing and design would be established through material specifications, quality control, and adherence to established engineering principles and medical device standards.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has a blue square with the letters FDA in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 31, 2023
Devicor Medical Products, Inc. Katy Austin Regulatory Affairs Specialist 300 E-Business Wav. Fifth Floor Cincinnati, Ohio 45241
Re: K221961
Trade/Device Name: HydroMARK Plus Breast Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU
Dear Katy Austin:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter 07/13/2023. Specifically, FDA is updating this SE Letter with the correct IFU in the 510K database as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Tek Lamichhane, OHT4: Office of Surgical and Infection Control Devices, 301-796-8983, tek.lamichhane@fda.hhs.gov.
Sincerely,
Tek N.
Lamichhane -S
Digitally signed by Tek N.
Lamichhane -S
Date: 2023.08.31 15:34:24 -04'00'
Tek N. Lamichhane, Ph.D. 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
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 13, 2023
Devicor Medical Products, Inc. Katy Austin Regulatory Affairs Specialist 300 E-Business Wav. Fifth Floor Cincinnati, Ohio 45241
Re: K221961
Trade/Device Name: HydroMARK Plus Breast Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: April 27, 2023 Received: April 27, 2023
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 (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
{2}------------------------------------------------
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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
David Krause, Ph.D. Deputy Director, OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K221961
Device Name
HydroMARK Plus Breast Biopsy Site Marker
Indications for Use (Describe)
HydroMARK™ Plus Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue graphic element on the left, resembling two crescent shapes facing each other. To the right of this graphic is the company name, "DEVICOR," in bold, black letters. Below the company name, in smaller, light blue font, is the text "MEDICAL PRODUCTS, INC.", with a trademark symbol next to the word "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
Katy Austin Regulatory Affairs Specialist Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Ph: +1-513-708-6267 E-mail: katy.austin@mammotome.com
Date Prepared
July 11, 2023
II. DEVICE [Per 807.92(a)(2)]
| Device Trade/Proprietary Name: | HydroMARK ™ Plus Breast Biopsy Site Marker |
|---|---|
| Device Common or Usual Name: | Implantable Marker |
| Device Classification Name: | Marker, Radiographic, Implantable |
| Device Regulatory Classification: | Class II |
| Device Classification Regulation: | 21 CFR §878.4300 |
| Product Code: | (NEU) Marker, Radiographic, Implantable |
| Submission Type: | Premarket Notification Traditional 510(k) Submission |
| Review Panel: | General & Plastic Surgery |
| Premarket Review: | Surgical and Infection Control Devices (OHT4)Division of Health Technology 4B (DHT4B) |
III. PREDICATE DEVICE [Per 807.92(a)(3)]
{5}------------------------------------------------
| PredicateDevice | The Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker[subject device] is substantially equivalent (SE) to the Sponsor's own predicatedevices: |
|---|---|
| ●Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker(K212158) [predicate devices] | |
| The Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker[subject device] is substantially equivalent (SE) to the Devicor Medical ProductsInc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate devices] interms of the identical indications for use / intended use to mark tissue during apercutaneous breast biopsy procedure, including axillary lymph nodes, beingvisible under ultrasound for at least 6 weeks, and being permanently visible byx-ray and MRI. | |
| ● Substantial equivalency (SE) of the subject device has also been basedon substantially equivalent design, functionality, and performancecharacteristics compared to the predicate device. |
IV. DEVICE DESCRIPTION [Per 807.92(a)(4)]
The HydroMARK™ Plus Breast Biopsy Site Marker contains a two-component implantable 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 implantable marker is not intended to be removed unless the marked tissue requires surgical removal.
The implantable component of the HydroMARK™ Plus Biopsy Site Marker is supplied preloaded 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.
Image /page/5/Figure/4 description: The image shows a product with several components. On the left side of the image, there are four distinct items: a metal stand with three legs, a metal pin, a clear plastic container, and an orange handled tool. To the right of these items, there is a bullet point followed by the text "Dragonfly Shape: Model Number 4010-02-15-T5".
