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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the EasyMark Tissue Marker. It details the device, its indications for use, and a comparison to predicate and reference devices. However, it does not contain specific acceptance criteria or the study results proving the device meets those criteria, nor does it include information about a standalone study, MRMC study, sample sizes, ground truth establishment, or expert details for such studies.

Based on the information provided, here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document lists the types of non-clinical tests performed but does not state the specific acceptance criteria for each test or the quantitative results from those tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the document only states "non-clinical testing and evaluation was conducted." It doesn't detail specific sample sizes for any of the performance tests.

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)
This information is not provided as the document does not describe any studies involving human experts or ground truth establishment in this manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no studies involving human interpretation or adjudication are described.

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
This information is not provided. The EasyMark Tissue Marker is a physical implantable device, not an AI software. Therefore, an MRMC study with human readers improving with AI assistance would not be relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical tissue marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The document describes performance testing, but not the specific methods used to establish ground truth for metrics like "Accuracy of Marker Deployment." It likely refers to objective measurements against predefined specifications.

8. The sample size for the training set
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.

Summary of Provided Information (within the scope of the document):

Device Name: EasyMark Tissue Marker
Intended 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.

Non-clinical Testing and Evaluation Performed to demonstrate substantial equivalence to the predicate device:

Performance Testing Bench:
- Accuracy of Marker Deployment
- Marker Deployment Force
- Usability of the Device
- Imaging Assessment (X-ray and MRI)
- Safety and Compatibility in Magnetic Resonance (MR) Environment
- Tissue Marker Migration Potential
- Delivery Device Cannula Tensile Test
- Delivery Device Push Rod Tensile Test
Biocompatibility
Sterilization
Packaging
Shelf Life

Predicate Device: UltraClip® Tissue Marker, K993785
Reference Device (for biocompatibility of delivery device): SelectCore, K093256

Conclusion: The non-clinical testing and evaluation demonstrated that the EasyMark Tissue Marker "does not raise new concerns of safety or effectiveness and is substantially equivalent to the predicate device."

Disclaimer: The provided document is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not typically include detailed acceptance criteria or study results in the format requested, especially since the device is a physical marker and not an AI or diagnostic software tool.

Summary

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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. 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

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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

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Indications for Use

510(k) Number (if known)

K183503

Device Name EasyMark Tissue Marker

Indications for Use (Describe)

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

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:

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Indications for Use:

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(K993785)	SelectCore(K093256)
Indicationsfor Use	The EasyMark TissueMarker is intended for useto attach to soft breasttissue at the surgical siteduring an open surgicalbreast biopsy or apercutaneous breastbiopsy to radiographicallymark the location of thebiopsy procedure.	The UltraClip® TissueMarker is intended for useto attach to soft breasttissue at the surgical siteduring an open surgicalbreast biopsy or apercutaneous breast biopsyto radiographically mark thelocation of the biopsyprocedure.	The SelectCore device isintended for use in obtainingbiopsies from soft tissuessuch as liver, breast, kidney,prostate, spleen, lymphnodes and various softtissue tumors. For breastbiopsy this product is fordiagnosis only - not fortherapeutic use.
Device	The EasyMark TissueMarker is a sterile, singleuse device comprised of adisposable delivery devicepreloaded with a tissuemarker.	Same	The SelectCore is a sterile,single use device comprisedof a disposable deliverydevice.
Marker	Titanium 6Al-4V ELI - 3DRibbon shaped316 LVM Stainless Steel -Anchor shaped	Titanium 6Al-4V ELI -Ribbon shaped316 Stainless Steel -Ribbon shaped	N/A
Markers -VisualizationTechniques	X-ray, MRI	Same	X-ray

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Description	Subject DeviceEasyMark Tissue Marker	Predicate DeviceUltraClip Tissue Marker(K993785)	Reference DeviceSelectCore(K093256)
DeliveryDevice	Plastic Handle andStainless Steel Cannula	Same	Plastic Handle and StainlessSteel Cannula
NeedleDimensions	17ga x 7cm17ga x 10cm	17ga x 10cm	16ga x 10cm
Packaging	Poly-tyvek pouch	Same	Thermoformed tray (materialPETG) - Tyvek lid
Method ofSterilization	Ethylene Oxide	Same	Same

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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.

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.