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 reabsorbable 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 HydroMARK® Breast Biopsy Site Marker is deployed by the delivery system and is left in the track created during the biopsy procedure.

This Special 510(k) is being submitted for modifications to two models of the cleared device, HydroMARK® Breast Biopsy Site Marker. The fundamental scientific technology of the two models of the modified HydroMARK® Breast Biopsy Site Markers has not changed. This submission contains information to support:

Modifications to the rigid delivery system of two models of the HydroMARK® Breast Biopsy Site Marker;
Compatibility for use of those two models with the Mammotome revolve® biopsy system; and
IFU updates related to the modifications noted for those two models.

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, no changes to packaging, no changes to shelf-life, and no changes to indications for use or intended use.

Changes to labeling include rebranding and legal manufacturer name and address, as well as updates to the IFU to incorporate instructions for use related to the added compatibility with the Mammotome revolve® Biopsy System.

AI/ML Overview

The provided document is a 510(k) summary for the HydroMARK® Breast Biopsy Site Marker, specifically for modifications to an already cleared device. As such, it does not detail a full study establishing device acceptance criteria from scratch but rather demonstrates that the modifications do not alter the existing performance and safety profile, maintaining substantial equivalence to the predicate device.

However, based on the information provided, we can extrapolate and structure the details as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mark tissue during a percutaneous breast biopsy procedure	Device performs as intended, accurately marking the biopsy site
Visible under ultrasound for at least 6 weeks	No change from predicate; predicate is visible for at least 6 weeks
Permanently visible by X-ray and MRI	No change from predicate; predicate is permanently visible by X-ray and MRI
Functions with specified commercially available biopsy devices	Modifications tested for compatibility with Mammotome revolve® biopsy system
Meets biocompatibility (ISO 10993-1)	Device continues to meet ISO 10993-1 requirements
Maintains original shelf-life (3 years/36 months)	Shelf-life remains 3 years/36 months
Maintains sterilization method (ETO)	Sterilization method remains ETO
Deployment as intended	Deployment testing conducted, devices performed as intended
Ease of insertion and deployment (Usability)	Usability testing conducted, devices performed as intended
Visual and dimensional conformity to specifications	Visual and dimensional testing conducted, performed as intended

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the traditional sense for a new device evaluation. Instead, it describes non-clinical performance data and comparison testing for the modified device against its predicate.

Sample Size for Non-Clinical Testing: Not explicitly stated for each test (Visual, Dimensional, Deployment, Usability).
Data Provenance: Not explicitly stated, but given it's a 510(k) submission by a US company, the testing is assumed to be conducted in a controlled lab/test environment, likely in the US. The tests are non-clinical (i.e., not performed on human subjects).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission concerns non-clinical performance and substantial equivalence based on material and design changes, not clinical outcomes requiring expert interpretation of human data.

4. Adjudication Method for the Test Set

Not applicable for this non-clinical testing. Performance was assessed against established specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is a physical marker, not an AI or imaging diagnostic tool that would typically involve a MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is not an algorithm. Performance tests related to deployment, visibility, and biocompatibility are reported.

7. Type of Ground Truth Used

For the non-clinical performance data:

Instrumental measurements/visual inspection for conformity: For visual and dimensional testing.
Engineering specifications/functional performance criteria: For deployment and usability testing.
ISO standards: For biocompatibility (ISO 10993-1).
Predicate device's established performance: For visibility (ultrasound, X-ray, MRI, and duration) as the modifications did not impact these characteristics.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for this device.

