The HydroMARK® Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

Device Description

The HydroMARK® Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking. The HydroMARK® Breast Biopsy Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The marker is deployed by the delivery system and is left in the tract created during the biopsy procedure. This Traditional 510(k) addresses the qualification and validation of a new source of raw material polymer of the same original formulation, produced in a new facility and in smaller batch sizes, to be used by the manufacturer of the hydrogel component of the HydroMARK® Breast Biopsy Site Marker. The hydrogel component is manufactured by Coldstream Laboratories, Inc. The new source of polymer for the hydrogel is Corden Pharma, replacing Genzyme polymer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the HydroMARK® Breast Biopsy Site Marker. The notification aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily due to a change in the raw material polymer supplier for the hydrogel component.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner for specific benchmarks (e.g., "Visibility under ultrasound: >95% detected"). Instead, it lists various tests performed and states that the device "met all original finished product specifications" or "performed as intended according to the specifications established for the original device."

However, we can infer the acceptance criteria from the tests conducted and the statements of equivalence:

Acceptance Criteria Category	Specific Criteria / Test Description	Reported Device Performance (New Device)
Material Equivalence	Polymer Raw Material:
	- Gel Permeation Chromatography (GPC): Equivalent molecular weight distribution (Number Average (Mn) and Weight Average (Mw)) and polydispersity between old and new polymer sources. No evidence of changed polymer composition.	"Results show the number (Mn) and weight averaged (Mw) molecular weights obtained from both sources are comparable. The polymer molecular weight distributions for both manufacturers are equivalent. There is no evidence of changed polymer composition..."
	- Nuclear Magnetic Resonance (NMR): Equivalent ratios of chemicals from first and second reaction steps, indicating no new chemical entities.	"Ratios of chemicals from the first reaction step demonstrate equivalency. NMR was also used to determine molar ratios of the secondary reaction step and also showed equivalency. ...No different or new chemical entities are identified."
	- Degradation Profiles: Hydrolysis products of both old and new polymers contain the same components in the same proportions.	"Finally, hydrolysis of both predicate and new polymers contained the same components, in the same proportions. Both raw material polymers are chemically equivalent."
Finished Product Quality	Physical Characteristics:
	- Visual Inspection: Free of visual defects.	"met all original finished product specifications including visual inspection..."
	- Critical Dimensions: Outer diameter and length (0.070 inches and 0.20 inches for marker, 0.035-0.0625 inches for coil length, 0.039 inches for coil width).	"met all original finished product specifications including... dimensions..." (Implied to match the predicate device dimensions listed in the comparison table: 0.070 inches OD, 0.20 inches length, 0.035-0.0625 inches coil length, 0.039 inches coil width).
	- % Moisture: Within specified range pre- and post-sterilization.	"met all original finished product specifications including... % moisture..."
	- Functional Deployment: Deploys as intended.	"met all original finished product specifications including... functional deployment..."
	- Hydration Rate: Within specified range.	"met all original finished product specifications including... hydration rate..."
Imaging Visibility	- Visibility under Ultrasound: Visible for at least 6 weeks.	"met all original finished product specifications including... visibility by ultrasound..." (The Indications for Use state "be visible under ultrasound for at least 6 weeks").
	- Visibility under X-ray: Permanently visible.	"met all original finished product specifications including... visibility by... x-ray..." (The Indications for Use state "be permanently visible by x-ray").
	- Visibility under MRI: Permanently visible and safe in an MRI environment (no significant radio frequency induced heating, image artifacts, magnetically induced torque, or displacement force).	"met all original finished product specifications including... visibility by... MRI..." (The Indications for Use state "be permanently visible by... MRI." This implies compliance with ASTM F2182-11a, ASTM F2119-07, ASTM F2213-06, ASTM F2503-13, ASTM F2052-15). The document states the "Finished devices performed as intended according to the specifications established for the original device." concerning these tests.
Biocompatibility	- Sterility: Sterile, meeting ISO 11135 requirements.	"met all original finished product specifications including... sterility..."
	- Bioburden: Within acceptable limits.	"met all original finished product specifications including... bioburden..."
	- Pyrogens: Apyrogenic.	"met all original finished product specifications including... pyrogens..."
	- EO Residuals: Within acceptable limits (if Ethylene Oxide sterilized).	"met all original finished product specifications including... ethylene oxide residuals."
	- Biological Evaluation: Meeting ISO 10993 requirements (Cytotoxicity, Systemic Toxicity, Chemical Characterization).	The document lists the ISO 10993 standards and states that the "Finished devices performed as intended according to the specifications established for the original device," implying that these criteria were met.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: For the polymer equivalence testing, "Three samples each of the predicate polymer and the new polymer" were tested by GPC. The same number seems implied for NMR and degradation profiles. For finished product testing, "The three manufacturing batches [of the new polymer] were combined and used to prepare HydroMARK® Breast Biopsy Site Markers which met all original finished product specifications". The exact number of finished devices tested is not specified, but it was enough to represent these combined batches.
Data Provenance:
- Polymer Raw Material: The new polymer batches were from the Corden Pharma Liestal, Switzerland facility. The predicate polymer was from Genzyme (original supplier/process).
- Finished Product: The finished devices were manufactured using the new Corden Pharma polymer. The testing protocols were "identical to the tests used in the original 510(k)". The study is retrospective in the sense that it aims to demonstrate equivalence to previously established specifications and predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable to this submission. This 510(k) is not for a diagnostic algorithm or a device requiring expert interpretation for performance evaluation. It's a submission for a physical medical device (breast biopsy site marker) that primarily relies on objective chemical, physical, and imaging characteristic tests, not human interpretive performance.

