(100 days)
The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.
This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established.
The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.
This document is a 510(k) summary for a medical device (Life Spine Cement Restrictor), which primarily establishes substantial equivalence to a predicate device rather than presenting a study demonstrating performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not directly applicable or available in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. For a 510(k) submission, the primary "acceptance criterion" is typically demonstrating substantial equivalence to a legally marketed predicate device, not meeting specific performance metrics defined by the applicant. The document states:
"This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required."
"The biocompatibility of this material for implantable contact over 30 days has been certified to ISO 10993 by the manufacturer of PEEK-OPTIMA®, Invibio."
So, the "performance" described is about material compliance and biocompatibility already established for the material itself, not the specific device's performance through new testing.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/provided. No specific test set data is presented for direct evaluation of the device's performance against acceptance criteria in a study. The demonstration of safety and effectiveness relies on substantial equivalence and material certifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/provided. There was no study requiring expert ground truth establishment for this 510(k) submission.
4. Adjudication Method
This information is not applicable/provided. No studies requiring adjudication were conducted for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided. This device is a physical implant, not an AI or imaging-based diagnostic tool, so an MRMC study is irrelevant.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
This information is not applicable/provided. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
This information is not applicable/provided for the device itself. The "ground truth" here is the established safety and effectiveness of the predicate device and the material from which both are made, as demonstrated by the predicate device's market history and the material manufacturer's certifications.
8. Sample Size for the Training Set
This information is not applicable/provided. There was no "training set" as this is not an AI/algorithmic device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. No training set was used.
Summary of Device Acceptance and "Study" (as described in the document):
The acceptance of the Life Spine Cement Restrictor is based on demonstrating substantial equivalence to a previously cleared device, the SIGNUS Medical RABEA™ Cement Restrictor, regarding its intended use, design, function, and materials.
The "study" or evidence provided to meet this acceptance criterion is:
- Comparison to a Predicate Device: The Life Spine Cement Restrictor is compared in design, function, and materials to the legally marketed SIGNUS Medical RABEA™ Cement Restrictor (K993077).
- Material Certification: Both devices are manufactured from PEEK-OPTIMA®. The biocompatibility of this material for implantable contact over 30 days was certified to ISO 10993 by the material manufacturer, Invibio. This certification, held in a Device Master File by the FDA, serves as evidence for the material's safety.
- Regulatory Classification: The device is classified as a non-load bearing Class II device (CFR 21 878.3300), which means no mechanical tests were explicitly required for this submission.
Therefore, the "acceptance criteria" were met by showing:
- The device is materially and functionally equivalent to a previously cleared device.
- The material used is biocompatible according to established standards (ISO 10993), as certified by the material manufacturer.
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Page 1 of 2 K060247
510(k) Summary of Safety and Effectiveness
MAY 11 2006
| Submitted By: | Life Spine2400 Hassel Road Suite 370Hoffman Estates, IL 60195Telephone: 847-884-6117Fax: 847-884-6118 |
|---|---|
| 510(k) Contact: | Erin MalloyLife Spine2400 Hassel Road Suite 370Hoffman Estates, IL 60195 |
| Date Prepared: | January 30, 2006 |
| Trade Name: | Life Spine Cement Restrictor |
| Common Name: | Cement Restrictor |
| Classification: | Prosthesis, Surgical MeshCFR 878.3300Class II |
| Device Product Code: | JDK |
| Predicate Device: | SIGNUS Medical RABEA™ Cement Restrictor |
Device Description:
The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.
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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Intended Use of the Device:
The Life Spine Cement Restrictor is intended for use in orthopedic surgeries involving the femoral canal, tibia, or the humerus ..
This device is NOT intended for use in any spinal indications or acetabular cup surgeries. The safety and effectiveness of this device for implantation in the spine has not been established.
Material:
The Life Spine Cement Restrictor is manufactured from PEEK-OPTIMA® according to ASTM F 2026-02.
Performance Data:
This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required.
This device is manufactured from PEEK-OPTIMA®. The previously cleared SIGNUS Medical RABEA™ Cement Restrictor was also manufactured from PEEK-OPTIMA®, which complies with ASTM F2026. The biocompatibility of this material for implantable contact over 30 days has been certified to ISO 10993 by the manufacturer of PEEK-OPTIMA®, Invibio. The Food and Drug Administration retains a Device Master File containing the biocompatibility information.
Substantial Equivalence:
The Life Spine Cement Restrictor was shown to be substantially equivalent to previously cleared device, the SIGNUS Medical RABEA™ Cement Restrictor, in indications for use, design, function, and materials used.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2006
Life Spine c/o Erin Malloy 2400 Hassell Road - Suite 370 Hoffman Estates, Illinois 60195
Re: K060247 : 分 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Life Spine Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: March 17, 2006 Received: March 20, 2006
Dear Ms. Malloy:
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 unse 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 Wamingson than 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 - Ms. Erin Malloy
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.
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 Section 510(k) premarket notification 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), it may be subject to 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/industry/support/index.html.
Sincerely yours,
Donna Bea Tillman, Ph.D., M.P.A.
Donna-Bea Tillman, Ph.D., M.P.A Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) number (if known): K060247
Device Name: Life Spine Cement Restrictor
The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.
This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established.
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
Prescription Use x (Part 21 CFR 801 Subpart D) And/Or
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Mark N. Wilkerson
ision Sign-Off) Timesion of General, Restorative and Neurological Devices
Number K060247
Submitted: 01-30-06
CONFIDENTIAL
Property of Life Spine
§ 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.