(84 days)
The Fortitude Cement Restrictor System 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. This device is not intended for use in spinal applications.
The Fortitude Cement Restrictor is a hollow, titanium allov device with teeth on two opposing flat sides. The device comes in various sizes and is offered in straight and tapered styles. The device is used to hold bone cement (PMMA) in the distal diaphyseal canal in patients requiring a cemented arthroplasty device.
The provided text is a 510(k) premarket notification for a medical device called the "Fortitude Cement Restrictor." This notification is concerned with demonstrating substantial equivalence to pre-existing devices, rather than presenting a study that proves the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not applicable or cannot be extracted from this document, as a performance study in the context of specific quantitative acceptance criteria was not the primary focus of this type of submission.
Here's an attempt to address the requested information based only on the provided text, indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other quantitative performance metrics) or reported device performance against such criteria. The submission is a 510(k) for substantial equivalence, which primarily focuses on comparing the new device's intended use, materials, and technological characteristics to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a performance study with a test set. This is a 510(k) submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The document does not describe a performance study involving the establishment of ground truth by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a performance study with an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The document describes a physical medical device (a cement restrictor) and not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The document does not describe a performance study involving ground truth.
8. The sample size for the training set
Not applicable. The document does not describe a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set or its ground truth establishment.
Summary of what the document does provide:
- Device Name: Fortitude Cement Restrictor Prosthesis
- Proposed Classification Name: Hip. Cement Restrictor (21CFR 878.3300)
- Product Code: JDK
- Predicate Devices: Medtronic Sofamor Danek Cement Restrictor(s) (K012255 and K013014) and the Signus RABEA 1M Cement Restrictor (K990345).
- Device Description: A hollow, titanium alloy device with teeth on two opposing flat sides, available in various sizes and straight/tapered styles. It holds bone cement (PMMA) in the distal diaphyseal canal for cemented arthroplasty.
- Intended 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.
- Specific Limitation/Warning: "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." This indicates that while the device is cleared for its stated orthopedic uses, its use in spinal applications has not been evaluated or proven safe/effective.
- Nature of Submission: A 510(k) premarket notification demonstrating "substantial equivalence" to previously cleared devices based on intended use, materials, and technological characteristics, rather than a clinical performance study with defined acceptance criteria.
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AUG 1 5 2002
Safety and Effectiveness Information
Submitted By:
David M. Hooper, PhD Manager, Clinical & Regulatory Affairs Spinal Concepts, Inc. 12012 Technology Blvd., Suite 100 Austin, TX 78727 512-918-2700 May 22, 2001
Device:
Trade Name: Proposed Classification Name: Product Code:
Fortitude Cement Restrictor Prosthesis. Hip. Cement Restrictor JDK (21CFR 878.3300)
musddy
Predicate Devices:
The Fortitude Cement Restrictor is similar in terms of intended use, materials of construction, and technological characteristics to the predicate devices reviewed, the Medtronic Sofamor Danek Cement Restrictor(s) (K012255 and K013014) and the Signus RABEA 1M Cement Restrictor (K990345).
Device Description:
The Fortitude Cement Restrictor is a hollow, titanium allov device with teeth on two opposing flat sides. The device comes in various sizes and is offered in straight and tapered styles. The device is used to hold bone cement (PMMA) in the distal diaphyseal canal in patients requiring a cemented arthroplasty device.
Intended Use:
The Fortitude Cement Restrictor System 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.
This device is not intended for use in spinal applications.
Substantial Equivalence:
The Fortitude Cement Restrictor was demonstrated to be substantially equivalent to previously cleared devices such as the Medtronic Sofamor Danek Cement Restrictor(s) (K012255 and K013014) and the Signus RABEA110 Cement Restrictor (K990345). A Design Review for the device was provided in this submission.
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Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the people in the United States.
Public Health Service
AUG 1 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Hooper, Ph.D. Manager, Clinical & Regulatory Affairs Spinal Concepts Incorporated 12012 Technology Blvd, Suite 100 Austin, Texas 78727
Re: K021719 Fortitude Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: May 22, 2002 Received: May 23, 2002
Dear Dr. Hooper:
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.
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
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Page 2 - David Hooper, Ph.D.
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 vou 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 Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
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INIDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): _ K ○ 2 1 7 / 9
Device Name: Spinal Concepts, Inc. Fortitude Cement Restrictor
Indications for Use:
The Fortitude Cement Restrictor System 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.
This device is not intended for use in spinal applications.
for Mark N. Mikkelsen
(Division Sign-Off)
ivision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K02179
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc: (Per 21 CFR 801.109) OR
Over-The-Counter: (Optional Format 1-2-96)
§ 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.