(97 days)
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No
The document describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended for the treatment of cervical disc disease and degenerative disc disease, facilitating fusion and alleviating pain, which are therapeutic uses.
No
The device is an interbody fusion device designed for spinal fusion, which is a treatment, not a diagnostic procedure. Its purpose is to facilitate fusion by holding the spine stable and providing space for bone graft, not to identify or assess a medical condition.
No
The device description explicitly states it consists of implants and bone screws manufactured from titanium alloy, indicating it is a physical hardware device, not software only.
Based on the provided information, this device 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.
- Device Description and Intended Use: The description clearly states that the Spinal USA Interbody Fusion Device is an implantable device used for spinal fusion surgery. It is a physical device inserted into the body to facilitate bone growth and stabilize the spine.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its purpose is therapeutic and structural.
Therefore, this device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The Spinal USA Interbody Fusion Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, KWQ
Device Description
The Spinal USA Interbody Fusion Device consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from Ti-6Al-4V titanium alloy (ASTM F136). The products are supplied clean and "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
cervical spine, from C3 to T1
lumbar spine, from L2 to S1
Indicated Patient Age Range
skeletally mature patients
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
510 (k) Summary of Safety and Effectiveness
FDA CDRH DMC
| Date Summary Prepared: | February 1, 2008 | MAY - 8 2008 |
|---|---|---|
| Submitter Information: | Spinal USA | |
| 644 Lakeland East Drive Suite A | ||
| Flowood, MS 39232 | Received | |
| Contact Name: | ||
| Phone: | ||
| Fax: | ||
| E-mail: | Jeffrey Johnson | |
| 601-420-4244 | ||
| 601-420-5501 | ||
| jeff@spinalusa.com | MAY 13 2008 | |
| Device Trade Name: | Spinal USA Intervertebral Body Fusion Device | |
| Common Name: | Intervertebral Body Fusion Device | |
| Regulatory Number: | ||
| Classification: | ||
| Product Code: | 888.3080, 888.3060 | |
| Class II | ||
| MAX, ODP, KWQ |
INTENDED USE:
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of nonoperative treatment prior to treatment with a lumbar intervertebral fusion device.
The Spinal USA Interbody Fusion Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.
xage 1 of 2
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Körüziv
DEVICE DESCRIPTION:
The Spinal USA Interbody Fusion Device consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from Ti-6Al-4V titanium alloy (ASTM F136). The products are supplied clean and "NON-STERILE".
EQUIVALENT DEVICE:
Documentation was provided which demonstrated the Spinal USA Interbody Fusion Device to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style with thick, black lines. The text is in a smaller font size and is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spinal USA % Mr. Jeffrey Johnson 644 Lakeland East Drive Suite A Flowood, MS 39232
MAY 1 3 2008
Re: K080314 Trade/Device Name: Spinal USA Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP, KWQ Dated: May 7, 2008 Received: May 8, 2008
Dear Mr. Johnson:
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) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.
3
Page 2 - Mr. Jeffrey Johnson
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark W. Miller
- . Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known);
Device Name: Spinal USA Interbody Fusion Device
Indications for Use:
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The Spinal USA Interbody Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evalu
(Division Sign-Off)
Division of General, Restorative.
page i of 1 and Neurological Devices
510(k) Number K080314