(75 days)
Not Found
No
The description focuses on the material, shape, and mechanical function of a physical implant for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to treat cervical disc disease by facilitating fusion, which is a therapeutic intervention.
No
Explanation: The device is an intervertebral body fusion device used for surgical procedures to treat cervical disc disease, not to diagnose it. Its purpose is to facilitate fusion and provide stability after diagnosis.
No
The device description clearly states it is a physical implant made from PEEK Optima LT1®, tantalum, and Nitinol, and is used with titanium alloy screws. This is a hardware device, not software.
No, 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: The PEEK PREVAIL® Cervical Interbody Device is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not in vitro (in a lab).
- Intended Use: The intended use is for anterior cervical interbody fusion procedures, which is a surgical intervention, not a diagnostic test.
The information provided clearly describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / 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.
Product codes
OVE
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 autograft.
The PEEK PREVAIL® Cervical Interbody device implant is manufactured from PEEK Optima LT1® and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical disc (C2-C3 disc to the C7-T1 disc)
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)
Non-Clinical Testing: The subject and predicate PEEK PREVAIL® Cervical Interbody Device are identical in terms of indications for use, intended use, performance specifications, and technological characteristics. Cleaning and sterilization assessments have been performed to provide the appropriate instructions for the use of the PEEK PREVAIL device.
Conclusions Drawn from the Non-Clinical Tests: The information above demonstrates equivalence and supports a determination of substantial equivalence between the subject and predicate PEEK PREVAIL® Cervical Interbody Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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MEDTRONIC Sofamor Danek PEEK PREVAIL® Cervical Interbody Device November 9, 2011
| I. | Company: | Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
(901) 396-3133 |
| ---- | ---------- | --------------------------------------------------------------------------------------------------- |
|---|
- Kristi Frisch II. Contact: Regulatory Affairs Specialist
| III. | Product Name: | PEEK PREVAIL® Cervical Interbody Device |
|---|---|---|
| IV. | Common Name: | Intervertebral Fusion Device |
| V. | Classification: | 21 CFR 888.3080 – Product Code: OVE |
- VI. Predicate: PEEK PREVAIL® Cervical Interbody Device (K094042)
- VII. 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 autograft.
The PEEK PREVAIL® Cervical Interbody device implant is manufactured from PEEK Optima LT1® and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.
- VIII. 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
1
113252
page 2 of 2
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.
- IX. Technological Characteristics: The purpose of this 510(k) is to include an additional instrument in the system to allow surgeons a tool to guide the screw into the interbody device and bone at the appropriate trajectory. Associated labeling changes were made based on the addition of the new instrumentation.
- X. Substantial Equivalence: Documentation was provided which demonstrated the subject intervertebral devices to be substantially equivalent to PEEK PREVAIL® Cervical Interbody Device components previously cleared in K094042 (S.E. 06/30/2010).
- XI. Non-Clinical Testing: The subject and predicate PEEK PREVAIL® Cervical Interbody Device are identical in terms of indications for use, intended use, performance specifications, and technological characteristics. Cleaning and sterilization assessments have been performed to provide the appropriate instructions for the use of the PEEK PREVAIL device.
- Conclusions Drawn from the Non-Clinical Tests: The information above demonstrates XII. equivalence and supports a determination of substantial equivalence between the subject and predicate PEEK PREVAIL® Cervical Interbody 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 the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with three distinct lines forming its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 7 2012
Medtronic Sofamor Danek, Inc. % Ms. Kristi Frisch Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K113252
RT15252
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: November 1, 2011 Received: November 3, 2011
Dear Ms. Frisch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreative to 10gary the enactment date of the Medical Device Amendments, or to Connineres proc to May 20, 1978, we ecordance with the provisions of the Federal Food, DDI8, 2 devices that have been recuired in assere approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not requent to the general controls provisions of the Act. The Tou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and devices, good manufacturing praction, as taxes information related to contract liability adulticlation. Ticasonote. Obreak as 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 If your device is classified (bee acove) institute major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in the Oods of reactively.
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not meant that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a actively administered by other Federal agencies. You must of any I cacar studies and regaranents, including, but not limited to: registration and listing (21 Comply with an the Fee Frequirements 801); medical device reporting (reporting of medical CTN Fat 807), labeling (21 OF R 803); good manufacturing practice requirements as set
3
Page 2 – Ms. Kristi Frisch
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 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 yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KI13252
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 radioulopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord posseries ion confirmed by radiographic studies. The PEEK PREVAIL® Cervical Interbody compression conninted of racrogisterew fixation provided by ZEPHIR® Anterior Cervical Dovice mast of about with @ 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.
OR Prescription Use x Per 21 CFR 801.109
Over-The-Counter Use ---
(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
KII3252 510(k) Number_