4. Adjudication method for the test set

Not applicable for the same reasons as #3. There was no "ground truth" established by expert consensus or adjudication in the context of human interpretation. The "ground truth" here is adherence to objective engineering, material science, and biological specifications.

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 submission is for a physical medical device (a biopsy site marker), not an AI/CAD system or a device that directly assists human readers in interpreting images. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate device and relevant industry standards (e.g., ISO, ASTM). Specifically:

Chemical Equivalence: Established by comparing molecular weight distribution, NMR spectra, and degradation profiles to the known composition and characteristics of the original Genzyme polymer.
Physical/Functional Performance: Established by existing specifications for visual inspection, critical dimensions, moisture content, functional deployment, hydration rate, invisibility under various imaging modalities, and biological safety (sterility, biocompatibility).
Imaging Visibility/Safety: Established by adherence to specific ASTM standards for MRI compatibility.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context refers to the qualification and validation of the manufacturing process for the new polymer source, which involved testing "3 consecutive test batches" from the new facility.

9. How the ground truth for the training set was established

Not applicable in the AI/ML sense. However, if interpreting "training set" as the batches used to qualify the new polymer manufacturing process:
The "ground truth" for qualifying these batches was established by comparison to the "original specifications" designed for the predicate device's polymer. This means the acceptable parameters (e.g., molecular weight range, chemical ratios) were already defined based on the performance of the previously approved device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2017

Devicor Medical Products, Inc. Ms. Shawna Rose Sr. Director, ORA 300 E-Business Wav. Fifth Floor Cincinnati. Ohio 45241

Re: K170803

Trade/Device Name: HydroMARK® Breast Biopsy Site Markers Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: March 13, 2017 Received: March 17, 2017

Dear Ms. Rose:

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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170803

Device Name HydroMARK® Breast Biopsy Site Marker

Indications for Use (Describe)

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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

The following information is provided as required by 21 CFR § 807.92 for the HydroMARK® Breast Biopsy Site Marker 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990 the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Company:

Devicor® Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Establishment Registration Number: 3008492462

Contact:

Shawna Rose Sr. Director, Quality and Regulatory Affairs Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Ph: 513-864-9178 Fax: 513-864-9011 E-mail: shawna.rose@leicabiosystems.com

