← Product Code [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU) · K221961 # HydroMARK Plus Breast Biopsy Site Marker (K221961) _Devicor Medical Products, Inc. · NEU · Jul 13, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K221961 ## Device Facts - **Applicant:** Devicor Medical Products, Inc. - **Product Code:** [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU.md) - **Decision Date:** Jul 13, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use 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 ## Device Story HydroMARK Plus is an implantable breast biopsy site marker. It consists of a polymerized, desiccated hydrogel cylinder containing an embedded titanium wire marker. Upon contact with bodily fluids, the hydrogel expands to an equilibrium point, providing ultrasound visibility for at least 6 weeks. The hydrogel is eventually resorbed, while the titanium wire remains permanently visible via x-ray and MRI. The device is supplied preloaded in a sterile, disposable applicator for use by clinicians during percutaneous breast biopsy procedures. It is deployed into the biopsy cavity via a compatible introducer or direct puncture. The device aids in long-term localization of the biopsy site for clinical follow-up or surgical planning. This submission introduces a new 'Dragonfly' shape for the titanium wire and minor modifications to packaging and shelf life. ## Clinical Evidence Bench testing only. Evidence includes biocompatibility testing (ISO 10993-1:2020, -5, -6, -10, -11, -12), residual moisture analysis, hydrogel degradation studies, and equilibrium time testing. Implantation studies (8-week and 26-week) confirmed safety and local tissue compatibility. Literature analysis supported safety and effectiveness in breast and lymph node tissue. No clinical trial data was required. ## Technological Characteristics Implantable marker composed of polymerized/desiccated hydrogel and titanium wire. Applicator system uses 304 stainless steel. Dimensions and packaging modified from predicate. Sterilization via Ethylene Oxide (ETO) per ISO 11135:2014. MRI conditional status. Shelf life 18 months. ## Regulatory Identification An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - HydroMARK™ Breast Biopsy Site Marker ([K212158](/device/K212158.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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}------------------------------------------------ | 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™ 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 Products
Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate devices] in
terms of the identical indications for use / intended use to mark tissue during a
percutaneous breast biopsy procedure, including axillary lymph nodes, being
visible under ultrasound for at least 6 weeks, and being permanently visible by
x-ray and MRI. | | | ● Substantial equivalency (SE) of the subject device has also been based
on substantially equivalent design, functionality, and performance
characteristics 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}------------------------------------------------ | Regulatory
Information | HydroMARK™ Plus
Breast Biopsy Site
Marker
(K221961)
[Subject Device] | HydroMARK™
Breast Biopsy Site
Marker
(K212158)
[Predicate Device] | Similarities /
Differences | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | 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™ Breast
Biopsy Site Marker | Different - Minor

Brand clarifier of
"Plus" creates no
concerns of safety
or efficacy | | 510(k) Number | K221961 | K212158 | N/A | | Device Class | Class II | Class II | Same | | Device
Classification
Name | Marker, Radiographic,
Implantable | Marker, Radiographic,
Implantable | Same | | Device Common
Name | Implantable Clip | Implantable Clip | 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 | Yes | Same | | Single-Use | Yes | Yes | Same | | Design Features | | | | | Marker
Composition | Polymerized and
desiccated
hydrogel | Polymerized and
desiccated
hydrogel | Same | | Coil (Marker)
Composition | Titanium | Titanium or Stainless
Steel | Same as the
Titanium
HydroMARK™
offerings | | Coil (Marker)
Shapes | Dragonfly (T5) | Barrel (T1, S1)
Butterfly (T4) Open
Coil (T3, S3) | Different shape, no
impact to safety or
efficacy | | | 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 with
Tyvek vent | Foil pouch with Tyvek
vent | Same just smaller,
no impact to
safety or efficacy | | Sterilization
Method | ETO | ETO | Same | | Shelf Life | 1.5 years/18 months | 3 years/36 months | Shorter shelf life,
no impact to
safety 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: PASSED
The results of the Non-Clinical Bench Performance Data are
provided in support of the substantial equivalence determination. | | | Conclusion Supporting Substantial Equivalence:
The results of Non-Clinical Bench Performance Data conducted on
the HydroMARK™ Plus Biopsy Site Marker 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 of the HydroMARK™
Plus Biopsy Site Marker [subject device] when compared with the
HydroMARK™ Biopsy Site Marker [predicate device]. | | Provision of Data to Demonstrate
