(313 days)
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No
The 510(k) summary describes a physical implant (a PEEK spacer) and its mechanical properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing, not algorithmic performance.
No
The device is an intervertebral body fusion device, which is an implant, not a therapeutic device. It is intended to facilitate fusion and provide stability in the cervical spine.
No
The device is an intervertebral body fusion device used for treatment, not for diagnosing medical conditions. Its purpose is to facilitate fusion in the cervical spine.
No
The device description clearly states it is a polyetherether cervical interbody fusion spacer, which is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a physical implant (a Cervical PEEK Spacer) that is surgically placed in the cervical spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one. It does not analyze any biological specimens.
The device's purpose is to provide structural support and space for bone graft to fuse, which is a treatment for cervical disc disease. This is a completely different function from an IVD.
N/A
Intended Use / Indications for Use
The Cervical PEEK Spacer is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Cervical PEEK Spacer is intended for use at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical PEEK Spacer is intended to be used with a supplemental internal fixation system.
Product codes
ODP
Device Description
The Cervical PEEK Spacer is a polyetherether cervical interbody fusion spacer. The device comprises a closed annular ring and hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces and expulsion. The device includes a radiopaque marker pin position wall of the device. The device is offered in two footbrints (depth x width, 9.5mm x 15mm), one lordotic angle (7°) and heights ranging from 6mm to 10mm in 1mm increments.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, C3 to T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Static axial compression, dynamic axial compression, static torsion testing per ASTM F 2077-03 and subsidence testing per ASTM F 2267-04 were performed on representative samples of the Cervical PEEK Spacers were found to have acceptable mechanical characteristics for the intended uses.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 7, 2016
The Orthopaedic Implant Company Douglas Fulton Ouality and Operations Manager 316 California Avenue, #701 Reno. Nevada 89509
Re: K160222
Trade/Device Name: OIC Cervical PEEK Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: October 20, 2016 Received: October 21, 2016
Dear Douglas Fulton:
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 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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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 -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160222
Device Name
OIC Cervical PEEK Spacer
Indications for Use (Describe)
The Cervical PEEK Spacer is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Cervical PEEK Spacer is intended for use at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical PEEK Spacer is intended to be used with a supplemental internal fixation system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared 12/5/2016
Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Dr, Suite 400 Reno, NV 89502
Contact: Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com
Device Identification: Trade Name: OIC Cervical PEEK Spacer Classification Name: Intervertebral body fusion device Classification: Class II, 21 CFR 888.3080 Panel: Orthopedic Product Code: ODP
Indications for Use:
The Cervical PEEK Spacer is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Cervical PEEK Spacer is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical PEEK Spacer is intended to be used with a supplemental internal fixation system.
Device Description:
The Cervical PEEK Spacer is a polyetherether cervical interbody fusion spacer. The device comprises a closed annular ring and hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces and expulsion. The device includes a radiopaque marker pin position wall of the device. The device is offered in two footbrints (depth x width, 9.5mm x 15mm), one lordotic angle (7°) and heights ranging from 6mm to 10mm in 1mm increments.
Comparison of Technological Characteristics (Substantial Equivalence):
- Predicate device K092540 InterPlate C-PS Interbody Spacers
- The modified Cervical PEEK Spacer has the following similarities to those which previously received 510(k) concurrence:
- · have the same indicated use,
- · use the same operating principle.
- · incorporate the same design,
- · incorporate the same materials,
- · have the same shelf life, and
- · are packaged using the same materials and processes.
- Additional Predicate device K111272 Rhausler Plage Anterior Cervical Fusion System
The materials, geometry and use of the instruments for implantation are the instruments in the secondary predicate device.
Performance Testing:
Static axial compression, dynamic axial compression, static torsion testing per ASTM F 2077-03 and subsidence testing per ASTM F 2267-04 were performed on representative samples of the Cervical PEEK Spacers were found to have acceptable mechanical characteristics for the intended uses.
Conclusion:
The OIC Cervical PEEK Spacer described in this submission is, in our opinion, substantially equivalent to the predicate devices.