(62 days)
The Spinal Spheres are intended to be inserted between 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 Spinal Spheres are intended to be used with bone graft.
These spheres may be inserted between the vertebral bodies into the disc space from L3 to S1. The Spinal Sphere implants are single use implants and should never be reused under any circumstances. These spheres are available in Ø10-Ø16mm.
Materials: PEEK Optima per ASTM F2026
Function: The Spinal Sphere is a spherical implant designed to hold bone parts in alignment while they heal in order to promote interbody fusion.
The provided text describes a 510(k) summary for PEEK Spinal Spheres but does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a regulatory submission for a medical device seeking clearance to market based on substantial equivalence to existing devices. It focuses on:
- Device Identification: Trade name, common name, classification, and product code.
- Predicate Devices: Identification of devices to which the PEEK Spinal Spheres are deemed substantially equivalent.
- Device Description: Materials (PEEK Optima per ASTM F2026), dimensions (Ø10-Ø16mm), function (to hold bone parts in alignment to promote interbody fusion), and single-use nature.
- Intended Use/Indications for Use: To be inserted between vertebral bodies (L3-S1) to provide stabilization and promote intervertebral body fusion, used with bone graft.
- Comparison to Predicate Devices: Stating equivalence in material, design, and indications.
- FDA Response (Clearance Letter): Affirming substantial equivalence but imposing a labeling limitation regarding motion-sparing, non-fusion procedures.
To answer your request, an actual performance study with defined acceptance criteria would be necessary, which is absent from this 510(k) summary. For devices cleared through the 510(k) pathway, especially those deemed substantially equivalent to a predicate, extensive clinical performance studies demonstrating new acceptance criteria are often not required if the new device is sufficiently similar to an already cleared device. The focus is more on demonstrating that the new device performs as intended and is as safe and effective as the predicate.
Therefore, for each of your points, the answer based solely on the provided text is as follows:
-
A table of acceptance criteria and the reported device performance:
- Not provided. The document does not specify any performance acceptance criteria or report on device performance against such metrics. It states the device's function and intended use.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. No test set or performance data from a study is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. No ground truth establishment is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set or related adjudication is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable / Not provided. This device is a physical spinal implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No ground truth is discussed in relation to device performance. The "ground truth" for a 510(k) device is primarily its substantial equivalence to a legally marketed predicate and its ability to perform its intended function safely.
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The sample size for the training set:
- Not applicable / Not provided. The document does not describe any training sets for an algorithm.
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How the ground truth for the training set was established:
- Not applicable / Not provided. This information is not relevant to the described device.
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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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510(k) Summary
JAN 3 - 2008
for the
PEEK Spinal Spheres
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the PEEK Spinal Spheres,
Date Prepared: October 31, 2007
1. Submitter:
Interbody Innovations LLP 24 Smith Road, Suite 503 Midland, TX 79705
Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
| 2. Trade name: | PEEK Spinal Spheres |
|---|---|
| Common Name: | Spinal device |
| Classification Name: | orthosis, spinal intervertebral fusion, solid sphereUnclassifiedNVR |
3. Predicate or legally marketed devices which are substantially equivalent:
The PEEK Spinal Sphere is a modification to the Interbody Innovations Spinal Sphere (K062992) and is substantially equivalent to the and Satellite Spinal System (K060415 - Sofamor Danek, Memphis, TN)
4. Description of the device:
These spheres may be inserted between the vertebral bodies into the disc space from L3 to S1. The Spinal Sphere implants are single use implants and should never be reused under any circumstances. These spheres are available in Ø10-Ø16mm.
Materials:
PEEK Optima per ASTM F2026
Function:
The Spinal Sphere is a spherical implant designed to hold bone parts in alignment while they heal in order to promote interbody fusion.
5. Intended Use:
The Spinal Spheres are intended to be inserted between 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 Spinal Spheres are intended to be used with bone graft.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
This device is substantially equivalent to the Interbody Innovations Spinal Sphere and Satellite Spinal System Satellite Spinal System (K060415). They are the same material, design and indications.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the eagle's body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Interbody Innovations, LLP % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681
JAN - 3 2008
Re: K073105
Trade/Device Name: PEEK Spinal Spheres Regulation Number: Pre-Amendment Regulation Name: N/A Regulatory Class: Unclassified Product Code: NVR Dated: November 30, 2007 Received: December 7, 2007
Dear Mr. Webb:
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 and Safety 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, of a similar point size, and in bold print:
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 - Mr. J.D. Webb
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 vour 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 (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.
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tilman, 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): 5073105
Device Name: _ _ PEEK Spinal Spheres
Indications for Use:
The Spinal Spheres are intended to be inserted between 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 Spinal Spheres are 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kaurice W. Cogan FOR M. MELKERSON
inn Sign. On Division of General, Restorative, and Neurological Devices
ii
510(k) Number K073105
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N/A