{6}------------------------------------------------
This Traditional 510(k) is being submitted to add a new marker device to the HydroMARK™ product line (K212158) [predicate device] that has an additional shape (named "Dragonfly") of the embedded titanium wire coil in the hydrogel. The fundamental scientific technology of the HydroMARK™ Plus Breast Biopsy Site Marker [subject device] has not changed compared to the HydroMARK™ Breast Biopsy Site Marker [predicate device]. This submission contains information to support:
- . Modifying the titanium wire shape to reflect the additional marker shape of Dragonfly under this HydroMARK™ Plus Breast Biopsy Site Marker [subject] submission.
- . Slight modification to the length of the hydrogel (shorter) than the other 4010-02-15 product codes
- . Full product dimensions for subject device were provided in figure and tabular format
- . Slight modification to the packaging configuration versus the other 4010-02-15 product codes have been made including a change in supplier
- . Slight modification in package dimensions reducing the overall length and width of the pouch from 22.5" x 6.125" to 21.5 x 4.5".
- Minor modifications to the product pouch folder including reducing the width of the folder and assembled length and reducing the length of the protective sheath.
- New User Instructions & Operations Guide providing guidance for safe and effective use of HydroMARK™ Plus, including MRI information and safety clarifications
- . New Safety Information Booklet has been provided with updates reflecting the new marker device shape including MRI information and safety clarifications
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 location and method, changes to packaging are minor including a smaller foil pouch with a new supplier (additional information on Sterilization, Shelf-Life and Packaging may be found in e-copy VOL_004_STERILE-SL-PKG), and no changes to indications for use or intended use.
The shelf life for HydroMARK™ Plus Breast Biopsy Site Mark [subject device] will be 18 months, whereas the HydroMARK™ Breast Biopsy Site Marker [predicate device] is sold with a 3 year shelf life. At the time of this submission, we are still awaiting device performance data for the 36 month time point for the Dragonfly 4010-02-15-T5 HydroMARK™ Plus medical device.
Please refer to the table below for additional details on the design and use of the device.
{7}------------------------------------------------
| Design and Use of the Device | Yes | No |
|---|---|---|
| Is the device intended for prescription use (21 CFR 801 Subpart D)? | X | |
| Is the device intended for over-the-counter use (21 CFR 807 Subpart C)? | X | |
| Does the device contain components derived from a tissue or other biologic source? | X | |
| Is the device provided sterile? [Probes and Introducers Only] | X | |
| Is the device intended for single use? [Probes and Introducers Only] | X | |
| Is the device a reprocessed single use device? | X | |
| If yes, does this device type require reprocessed validation data? | X | |
| Does the device contain a drug? | X | |
| Does the device contain a biologic? | X | |
| Does the device use software? | X | |
| Does the submission include clinical information? | X | |
| Is the device implanted? | X |
V. INTENDED USE / INDICATIONS FOR USE [Per 807.92(a)(5)]
The intended use and the indications for use are the same for the HydroMARK™ Plus Breast Biopsy Site Marker [subject device] and the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate devices].
The HydroMARK™ Plus Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]
The Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate 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.
The HydroMARK™ Plus Biopsy Site Marker Implant Component and Applicator System of the medical device in its final finished form are comprised of identical materials for the implant components and the same applicator system of the currently marketed Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K212158) [predicate device]. The HydroMARK™ Plus Biopsy Site Marker is identical in formulation, processing, sterilization, and chemicals (e.g., no additional plasticizers, fillers, additives, cleaning agents, mold release agents in subject device).
As shown below, a side-by-side comparison of the technological characteristics of between the subject device and the predicate devices, do not raise new or different issues of safety and effectiveness, support a determination of substantial equivalency (SE).
