The implanted SmartClip™ is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

Device Description

The SmartClip™ is an ethylene oxide sterile, single use device composed of a soft tissue marker preloaded in a Delivery System. The marker is intended to be placed within soft tissue. The marker is visible using radiography (including mammographic imaging), ultrasound and MRI.

Marker:
A sterile, single use device permanently implanted marker is approximately 8 mm wide. The marker is placed into the barrel of the introducer and maintained in place prior to insertion by a biocompatible bone wax plug. The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and breast) and subsequently be detected by means of radiography (including mammographic imaging), ultrasound and MRI.

Delivery System:
The Delivery System consists of a stylet, a stylet-lock to prevent and 15ga introducer needle. The stainless steel needle is approximately 10.8 cm long with 1cm depth reference marks. The marker is preloaded inside the needle and retained by a bone wax plug. When the stylet is completely depressed the marker and bone wax plug, are deployed from the end of the needle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not include specific acceptance criteria with quantifiable metrics for the SmartClip™ Soft Tissue Marker alongside reported device performance data, nor does it detail a specific study with the characteristics you requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria. While it mentions "Performance Testing," it lists the types of tests conducted (e.g., Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility, Biocompatibility, Packaging, Sterilization) but does not provide the concrete results, statistical analyses, or the detailed parameters of these tests.

Based on the provided text, I can extract the following information, but cannot fully populate the requested table or answer all questions due to the lack of specific performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated with Metrics)	Reported Device Performance (Summary, not granular data)
Simulated Use: Device performs as intended during simulated use.	"Met all specified criteria" (general statement)
Mechanical Integrity: Device maintains structural integrity under relevant conditions.	"Met all specified criteria" (general statement)
Imaging Assessment: Marker is visible using radiography, ultrasound, and MRI.	"The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and breast) and subsequently be detected by means of radiography (including mammographic imaging), ultrasound and MRI." (Qualitative assertion)
MR Compatibility: Device is safe and compatible with MRI environments.	"Passed" (Biocompatibility and MR Compatibility are listed under "Technological and Performance Characteristics Comparison" as having "Passed").
Biocompatibility: Device materials are biologically compatible.	"Passed" (Biocompatibility and MR Compatibility are listed under "Technological and Performance Characteristics Comparison" as having "Passed").
Packaging: Integrity and sterility of packaging are maintained.	"Met all specified criteria" (general statement)
Sterilization: Device achieves specified sterility assurance level (SAL).	"Terminal sterilization by ethylene oxide, sterility assurance level 10-6" (This is a characteristic, achieving this SAL would be the criterion).
Overall Safety & Effectiveness: Device is as safe and effective as predicate.	"The SmartClip™ met all specified criteria and did not raise new safety or performance questions." "The SmartClip™ is found to have a safety and effectiveness profile that is the same as the predicate device and is determined by Elucent Medical to be substantially equivalent."

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

The document does not specify the sample size for any of the performance tests (e.g., simulated use, mechanical integrity, imaging assessment). The data provenance is also not detailed (e.g., country of origin, retrospective/prospective). The emphasis is on types of tests performed rather than the experimental design or results.

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

This information is not provided in the document. The tests described (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility) are primarily bench-top or in vitro tests and physical characterizations, which generally do not require expert adjudication in the way clinical diagnostic studies might. For "Imaging Assessment," while expert interpretation would be involved, the text doesn't detail a specific study with expert readers.

4. Adjudication Method for the Test Set

As the document primarily discusses engineering and material tests, a formal "adjudication method" (like 2+1 or 3+1 for clinical image interpretation) is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not mentioned or indicated in this submission. This device is a passive tissue marker, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable as the SmartClip™ is a physical medical device (a tissue marker) and not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests mentioned:

Mechanical Integrity/Simulated Use: Ground truth would be based on engineering specifications and acceptable performance parameters.
Imaging Assessment: Ground truth would be the presence of the marker and its visibility under various imaging modalities, likely assessed visually by imaging professionals or engineers against expected image characteristics.
MR Compatibility: Ground truth established through adherence to recognized MR safety standards and testing protocols (e.g., heating, artifact assessment).
Biocompatibility: Ground truth established through in vitro and/or in vivo studies following ISO 10993 standards. The document states it "Passed."

8. The Sample Size for the Training Set

This is not applicable as the SmartClip™ is not a machine learning or AI device that requires a training set.

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

This is not applicable as the SmartClip™ is not a machine learning or AI device.

In summary: The provided 510(k) summary for the SmartClip™ Soft Tissue Marker focuses on demonstrating substantial equivalence through a comparison of "Indications for Use," "Technological and Performance Characteristics," and listing the types of performance tests conducted (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility, Biocompatibility, Packaging, Sterilization). It explicitly states that "The SmartClip™ met all specified criteria and did not raise new safety or performance questions." However, it does not provide detailed quantitative acceptance criteria or the specific results and statistical data from these performance tests.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 4, 2018

Elucent Medical, Inc. Ms. Debra Kridner VP Regulatory and Quality 7480 Flying Cloud Drive, Suite 101 Eden Prairie, Minnesota 55344

Re: K180640

Trade/Device Name: SmartClip Soft Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: May 21, 2018 Received: May 22, 2018

Dear Ms. Kridner:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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Indications for Use

510(k) Number (if known) K180640

Device Name

SmartClip™ Soft Tissue 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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510(k) Summary

