(239 days)
When used as an intervertebral body fusion device, the ROI-A Implant System 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 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 ROI- A Oblique implant is intended for use as an interbody fusion device in the lumbar spine. The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F560 embedded in the implant extremities to facilitate visibility in x-ray imaging. The subject device is designed for placement using an anterolateral approach with an approximate offset angle of 25° from the straight anterior axis.
The provided document describes the LDR Spine ROI-A® Implant System, an intervertebral body fusion device. The acceptance criteria and the studies that prove the device meets these criteria are outlined as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Static Shear Compression | Performance comparable to the legally marketed predicate device (LDR Spine ROI Implant System, K082262, K090507) as specified by ASTM F2077. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Dynamic Axial Compression | Performance comparable to the legally marketed predicate device as specified by ASTM F2077. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Dynamic Bending | Performance comparable to the legally marketed predicate device as specified by ASTM F2077. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Expulsion | Performance comparable to the legally marketed predicate device as specified by ASTM F-04.25.02.02. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Wear Debris Analysis | Performance comparable to the legally marketed predicate device as specified by ASTM F1877. This typically involves demonstrating that wear debris generation is within acceptable limits or comparable to the predicate. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Low Cycle Cadaver Testing | Clinical stability and absence of device expulsion/pull-out comparable to the legally marketed predicate device under low cycle conditions. This would imply demonstrating the device maintains its position and stability. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." (This statement implicitly covers the cadaver testing results by reaffirming substantial equivalence to the predicate in overall performance.) |
| High Cycle Cadaver Testing | Absence of device loosening or migration, blade back-out, and vertebral body damage comparable to the legally marketed predicate device under high cycle conditions. This would imply demonstrating long-term stability and integrity. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." (This statement implicitly covers the cadaver testing results by reaffirming substantial equivalence to the predicate in overall performance.) |
| Biocompatibility | The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026. This implies the material meets biocompatibility standards. The document doesn't explicitly state biocompatibility testing results, but the material choice and standard compliance address this. | The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026. |
| Radiographic Visibility | The device has tantalum markers conforming to ASTM F560 embedded in the implant extremities to facilitate visibility in x-ray imaging. This implies the device is adequately visible for post-operative assessment. | "[...] and has tantalum markers conforming to ASTM F560 embedded in the implant extremities to facilitate visibility in x-ray imaging." |
| Indications for Use | The device must be suitable for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients with six months of non-operative treatment, for one or two contiguous levels, treating DDD with up to Grade I spondylolisthesis, and used with supplemental fixation and autograft, equivalent to the predicate. | The device's stated Indications for Use are identical to those implicitly accepted for the predicate, showing equivalence in intended clinical application. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical performance data primarily involving in-vitro mechanical and cadaveric testing. It does not refer to a "test set" in the context of clinical data, as it is not a clinical study assessing patient outcomes.
- Sample Size for Mechanical Testing: Not explicitly stated for each test (static, dynamic, expulsion, wear debris). Standard practice for such tests involves using a statistically significant number of samples, but the exact count is not given.
- Sample Size for Cadaver Testing: Not explicitly stated for low cycle and high cycle cadaver testing.
- Data Provenance: Not applicable in the context of "country of origin of the data" or "retrospective or prospective" as these are non-clinical biomechanical and material tests, not patient studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of study presented. The studies are non-clinical engineering and biomechanical tests, where "ground truth" is established by physical measurements, material properties, and adherence to ASTM standards, rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" of clinical data requiring expert adjudication. The study involves objective engineering and biomechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device is an intervertebral fusion implant, not an AI-powered diagnostic or decision support system. Therefore, no MRMC study or AI assistance evaluation was performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance studies, the "ground truth" is based on:
- Physical Measurements and Mechanical Properties: Measured forces, displacements, wear rates, and other biomechanical parameters.
- ASTM Standards: Adherence to established industry standards like ASTM F2077, ASTM F-04.25.02.02, ASTM F1877, ASTM F2026, and ASTM F560.
