(26 days)
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.
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.
The provided document is a 510(k) summary for the Life Spine Cement Restrictor. It focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting on specific performance criteria and a study proving those criteria are met, as would be expected for a novel device or a device with new indications requiring clinical data.
Based on the provided text, here's an analysis regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance:
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." This explicitly indicates that no specific performance acceptance criteria or corresponding test results are provided in this submission. The regulatory pathway chosen (Special 510(k) Summary) relies on substantial equivalence.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance:
No performance data, test sets, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned because the device is classified as non-load bearing and no mechanical tests were required. The submission relies on substantial equivalence to predicate devices, not new performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. As no test set performance data is provided, there is no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
Not applicable. No test set or associated adjudication methods are described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No MRMC study was done or reported in this document.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a medical device (cement restrictor), not an AI algorithm.
7. Type of Ground Truth Used:
Not applicable. No data requiring ground truth establishment is presented. The basis for clearance is substantial equivalence to predicate devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/algorithm-based device.
Summary from the Document:
The Life Spine Cement Restrictor was cleared based on its substantial equivalence to previously cleared predicate devices in terms of indications for use, design, function, and materials. Because it is a non-load bearing Class II device (CFR 21 878.3300), no mechanical tests or associated performance data were required for this submission. The critical aspect of its clearance was the comparison to existing devices on the market, not through a study demonstrating specific acceptance criteria for its own performance.
A key warning added during the 510(k) process is: "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 substantial equivalence for its intended use (femoral canal, tibia, or humerus), there was specific concern about off-label use in the spine.
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Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is underneath the word "Spine". A registered trademark symbol is to the right of the word "Spine".
K061698 P& LOF Z
| Special 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|
| 510(k) Summary - Life Spine Cement Restrictor | ||
| Submitted By: | Life Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60195Telephone: 847-884-6117Fax: 847-884-6118 | JUL 1 2 2006 |
| 510(k) Contact: | Erin MalloyLife Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60195 | |
| Date Prepared: | June 15, 2006 | |
| Trade Name: | Life Spine Cement Restrictor | |
| Common Name: | Cement Restrictor | |
| Classification: | Prosthesis, Surgical MeshCFR 878.3300Class II | |
| Device Product Code: | JDK | |
| Predicate Device: | Previously cleared devices |
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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Image /page/1/Picture/0 description: The image shows the words "Life Spine" in a bold, sans-serif font. The word "Life" is in a larger font size than the word "Spine". There is a curved line underneath the word "Spine", and the registered trademark symbol is to the right of the word "Spine".
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.
Substantial Equivalence:
The Life Spine Cement Restrictor was shown to be substantially equivalent to previously cleared devices 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 border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Life Spine LLC % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195
Re: K061698
Trade/Device Name: Life Spine Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: June 15, 2006 Received: June 16, 2006
Dear Ms. Malloy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 10 mo been in 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 - Ms. Erin Malloy
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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buell MD
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices 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 logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is underneath the word "Spine". The registered trademark symbol is next to the word "Spine".
KØ61698
Indications for Use
510(k) number (if known): ________
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)
K061698 Barbara Buehno
(Divis Division of General, Restor and Neurological Devices
510(k) Number K061196
§ 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.