(112 days)
Harmon Spinal Sphere
Not Found
No
The summary describes a physical implant (cobalt chrome spheres) for spinal fusion and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is intended to help promote intervertebral body fusion and provide temporary stabilization during healing, which are therapeutic functions.
No
The text describes the SATELLITE™ Spinal System as an "internal fixation device" intended for stabilization and to "promote intervertebral body fusion" by holding bone parts in alignment while they heal. Its purpose is treatment and support, not diagnosis.
No
The device description clearly states it consists of "cobalt chrome spheres," which are physical hardware components intended for implantation.
Based on the provided information, the SATELLITE™ Spinal System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SATELLITE™ Spinal System Function: The description clearly states that the SATELLITE™ Spinal System is an internal fixation device intended to be inserted between vertebral bodies to provide stabilization and promote fusion. This is a surgical implant, not a diagnostic test performed on a sample outside the body.
The information provided describes a medical device used for surgical intervention and support, not for diagnosing a condition.
N/A
Intended Use / Indications for Use
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.
Product codes
NVR
Device Description
The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from L3 to S1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Harmon Spinal Sphere
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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SATELLITE™ SPINAL SYSTEM 510(k) Summary - K051320 August 2005
| I. | Company: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133 | SEP - 9 2005 |
|----|----------|--------------------------------------------------------------------------------------|--------------|
| | Contact: | Richard W. Treharne
Sr. Vice President, Regulatory Affairs | |
- Proprietary Trade Name: SATELLITE™ Spinal System II.
- Classification Name: Spinal Device III.
- Regulation Number: Preamendment Device IV.
Product Description V.
The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
Indications VII
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.
Substantial Equivalence VIII
- Documentation was provided which demonstrated the SATELLITE™ Spinal System to be substantially equivalent to a legally recognized preamendment device, namely the Harmon Spinal Sphere manufactured by the Austenal Company of New York, NY.
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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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - U.S.A." are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2005
Richard W. Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132
Re: K051320
Trade/Device Name: SATELLITE Spinal System Regulation Number: Pre-amendment Regulatory Class: Unclassified Product Code: NVR Dated: May 18, 2005 Received: May 20, 2005
Dear Dr. Treharne:
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 be prominently displayed in all labeling, including pouch, box and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name:
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.
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Page 2 - Richard W. Treharne, Ph.D.
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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K051320
Device Name: SATELLITE™ Spinal System
Indications for Use:
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.
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)
Mark A. Wilkerson
Division Sign-Off) Division of General, Restorative and Neurological Device
510(k) Number K051321
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