EasyMark Tissue Marker

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable. October 17, 2019 INRAD Inc. Steve Field CEO 4375 Donker Court SE Kentwood, Michigan 49512 Re: K183503 Trade/Device Name: EasyMark Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: September 16, 2019 Received: September 18, 2019 Dear Mr. Field: 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Cindy Chowdhury, Ph.D., M.B.A. Acting 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183503 Device Name EasyMark Tissue Marker Indications for Use (Describe) The EasyMark Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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A registered trademark symbol is located in the upper right corner of the logo. # 510(k) Summary | Date Prepared: | October 14, 2019 | |-------------------------|------------------------------------------------------| | Applicant: | INRAD Inc. | | | 4375 Donker Court SE, | | | Kentwood, MI 49512, USA | | Official Correspondent: | Steve Field | | | Tel. (616) 301-7800 / Fax. (616) 301-7799 | | | sfield@inradinc.com | | Trade Name: | EasyMark™ Tissue Marker | | Common Name: | Implantable Radiographic Marker | | Classification Name: | Implantable Clip (21 CFR 878.4300, Product Code NEU) | | Device Classification: | Class II | | Predicate Device: | UltraClip® Tissue Marker, K993785 | ## Device Description: The EasyMark Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 17 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. This device offers the user the choice of two unique tissue markers (i) 316 LVM Stainless Steel Anchor shaped Marker (ii) Titanium 6AI-4V ELI Ribbon shaped Marker. {4}------------------------------------------------ #### Indications for Use: The EasyMark Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure. #### Technological Comparison to Predicate Device: The EasyMark Tissue Marker has the same indications for use, principles of operation, fundamental scientific technology, and performance as that of predicate device UltraClip. In addition, SelectCore was chosen as the reference device to support the biocompatibility of the EasyMark's delivery device. The patient contact materials of the EasyMark (cannula and push rod) and SelectCore (cannula and stylet) are made of same material 304 Stainless Steel and have the same manufacturing processes. Therefore, a biological evaluation was conducted for the EasyMark delivery device in reference to SelectCore, to establish the biocompatibility of the delivery device. | | Subject Device | Predicate Device | Reference Device | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | EasyMark Tissue Marker | UltraClip Tissue Marker<br>(K993785) | SelectCore<br>(K093256) | | Indications<br>for Use | The EasyMark Tissue<br>Marker is intended for use<br>to attach to soft breast<br>tissue at the surgical site<br>during an open surgical<br>breast biopsy or a<br>percutaneous breast<br>biopsy to radiographically<br>mark the location of the<br>biopsy procedure. | The UltraClip® Tissue<br>Marker is intended for use<br>to attach to soft breast<br>tissue at the surgical site<br>during an open surgical<br>breast biopsy or a<br>percutaneous breast biopsy<br>to radiographically mark the<br>location of the biopsy<br>procedure. | The SelectCore device is<br>intended for use in obtaining<br>biopsies from soft tissues<br>such as liver, breast, kidney,<br>prostate, spleen, lymph<br>nodes and various soft<br>tissue tumors. For breast<br>biopsy this product is for<br>diagnosis only - not for<br>therapeutic use. | | Device | The EasyMark Tissue<br>Marker is a sterile, single<br>use device comprised of a<br>disposable delivery device<br>preloaded with a tissue<br>marker. | Same | The SelectCore is a sterile,<br>single use device comprised<br>of a disposable delivery<br>device. | | Marker | Titanium 6Al-4V ELI - 3D<br>Ribbon shaped<br>316 LVM Stainless Steel -<br>Anchor shaped | Titanium 6Al-4V ELI -<br>Ribbon shaped<br>316 Stainless Steel -<br>Ribbon shaped | N/A | | Markers -<br>Visualization<br>Techniques | X-ray, MRI | Same | X-ray | {5}------------------------------------------------ | Description | Subject Device<br>EasyMark Tissue Marker | Predicate Device<br>UltraClip Tissue Marker<br>(K993785) | Reference Device<br>SelectCore<br>(K093256) | |----------------------------|-----------------------------------------------|----------------------------------------------------------|--------------------------------------------------| | Delivery<br>Device | Plastic Handle and<br>Stainless Steel Cannula | Same | Plastic Handle and Stainless<br>Steel Cannula | | Needle<br>Dimensions | 17ga x 7cm<br>17ga x 10cm | 17ga x 10cm | 16ga x 10cm | | Packaging | Poly-tyvek pouch | Same | Thermoformed tray (material<br>PETG) - Tyvek lid | | Method of<br>Sterilization | Ethylene Oxide | Same | Same | {6}------------------------------------------------ ## Performance Data: Non-clinical testing and evaluation was conducted to demonstrate that the EasyMark Tissue Marker is substantially equivalent to the predicate device. The following nonclinical testing and evaluations were performed: - Performance Testing Bench ● - Accuracy of Marker Deployment O - Marker Deployment Force O - Usability of the Device O - Imaging Assessment (X-ray and MRI) O - Safety and Compatibility in Magnetic Resonance (MR) Environment O - Tissue Marker Migration Potential O - Delivery Device Cannula Tensile Test o - Delivery Device Push Rod Tensile Test - Biocompatibility ● - Sterilization ● - Packaging ● - Shelf Life ● ## Conclusion: The results of non-clinical testing and evaluation demonstrates that the EasyMark Tissue Marker does not raise new concerns of safety or effectiveness and is substantially equivalent to the predicate device.