The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.

Device Description

The SATELLITE™ Spinal System consists of spheres manufactured from either cobalt chrome or medical grade PEEK-OPTIMA LT1, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

AI/ML Overview

The provided text describes the regulatory classification and marketing authorization for the SATELLITE™ Spinal System. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary and the FDA's clearance letter for the device, focusing on its substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.

The information provided only discusses:

Device Name: SATELLITE™ Spinal System
Manufacturer: Medtronic Sofamor Danek
Product Description: Spheres manufactured from cobalt chrome or PEEK-OPTIMA LT1, implanted from L3-S1 for temporary stabilization and to promote fusion.
Indications for Use: Inserted between vertebral bodies L3-S1 to provide stabilization and promote intervertebral body fusion, used with bone graft. Designed solely for holding bone parts in alignment while they heal.
Regulatory Classification: Unclassified (at the time of clearance), later reclassified as Class III (Premarket Approval) on March 30, 2023.
Substantial Equivalence: Demonstrated the PEEK-OPTIMA LT1 spheres with Tantalum markers were substantially equivalent to previously cleared cobalt chrome SATELLITE™ Spinal System devices (K051320).
FDA Clearance: K060415/S1 on January 5, 2007, with a specific labeling limitation: "The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established."

To answer your questions about acceptance criteria and study data, information beyond what is supplied in these specific documents would be required. This type of information would typically be found in detailed clinical study reports or premarket approval (PMA) applications, which are generally more comprehensive than a 510(k) summary.

Summary

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A final rule classifying spinal spheres for use in intervertebral fusion procedures, a preamendments, unclassified device type, into class III (premarket approval), was published on March 30, 2023. See here: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinalspheres-for-use-in-intervertebral-fusion. Concurrently, FDA published a final order to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures. See here: https://www.federalregister.gov/documents/2023/03/30/2023-06565/effective-date-of-requirement-for-premarket-approvalapplications-for-spinal-spheres-for-use-in.

Please refer to the aforementioned final rule and final order for current regulatory requirements for this device type.

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K060415

SATELLITE™ SPINAL SYSTEM 510(k) Summary February 2006

JAN - 5 2007 I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Contact: Edward S. Chin Group Director, Clinical and Regulatory Affairs

II. Proprietary Trade Name: SATELLITE™ Spinal System
Classification Name: Orthosis, Spinal Intervertebral Fusion, Solid Sphere III.
Regulation Number: Preamendment Device IV.
V. Product Code: NVR

VI. Product Description

VII Indications

VIII Substantial Equivalence

The purpose of this submission was to add PEEK-OPTIMA LT1 spheres with Tantalum markers to the system. Documentation was provided which demonstrated the subject SATELLITE™ Spinal System devices to be substantially equivalent to the cobalt chrome SATELLITE™ Spinal System devices previously cleared in K051320 (SE 09/09/05).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Ms. Christine Scifert Group Director, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

JAN - 5 2007

Re: K060415/S1

Trade Name: SATELLITE® Spinal System Regulatory Class: Unclassified Product Code: NVR Dated: September 28, 2006 Received: September 29, 2006

Dear Ms. Scifert:

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:

"The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established."

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.

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Page 2 - Ms. Christine Scifert

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 aft 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.

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KO60415

Device Name: SATELLITE™ Spinal System

Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Riemke

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K060415/c

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Regulation Number and Section

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