SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER

K120796 · Superdimension, Inc. · JAK · Oct 26, 2012 · Radiology

Device Facts

• Record ID: K120796
• Device Name: SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
• Applicant: Superdimension, Inc.
• Product Code: JAK · Radiology
• Decision Date: Oct 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The superDimension superLock Cobra is intended to be used to radiographically mark soft tissue for future surgical or therapeutic purposes.

Device Story

The superDimension superLock Cobra is an implantable fiducial marker used to radiographically mark soft tissue for future surgical or therapeutic procedures. The device consists of gold and nitinol materials and is supplied in a sterile, pre-loaded delivery cartridge for single use. It is placed at or near the intended treatment site to allow for visualization in subsequent imaging studies, enabling clinicians to identify the treatment area location relative to the marker. The device is compatible with imaging equipment such as Cyberknife and OBI systems. It is intended for use by healthcare professionals in clinical settings.

Clinical Evidence

Bench testing only. Performance testing included radiographic visibility, compatibility with imaging equipment (Cyberknife, OBI), and migration resistance.

Technological Characteristics

Implantable fiducial marker composed of gold and nitinol. Delivered via sterile pre-loaded cartridge. Single-use. Radiopaque for visualization in imaging studies. Compatible with 3T MRI and specific radiotherapy imaging equipment.

Indications for Use

Indicated for radiographic marking of soft tissue for future surgical or therapeutic procedures. Contraindicated for use of more than 10 devices per patient and use in MRI machines with magnetic coils exceeding 3T.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• RadioMed Visicoil (K031206)
• Cortex Manufacturing Fleximarc (K100267)
• Somatex Tumark Professional (K093064)

Submission Summary (Full Text)

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

superDimension

State the country of the state of the states of the states of the states of

superDimension, Inc. 161 Orechie Lane Sone 160 Ministers Min 55441 5413
p 500 337 3110 not veej, 703 210 1000 1703,210-1099 www.bserdment.com

A 2008 For 2000 Section

# 510(k) Summary

OCT 2 6 2012 |

1975 - Bartical Station

| superDimension® superLock Cobra fiducial marker | | |
|-------------------------------------------------|--|--|
| | | |

| Submitter Information | |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | superDimension, Ltd. |
| Address | 161 Cheshire Lane, Suite 100<br>Minneapolis MN 55441. |
| Telephone number | 763.210.4000 |
| Facsimile number | 763.210.4098 |
| Establishment Registration<br>Number | 3004962788 |
| Name of contact person | Karyl Haskell<br>Vice President of Quality and Regulatory Affairs |
| Date prepared | March 14, 2012 |
| Trade or proprietary name | superDimension® superLock Cobra |
| Common or usual name | Fiducial Marker |
| Classification name | Marker, Radiographic, Implantable |
| Classification panel | Radiology |
| Regulation/Product Code | 21 CFR Part §892.1750 / JAK |
| Legally marketed device(s) to<br>which equivalence is claimed | 510(k) K031206 RadioMed Visicoil (JAK 21 CFR §892.1750)<br>510(k) K100267 Cortex Manufacturing Fleximarc IYE 21 CFR §892.5050)<br>510(k) K093064 Somatex Tumark Professional (NEU 21 CFR §878.4300) |
| Device description | The superDimension superLock Cobra is an implantable marker intended to be<br>used to radiographically mark soft tissue for future surgical or therapeutic<br>purposes. The marker is placed at or near the intended treatment site and can<br>easily be visualized in subsequent imaging studies. The location of the treatment<br>area is identified with respect to the marker. The superDimension superLock Cobra<br>is manufactured of gold and nitinol. The marker is delivered in a sterile pre-loaded<br>delivery cartridge. The device is intended for single use. |
| Intended use of the device | The superDimension superLock Cobra is intended to be used to radiographically<br>mark soft tissue for future surgical or therapeutic purposes. |
| Technological characteristics | The superDimension superLock Cobra has the same technological characteristics as<br>the predicate device(s) in terms of the design and materials. The predicate devices<br>are gold or nitinol; whereas the superDimension device is nitinol/gold. |
| Performance Tests | Tests were performed to demonstrate substantial equivalence of the<br>superDimension device in comparison to the predicated as follows:<br>• Radiographic Visibility<br>• Compatibility with imaging equipment (Cyberknife, OBI)<br>• Migration resistance |
| Conclusions | The results of the nonclinical tests demonstrate that the superDimension superLock<br>Cobra is as safe and effective as the legally marketed predicate devices, and<br>performs as well as or better than the predicate device(s). |

لقرب المنتدى المنتدى المنتدى المنتدى المنتدى المنتدى المنتدى المنتدى المنتدى المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتدى

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

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Karyl Haskell Vice President, Quality and Regulatory Affairs superDimension, Inc. 161 Cheshire Lane, Suite 100 MINNEAPOLIS MN 55441-5433

Re: K120796

Trade/Device Name: superDimension superLock Cobra Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 3, 2012 Received: October 4, 2012

#### Dear Mr. Haskell:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

OCT 2 6 2012 .

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris
Director

Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known):

### Device Name: superDimension superLock Cobra

Indications For Use: The superDimension superLock Cobra is intended for use to radiographically mark soft tissue for future surgical therapeutic procedures.

The superLock Cobra is contraindicated as follows:

- No more than 10 devices should be used per patient -
- Devices should not be used in an MRI machine with magnetic coils that exceed |

3T

Prescription Use × (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 In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off)

Division of Radiologic

Office of In Vitro Diagnostics an

51000K120796