{8}------------------------------------------------
| RegulatoryInformation | HydroMARK™ PlusBreast Biopsy SiteMarker(K221961)[Subject Device] | HydroMARK™Breast Biopsy SiteMarker(K212158)[Predicate Device] | Similarities /Differences |
|---|---|---|---|
| Manufacturer | Devicor MedicalProducts De Mexico S DeRL De CV | Devicor MedicalProducts De Mexico SDe RL De CV | Same |
| Device Trade orProprietaryName | HydroMARK™ PlusBreast Biopsy SiteMarker | HydroMARK™ BreastBiopsy Site Marker | Different - MinorBrand clarifier of"Plus" creates noconcerns of safetyor efficacy |
| 510(k) Number | K221961 | K212158 | N/A |
| Device Class | Class II | Class II | Same |
| DeviceClassificationName | Marker, Radiographic,Implantable | Marker, Radiographic,Implantable | Same |
| Device CommonName | Implantable Clip | Implantable Clip | 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 apercutaneous breastbiopsyprocedure, includingaxillary lymph nodes, bevisible underultrasound for at least 6weeks, and bepermanently visible by x-ray and MRI. | To mark tissue during apercutaneous breastbiopsyprocedure, includingaxillary lymph nodes, bevisible underultrasound for at least 6weeks, and bepermanently visible byx-ray and MRI. | Same |
| Prescription orOver-the-Counter (OTC)Use | Prescription | Prescription | Same |
| Use Environment | |||
| Sterile | Yes | Yes | Same |
| Single-Use | Yes | Yes | Same |
| Design Features | |||
| MarkerComposition | Polymerized anddesiccatedhydrogel | Polymerized anddesiccatedhydrogel | Same |
| Coil (Marker)Composition | Titanium | Titanium or StainlessSteel | Same as theTitaniumHydroMARK™offerings |
| Coil (Marker)Shapes | Dragonfly (T5) | Barrel (T1, S1)Butterfly (T4) OpenCoil (T3, S3) | Different shape, noimpact to safety orefficacy |
| Cannula Type | |||
| 4010-02-15 | Rigid | Rigid | Same |
| Cannula Material | |||
| 4010-02-15 | 304 Stainless Steel | 304 Stainless Steel | Same |
| Plunger Rod Type | |||
| 4010-02-15 | Rigid Stainless Steel Rod | Rigid Stainless Steel Rod | Same |
| Packaging and Sterilization | |||
| Packaging | Smaller foil pouch withTyvek vent | Foil pouch with Tyvekvent | Same just smaller,no impact tosafety or efficacy |
| SterilizationMethod | ETO | ETO | Same |
| Shelf Life | 1.5 years/18 months | 3 years/36 months | Shorter shelf life,no impact tosafety or efficacy |
| MRI Status | |||
| MRI Status(Marker) | Conditional | Conditional | Same |
| MRI Status(Applicator) | Unsafe | Unsafe | Same |
{9}------------------------------------------------
VII. SUMMARY OF VERIFICATION DATA AND VERIFICATION TEST CONCLUSIONS_ [Per 807.92(b)(1)(2)(3)]
Verification Testing is summarized in the table below.
{10}------------------------------------------------
| Summary of Non-Clinical Performance Testing | |
|---|---|
| Performance Testing HydroMARK™Plus vs. HydroMARK™ | Test results: PASSEDThe results of the Non-Clinical Bench Performance Data areprovided in support of the substantial equivalence determination. |
| Conclusion Supporting Substantial Equivalence:The results of Non-Clinical Bench Performance Data conducted onthe HydroMARK™ Plus Biopsy Site Marker demonstrates that thesubject device is as safe, as effective, and performs as well as thelegally marketed predicate device. This testing supports adetermination of substantial equivalence of the HydroMARK™Plus Biopsy Site Marker [subject device] when compared with theHydroMARK™ Biopsy Site Marker [predicate device]. | |
| Provision of Data to DemonstrateSafety and Effectiveness of SubjectDevice | RESULTS: Both immediate post-deployment testing and long-term migration performance of HydroMARK Plus Breast BiopsySite Markers were confirmed. |
| Provision of Support DemonstratingSafety and Effectiveness forHydroMARK™ Plus implantation | RESULTS: Literature analysis was provided demonstrating productis safe and effective in both breast and lymph node. |
| Performance Testing: ResidualMoisture | RESULTS: Testing provided no statistical difference with 95%confidence comparing predicate and subject devices, provingsubstantial equivalence. |
| Performance Testing: HydrogelDegradation | RESULTS: Testing and existing clinical evidence of HydroMARK™hydrogel was provided demonstrating substantial equivalencebetween predicate and subject devices. |
| Performance Testing: Time toEquilibrium | RESULTS: Testing proved both subject and predicate devicesachieved hydrogel equilibrium within 24 hours, demonstratingsubstantial equivalence. |
| Summary of Biocompatibility Testing | |
