(152 days)
The SOCON® Spinal System is intended for patients: a.) having severe spondylolisthesis (Grades 3 and 4) at the Lg-S, vertebral joint; b.) who are receiving fusions using autologous bone grafts only; c.) who are having the device fixed or attached to the lumbar and sacral spine; and d.) who are having the device removed after the development of a solid fusion mass. Levels of pedicle screw fixation for this indication are from L3 to S1.
The SOCON® Spinal System is a construct composed of implant-grade 6mm transpedicular bone screws of varying lengths (35mm to 65mm), straight and pre-bent rods, cross bars and specially designed clamps that are tightened by only one locking screw.
The provided text discusses the "Aesculap SOCON® Spinal System," a medical device. While it details the product's intended use, materials, and substantial equivalence to other devices, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, the document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence. This type of clearance often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new performance studies against predefined acceptance criteria for novel claims.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving the device meets them because that data is not present in the provided text.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
- The type of ground truth used, sample size for the training set, or how ground truth was established for a training set.
The section "Biomechanical Testing" states: "The implants and construct has undergone a variety of biomechanical testing, including static and dynamic testing for spinal implant assemblies in accordance with a draft ASTM standard. The test results show that the device components and system are able to provide significant stability with comparative realignment forces as other comparative devices." This indicates some testing was performed, but it lacks the specific details and quantitative results necessary to answer your questions thoroughly. It refers to comparing its performance to "other comparative devices" rather than predefined acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image contains the text '#K970285, Amendment 1' in the upper left corner. To the right of the text is a logo that is mostly black. The logo appears to have a crown at the top and a snake in the middle.
Image /page/0/Picture/2 description: The image shows the logo for AESCULAP. To the left of the company name is a black square with a white caduceus symbol inside of a white circle. Above the company name is the text "K9 +0285" in a handwritten font.
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990 Aesculap SOCON® Spinal System 510(k) #K970285
JUN 2 5 1997
Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon (415) 876-7000 x346 Phone: (415) 589-3007 FAX:
Product:
Common Names:
Classification Names and Product Codes:
Product Classification:
Regulatory Classification:
Class II
Unclassified, as per CDRH draft quidance document: "Draft Guideline for Reviewing Spinal Fixation Device Systems", dated July 18, 1995.
Aesculap SOCON® Spinal System
Posterior Pedicle Spinal System
MNH - Spondylolisthesis Spinal
Fixation Device System
The SOCON® Spinal System is a construct composed of implant-grade 6mm transpedicular bone screws of varying lengths (35mm to 65mm), straight and pre-bent rods, cross bars and specially designed clamps that are tightened by only one locking screw.
Intended Use
The SOCON® Spinal System is intended for patients: a.) having severe spondylolisthesis (Grades 3 and 4) at the Lg-S, vertebral joint; b.) who are receiving fusions using autologous bone grafts only; c.) who are having the device fixed or attached to the lumbar and sacral spine; and d.) who are having the device removed after the development of a solid fusion mass. Levels of pedicle screw fixation for this indication are from L3 to S1.
{1}------------------------------------------------
Technological Characteristics
Biomechanical Testing
The implants and construct has undergone a variety of biomechanical testing, including static and dynamic testing for spinal implant assemblies in accordance with a draft ASTM standard. The test results show that the device components and system are able to provide significant stability with comparative realignment forces as other comparative devices.
Material Composition
The implants in SOCON® Spinal System are composed of implant-grade titanium alloy (TiAL4V4), in accordance to ISO 5832/III. The predicate devices noted in this application are also manufactured of titanium / titanium alloy material.
Substantial Equivalence
The SOCON® Spinal System presented in this application has similar design concept, materials, features, intended use and surgical approach as existing legally marketed spine systems, such as:
- . Spine System® by Aesculap JBS;
- TSRH Spinal Screws & System by Sofamor Danek: .
- Selby System by Advanced Spine Fixation System Inc.; .
- VSP® Spinal Fixation System by AcroMed Corp .; .
- SYNERGY™ Posterior Spinal System by Cross Medical Products Inc.; . and
- . Varifix System by Advanced Spine Fixation System Inc .; and
These systems are similar in that:
-
- The devices have the same pedicle screw use;
-
- With the exception of SYNERGY™ Posterior Spinal System, these devices are manufactured of titanium / titanium alloy;
-
- The devices have similar components, dimensions, geometry and features.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a white eagle with three human profiles within its body. The eagle is facing right and has its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Victoria Mackinnon Manager, Requlatory Affairs Aesculap® 1000 Gateway Boulevard South San Francisco, California 94080-7030
IN 5 1997
Re: K970285 SOCON® Spinal System Requlatory Class: Unclassified Product Code: MNH Dated: May 13, 1997 Received: May 14, 1997
Dear Ms. Mackinnon:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Druq, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified 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. Note that labeling or otherwise
{3}------------------------------------------------
Page 2 - Ms. Victoria Mackinnon
promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
-
- All labeling for this device, including the package label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
-
- You may not label or in anyway promote this device system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- t When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- . The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
{4}------------------------------------------------
Page 3 - Ms. Victoria Mackinnon
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
-
- Any pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- 4 . Any previous warning statements identified as part of previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major
{5}------------------------------------------------
Page 4 - Ms. Victoria Mackinnon
regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodicans ww GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An 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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in yitro 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
{6}------------------------------------------------
Page 5 - Ms. Victoria Mackinnon
obtained from the Division of Small Manufacturers Assistance
Casino Check Cases of Case Case on (201) 443-6597 or 2 obtained from the Division of BM-22.
at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its toll-free number (800) 050 2011 02 (7) (1) 10 mm in.html".
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, -
Marie A. Schroeder, MS, PT
n Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
510(k) Premarket Notification
Aesculap SOCON® Spinal System
Page 1 of 1
INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indication for Use:
The Aesculap SOCON® Spinal System presented in this submission is intended only for patients with severe spondylolisthesis grades 3 and 4, at the L5-S1 vertebral joint, utilizing autologous bone graft, who are having the device fixed or attached to the lumbar and sacral spine and who are having the implants removed after the development of a solid fusion mass. Levels of pedicle screw fixation for this indication are from L3 to S1.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Ma A. Finoceden, MS, PT, facmw | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K970285 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
N/A