(90 days)
No
The summary describes a mechanical interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for intervertebral body fusion and vertebral body replacement to treat degenerative disc disease, tumors, or trauma/fracture, which are medical conditions, and aims to restore biomechanical integrity.
No
The device is an implantable intervertebral body fusion device and vertebral body replacement device, designed for treatment (fusion and replacement), not for diagnosing conditions. The text describes its use for treating degenerative disc disease and replacing resected or excised vertebral bodies.
No
The device description explicitly states it is comprised of "various sizes and configurations" and is an "Interbody Fusion System" and "System of implants," indicating physical hardware components.
Based on the provided text, 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 this device is an implantable medical device used for spinal fusion and vertebral body replacement. It is surgically inserted into the patient's body.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information about a patient's health status. Its function is structural support and facilitating fusion.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Intervertebral Body Fusion Device: The Eminent Spine Interbody Fusion System (Sidewinder, Python, and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Eminent Spine Interbody Fusion System (Copperhead) is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-Tl disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Vertebral Body Replacement Device: The Eminent Spine System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or traumalfracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
Product codes
MAX, ODP, MQP
Device Description
The Eminent Spine Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options.
The Eminent Spine Interbody Fusion System will be offered in four (4) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) Copperhead, anterior cervical approach 2) Sidewinder, transforaminal lumbar approach 3) Python, posterior lumbar approach and 4) Cottonmouth, anterior lumbar approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L2 to S1; Cervical spine, from C2-C3 disc to C7-T1 disc; Thoracolumbar spine, from T1 to L5
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)
Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P970015, P950002, P950019, P960025, P980048, P000028, K081614
Reference Device(s)
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
Eminent Spine Interbody Fusion System
APR - 9 2009
Premarket Notification
SUBMITTED BY Eminent Spine 16001 Ronald Reagan Blvd Leander, TX 78641 ESTABLISHMENT Pending REGISTRATION NUMBER OWNER/OPERATOR NUMBER 10028153 CONTACT PERSON Primary Alternate Steve Courtney, M.D. Dave Freehill President/Co-Founder President/Co-Founder Phone: 512-259-9002 Phone: 214-415-5243 Fax: 512-259-9515 Fax: 972-250-5651 SUBMISSION PREPARED BY Lisa Peterson QA Consulting. Inc. Phone: 512-507-0746 DATE PREPARED January 6, 2009 CLASSIFICATION NAME MAX 888.3080- Intervertebral Fusion Device with Bone Graft. Lumbar ODP 888.3080 - Intervertebral Fusion Device with Bone Graft, Cervical MQP 888.3060 - Spinal Intervertebral Body Fixation Orthosis COMMON NAME Intervertebral Body Fusion Device (MAX, ODP) Spinal Vertebral Body Replacement Device (MQP) PROPRIETARY NAME Eminent Spine Interbody Fusion System PREDICATE DEVICE(S) Predicate devices include several recently down classified cages, as well as various cleared interbody fusion/VBR systems: LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, . Medtronic Sofamor Danek, Approved 9/10/03) BAK® Cage (P950002. Zimmer Spine, Approved 7/8/03) -RAY® Threaded Fusion Cage (P950019, Stryker, Approved -9/4/03) Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) -BAK/C (P980048, Zimmer Spine, Approved 4/20/01) -Affinity Cage System (P000028, Medtronic, Approved 6/13/02) . Zeus Cages (K081614, Interbody Innovations, Cleared 9/5/08) -
- MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05) -
- -Crystal (K073351, Spinal Elements, Inc., Cleared 1/24/08)
1
SUBSTANTIAL EQUIVALENCE
The Eminent Spine Interbody Fusion System was determined to be substantially equivalent to several commercially available systems.
DEVICE DESCRIPTION
The Eminent Spine Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options.
The Eminent Spine Interbody Fusion System will be offered in four (4) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) Copperhead, anterior cervical approach 2) Sidewinder, transforaminal lumbar approach 3) Python, posterior lumbar approach and 4) Cottonmouth, anterior lumbar approach.
INDICATIONS:
Intervertebral Body Fusion Device:
The Eminent Spine Interbody Fusion (Sidewinder. Python and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Eminent Spine Interbody Fusion System (Copperhead) is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Vertebral Body Replacement Device:
The Eminent System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
MECHANICAL TEST DATA
Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eminent Spine % Mr. Dave Freehill President 16001 Ronald Reagan Boulevard Leander, Texas 78641
APR - 9 2009
Re: K090064
Trade/Device Name: Eminent Spine Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: January 6, 2009 Received: January 9, 2009
Dear Mr. Freehill:
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.
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.
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Page 2 - Mr. Dave Freehill
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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Cbarbare buchung
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Eminent Spine Interbody Fusion System
Indications for Use:
Intervertebral Body Fusion Device:
The Eminent Spine Interbody Fusion System (Sidewinder, Python, and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Eminent Spine Interbody Fusion System (Copperhead) is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-Tl disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Vertebral Body Replacement Device:
The Eminent Spine System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or traumalfracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
x Prescription Use (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 IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| for MYM | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K090064 |