Summary

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

May 5, 2016

Devicor Medical Products, Inc. Ms. Shawna Rose Director, Regulatory Affairs 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241

Re: K161021

Trade/Device Name: HydroMARK Breast Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: April 8, 2016 Received: April 12, 2016

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

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device-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

David Krause -S

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

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Indications for Use

510(k) Number (if known) K161021

Device Name HydroMARK® Breast Biopsy Site Marker

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY (21 CFR 807.92)

HYDROMARK® BREAST BIOPSY SITE MARKER

510(k) Owner: Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241 Tel: 513-864-9000 Fax: 513-864-9011
Contact Person: Shawna Rose Tel: 513-864-9178 E-mail: srose@mammotome.com

Date Prepared: April 8, 2016

HydroMARK® Breast Biopsy Site Marker Trade Name:

Common Name: Biopsy Site Marker

Classification: Class II

Implantable clip per 21 CFR 878.4300, NEU Classification Name:

Predicate Devices: Biopsy Sciences HydroMark Breast Biopsy Site Marker, K121113 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K130537
Device Description: The HydroMARK® Breast Biopsy Site Marker contains a reabsorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking.

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HydroMARK® Breast Biopsy Site Markers has not changed. This submission contains information to support:

1. Modifications to the rigid delivery system of two models of the HydroMARK® Breast Biopsy Site Marker;
1. Compatibility for use of those two models with the Mammotome revolve® biopsy system; and
1. IFU updates related to the modifications noted for those two models.

The indications for use and the intended use are the same for the predicate Intended Use: and the modified devices.
The indications for use are:

"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."

The intended use is:

"The HydroMARK® Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, to 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 marker at the exact location of biopsy.

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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 modifications to the HydroMARK® Breast Biopsy Site Markers delivery system for the two models, the device compatibility testing, and the associated IFU and label changes represent minor updates to the products. The changes do not raise new questions of safety or efficacy. The technological characteristics are identical to those of the predicate devices.

Non-Clinical Performance Data: Non-clinical testing included the following:

Visual and Dimensional Testing
Deployment Testing
Usability testing for ease of insertion and deployment ●

The devices performed as intended according to the specifications established for the finished device. The device continues to meet the ISO 10993-1 requirements for biocompatibility.

Summary of

Substantial Equivalence:

Side-by-Side Comparison to Legally Marketed Device

HydroMARK® Breast Biopsy Site Marker

DeviceCharacteristics	Marketed Device HydroMARK®Breast Biopsy Site Marker	Modified Device HydroMARK®Breast Biopsy Site Marker
Indications for Use	To mark tissue during apercutaneous breast biopsyprocedure, be visible underultrasound for at least 6 weeks,and be permanently visible by x-ray and MRI.	To mark tissue during apercutaneous breast biopsyprocedure, be visible underultrasound for at least 6 weeks,and be permanently visible by x-ray and MRI.
Device Composition
Marker Composition	Polymerized and desiccatedhydrogel	Polymerized and desiccatedhydrogel
Coil (Marker)Composition	Titanium or Stainless Steel	Titanium or Stainless Steel
Coil (Marker) Shapes	Barrel (T1)Open Coil (T3)	Barrel (T1)Open Coil (T3)

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DeviceCharacteristics	Marketed Device HydroMARK®Breast Biopsy Site Marker	Modified Device HydroMARK®Breast Biopsy Site Marker
Cannula Type	Rigid Cannula	Rigid Cannula
Cannula Material	304 Stainless Steel	304 Stainless Steel
Plunger Rod Type	Rigid Plunger Rod	Rigid Plunger Rod
Plunger Rod Material	302 Stainless Steel	302 Stainless Steel
Plunger Rod Tip	Welded Flexible Tip	Welded Spring
Packaging and Sterilization
Sterile Packaging	Foil pouch with Tyvek® vent	Foil pouch with Tyvek® vent
Sterilization Method	ETO	ETO
Shelf Life	3 years/36 months	3 years/36 months

The comparison testing, including functionality, usability testing, as well as Conclusions: side-by-side comparison of technological characteristics of design, components and materials of construction, and clinical application, demonstrates that the two modified models of the HydroMARK® Breast Biopsy Site Markers perform as intended, accurately marking the biopsy site in the cavity of the breast biopsy. The two modified devices work in an identical manner to previously cleared HydroMARK® Breast Biopsy Site Markers. Thus, the two modified devices can be considered substantially equivalent.

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.