The ClipLoc™ Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure.

It is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.

Device Description

The ClipLoc Soft Tissue Marker is a sterile, single patient use device comprised of a small nickeltitanium marker (clip), a well as a disposable introducer and applier. The introducer is a coaxial cannula with a beveled tip and a molded hub. The ClipLoc is preloaded near the distal end of the cannula. The applier is a stylette with a cap. A plastic safety connector holds the applier and introducer needle in the appropriate position ("Ready") and helps prevent premature deployment of the marker. After removal of the safety connector, the ClipLoc is deployed by manually advancing the needle.

The ClipLoc may be used with either visual or imaging guidance (such as ultrasound, X-Ray, stereotaxy, or Magnetic Resonance). It may be used directly, or applied through another coaxial needle or guide associated with percutaneous biopsy. The entire system including ClipLoc, introducer, and applier is Magnetic Resonance (MR) safe and compatible up to and including 1.5 Tesla magnetic field strength. The marker, when present in a patient undergoing an MR exam at 3.0 Tesla or less, will not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the ClipLoc Soft Tissue Marker, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Radiographic Visualization	Device should be radiographically visible across various imaging modalities.	Satisfactory radiographic visualization of the deployed ClipLoc was achieved using X-Ray, Ultrasound, and Magnetic Resonance (up to and including 3.0 Tesla).
MR Safety and Compatibility (1.5 Tesla)	Device must perform as indicated and be safe and compatible in magnetic fields up to and including 1.5 Tesla.	The device performs as indicated in magnetic fields up to and including 1.5 Tesla. The entire system including ClipLoc, introducer, and applier is Magnetic Resonance (MR) safe and compatible up to and including 1.5 Tesla magnetic field strength.
MR Safety and Compatibility (3.0 Tesla)	Device marker, when present, should not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating during an MR exam at 3.0 Tesla or less.	The ClipLoc Marker is MR safe and compatible up to and including 3.0 Tesla magnetic field strength. The marker, when present in a patient undergoing an MR exam at 3.0 Tesla or less, will not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating.
Material Compatibility & Functional Equivalence	Device should use implant-grade materials and have similar technological characteristics and components to predicate devices to perform its intended functions.	The ClipLoc Soft Tissue Marker is made of implant grade materials and has similar technological characteristics as the predicate devices. The proposed and predicate devices contain the same primary components to achieve these functions. The patient contact components and component materials for positioning the tissue marker in both the new and predicate devices are equivalent. The materials, packaging configuration, sterilization methods and sterility assurance level are also equivalent.

Study Details:

The provided document describes a premarket notification (510(k)) for the ClipLoc Soft Tissue Marker. The "study" referenced in the document is a preclinical testing phase to confirm the device performs as intended.

Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of human subjects or a dataset. The performance data presented refers to preclinical testing. Therefore, information on sample size and data provenance in this context (e.g., country of origin, retrospective/prospective) is not applicable or provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the performance data is from preclinical testing, not a study involving human interpretation or ground truth establishment by experts in the typical clinical study sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as the performance data is from preclinical testing and does not involve a "test set" requiring adjudication.
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:
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (tissue marker), not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "satisfactory radiographic visualization," the "ground truth" would be the direct observation and assessment of the marker's visibility by the engineers/technicians performing the preclinical tests using the specified imaging modalities (X-Ray, Ultrasound, MR). For MR safety and compatibility, the "ground truth" would be the physical measurements and observations of the device's behavior in MR environments according to established standards.
The sample size for the training set:
Not applicable. This is a physical medical device, and the "performance data" refers to preclinical testing and material characteristics, not machine learning model training.
How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning model.

Summary

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JAN 2 8 2004

033447 (P. 1 of 2)

Appendix VII: 510(k) Summary of Safety and Effectiveness

ClipLoc Soft Tissue Marker

Company:

MRI Devices Corporation 1515 Paramount Drive Waukesha. Wi 53186

Contact:

Thomas E. Schubert President/CEO Phone: 262-524-1402 X151 Fax: 262-832-0172 Email: Tom.Schubert@mridevices.com

Date Prepared:

15 October 2003

Name of Device

Trade Name: ClipLoc Soft Tissue Marker Classification Name: Implantable Staple

Predicate Devices

Biopsys Medical, Inc (BMI) MicroMark™ Clip (K970817) Inrad, Inc UltraClip Tissue Marker (K993785) Ethicon Endo-Surgery, Inc MicroMark II TM Tissue Marker (K013413) Ethicon Endo-Surgery, Inc 8 Gauge MicroMark II™ Tissue Marker (K020276) Sanarus Medical, Inc Sanarus Indica Marker System (K020054) Vivant Medical, Inc VMI Biopsy Marker System (K000278)

Device Description

Intended Use

The ClipLoc Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure.

The ClipLoc® Soft Tissue Marker is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.

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033447 (K.2 of 2)

Technological Characteristics

The ClipLoc® Soft Tissue Marker is made of implant grade materials and has similar technological characteristics as the predicate devices. The proposed and predicate devices contain the same primary components to achieve these functions: a handheld applier with deployment mechanism, and a marking clip located at the distal end of the applier. A single marker is deployed through the handheld applier by a push rod. A plastic safety connector holds the applier and introducer needle in the appropriate position ("Ready") and helps prevent premature deployment of the marker. The patient contact components and component materials for positioning the tissue marker in both the new and predicate devices are equivalent. The for poolibring materials, packaging configuration, sterilization methods and sterility assurance level are also equivalent.

Performance Data

Preclinical testing was performed to confirm the device performs as intended. Satisfactory radiographic visualization of the deployed ClipLoc was achieved using X-Ray, Ultrasound, and Margetic Resonance (up to and including 3.0 Tesla). The device performs as indicated in magnetic fields up to and including 1.5 Tesla. The ClipLoc Marker is MR safe and compatible up to and including 3.0 Tesla magnetic field strength.

Based on the indications for use, the materials used, as well as the technological characteristics and preclinical testing results, the ClipLoc Soft Tissue Marker does not raise significant new questions of safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2004

Mr. Thomas Schubert President, CEO MRI Devices Corporation 1515 Paramount Drive Waukesha, Wisconsin 53186

Re: K033447

Trade/Device Name: ClipLoc Soft Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Radiographic implantable marker Regulatory Class: II Product Code: NEU Dated: October 15, 2004 Received: November 10, 2003

Dear Mr. Schubert:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 l'ederal 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 complics with other requirements of the Act or any Fedcral 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); good manufacturing practice requirements as sct 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.

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Page 2 - Mr. Thomas Schubert

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maine of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spocitie active in 3 at (301) 594-4659. Also, please note the regulation entitled, Connect the Office or Louis County of Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K033447

Device Name: ClipLoc Soft Tissue Marker

Indications For Use:

The ClipLoc™ Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure.

It is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

Page 1 of

510(k) Number: K033447

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.