(520 days)
Not Found
No
The document describes a mechanical spinal implant and does not mention any AI or ML components.
Yes
The device is an intervertebral body fusion device intended for spinal fusion procedures in patients with Degenerative Disc Disease, designed to provide stability during intervertebral body fusion. These are direct therapeutic actions to treat a medical condition.
No
This device is an implant designed for spinal fusion procedures, not for diagnosing conditions. Its purpose is to provide stability after existing diagnoses.
No
The device description clearly states it is a "lumbar interbody fusion system" and mentions mechanical testing of the physical implant, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the Octane Elevate Spinal Implant is an "intervertebral body fusion device" and a "lumbar interbody fusion system." It's a physical implant designed to be placed within the body during surgery.
- Intended Use: The intended use describes a surgical procedure for spinal fusion, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
Therefore, the Octane Elevate Spinal Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.
Product codes
MAX
Device Description
This submission proposes a new lumbar interbody fusion system. The Octane Elevate Spinal Implant is designed to provide stability during intervertebral body fusion in the lumbrosacral spine.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lumbar spine from L2 to S1, lumbosacral spine
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing results summarized in this 510(k) premarket notification demonstrate Octane Elevate devices have substantially equivalent performance characteristics compared to cited predicates based on testing per ASTM F2077 and ASTM F2267:
- Static compression
- Dynamic compression
- Static compressive shear
- Dynamic compression shear
- Subsidence vield force
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071724, K120464, K112095, K123281
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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Exactech® Octane® Elevate™ Spinal Implant System Traditional 510(k)
510(k) Summary
APR 2 5 2014
Exactech®, Inc Company: 2320 Northwest 66th Court Gainesville, FL 32653-1630 Date: April 21, 2014 Contact Person: Patrick Hughes Senior Regulatory Affairs Specialist Phone: 352-327-4762 Fax: 352-378-2617 E-mail: patrick.hughes@exac.com Exactech® Octane® Elevate™ Spinal Implant Proprietary Name: Common Name: Intervertebral body fusion system
Classification Name:
Intervertebral Fusion Device - Lumbar (21 CFR 888.3080, Class II, Product Code MAX)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
Spinal Elements Lucent (#K071724) Innesis PEEK Cage System (#K120464) AccuLiF TL-PEEK Cage (#K112095 & #K123281)
Device Description
This submission proposes a new lumbar interbody fusion system. The Octane Elevate Spinal Implant is designed to provide stability during intervertebral body fusion in the lumbrosacral spine.
Indications for Use
The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.
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Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use
Proposed Octane Elevate devices and cited predicates are intended to be used with bone graft and supplemental fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) for intervertebral fusion for treatment of degenerative disc disease at the levels of L2-S1.
Materials .
Octane Elevate devices and cited predicate devices are made from the same PEEK-Optima and tantalum materials having demonstrable histories of safe and effective use in medical applications. per internationally recognized consensus standards.
. Dimensions
Octane Elevate devices and cited predicate devices have substantially equivalent dimensions and are available in substantially equivalent size ranges.
. Sterilization processes
Octane Elevate devices are provided sterile. These devices are sterilized using sterilization processes conforming to recognized industry standards.
Performance specifications .
Mechanical testing results summarized in this 510(k) premarket notification demonstrate Octane Elevate devices have substantially equivalent performance characteristics compared to cited predicates based on testing per ASTM F2077 and ASTM F2267:
- Static compression .
- . Dynamic compression
- Static compressive shear .
- Dynamic compression shear .
- . Subsidence vield force
Substantial Equivalence Conclusion
The Octane Elevate Spinal Implant System is substantially equivalent to cited predicates per intended use, materials, dimensions, sterilization processes, and performance characteristics.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
Exactech®. Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K123607
Trade/Device Name: Exactech® Octane® Elevate™ Spinal Implant Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 21. 2014 Received: April 23, 2014
Dear Mr. Hughes:
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 cither 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 is 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. Patrick Hughes
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 requlation 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/Reportal?roblem/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.
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exactech® Octane® Elevate™ Spinal Implant System Traditional 510(k)
Indications for Use Statement
510(k) Number: K123607
Device Name: Exactech® Octane® Elevate™ Spinal Implant
INDICATIONS FOR USE:
The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.
Prescription Use X and/or (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)