Following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92

Date Prepared:	May 18, 2018
Applicant:	Elucent Medical, Inc.7480 Flying Cloud Drive, Suite 110Eden Prairie, MN 55344 USA
Official Correspondent:	Debra KridnerTel: (844) 417 1700 / Fax: (952) 314-7105debra.kridner@elucent.com
Trade Name:	SmartClip™ Soft Tissue Marker
Common Name:	Implanted, Radiographic, Tissue Marker
Classification Number:	21 CFR 878.4300
Classification Name:	Implantable Clip
Device Class:	Class II
Product Code:	NEU
Review Panel:	General and Plastic Surgery
Predicate Device (primary):	Focal Therapeutics BioZorb Marker - K143484/K152070
Reference Device:	Cianna Medical Permanent Tissue Marker - K132463

Indications for Use for the Device Subject to this 510(k) Notification:

The SmartClip™ is indicated for radiographic marking of sites in addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

Device Description for the Device Subject to this 510(k) Notification:

Image /page/3/Figure/8 description: This image shows a medical device with labels pointing to its different parts. The introducer needle length is labeled as 10.8 cm. Other labeled parts include the unlock button, deployment plunger, stylet, bone wax (3-4 mm), and SmartClip (8 mm x 1.4 mm).

Image /page/3/Figure/9 description: The image shows the word "SmartClip" with the trademark symbol next to it. The text is in a serif font and is black. The background is white.

Marker:

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K180640 pg. 2 of 3

A sterile, single use device permanently implanted marker is approximately 8 mm wide. The marker is placed into the barrel of the introducer and maintained in place prior to insertion by a biocompatible bone wax plug. The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and breast) and subsequently be detected by means of radiography (including mammographic imaging), ultrasound and MRI.

Delivery System:

The Delivery System consists of a stylet, a stylet-lock to prevent and 15ga introducer needle. The stainless steel needle is approximately 10.8 cm long with 1cm depth reference marks. The marker is preloaded inside the needle and retained by a bone wax plug. When the stylet is completely depressed the marker and bone wax plug, are deployed from the end of the needle.

Comparison ofSubject Deviceto PredicateDevice	Subject Device(under review)	Primary Predicate DeviceFocal Therapeutics BioZorb Marker(K143484/K152070)	Reference Device:Cianna Medical PermanentTissue Marker(K132463)
Indications forUse	The SmartClip™ is indicated forradiographic marking of sites insoft tissue. In addition, theMarker is indicated in situationswhere the soft tissue site needs tobe marked for future medicalprocedures.	The BioZorb LP Marker is indicatedfor radiographic marking of sites insoft tissue. In addition, the Marker isindicated in situations where the softtissue site needs to be marked forfuture medical procedures	The Cianna MedicalPermanent Tissue Marker isintended to mark tissueduring a percutaneousbreast biopsy procedure andbe permanently visible byradiography and visible forup to thirty days byultrasound.
Intended Use	Implanted Soft Tissue Marker	Implanted Soft Tissue Marker	Implanted Soft Tissue -"Breast" Marker
Anatomical Site	Soft Tissue	Soft Tissue	Soft Tissue - Breast

Indications for Use Comparison:

Technological and Performance Characteristics Comparison:

Comparison ofSubject Device toPredicate Device	Subject Device(under review)	Primary Predicate DeviceFocal Therapeutics BioZorbMarker(K143484/K152070)	Predicate Device:Cianna Medical PermanentTissue Marker(K132463)
Overall TechnologicalCharacteristics	Radiographically visiblepermanent marker	Radiographically visiblepermanent marker	Radiographically visiblepermanent marker
Principle of Operation	Marker is positioned intotissue site for radiographicvisualization of tissue site	Marker is positioned into tissuesite for radiographicvisualization of tissue site	Marker is positioned intotissue site for radiographicvisualization of tissue site
VisualizationCompatibility	X-Ray, MammographyUltrasound, MR	X-Ray, MammographyUltrasound, CT, MR	Radiographic andUltrasound (30 days)
Deployment Method	Introducer	Manual, open surgical	Introducer
Implant Duration	Permanent	Permanent	Permanent
Marker Materials	Parylene C coated glass vial	Titanium (marker clip),bioabsorbable polymer (spacer)	Titanium beads and Nitinol
Sterility	Terminal sterilization byethylene oxide, sterilityassurance level 10-6	Terminal sterilization byradiation, sterility assurancelevel 10-6	Terminal sterilization byethylene oxide, sterilityassurance level 10-6
Biocompatibility	Passed	Passed	Passed

Performance Testing:

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All necessary testing has been performed for the SmartClip™ to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended.

The device design was qualified through the following tests:

Simulated Use .
. Mechanical Integrity
. Imaging Assessment
MR Compatibility
Biocompatibility
Packaging
Sterilization ●

Conclusion:

The SmartClip™ met all specified criteria and did not raise new safety or performance questions.

Basis for Determination of Substantial Equivalence:

The Indications for Use, Intended Use, Fundamental Scientific Technology and Principles of Operation for the SmartClip™ are the same as those described for the predicate device. The SmartClip™ is found to have a safety and effectiveness profile that is the same as the predicate device and is determined by Elucent Medical to be substantially equivalent.

In summary, the SmartClip™ has the following similarties to the predicate device which have previously received 510(k) clearance:

Has the same indications for use
Has the same intended use
Has the same implant duration
Used in the same anatomical site
Uses similar technological characteristics
Uses the same principles of operation
Uses biocompatible materials
Has the same sterility assurance level

Therefore, the conclusions drawn from the and clinicaltests (biocompatibility) demonstrate that the devices as safe, as effective, and performs as well as the beatly marketed device predicate. The SmartClip™ 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.