(66 days)
Not Found
No
The summary describes a physical implant device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "Interbody Fusion Device" used for fusion of the spine in patients with degenerative disc disease, which is a therapeutic intervention.
No
Explanation: This device is an interbody fusion device designed to facilitate spinal fusion and is not used for diagnosis.
No
The device description explicitly states it consists of implants made from titanium alloy or PEEK, which are physical hardware components.
No, 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: The provided text describes a physical implantable device (Interbody Fusion Device) made of titanium alloy or PEEK, designed to be surgically placed in the spine to facilitate fusion.
- Intended Use: The intended use is for surgical implantation in the spine to treat degenerative disc disease and facilitate fusion. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not an in vitro diagnostic device.
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 for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.
The Spinal USA Interbody Fusion Device ALIF, LLIF, T-PLIF and PLIF 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 autogenous bone graft. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device.
The Spinal USA Interbody Device Stabilizer RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The Stabilizer RPIF device is not meant for stand alone use.
Product codes (comma separated list FDA assigned to the subject device)
MAX, 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-6AI-4V titanium alloy (ASTM F136) or medical grade polyetheretherketone (Peek LT1). The products are supplied clean and "NON-STERILE".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (lumbar spine, from L2 to S1)
Indicated Patient Age Range
skeletally mature patients
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): 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.
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.
Not Found
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).
Not Found
§ 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
| Date Summary Prepared: | July 17, 2009 |
|---|---|
| Submitter Information: | Spinal USA |
| 2050 Executive Drive | |
| Pearl, MS 39208 | |
| Contact Name: | Jeffrey Johnson |
| Phone: | 601-420-4244 |
| Fax: | 601-420-5501 |
| E-mail: | jeff@spinalusa.com |
| Device Trade Name: | Spinal USA Intervertebral Body Fusion Device |
| Common Name: | Intervertebral Body Fusion Device |
| Product Code: | MAX (Class II) 888.3080 |
| KWQ (Class II) 888.3060 | |
| Basis for Submission: | Modification to components |
| Additional components |
inal USA Interbody Fusion Device (K081196) Spinal USA Interbody Fusion Device (K080314)
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 for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.
The Spinal USA Interbody Fusion Device ALIF, LLIF, T-PLIF and PLIF 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 autogenous bone graft. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device.
The Spinal USA Interbody Device Stabilizer RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The Stabilizer RPIF device is not meant for stand alone use.
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-6AI-4V titanium alloy (ASTM F136) or medical grade polyetheretherketone (Peek LT1). The products are supplied clean and "NON-STERILE".
EOUIVALENT 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.
/.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Spinal USA % Mr. Jeffrey Johnson Manager, Regulatory Affairs 2050 Executive Drive Pearl, Mississippi 39208
SEB 2 5 2009
Re: K092193
Trade/Device Name: Interbody fusion device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervetebral body fixation orthosis Regulatory Class: II Product Code: MAX, KWO Dated: September 1, 2009 Received: September 1, 2009
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 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); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); 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.
2
Page 2 - Mr. Jeffrey Johnson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kaibare briehm
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _K092193
Device Name: Interbody Fusion Device
Indications for Use:
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine The Spinal USA Interbody Fusion Device is indicated for use with autograft to facilitate
in skeletally mature patients. The device system is designed for use with autograft t in skeletally mature patients. The device system is designed for the ALIF, TLIF and T-PLIF system.
fusion. One device is used per intervertebral space for the ALIF, TLIF and fusion. One device is used per intervertebral space for the FLIF system.
Two devices are used per intervertebral space for the FLIF system.
The Spinal USA Interbody Fusion Device ALIF, LLIF, T-P.JF, T-P.JF and PLIF System are
ntil L2 to the states and makes two contiguous levels in the lumbar spine, from L2 to The Spinal USA Interbody Fusion Device ALLF, LED', TLA ; T DAP Mar spine, from L2 to S )
intended for use at either one level or two contiguous levels in the lumbar spine, fr intended for use at either one level of two contiguous levels in the hander opmaylolisthesis. DDD
for the treatment of degenerative disc disease (DDD) with up to Crade I soco for the treatment of degenerative disease (DDD) with up to Grade reportinged by history
is defined as back pain of discolent origin with degeneral fixation and is defined as back pain of discogenti origin will degencently or molemental fixation and and radiographic studies. The lumbar device is to be lised with suppenentive treatment prior
autogenuos bone graft. Patients should have at least six months of non-operative autogentios bone grant. Fatients should fusion device.
The Spinal USA Interbody Device Stabilizer RPIF System is intended to be used only in The Spinal USA Interbody Device Stabilizer NY 11 : System he height is implanted. The
anterior procedures in which an ALIF acture of the same height is implanted. The anterior procedures in which all the meant for stand alone use.
X Prescription Use (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 NOT WRITE BELOW THIS LINE OF NEEDED) OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kareen S. Burney for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092193