| Biological Evaluation Testing | Test Results: PASSEDAll the biocompatibility testing conducted on the HydroMARK™device is applicable to HydroMARK™ Plus devices as well since it is anextension of the existing HydroMARK™ product family and does notserve as a new worst-case. Hence, no additional biocompatibilitytests were conducted except for the implantation study for 8 weekstimepoint in order to assess the local tissue effects due to theexposed region of the marker. The materials utilized in theHydroMARK™ and HydroMARK™ Plus Biopsy Site Marker deviceshave been evaluated against all applicable biological endpoints andare considered biocompatible in accordance with EN ISO 10993-1:2020 – Biological Evaluation of Medical Devices – Part 1: Evaluationand Testing within a Risk Management Process |
| Acute Systemic Toxicity | Results: PASSEDAll tests passed per ISO 10993-11:2017. There was no mortalityduring the studies of the implant and delivery device. All animalswere clinically normal throughout both studies. Body weight datawas acceptable. Each test article met the requirements of the study. |
| HydroMARK™ Implantation Data | Results: PASSEDAll tests passed and no local tissue side effects were observed atboth lymph node and intramuscular sites at 8 and 26 weeks. Appliesonly to implant portion of the device. |
| HydroMARK™ Plus Implantation Data | Results: PASSEDAll animals survived, and no abnormalities or adverse reactionswere observed at necroscopy. Overall, the test article scored arelative score of "0" with a reactivity grade of "minimal or noreaction" per Table E.3. of ISO 10993-6:2016 and met therequirements of the study. |
| HydroMARK™ Cytotoxicity Data | Results: The test article extract met the requirements of the testsince the grade was less than a grade 2 (mild reactivity) in each testand passed per ISO 10993-5:2009 |
| HydroMARK™ BiocompatibilityChemical Analysis | Results: The toxicological analysis shows a margin of safety greaterfor the chemicals and based on the analysis, they are consideredacceptable. Subacute/Subchronic/Chronic Toxicity/Carcinogenicity/Genotoxicity/Reproductive Toxicity - No additional tests wereconducted based on the toxicological analysis which showed the riskto be acceptable in adult women. |
| HydroMARK™ Irritation Data | Results: The difference between each test article extract overallmean score and corresponding control extract overall mean scorewas 0.0 and 0.0 for the polar and non-polar test article extracts,respectively, for both the implant and delivery device. Each testarticle met the requirements of the test per ISO 10993-10:2010. |
| HydroMARK™ Sensitization Data | Results: The test article extracts showed no evidence of causingdelayed dermal contact sensitization in the guinea pig for either theimplant or delivery device. The test article was not considered asensitizer in the guinea pig maximization tests and met therequirements of the test per ISO 10993-10:2010. |
| HydroMARK™ Pyrogenicity Data | Results: No single animal showed a temperature rise of 0.5°C ormore above its baseline temperature. The total temperature riseduring 3 hours was 0.1°C for the implant and 0.3°C for the deliverydevice. Each test article met the requirements for the absence ofpyrogens per ISO 10993-11:2017. |
| Materials Assessment and Plan | Results: The manufacturing process along with the packagingmaterials and the sterilization process is very similar for bothHydroMARK™ and HydroMARK™ Plus. However,considering the geometry and design of the marker forHydroMARK™ Plus, a portion of the marker is exposed from thehydrogel. Therefore, an additional implantation study wasperformed to assess the local tissue effects of the implantcomponent materials due to new marker configuration outside ofgel when implanted. The implantation data on file for theHydroMARK™ device includes both the standard muscleimplantation and lymph node sites and were used to supplementthe additional implantation study. The implantation time point forassessment was based on the degradation profile of the device andhistorical data on the hydrogel material.The primary implantation assessment was completed at 8 weeks.Additional implantation data at 26 weeks (steady state) followingimplantation is found in PCR-000237 (HydroMARK™ ImplantationData GLP 26 wks) considering the similarity between theHydroMARK™ and HydroMARK™ Plus markers. |
| FDA Recognized Testing Standards forbiocompatibility: | Conclusion (Biocompatibility Testing Standards) SupportingSubstantial Equivalence: |