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (LDR Spine ROI Implant System, K082262, K090507), against which the new device is compared for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" or corresponding ground truth establishment process in the context of this device's evaluation.
Summary of the Study:
The study performed was a series of non-clinical bench and cadaveric tests designed to demonstrate the mechanical and functional substantial equivalence of the LDR Spine ROI-A® Implant System to its legally marketed predicate device. The tests covered static and dynamic mechanical properties, expulsion resistance, wear debris, and cadaveric stability and migration. The primary conclusion was that the new device's performance is substantially equivalent to that of the predicate, thus satisfying the requirements for 510(k) clearance.
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510(k) Summary of Safety and Effectiveness
SEP 3 0 2011
LDR Spine ROI-A® Implant System
| Owner's Name & Address:Contact Person: | LDR Spine USA4030 West Braker Lane, Suite 360Austin, TX 78759Phone: (512) 344-3333Fax: (512) 344-3350Maritza EliasRegulatory Affairs Project ManagerLDR Spine USA4030 West Braker Lane, Suite 360Austin, TX 78759Phone: (512) 344-3471Fax: (512) 344-3350Email: maritzaelias@ldrspine.com |
|---|---|
| Date 510(k) Summary Prepared: | September 29, 2011 |
| Trade Name: | LDR Spine ROI-A® Implant System |
| Common Name: | Intervertebral Body Fusion Device (MAX) |
| Classification: | MAX 888.3080 - Intervertebral Fusion Device with BoneGraft, Lumbar |
| Legally Marketed Predicate Device: | LDR Spine ROI Implant System (K082262, K090507) |
| Device Description | The ROI- A Oblique implant is intended for use as an interbodyfusion device in the lumbar spine. The device is manufacturedfrom medical grade PEEK OPTIMA® LT1 in accordance withASTM F2026 and has tantalum markers conforming to ASTMF560 embedded in the implant extremities to facilitate visibility inx-ray imaging. The subject device is designed for placementusing an anterolateral approach with an approximate offset angleof 25° from the straight anterior axis. |
| Indications for Use: | When used as an intervertebral body fusion device, the ROI-AImplant System is indicated for intervertebral body fusion of thelumbar spine, from L2 to S1, in skeletally mature patients whohave had six months of non-operative treatment. The device isintended for use at either one or two contiguous levels for thetreatment of degenerative disc disease (DDD) with up to Grade Ispondylolisthesis. DDD is defined as back pain of discogenicorigin with degeneration of the disc confirmed by history andradiographic studies. The device system is designed for use withsupplemental fixation and with autograft to facilitate fusion. |
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K110327
510(k) Summary of Safety and Effectiveness
LDR Spine ROI-A® Implant System
Non-Clinical Performance Data:
Testing was comprised of static shear compression, dynamic axial compression and dynamic bending (per ASTM F2077), expulsion (per ASTM F-04.25.02.02), wear debris analysis (per ASTM F1877), low cycle cadaver testing to evaluate clinical stability and device expulsion/pull-out, and high cycle cadaver testing to evaluate device loosening or migration, blade back-out and vertebral body damage. The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 30 2011
LDR Spine USA % Ms. Maritza Elias Regulatorv Affairs Project Manager 4030 West Braker Lane. Suite 360 Austin, Texas 78759
Re: K110327
Trade/Device Name: LDR ROI-A Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: OVD Dated: August 31, 2011 Received: September 1, 2011
Dear Ms. Elias:
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 10 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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 – Ms. Maritza Elias
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.
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.him 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eunl Keith
- Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KI10327
INDICATIONS FOR USE
510(k) Number (if known): K110327
LDR Spine USA ROI-A® Implant System Device Name:
Indications for Use:
When used as an intervertebral body fusion device, the ROI-A Implant System 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 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.
Prescription Use X (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)
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Division of Surgical, Orthopedic, and Restorative Devices
KII0327 510(k) Number_
§ 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.