Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a tissue marker and its delivery system, with no mention of AI/ML capabilities or data-driven analysis.

Therapeutic

No.
The device is used to mark a biopsy site, not to treat a condition or disease.

Diagnostic

No
The device is a tissue marker used to mark a biopsy site for future radiographic identification. It does not perform diagnosis itself, but rather aids in localizing an area of interest for subsequent diagnostic evaluation.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, single-use device comprised of a disposable delivery device and a tissue marker, which are physical components. The performance studies also include testing on physical attributes like deployment force, tensile strength, and biocompatibility.

IVD (In Vitro Diagnostic)

Based on the provided information, the EasyMark Tissue Marker is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "attach to soft breast tissue at the surgical site... to radiographically mark the biopsy procedure." This describes a device used in vivo (within the body) to mark a location for imaging, not a device used in vitro (outside the body) to examine specimens or samples.
Device Description: The description details a delivery device and a tissue marker designed to be implanted into tissue. This is consistent with an in vivo medical device.
Lack of IVD Characteristics: IVD devices typically involve analyzing biological samples (blood, urine, tissue samples, etc.) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The EasyMark Tissue Marker does not perform any such analysis. It is a physical marker.

Therefore, the EasyMark Tissue Marker is classified as an in vivo medical device, specifically a tissue marker used during biopsy procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 biopsy procedure.

Product codes (comma separated list FDA assigned to the subject device)

NEU

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray, MRI

Anatomical Site

soft breast tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
- 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

UltraClip® Tissue Marker, K993785

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

SelectCore (K093256)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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)

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)

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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:

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.

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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
(K993785)	SelectCore
(K093256)
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.	The UltraClip® 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.	The SelectCore device is
intended for use in obtaining
biopsies from soft tissues
such as liver, breast, kidney,
prostate, spleen, lymph
nodes and various soft
tissue tumors. For breast
biopsy this product is for
diagnosis only - not for
therapeutic use.
Device	The EasyMark Tissue
Marker is a sterile, single
use device comprised of a
disposable delivery device
preloaded with a tissue
marker.	Same	The SelectCore is a sterile,
single use device comprised
of a disposable delivery
device.
Marker	Titanium 6Al-4V ELI - 3D
Ribbon shaped
316 LVM Stainless Steel -
Anchor shaped	Titanium 6Al-4V ELI -
Ribbon shaped
316 Stainless Steel -
Ribbon shaped	N/A
Markers -
Visualization
Techniques	X-ray, MRI	Same	X-ray

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| Description | Subject Device
EasyMark Tissue Marker | Predicate Device
UltraClip Tissue Marker
(K993785) | Reference Device
SelectCore
(K093256) |
|----------------------------|-----------------------------------------------|----------------------------------------------------------|--------------------------------------------------|
| Delivery
Device | Plastic Handle and
Stainless Steel Cannula | Same | Plastic Handle and Stainless
Steel Cannula |
| Needle
Dimensions | 17ga x 7cm
17ga x 10cm | 17ga x 10cm | 16ga x 10cm |
| Packaging | Poly-tyvek pouch | Same | Thermoformed tray (material
PETG) - Tyvek lid |
| Method of
Sterilization | 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.