| ISO 10993-1:2018-BiologicalEvaluation of Medical Devices –Part 1: Evaluation and TestingWithin a Risk Management Process ISO 10993-5:2009-BiologicalEvaluation of Medical Devices –Part 5: Tests for In VitroCytotoxicity ISO 10993-6:2016-BiologicalEvaluation of Medical Devices –Part 6: Tests for local effects afterimplantation ISO 10993-10:2010-BiologicalEvaluation of Medical Devices –Part 10: Tests for Irritation and SkinSensitization ISO 10993-11:2017-BiologicalEvaluation of Medical Devices –Part 11: Tests for Systemic Toxicity ISO 10993-12:2012-BiologicalEvaluation of Medical Devices –Part 12: Sample preparation andreference materials. | The data generated from the results of the Biocompatibility Testing(GLP Cytotoxicity, GLP Sensitization, GLP Irritation, GLP AcuteSystemic Toxicity, GLP Pyrogenicity, GLP Implantation, and chemicalcharacterization) performed on the Devicor Medical Products, Inc.HydroMARK™ and HydroMARK™ Plus Breast Biopsy Site Marker[subject device] and the rationale to use existing biocompatibilitytest results for many of the biological endpoints demonstrate thatthe subject device is as safe, as effective, and performs as well as thepredicate device, and meets the requirements of EN ISO 10993-1:2020.Therefore, the information provided may be relied on to support adetermination of substantial equivalence (SE). |
| Risk Management | |
| HydroMARK™ Risk ManagementReport | Results: All risks have been reduced as far as possible throughallowed controls. The results of the Risk Management Report areprovided in support of the substantial equivalence determination.• The product risk is acceptable in view of the benefits of the device. |
| HydroMARK™ System FMEA | Results: Based on the clinical steps and failure modes tested onHydroMARK™ Plus vs. HydroMARK™, risks have been determined tobe acceptable to risk management policies. |
| General Testing Standards Summary | |
| FDA Recognized Testing Standards:o ISO 13485:2016 Certification –Medical Devices – Quality ManagementSystems - Requirements for RegulatoryPurposes process for medical deviceso ISO 14971:2019 (Ed.3.0) - MedicalDevices - Application of RiskManagement to Medical Devices | Conclusion Supporting Substantial Equivalence: Design verificationprocess is compliant with Devicor Medical Product's ISO 13485Quality Management System. Results of the design verificationconducted on the HydroMARK™ Plus Breast Biopsy Site Marker[subject device] demonstrates that the subject device is as safe andas effective as the legally marketed predicate devices. This evidencein conjunction with the ISO 14971 compliant Risk Managementprocess supports a determination of substantial equivalence of theDevicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy SiteMarker [subject device] when compared to the Devicor MedicalProducts Inc. HydroMARK™ Breast Biopsy Site Marker (K212158)[predicate devices]. |
| Sterilization, Shelf Life and Packaging | |
| HydroMARK™ Plus ETO SterilizationReport | Sterilization: PASSEDMeets standard for ISO 11135:2014 Sterilization of Health CareProducts; Ethylene Oxide Requirements for Development, Validationand Routine control of a sterilization process for medical devices. |
| HydroMARK™ Plus 18M Real-Time AgingReport [device] | Shelf Life [Device]: The shelf life for the HydroMARK™ Plus BreastBiopsy Site Marker [subject device] is 1.5 years/18 months. |
| HydroMARK™ Plus 36M AcceleratedAging [packaging] | Shelf Life [Packaging]: HydroMARK™ Plus Breast Biopsy Site Marker[subject device] has been assessed and passed for up to 36 months. |
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
T
{14}------------------------------------------------
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 [subject device] meets all design and functional requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].
Various test reports mentioned above are referenced in further detail in Section 12: Substantial Equivalence.
{15}------------------------------------------------
VIII. CONCLUSIONS
Based on the verification results and a side-by-side comparison of the technological characteristics of design, indication for use / intended use, components, performance and biological data, literature reviews, and materials of construction, it is concluded that the Devicor Medical Products, Inc. HydroMARK™ Plus Biopsy Site Marker [subject device] is substantially equivalent to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate devices]. The User Instructions & Operations Guide, Safety Information Booklet, labels, shape of the implantable marker, manufacturing, and packaging have been found to be safe and effective for the intended users, uses, and use environments.
The identical indications for use / intended use, and technological characteristics for the proposed Devicor Medical Products, Inc. HydroMARK™ Plus Biopsy Site Marker [subject device] have been assessed to be substantially equivalent (SE) to the predicate device, and minor differences between the subject device and predicate device design, manufacturing, packaging, and labeling do not raise new or different issues of safety and effectiveness.
Therefore, the Devicor Medical Products, Inc. HydroMARK™ Plus Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate devices].
§ 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.