(73 days)
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No
The summary describes a mechanical implant (bone graft washer) and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an aid to spinal fusion, which implies it is used to treat or manage a medical condition (spinal instability).
No
Explanation: The device, a BONE GRAFT WASHER, is intended to stabilize bone grafts for spinal fusion. Its description focuses on its mechanical function and material composition, not on providing diagnostic information or detecting medical conditions.
No
The device description explicitly states that the BONE GRAFT WASHER is a physical component fabricated from medical grade titanium alloy or commercially pure titanium, and is used with a screw. This indicates a hardware device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the BONE GRAFT WASHER is a physical implant used to stabilize bone graft during spinal fusion surgery. It is a mechanical device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is to aid in spinal fusion by stabilizing bone graft, which is a surgical procedure, not a diagnostic process.
Therefore, based on the provided information, the BONE GRAFT WASHER is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).
Product codes
KWQ
Device Description
The BONE GRAFT WASHER is used with a 6.5mm low profile screw to provide bone graft stabilization during the development of a solid spinal fusion. Instrumentation is also available to facilitate implantation of the device components. BONE GRAFT WASHER components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The BONE GRAFT WASHER may also be fabricated from commercially pure titanium described by such standards as ASTM F67 or ISO 5832-2. The implant components may be sold either sterile or non-sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
T1-S1 (Spinal)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
FEB 1 8 2000
BONE GRAFT WASHER 510(k) Summary
February 14, 2000
Medtronic Sofamor Danek USA I, Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: BONE GRAFT WASHER II.
III. Description
The BONE GRAFT WASHER is used with a 6.5mm low profile screw to provide bone graft stabilization during the development of a solid spinal fusion. Instrumentation is also available to facilitate implantation of the device components.
BONE GRAFT WASHER components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The BONE GRAFT WASHER may also be fabricated from commercially pure titanium described by such standards as ASTM F67 or ISO 5832-2. The implant components may be sold either sterile or non-sterile.
IV. Indications for Use
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).
V. Substantial Equivalence
The BONE GRAFT WASHER is substantially equivalent to other commercially accepted devices. C2000 Medtronic Sofamor Danek
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2000
Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K994122
Trade Name: Bone Graft Washer Regulatory Class: II Product Code: KWQ Dated: December 3, 1999 Received: December 7, 1999
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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Page 2 - Richard W. Treharne, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Nef R.P. Ogden
James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): (99-4122
BONE GRAFT WASHER Device Name: __________
Indications for Use:
.
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (TI-SI) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Evaluation (ODE) | |
|---|---|
| NRO for JTO | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K994122 |
| Prescription Use | X |
| (Per 21 CFR 801.109) | OR |
| (Optional 1-2-96) | Over-the-counter Use |