Date of Submission: March 13, 2017

Proprietary Name: HydroMARK® Breast Biopsy Site Marker

Common Name: Breast Biopsy Site Marker

Regulation: 21 CFR 878.4300

Regulatory Class: II

Product Codes: NEU

Classification Name: General and Plastic Surgery Panel

HydroMARK® Breast Biopsy Site Markers (K161021) (Primary Predicate) Predicate Devices: HydroMARK® Breast Biopsy Site Markers (K121113) (Reference Predicate) HydroMARK® Breast Biopsy Site Markers (K130537) (Reference Predicate)

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Device Description:

The HydroMARK® Breast Biopsy Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The marker is deployed by the delivery system and is left in the tract created during the biopsy procedure.

This Traditional 510(k) addresses the qualification and validation of a new source of raw material polymer of the same original formulation, produced in a new facility and in smaller batch sizes, to be used by the manufacturer of the hydrogel component of the HydroMARK® Breast Biopsy Site Marker. The hydrogel component is manufactured by Coldstream Laboratories, Inc. The new source of polymer for the hydrogel is Corden Pharma, replacing Genzyme polymer.

Intended Use:

The HydroMARK® Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The indications are identical to those of the predicate device, the HydroMARK® Breast Biopsy Site Marker, indicated "to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI."

Technological Characteristics:

The hydrogel component expands on fluid contact to fill the track of the biopsy needle anchoring the HydroMARK® Breast Biopsy Site Marker at the exact location of biopsy. Because the hydrogel is hydrophilic, it is clearly distinct from normal breast structure under ultrasound imaging. The hydrogel material degrades via hydrolysis over time leaving the internal stainless steel or titanium coil which provides permanent visibility under x-ray and MRI. The hydrogel material uses polymer raw material from a new suppler which has been shown to be chemically equivalent to the original raw material using molecular weight distribution, nuclear magnetic resonance spectra, and degradation profiles from gel permeation chromatography and high performance liguid chromatography.

Non-clinical testing of the modified finished HydroMARK® Breast Biopsy Site Markers is identical to the tests used in the original 510(k) and includes the following:

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. Visual inspection
Critical dimensions ●
% Moisture
Functional Deployment
Hydration Rate
Visibility under ultrasound, x-ray and MRI
Sterility, bioburden, pyrogens, and EO residuals

The finished devices performed as intended according to the specifications established for the original device. The change to the polymer vendor had no impact to the finished products as demonstrated by repeating the original test protocols and meeting the pre-established acceptance criteria. The modified devices are substantially equivalent to the predicate devices.

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The modified HydroMARK® Breast Biopsy Site Markers are compared to those cleared in the prior 510(k) submissions in the table below.

Feature / TechnologicalCharacteristics	Modified HydroMARK®Breast Biopsy Site Marker	HydroMARK® Breast BiopsySite Markers (predicates)K161021 (Primary)K121113 (Reference)K130537 (Reference)
Device	Breast biopsy marker	Breast biopsy marker
Resorbable component	Polymerized and DesiccatedHydrogel with CordenPharma polymer	Polymerized and DesiccatedHydrogel with Genzymepolymer
Permanent component	Titanium (grade 2)Stainless steel	Titanium (grade 2)Stainless steel
Marker outer diameter	0.070 inches	0.070 inches
Marker length	0.20inches	0.20inches
Coil (permanent component)length	0.035-0.0625inches	0.035-0.0625inches
Coil (permanent component)width	0.039 inches	0.039 inches
Detection	Ultrasound, x-ray and MRI	Ultrasound, x-ray and MRI
Sterilization	ETO	ETO
Delivery system (non-patientcontacting)	Flexible, Rigid , and RigidSharp styles	Flexible, Rigid , and RigidSharp styles

PREDICATE DEVICE COMPARISON TABLE

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Finished Product Performance Testing

The polymer used in the hydrogel was historically manufactured by Genzyme in their Lexington, Massachusetts facility. Genzyme transferred the process to their Swiss facility. This facility was later purchased by Corden Pharma. This polymer will now be made in the Corden Pharma Liestal, Switzerland facility in smaller batches than Genzyme originally used, but to the same specifications. The equipment, batch size and processes were qualified by testing 3 consecutive test batches from Liestal, Switzerland to the original specifications. The three manufacturing batches were combined and used to prepare HydroMARK® Breast Biopsy Site Markers which met all original finished product specifications to demonstrate that the changes in polymer manufacturing have had no effect on the finished product.

