(335 days)
The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static and dynamic axial compression bending testing per ASTM F1717 | Performed; results demonstrate substantial equivalence to predicate devices. |
| Static torsion testing per ASTM F1717 | Performed; results demonstrate substantial equivalence to predicate devices. |
| Use of titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 | Device manufactured from this material, consistent with predicates. |
| Same intended use as predicate devices | Confirmed. |
| Similar primary implant design as predicate devices | Confirmed. |
| Equivalent material of manufacture as predicate devices | Confirmed. |
| Overall substantial equivalence to predicate devices | Concluded based on non-clinical testing and shared characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical mechanical testing of the device components. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable to this type of study as described. The testing involves physical samples of the pedicle screw system components.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Given this is a non-clinical mechanical performance study rather than a clinical study evaluating diagnostic or treatment outcomes, there were no experts used to establish ground truth in the way one would for clinical data interpretation. The "ground truth" for this study is defined by the established standards of ASTM F1717 for mechanical testing. Compliance with these standards is objectively measured.
4. Adjudication Method
Since no experts were establishing ground truth for a clinical test set, an adjudication method is not applicable. The testing involves objective physical measurements against established 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 submission focuses on the mechanical substantial equivalence of a medical implant, not the effectiveness of a diagnostic or treatment method involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone "algorithm only" performance study was not done. This is a physical medical device, not a software algorithm. The "standalone performance" here refers to the mechanical integrity of the device components in isolation (i.e., without being implanted in a patient, but using standardized test fixtures). The study conducted was precisely that – standalone mechanical testing of the device components.
7. The Type of Ground Truth Used
The "ground truth" used for this study is based on established engineering standards (ASTM F1717) for mechanical performance and material specifications (ASTM F136). The performance of the Athena Pedicle Screw System was compared directly against these standards and to the mechanical performance of predicate devices that previously met these standards.
8. The Sample Size for the Training Set
Since this is a non-clinical mechanical study rather than a machine learning or clinical study, the concept of a "training set" is not applicable. The device's design is developed through engineering principles, not through training on a dataset.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" does not apply to this type of study, the question of how ground truth was established for a training set is not applicable. The design and manufacturing processes are validated against engineering specifications and industry standards.
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DEC - 7 2011
Royal Oak Medical Devices Athena Pedicle Screw System
510(K) Summary
SUBMITTED BY
Royal Oak Medical Devices 39533 Woodward Avenue, Suite 175 Bloomfield Hills, MI 48304 USA
ESTABLISHMENT REGISTRATION NUMBER Pending
OWNER/OPERATOR NUMBER
CONTACT PERSON
SUBMISSION PREPARED BY
DATE PREPARED
CLASSIFICATION NAME
DEVICE CLASS
REGULATION NUMBER
COMMON NAME
PROPRIETARY NAME
IDENTIFICATION OF
Pending
Matthew Kroll Vice President of Technical Services Royal Oak Medical Devices Phone: 248-628-2830 Fax: 248-969-8263
Anne Wilson QA Consulting, Inc. 9433 Bee Cave Road Bldg.1, Suite 140 Austin, TX 78733 Phone: 512-328-9404 Fax: 512-532-9434
22 September 2011
Pedicle Screw Spinal System
Class III (product code NKB) Class II (product codes MNI, MNH)
NKB 888.3070 MNI 888.3070 MNH 888.3070
Spinal Fixation System
Athena Pedicle Screw System
The Athena Pedicle Screw System is
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PREDICATE DEVICE(S)
substantially equivalent to the Interpore Cross Synergy Polyaxial System (K950099/K974749), Rogozinski System (K930298/K983904) and Depuv Spine Moss Miami System (K992168/K022623)
DEVICE DESCRIPTION
The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
INDICATIONS:
The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this submission is to obtain clearance to market the Athena Pedicle Screw System. The Athena Pedicle Screw System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. The subject device has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:
- । Same intended use.
- Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F1717).
DISCUSSION OF NON-CLINICAL TESTING
The following non-clinical tests were conducted, the results of which demonstrate that the Athena Pedicle Screw System is substantially equivalent to the predicate(s):
- Static and dynamic axial compression bending testing, conducted in । accordance with ASTM F1717
- Static torsion testing, conducted in accordance with ASTM F1717 -
CONCLUSIONS
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Athena Pedicle Screw System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Royal Oak Medical Devices % Mr. Matthew Kroll Vice President of Technical Services 39533 Woodward Avenue, Suite 175 Bloomfield Hills, Michigan 48304
DEC - 7 2011
Re: K110046
Trade/Device Name: Athena Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: December 1, 2011 Received: December 2, 2011
Dear Mr. Kroll:
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. 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 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
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Page 2 - Mr. Matthew Kroll
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/ycm115809.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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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INDICATIONS FOR USE
510(k) Number: K110046
Device Name: Athena Pedicle Screw System
Indications for Use:
The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
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) Division of Surgical, Orthopedic, and Restorative Devices
KI10046 510(k) Number_
N/A