(29 days)
Not Found
Not Found
No
The summary describes a physical orthopedic device (cement restrictor) and contains no mention of software, algorithms, image processing, AI, ML, or performance studies related to data analysis.
No
The device is a cement restrictor intended for use in orthopedic surgeries, which is a surgical tool and not a device that provides therapy.
No
The device is a cement restrictor intended for use in orthopedic surgeries, not for diagnosis. Its function is to restrict cement, which is a therapeutic/surgical tool, not a diagnostic one.
No
The device is described as a "Cement Restrictor," which is a physical object used in orthopedic surgery. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in orthopedic surgeries as a cement restrictor. This is a surgical device used in vivo (within the body) during a procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The function of the Medtronic Sofamor Danek Cement Restrictor is to physically restrict cement during orthopedic surgery, not to analyze biological samples.
N/A
Intended Use / Indications for Use
The Medtronic Sofamor Danek Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Medtronic Sofamor Danek Cement Restrictor is NOT intended for any spinal indications.
Product codes
JDK
Device Description
Cement Restrictor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal and tibial plateau in hip stem and total knee replacement
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeries
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)
Not Found
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.
Not Found
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.
AUG 3 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K011998 Cement Restrictor Regulation Number: 878.3300 Regulatory Class: II Product Code: JDK Dated: June 25, 2001 Received: June 27, 2001
Dear Dr. Treharne:
This letter corrects our substantially equivalent letter of July 26, 2001.
We have reviewed your Section 510(k) notification of intent to market the device referenced we have toviously of the bevice is substantially equivalent (for the indications for use above and we nave determined the arteted predicate devices marketed in interstate commerce stated in the onerobate, to regary ont date of the Medical Device Amendments, or to devices that provisions of the recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (ree). Tot may) ansieses, described below. The general controls provisions of the provisions of the Are and for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Device Erantation use not identified in the proposed labeling and that such use device with be assed for an meniaso ardance with Section 513(i)(1)(E) of the Act, the following court each intime "The Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
1
Page 2 - Richard W. Treharne, Ph.D.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.
Владева
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 3 – Richard W. Treharne, Ph.D.
510(k) Number: K011998
Medtronic Sofamor Danek Cement Restrictor Device Name:
FDA's Statement of the Indications For Use for Device:
The Medtronic Sofamor Danek Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Medtronic Sofamor Danek Cement Restrictor is NOT intended for any spinal indications.
for Mark N. Mulkerron
I. Restorative and Neurologic 011998
510(k) Number
Prescription Use_ OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________