(27 days)
The Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.
The Block CR-Titanium is NOT intended for any spinal indications.
The BLOCK CR - TITANIUM is a tapered block that is titanium. The device is intended to be used in conjunction with standard PMMA cement.
The BLOCK CR - TITANIUM implants are manufactured from titanium alloy as described by ASTM F136 or ISO 5832-3.
The purpose of this submission is to obtain clearance for the alternative design. All other aspects of the device including material, indications for use, and fundamental scientific technology are the same as the previous cleared TITANIUM CEMENT RESTRICTOR.
This 510(k) summary for the BLOCK CR - TITANIUM device does not contain the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
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No Acceptance Criteria and Reported Performance Table: The document describes the device, its intended use, and its substantial equivalence to a predicate device. It explicitly states, "A Design Review for the device was provided in this submission." However, the 510(k) summary itself does not provide an acceptance criteria table or the results of any specific performance testing. In a 510(k), manufacturers often rely on substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria for performance.
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No Study Details:
- Sample size and data provenance: Not mentioned.
- Number and qualifications of experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a physical implant, not an AI or imaging diagnostic tool, so an MRMC study would generally not be applicable.
- Standalone algorithm performance: Not applicable as it's not an algorithm.
- Type of ground truth: Not mentioned, and likely not applicable in the context of this device's regulatory pathway.
- Training set sample size and ground truth establishment: Not applicable as it's not a machine learning model.
What the document does indicate regarding "proof":
The document relies on the concept of Substantial Equivalence. The key statement is:
"The BLOCK CR - TITANIUM was demonstrated to be substantially equivalent to previously cleared devices such as TITANIUM CEMENT RESTRICTOR (K003718). A Design Review for the device was provided in this submission."
This means that instead of conducting new performance studies against predefined acceptance criteria, the manufacturer demonstrated that the new device is as safe and effective as a legally marketed predicate device (K003718) because:
- It has the same intended use.
- It has the same technological characteristics (made from titanium alloy, used with PMMA cement).
- Any differences in technological characteristics (alternative "tapered block" design) do not raise new questions of safety or effectiveness.
The "Design Review" mentioned would have likely included engineering analyses, material testing (referencing ASTM F136 or ISO 5832-3), and potentially bench testing to ensure the device performs as intended and is comparable to the predicate. However, specific results of these tests and the acceptance criteria used are not included in this summary.
In summary, based only on the provided text, it's not possible to provide the requested information because the 510(k) summary relies on substantial equivalence rather than reporting on a study designed to meet specific acceptance criteria for device performance as would be detailed for a new in-vitro diagnostic or AI device.
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K01-3014
OCT - 4 2001
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BLOCK CEMENT RESTRICTOR (CR) - TITANIUM 510(k) Summary September 2001
Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: II.
BLOCK CR - TITANIUM
III. Device Description:
The BLOCK CR - TITANIUM is a tapered block that is titanium. The device is intended to be used in conjunction with standard PMMA cement.
The BLOCK CR - TITANIUM implants are manufactured from titanium alloy as described by ASTM F136 or ISO 5832-3.
The purpose of this submission is to obtain clearance for the alternative design. All other aspects of the device including material, indications for use, and fundamental scientific technology are the same as the previous cleared TITANIUM CEMENT RESTRICTOR.
IV Intended Use:
The BLOCK CR-Titanium 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 BLOCK CR-Titanium is NOT intended for any spinal indications.
Substantial Equivalence: V.
The BLOCK CR - TITANIUM was demonstrated to be substantially equivalent to previously cleared devices such as TITANIUM CEMENT RESTRICTOR (K003718). A Design Review for the device was provided in this submission.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 4 2001
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K013014 Block Cement Restrictor (CR) - Titanium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: September 5, 2001 Received: September 7, 2001
Dear Dr. Treharne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in 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.
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Page 2 - Richard W. Treharne, Ph.D.
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 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 Part 801); good manufacturing practice requirements as set 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.
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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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.
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K013014
Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium Device Name:
FDA's Statement of the Indications For Use for Device:
The Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.
The Block CR-Titanium is NOT intended for any spinal indications.
for Mark n Mulkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. __ K013014
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.