Safety and Effectiveness of Subject
Device | RESULTS: Both immediate post-deployment testing and long-
term migration performance of HydroMARK Plus Breast Biopsy
Site Markers were confirmed. | | Provision of Support Demonstrating
Safety and Effectiveness for
HydroMARK™ Plus implantation | RESULTS: Literature analysis was provided demonstrating product
is safe and effective in both breast and lymph node. | | Performance Testing: Residual
Moisture | RESULTS: Testing provided no statistical difference with 95%
confidence comparing predicate and subject devices, proving
substantial equivalence. | | Performance Testing: Hydrogel
Degradation | RESULTS: Testing and existing clinical evidence of HydroMARK™
hydrogel was provided demonstrating substantial equivalence
between predicate and subject devices. | | Performance Testing: Time to
Equilibrium | RESULTS: Testing proved both subject and predicate devices
achieved hydrogel equilibrium within 24 hours, demonstrating
substantial equivalence. | | Summary of Biocompatibility Testing | | | Biological Evaluation Testing | Test Results: PASSED
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 and does not
serve as a new worst-case. Hence, no additional biocompatibility
tests were conducted except for the implantation study for 8 weeks
timepoint in order to assess the local tissue effects due to the
exposed region of the marker. 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 – Biological Evaluation of Medical Devices – Part 1: Evaluation
and Testing within a Risk Management Process | | Acute Systemic Toxicity | Results: PASSED
All tests passed per ISO 10993-11:2017. There was no mortality
during the studies of the implant and delivery device. All animals
were clinically normal throughout both studies. Body weight data
was acceptable. Each test article met the requirements of the study. | | HydroMARK™ Implantation Data | Results: 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 | Results: 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. | | HydroMARK™ Cytotoxicity Data | Results: The test article extract met the requirements of the test
since the grade was less than a grade 2 (mild reactivity) in each test
and passed per ISO 10993-5:2009 | | HydroMARK™ Biocompatibility
Chemical Analysis | Results: The toxicological analysis shows a margin of safety greater
for the chemicals and based on the analysis, they are considered
acceptable. Subacute/Subchronic/Chronic Toxicity/Carcinogenicity/
Genotoxicity/Reproductive Toxicity - No additional tests were
conducted based on the toxicological analysis which showed the risk
to be acceptable in adult women. | | HydroMARK™ Irritation Data | Results: The difference between each test article extract overall
mean score and corresponding control extract overall mean score
was 0.0 and 0.0 for the polar and non-polar test article extracts,
respectively, for both the implant and delivery device. Each test
article met the requirements of the test per ISO 10993-10:2010. | | HydroMARK™ Sensitization Data | Results: The test article extracts showed no evidence of causing
delayed dermal contact sensitization in the guinea pig for either the
implant or delivery device. The test article was not considered a
sensitizer in the guinea pig maximization tests and met the
requirements of the test per ISO 10993-10:2010. | | HydroMARK™ Pyrogenicity Data | Results: No single animal showed a temperature rise of 0.5°C or
more above its baseline temperature. The total temperature rise
during 3 hours was 0.1°C for the implant and 0.3°C for the delivery
device. Each test article met the requirements for the absence of
pyrogens per ISO 10993-11:2017. | | Materials Assessment and Plan | Results: The manufacturing process along with the packaging
materials and the sterilization process is very similar for both
HydroMARK™ and HydroMARK™ Plus. However,
considering the geometry and design of the marker for
HydroMARK™ Plus, a portion of the marker is exposed from the
hydrogel. Therefore, an additional implantation study was
performed to assess the local tissue effects of the implant
component materials due to new marker configuration outside of
gel when implanted. The implantation data on file for the
HydroMARK™ device includes both the standard muscle
implantation and lymph node sites and were used to supplement
the additional implantation study. The implantation time point for
assessment was based on the degradation profile of the device and
historical data on the hydrogel material.
The primary implantation assessment was completed at 8 weeks.
Additional implantation data at 26 weeks (steady state) following
implantation is found in PCR-000237 (HydroMARK™ Implantation
Data GLP 26 wks) considering the similarity between the
HydroMARK™ and HydroMARK™ Plus markers. | | FDA Recognized Testing Standards for
biocompatibility: | Conclusion (Biocompatibility Testing Standards) Supporting
Substantial Equivalence:… --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K221961](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K221961) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com