(225 days)
Not Found
No
The description focuses on the physical properties and intended use of an implantable marker, with no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is described as an implantable marker intended to radiographically mark soft tissue for future surgical or therapeutic procedures, but it does not perform any therapeutic function itself. It facilitates future procedures by marking the site.
No
The device is an implantable marker used to radiographically mark soft tissue for future surgical or therapeutic purposes. It helps locate a treatment area but does not diagnose a condition.
No
The device description explicitly states it is an "implantable marker" manufactured of gold and nitinol, delivered in a sterile pre-loaded delivery cartridge. This indicates a physical, hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The superDimension superLock Cobra is an implantable marker used to radiographically mark soft tissue for future surgical or therapeutic procedures. It is physically placed within the body and its purpose is to be visible in imaging studies to guide treatment.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a physical object implanted in the body.
The description clearly indicates it's an implantable device used for marking tissue within the body, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The superDimension superLock Cobra is intended for use to radiographically mark soft tissue for future surgical therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The superDimension superLock Cobra is an implantable marker intended to be used to radiographically mark soft tissue for future surgical or therapeutic purposes. The marker is placed at or near the intended treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is identified with respect to the marker. The superDimension superLock Cobra is manufactured of gold and nitinol. The marker is delivered in a sterile pre-loaded delivery cartridge. The device is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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)
Tests were performed to demonstrate substantial equivalence of the superDimension device in comparison to the predicated as follows:
• Radiographic Visibility
• Compatibility with imaging equipment (Cyberknife, OBI)
• Migration resistance
The results of the nonclinical tests demonstrate that the superDimension superLock Cobra is as safe and effective as the legally marketed predicate devices, and performs as well as or better than the predicate device(s).
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.
K031206 RadioMed Visicoil, K100267 Cortex Manufacturing Fleximarc, K093064 Somatex Tumark Professional
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.
Not Found
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
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
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 |
| Minneapolis MN 55441. | |
| Telephone number | 763.210.4000 |
| Facsimile number | 763.210.4098 |
| Establishment Registration | |
| Number | 3004962788 |
| Name of contact person | Karyl Haskell |
| 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 | |
| which equivalence is claimed | 510(k) K031206 RadioMed Visicoil (JAK 21 CFR §892.1750) |
| 510(k) K100267 Cortex Manufacturing Fleximarc IYE 21 CFR §892.5050) | |
| 510(k) K093064 Somatex Tumark Professional (NEU 21 CFR §878.4300) | |
| Device description | The superDimension superLock Cobra is an implantable marker intended to be |
| used to radiographically mark soft tissue for future surgical or therapeutic | |
| purposes. The marker is placed at or near the intended treatment site and can | |
| easily be visualized in subsequent imaging studies. The location of the treatment | |
| area is identified with respect to the marker. The superDimension superLock Cobra | |
| is manufactured of gold and nitinol. The marker is delivered in a sterile pre-loaded | |
| 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 |
| mark soft tissue for future surgical or therapeutic purposes. | |
| Technological characteristics | The superDimension superLock Cobra has the same technological characteristics as |
| the predicate device(s) in terms of the design and materials. The predicate devices | |
| are gold or nitinol; whereas the superDimension device is nitinol/gold. | |
| Performance Tests | Tests were performed to demonstrate substantial equivalence of the |
| superDimension device in comparison to the predicated as follows: | |
| • Radiographic Visibility | |
| • Compatibility with imaging equipment (Cyberknife, OBI) | |
| • Migration resistance | |
| Conclusions | The results of the nonclinical tests demonstrate that the superDimension superLock |
| Cobra is as safe and effective as the legally marketed predicate devices, and | |
| 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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