CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376

K033447 · Mri Devices Corp. · NEU · Jan 28, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033447
• Device Name: CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
• Applicant: Mri Devices Corp.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Jan 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

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.

Device Story

ClipLoc Soft Tissue Marker is a sterile, single-use device for marking surgical sites in breast or soft tissue. System consists of a nickel-titanium marker (clip), a disposable introducer (coaxial cannula with beveled tip), and an applier (stylette with cap). A plastic safety connector prevents premature deployment. Device is used under visual or imaging guidance (ultrasound, X-ray, stereotaxy, or MRI). Clinician manually advances the needle to deploy the marker. The device is MR safe and compatible up to 3.0 Tesla. By providing a permanent radiographic marker, the device assists clinicians in locating surgical sites for follow-up monitoring or subsequent procedures, benefiting patients by ensuring accurate site identification.

Clinical Evidence

Bench testing only. Satisfactory radiographic visualization of the deployed marker was confirmed using X-ray, ultrasound, and Magnetic Resonance imaging (up to 3.0 Tesla).

Technological Characteristics

Implant-grade nickel-titanium marker. System includes a coaxial cannula introducer and stylette applier. MR safe and compatible up to 3.0 Tesla. Manual deployment mechanism with plastic safety connector. Sterile, single-patient use.

Indications for Use

Indicated for radiographic and radiological marking of surgical sites in breast or other soft tissue following open or percutaneous procedures. Intended for attachment to soft tissue at the surgical site.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• MicroMark™ Clip (K970817)
• UltraClip Tissue Marker (K993785)
• MicroMark II TM Tissue Marker (K013413)
• 8 Gauge MicroMark II™ Tissue Marker (K020276)
• Sanarus Indica Marker System (K020054)
• VMI Biopsy Marker System (K000278)

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone] X151 Fax: [phone] Email: [e-mail]

# 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

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.

#### 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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, symbolizing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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.

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

# 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