(90 days)
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.
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.
Here's an analysis of the provided text regarding the Eminent Spine Interbody Fusion System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) premarket notification and subsequent FDA clearance letter. For interbody fusion devices (Class II medical devices), clearance is typically based on demonstration of substantial equivalence to a previously legally marketed predicate device, rather than a full clinical trial with "acceptance criteria" in the sense of a new drug or novel high-risk device. The primary "study" referred to here is generally a mechanical test study to demonstrate that the new device performs equivalently to the predicate devices in terms of biomechanical properties.
Eminent Spine Interbody Fusion System: Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
As per the nature of a 510(k) submission for this type of device, explicit "acceptance criteria" for clinical outcomes (e.g., fusion rates, pain reduction scores) and specific "reported device performance" in a clinical trial are not provided nor required. Instead, the acceptance is based on demonstrating substantial equivalence through mechanical testing.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence via Mechanical Testing) | Reported Device Performance (Summary from Text) |
|---|---|
| Biomechanical performance (e.g., strength, stiffness, fatigue resistance) of the new device is comparable to the predicate devices. | "Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device." |
| Material properties (e.g., biocompatibility, resistance to degradation) are comparable to predicate devices. | (Implicit, as the device is cleared based on materials commonly used in predicate devices, but specific test results are not detailed in this summary document.) |
| Device design (e.g., size, geometry) allows for similar surgical approaches and indications as predicate devices. | "The Eminent Spine Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy... The configurations are designed based on indicated spinal implant level and surgical approach..." |
| Indications for Use are consistent with those of the predicate devices. | The stated Indications for Use for both Intervertebral Body Fusion Device (lumbar L2-S1, cervical C2-T1) and Vertebral Body Replacement Device (thoracolumbar T1-L5) align with the general scope of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Mechanical Testing): The document states "Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device." However, specific sample sizes (e.g., number of implants tested) for these mechanical tests are not provided in this summary document.
- Data Provenance: The mechanical test data would have been generated in a prospective manner, specifically for this submission, likely within a laboratory setting. The origin is implicitly the applicant (Eminent Spine). This is not human clinical data, so country of origin for patients is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For mechanical testing, the "ground truth" is established through standardized engineering test protocols (e.g., ASTM standards for spinal implants) and objective measurements. There isn't a concept of "experts" establishing ground truth in the same way as in clinical image interpretation. The testing itself, conducted by engineers or technicians in a certified lab, provides the data supporting substantial equivalence.
4. Adjudication Method for the Test Set
- Adjudication methods like "2+1" or "3+1" are relevant for clinical studies, particularly those involving subjective assessments or disagreements among readers/experts. Since the "study" referred to here is mechanical testing, no such adjudication method is applicable or mentioned. The results are based on objective physical measurements and adherence to engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance in interpreting medical images. For a spinal implant system like the Eminent Spine Interbody Fusion System, such studies are not part of the 510(k) clearance process. The device itself is a physical implant, not an imaging or diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this is not applicable. A "standalone" performance study refers to the isolated performance of an algorithm or AI system without human intervention. The Eminent Spine Interbody Fusion System is a physical medical device.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical performance claim is derived from objective physical measurements and engineering standards (e.g., ASTM) applied to the device and predicate devices. These standards define the expected biomechanical behavior for interbody fusion devices in terms of strength, fatigue, and other relevant properties. The comparison against predicate devices establishes the basis for substantial equivalence.
8. The Sample Size for the Training Set
- This concept is not directly applicable to a 510(k) for a physical implant based on mechanical testing. "Training set" refers to data used to train an algorithm or AI model.
- If we consider the design and manufacturing process, the "training" aspect would relate to the iterative design and engineering process, where prototypes are tested, refined, and potentially re-tested, drawing upon established engineering principles and data from similar devices. However, this isn't a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- As explained in point 8, the concept of a "training set" and associated "ground truth" in the AI/machine learning sense is not relevant for this medical device clearance based on pre-clinical mechanical testing for substantial equivalence. The "ground truth" for evaluating the design of such a device is rooted in biomechanical principles, material science, and the performance characteristics of previously cleared, safe, and effective predicate devices.
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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)
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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.
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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 |
§ 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.