(172 days)
The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus.
The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.
The provided document is a 510(k) summary for the Interpore Cross CEMENT RESTRICTOR. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the device itself.
Based on the provided text, there is no detailed study described that proves the device meets specific acceptance criteria in terms of performance metrics. The submission argues for substantial equivalence based on indications for use, design features, principles of operation, and materials compared to already marketed predicate devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) cannot be answered.
Here's what can be extracted from the document in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. The implicit "acceptance criterion" is proving substantial equivalence to predicate devices. The "reported device performance" is described qualitatively by stating it functions similarly to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Substantial Equivalence | The Interpore Cross CEMENT RESTRICTOR is substantially equivalent to the cited predicate devices based on the indications for use, design features, principles of operation and materials. |
| Functionality | Designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. (Similar to predicate devices) |
| Materials | Manufactured from a polymer-ceramic composite. (Comparable to predicate devices) |
| Indicated Use | Intended for use as a cement restrictor in the femur, tibia and/or humerus. (Same as predicate devices) |
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. The document explicitly states it is a 510(k) summary demonstrating substantial equivalence, not a performance study. Therefore, there is no "test set" or associated data described.
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. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is 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. This device is a physical cement restrictor, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth for performance evaluation is mentioned. The "ground truth" for the 510(k) substantial equivalence determination is the established understanding and performance of the predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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Interpore Cross International Confidential
MAY 1 6 2003
K023908
page 1 of 1
510(k) SUMMARY
SUBMITTED BY
Prosie Rey-Fessler, RAC Director, Regulatory Affairs and Quality Assurance INTERPORE CROSS International 181 Technology Drive Irvine, California 92618
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Cement Restrictor Common/Usual Name: Cement Restrictor Product Classification: Unclassified Proprietary Name: Interpore Cross CEMENT RESTRICTOR
PREDICATE DEVICES
Medtronic Sofamor Danek Cement Restrictor Macropore IB Resorbable Plug Pro Osteon 500R Resorbable Bone Graft Substitute Pro Osteon 500R Resorbable Bone Void Filler
INDICATIONS-FOR-USE
The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus.
DEVICE DESCRIPTION
The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.
COMPARISON TO THE PREDICATE DEVICE
The Interpore Cross CEMENT RESTRICTOR is substantially equivalent to the cited predicate devices based on the indications for use, design features, principles of operation and materials.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper half of the circle. The text is in all capital letters and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Prosie Rey-Fessler, RAC Director, Regulatory Affairs and Quality Assurance INTERPORE CROSS International 181 Technology Drive Irvine, California 92618
MAY 1 6 2003
K023908 Re:
Trade/Device Name: Interpore Cross Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: February 28, 2003 Received: March 3, 2003
Dear Ms. Rey-Fessler:
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 - Ms. Prosie Rey-Fessler, RAC
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,
Daniel Schultz, M.D.
Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ള
Device Name: INTERPORE CROSS CEMENT RESTRICTOR
Indications-For-Use:
The Interpore Cross CEMENT RESTRICTOR is indicated for use as a cement restrictor in the femur, tibia and/or humerus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (PER 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Mark A. Milhurn
General, Restorative Division of and Nearological Devices
510(k) Number K023908
§ 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.