(182 days)
The PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The key difference between the predicate PEEK PREVAIL™ Cervical Interbody Device and the subject PEEK PREVAIL™ Cervical Interbody Device is the reduction of the device footprint by 2mm in the anterior/posterior dimension (i.e., adding a smaller footprint cage).
This product will be manufactured from PEEK Optima and will have tantalum radiopaque markers and a nitinol screw locking mechanism. The screw designed to be used with this device will be manufactured from titanium alloy.
Here's an analysis of the provided text regarding the PEEK PREVAIL™ Cervical Interbody Device, addressing your requested information:
This submission (K094042) is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness. Therefore, many of your requested points regarding clinical study design, ground truth, and expert evaluation will not be directly relevant or available in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static axial torsion | In accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. | The acceptance criteria was/were met. |
| Dynamic axial torsion | In accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. | The acceptance criteria was/were met. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Non-Clinical Testing" and specifically mentions the mechanical tests performed.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. For mechanical testing of medical devices, sample sizes are typically determined by the relevant ASTM standard (ASTM F2077-03 in this case), often involving a small number of devices (e.g., 5-10) per test condition.
- Data Provenance: Not applicable in the context of this 510(k) submission, as it relies on non-clinical, in-vitro mechanical testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for mechanical testing is defined by the objective pass/fail criteria set forth in the ASTM standard, not by expert consensus on clinical findings.
4. Adjudication method for the test set
- This is not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or image interpretation. Mechanical testing results are objectively measured against predefined criteria.
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
- No MRMC comparative effectiveness study was done. This device is a physical implant (interbody fusion device), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm, so standalone AI performance is not relevant.
7. The type of ground truth used
- The "ground truth" for this device's evaluation is defined by the objective, quantitative results of mechanical tests performed according to the specified ASTM standard (F2077-03). The standard itself outlines the methods and criteria for evaluating the mechanical properties of intervertebral body fusion devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. No "training set" in that sense was used. The design and manufacturing processes are based on engineering principles and material science, validated through benchtop testing.
9. How the ground truth for the training set was established
- Not applicable. As no training set for an AI/ML model was used, there's no ground truth to establish for it. The design of the device is informed by engineering knowledge, material properties, and surgeon feedback (as mentioned, to accommodate variations in patient anatomies by providing a smaller footprint).
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JUN 3 0 2010
510(k) Summary PEEK PREVALTMCervical Interbody Device June 29, 2010
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I. Medtronic Sofamor Danek, Inc. Company: 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133
Contact: Justine Viera Regulatory Affairs Specialist Telephone: (901) 399-2239 Fax: (901) 346-9738 -
II. Proposed Proprietary Trade Name: PEEK PREVAIL™ Cervical Interbody Device
| III. | Classification Names(s): | Intervertebral Body Fusion Device |
|---|---|---|
| Class: | II | |
| Product Code(s): | ODP | |
| Regulation No.: | 21 CFR 888.3080 |
- IV. Device Description: The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The key difference between the predicate PEEK PREVAIL™ Cervical Interbody Device and the subject PEEK PREVAIL™ Cervical Interbody Device is the reduction of the device footprint by 2mm in the anterior/posterior dimension (i.e., adding a smaller footprint cage).
This product will be manufactured from PEEK Optima and will have tantalum radiopaque markers and a nitinol screw locking mechanism. The screw designed to be used with this device will be manufactured from titanium alloy.
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K0940412
- Indications for Use: The PEEK PREVAIL™ Cervical Interbody Device is indicated V. for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
- VI. Summary of the Technological Characteristics: The subject device is the result of surgeon feedback where a device with a smaller footprint than the predicate device was desired in order to accommodate variations in patient anatomies. Table 1 summarizes the similarities between the predicate device and the subject device.
Table 1: Similarities between the Predicate device to Subject device
| Predicate | Subject |
|---|---|
| Indications for Use/Intended Use | Identical |
| Levels of Attachment: Cervical C2-C3 to C7-T1 | Identical |
| Material (PEEK) | Identical |
| Fundamental Scientific Technology | Identical |
| Surgical Technique - Anterior approach | Identical |
| Mating components: ZEPHIR® Anterior Cervical System screw | Identical |
| Sub-assembly components: Nickel Titanium alloy wireTantalum radiopaque markers | Identical |
| Packaging | Identical |
| Sterilization method - Gamma | Identical |
- VII. Identification of Legally Marketed Device(s): Documentation was provided which demonstrated that the PEEK PREVAIL™ Cervical Interbody Device components are substantially equivalent to previously approved device PEEK PREVAIL™ Cervical Interbody Device (K073285, S.E. 05-15-2008).
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- VIII. Discussion of the Non-Clinical Testing: The following mechanical tests of the subject device were performed:
- . Static axial torsion in accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. The acceptance criteria was/were met.
- Dynamic axial torsion in accordance with ASTM F2077-03 "Test . Methods for Intervertebral Body Fusion Devices," approved April 10, 2003. The acceptance criteria was/were met.
- IX. Conclusions: The subject device passed the mechanical testing in accordance with ASTM F2077-03 and was found to be safe and effective as compared to the predicate device PEEK PREVAIL™ Cervical Interbody Device (K073285, S.E. 05-15-2008).
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Image /page/3/Picture/1 description: The image shows the seal of the United States Department of Health and Human Services. The seal features a stylized eagle with three heads, representing health, human services, and the public. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek, Inc. % Ms. Justine Viera Regulatory Affairs Specialist 1800 Pyramid Place Memphis, TN 38132
SEP 12 2011
Re: K094042
Trade/Device Name: PEEK PREVAIL™ Cervical Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: April 27, 2010 Received: April 28, 2010
Dear Ms. Viera:
This letter corrects our substantially equivalent letter of June 30, 2010.
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 (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.
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
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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.
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.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Murk M. Milkens
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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K094042 510(k) Number (if known):
Device Name: PEEK PREVAIL™ Cervical Interbody Device
Indications for Use:
The PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody. fusion procedures in skeletally mature patients with cervical disc disease at one · level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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-O)
fur Division
W Division of Surgic: . Orthopedic, and Restorative Le vices
510(k) Number K099042.
§ 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.