(34 days)
The 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.
The Cadence™ Cement Restrictor is a hollow device with teeth on two opposing flat sides. The device is crafted of titanium alloy (ASTM F136) and is offered in a tapered style of various sizes. The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.
This document is a 510(k) summary for the Cadence™ Cement Restrictor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria with numerical performance metrics.
Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance, sample sizes, ground truth establishment methods, MRMC studies, standalone performance) cannot be filled with information from the provided text.
Based on the information provided, here's what can be inferred or stated:
Acceptance Criteria and Device Performance Study Information
The provided document is a 510(k) submission, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. In this context, "acceptance criteria" are generally met by demonstrating substantial equivalence, often through a comparison of technological characteristics, materials, and intended use, rather than a clinical trial with performance metrics.
Therefore, there is no table of acceptance criteria and reported device performance as would be found in a clinical study report proving performance against specific numerical benchmarks. The "acceptance" for this submission is FDA's determination of substantial equivalence.
1. A table of acceptance criteria and the reported device performance
Not applicable. The provided document is a 510(k) summary demonstrating substantial equivalence to predicate devices, not a study reporting performance against specific numerical acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or clinical data is described in this 510(k) summary. The submission relies on a comparison to predicate devices, not independent testing for performance.
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. There is no test set, and therefore no ground truth established by experts, described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
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. No MRMC study is mentioned. This device is a cement restrictor, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical cement restrictor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth described as this is not a study assessing diagnostic or predictive performance.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/ML device or a study involving data training.
9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth described.
Summary of the 510(k) submission and "Study" (Demonstration of Substantial Equivalence):
The "study" in this context is the design review provided to demonstrate substantial equivalence to previously cleared devices.
- Predicate Devices: Medtronic Sofamor Danek Cement Restrictor (K010528) and its predicates (K003718 and K010529).
- Method of Equivalence: Comparison of intended use, materials of construction (titanium alloy - ASTM F136), and technological characteristics (hollow device with teeth on two opposing flat sides, tapered style).
- Outcome for "Acceptance Criteria": FDA's determination of "Substantial Equivalence," allowing the device to be marketed. The primary "acceptance criterion" was that the device must be as safe and effective as the predicate devices, which was argued through design review and direct comparison.
- Limitation: FDA required a specific warning label stating: "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 it met the criteria for non-spinal use, its safety and effectiveness for spinal indications were not established and therefore not substantially equivalent for that specific use.
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K022218
page lot 1
510(K) Summary
| Submitted By: | David M. Hooper, PhDManager, Clinical & Regulatory AffairsSpinal Concepts, Inc.12012 Technology Blvd., Suite 100Austin, TX 78727512-918-2700May 22, 2001 |
|---|---|
| --------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Trade Name: | Cadence™ Cement Restrictor |
|---|---|
| Proposed Classification Name: | Prosthesis, Hip, Cement Restrictor |
| Product Code: | JDK (21CFR 878.3300) |
Predicate Devices: The Cadence™ 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 (K010528) and its Medtronic Sofamor Danek predicates (K003718 and K010529).
Device Description: The Cadence™ Cement Restrictor is a hollow device with teeth on two opposing flat sides. The device is crafted of titanium alloy (ASTM F136) and is offered in a tapered style of various sizes. The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.
Intended Use: The Cadence™ 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 any spinal indications. The safety and effectiveness of this device WHEN IMPLANTED in the spine have not been established.
Substantial Equivalence: A design review was provided to demonstrate that the Cadence™ Cement Restrictor is substantially equivalent to previously cleared devices such as the Medtronic Sofamor Danek Cement Restrictor(s) (K010528, K003718 and K010529).
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Page 1 - Dr. David Hooper
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David M. Hooper, Ph.D. Manager, Clinical & Regulatory Affairs Spinal Concepts Incorporated 12012 Technology Blvd, Suite 100 Austin, Texas 78727
Re: K022218
CADENCE TITANIUM Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: July 3, 2002 Received: July 9, 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.
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Page 2 - David M. Hooper, 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 (OS) 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.
B
Bernard Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
Device Name: Spinal Concepts, Inc. Cadence™ Cement Restrictor
Indications for Use:
The 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use: (Per 21 CFR 801.109) Over-The-Counter: (Optional Format 1-2-96)
Mark A. Milliken
(Division Sign-Off) (Division Sign-Oral, Restorative and Neurological Devices
510(k) Number -
§ 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.