(98 days)
P970015, P950019, P950002
Not Found
No
The summary describes a physical implantable device and associated instrumentation, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is an interbody fusion device used to treat degenerative disc disease and is implanted in the body, indicating a therapeutic purpose.
No
The device description indicates it is a system of implants and associated instrumentation for interbody fusion in patients with Degenerative Disc Disease, not for diagnosing the condition.
No
The device description explicitly states it is comprised of implantable components manufactured from titanium alloy, indicating it is a hardware device, not software-only.
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 Turbo Prime IBD System is an implantable device made of titanium alloy, designed to be surgically placed in the spine (L2-S1) to treat Degenerative Disc Disease.
- Intended Use: The intended use is to provide structural support and facilitate fusion in the spine, not to perform diagnostic tests on bodily samples.
The information provided clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Turbo Prime IBD (Interbody Device) System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies who have had at least six months of non-operative care for their DDD. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes
MAX
Device Description
The Turbo Prime IBD System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
L2-S1 (spine)
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
Pre-clinical testing performed indicated that the Turbo Prime IBD System is adequate for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), Ray Threaded Fusion Cage (Surg cal Dynamics, P950019), BAK Interbody Fusion Device (Spine Tech, P950002)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SpineSelect
APR 1 6 2008
9. 510(k) Summary according to $107.92(c)
| Contact: | Walter Eckman, M.D.
662-841-7585 | SpineSelect, LLC
408 Council Circle
PO Box 3660
Tupelo, MS 38803 |
|----------------------------|--------------------------------------------------|---------------------------------------------------------------------------|
| Trade Name: | Turbo Prime IBD System | |
| Classification Regulation: | 21 CFR §888.3080 Orthosis, intervertebral fusion | |
| Product Class: | Class II | |
| Product Codes: | MAX | |
| Panel Code: | 87 | |
Indications for Use:
The Turbo Prime IBD (Interbody Device) System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by p& tient history and radiographic studies who have had at least six months of non-operative care for their DDD. T rese DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Device Description:
The Turbo Prime IBD System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).
Predicate Device(s):
The Turbo Prime IBD System was shown to be substantially equivalent to previously cleared devices in:luding the Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surg cal Dynamics, P950019) and the BAK Interbody Fusion Device (Spine Tech, P950002) and has the same indications for use, design, function, and materials used
Performance Testing:
The pre-clinical testing performed indicated that the Turbo Prime IBD System is adequate for the intendiad use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SpineSelect, LLC c/o Richard Jansen, Pharm.D. 13540 Guild Ave. Apple Valley, MN 55124
APR 1 6 2008
K080058 Re:
Trade Name: TurboPrime IBD System Regulation Number(s): 21 CFR 888.3080 Regulation Names: Spinal intervertebral fusion orthosis Regulatory Class: Class II Product Code: MAX Dated: March 26, 2008 Received: March 27, 2008
Dear Dr. Jansen:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval (PMA) application. 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.
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.
2
Page 2 - Richard Jansen, Pharm.D.
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 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 N Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K080058
Indications for Use:
The Turbo Prime IBD (Interbody Device) System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies who have had at least six months of nonoperative care for their DDD. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Ogil-Franken
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K080058