The following tests were performed to demonstrate substantial equivalence:

Reference No.	Title
ISO 11135	Sterilization of health care products-Ethylene Oxide, Part I, Requirementsfor development, validation, and routine control of sterilization processfor medical devices.
ISO 10993-1	Biological evaluation of medical devices, Part 1: Evaluating and testingwithin a risk management process.
ISO 10993-5	Biological evaluation of medical devices, Part 5: Tests for in vitroCytoxicity
ISO 10993-11	Biological evaluation of medical devices, Part 11: Tests for systemictoxicity
ISO 10993-18	Biological evaluation of medical devices, Part 18: Chemicalcharacterization of materials
ASTM F2182-11a	Standard test method for measurement of radio frequency inducedheating on or near passive implants during magnetic resonance imaging.
ASTM F2119-07	Standard test method for evaluation of magnetic resonance imageartifacts from passive implants
ASTM F2213-06	Standard test method for measurement of magnetically induced torqueon medical devices in the magnetic resonance environment
ASTM F2503-13	Marking medical devices and other items for safety in the magneticresonance environment
ASTM F2052-15	Standard test method for measurement for magnetically induceddisplacement force on medical devices in the magnetic resonanceenvironment.

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. Visual Inspection – free of visual defects
Critical Dimensions – outer diameter and length
% Moisture - pre- and post-sterilization
Functional Deployment
Hydration Rate
. Visibility under ultrasound, x-Ray and MRI imaging modalities
Sterilization method
Bioburden
. Pyrogens
. EO residuals

Polymer Equivalence Testing

Gel permeation chromatography, NMR analyses and degradation profiles were used to establish the equivalency of the raw material polymers

Three samples each of the predicate polymer and the new polymer, both of identical formulations, were tested by gel permeation chromatography with differential refractive index detection. Results show the number (Mn) and weight averaged (Mw) molecular weights obtained from both sources are comparable. The polymer molecular weight distributions for both manufacturers are equivalent. There is no evidence of changed polymer composition that would have ramifications in further processing of the polymer. Therefore no unanticipated reactions are expected to be encountered during subsequent hydrogel production.

The possibility of new chemical entities being created at the new polymer manufacturing facility was studied using nuclear magnetic resonance (NMR). Ratios of chemicals from the first reaction step demonstrate equivalency. NMR was also used to determine molar ratios of the secondary reaction step and also showed equivalency.

Polymer from both synthesis sites was compared in every way. The results of the processes for the predicate and the new material are identical. No different or new chemical entities are identified.

Substantial Equivalence Discussion

The raw material polymer used to make the hydrogel component of the modified HydroMARK® Breast Biopsy Site Markers was demonstrated to be equivalent to the original polymer. Material characterization testing with gel permeation chromatography established equivalent molecular weight distribution and polydispersity between the two sources of the material. Nuclear magnetic resonance established the chemical ratios from each of the two reaction steps were equivalent. No new or different chemical entities were identified. Finally, hydrolysis of both

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predicate and new polymers contained the same components, in the same proportions. Both raw material polymers are chemically equivalent.

Conclusion

HydroMARK® Breast Biopsy Site Markers manufactured with hydrogel made from Corden Pharma raw material polymer met all original finished product specifications including visual inspection, dimensions, % moisture, functional deployment, hydration rate, visibility by ultrasound, x-ray and MRI, sterility, bioburden, pyrogens and ethylene oxide residuals. The finished product HydroMARK® Breast Biopsy Site Markers made with Corden Pharma raw material polymer are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.