(41 days)
The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal 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.
The INNOVASIS 'X-Box' PEEK Cement Restrictor is an implant system for use as a non-load bearing 'cement plug' in orthopedic surgery.
The design of the X-Box include rectangular components of different cross-sectional sizes to accommodate various configurations in the midsection femoral/tibial diaphyseal canal. These various size components will aid in placement and retention of the device in the medullary canal in order to prevent the migration of PMMA cement into the canal for patients receiving orthopedic cemented femoral hip or tibial total knee components. The X-Box is a hollow, PEEK material, rectangular frame with fenestrated sides and exterior ribs.
The device is intended to be used in conjunction with standard PMMA bone cement.
Acceptance Criteria and Device Performance Study for Innovasis 'X-Box' PEEK Cement Restrictor
The provided text does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary for a medical device (PEEK Cement Restrictor "X-Box") and primarily focuses on establishing substantial equivalence to previously marketed devices. It details the device's description, intended use, materials, and asserts safety and effectiveness based on this substantial equivalence, rather than new performance data.
Here's why the requested information cannot be extracted from the provided text:
- No mechanical tests were performed to support this application. The document explicitly states: "No mechanical tests were performed to support this application. The Innovasis PEEK Cement Restrictor is a non-load bearing device." This indicates that no performance study was conducted to generate data against specific acceptance criteria.
- Basis of Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through "substantial equivalence" to predicate devices. This means that if the new device is sufficiently similar to an already approved device, and the predicate device was found safe and effective, then the new device is also considered safe and effective without requiring extensive new performance data.
- Absence of Performance Data Section: The "Performance Data" section in the document directly follows the "Material" section and explicitly states that no mechanical tests were performed. There are no other sections that describe a study, acceptance criteria, or performance data.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies because this information is not present in the provided 510(k) summary. The FDA's approval appears to be based on the device's classification as non-load bearing and its material composition being compliant with established biocompatibility standards.
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JUL 2 2 2004
510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| Name of Firm: | Innovasis, Inc.997 East 3900 South, Suite 103Salt Lake City, Utah 84124 |
|---|---|
| 510(k) Contact: | Brent A. FelixSame address as above |
| Trade Name: | PEEK Cement Restrictor "X-Box" |
| Common Name: | Cement Restrictor |
| Classification: | Prosthesis, Hip, Cement Restrictor.Class II (see 21CRF, Sec. 888.3300) |
| Device Product Code: | JDK. The Panel code is 87. |
| SubstantiallyEquivalent Devices: | Spinal Concepts, Inc. (K031837, K031318, & K021719)Medtronic Sofamor Danek (K0010528) |
Device Description:
The INNOVASIS 'X-Box' PEEK Cement Restrictor is an implant system for use as a non-load bearing 'cement plug' in orthopedic surgery.
The design of the X-Box include rectangular components of different cross-sectional sizes to accommodate various configurations in the midsection femoral/tibial diaphyseal canal. These various size components will aid in placement and retention of the device in the medullary canal in order to prevent the migration of PMMA cement into the canal for patients receiving orthopedic cemented femoral hip or tibial total knee components. The X-Box is a hollow, PEEK material, rectangular frame with fenestrated sides and exterior ribs.
The device is intended to be used in conjunction with standard PMMA bone cement.
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Intended Use:
The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal 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
Material:
The Innovasis 'X-Box' PEEK Cement Restrictor is made from PEEK -OPTIMA™ (Polyetheretherketone) material according to ASTM F 2026-00 with embedded 6-4 Alloy Titanium (ASTM F 136) wires as radiological markers.
These materials are proven to be biocompatible as implant materials.
Performance Data:
No mechanical tests were performed to support this application. The Innovasis PEEK Cement Restrictor is a non-load bearing device.
Basis of Substantial Equivalence:
The Innovasis 'X-Box'' PEEK Cement Restrictor is similar to the predicate Spinal Concepts. Inc. (K031837. K031318. & K021719) and Medtronic Sofamor Danek (K010528) with respect to technical characteristics and performance.
Summary of Safety and Effectiveness:
The Innovasis "X-Box" PEEK Cement Restrictor system is shown to be safe and effective for use as a cement plug for use in orthopedic total hip and knee implant replacements.
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Image /page/2/Picture/1 description: The image is a black and white emblem. The emblem is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the emblem is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2004
Mr. Brent A. Felix President Innovasis. Inc. 997 East 3900 South Suite 103 Salt Lake City, Utah 84124
Re: K041583
Trade/Device Name: PEEK Cement Restrictor "X-Box" Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: JDK Dated: June 9, 2004 Received: June 11, 2004
Dear Mr. Felix:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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). 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 labeling 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 - Mr. Brent A. Felix
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I loast note that the above these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate I he i Dri inding of basification for your device and permits your device to proceed to the ucerice results in a classification of to begin marketing your device as described in your Section market. "This letter will aton if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified possible in the 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 r read be actived a determination that your device complies with other requirements of the Act that I Drinas Intactions and regulations administered by other Federal agencies. You must or any I odera: blacked and st 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Alwaton MD for
Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the text "INNOVASIS, INC." in a bold, serif font. The text is black and appears to be a company name. The letters are large and spaced closely together, giving the text a strong visual presence. There is a horizontal line underneath the text.
Salt Lake City, Utah 84124 (801) 557-1445 (801) 424-2097 Fax
Page 1 of 1
510(k) NUMBER: __ Ko4 158 3 DEVICE NAME: PEEK CEMENT RESTRICTOR INDICATIONS FOR USE:
The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal 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.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-the-Counter-Use |
| (Per 21 CFR 801.109) |
(Optional Format)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
§ 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.