(69 days)
Not Found
No
The 510(k) summary describes a standard intervertebral fusion device and does not mention any AI or ML components or capabilities.
Yes
The device is described as an "Intervertebral Fusion Device" intended for "spinal fusion procedures," which are therapeutic interventions.
No
The device is an intervertebral fusion device intended for use in spinal fusion procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly refers to "Proposed Octane Straight Intervertebral Fusion Device components (Figure 1)" and describes non-clinical performance data related to mechanical testing (compression, shear, subsidence), indicating it is a physical implant device.
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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a physical implantable device (an intervertebral fusion device) used in spinal surgery. It is intended to be placed within the body to facilitate bone fusion.
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on such analysis.
This device falls under the category of a surgical implant or medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 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 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
Proposed Octane Straight Intervertebral Fusion Device components (Figure 1) are line extensions of the Octane interbody fusion device system cleared for US distribution per 510(k) #K082270.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
Indicated Patient Age Range
Patients should be skeletally mature
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 Performance Data:
Static compression testing per ASTM F2077 for Loss of mechanical integrity: fracture/breakage
Dynamic compression testing per ASTM F2077 for Loss of mechanical integrity: fracture/breakage
Static compressive shear testing per ASTM F2077 for Loss of mechanical integrity: fracture/breakage
Subsidence Yield Force per ASTM F2267 for Implant subsidence
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
K130434 Page 1 of 3
Exactech® Octane® Straight Intervertebral Fusion Device 510(k) Summary
| Sponsor: | Exactech ® Inc. |
|---|---|
| 2320 N.W. 66 th Court | |
| Gainesville, FL 32653 |
Phone: (352) 327-4762 Fax: (352) 378-2617
FDA Establishment Number 1038671
- Contact: Patrick Hughes Senior Regulatory Affairs Specialist
May 1, 2013 Date:
Trade or Proprietary or Model Name(s): Exactech® Octane® Straight Intervertebral Fusion Device
Common Name: Intervertebral body fusion device
Classification Name:
21 CFR 888.3080 - Intervertebral body fusion device
Product Code: MAX
FDA Classification: Class II
Predicate Device:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K082270 | Octane® P Intervertebral Body Fusion Device | Exactech |
Page 1 of 3
1
Exactech® Octane® Straight Intervertebral Fusion Device 510(k) Summary
Indications for Use:
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 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 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
Device Description:
Image /page/1/Picture/5 description: The image shows two perspective views of a gray-colored medical implant. The implant has a rectangular base with a hollowed-out center. The top surface of the implant has a series of ridges or teeth-like structures. The implant also has a hole on the side.
Figure 1: Octane Straight Intervertebral Fusion Device implant options
Proposed Octane Straight Intervertebral Fusion Device components (Figure 1) are line extensions of the Octane interbody fusion device system cleared for US distribution per 510(k) #K082270.
Comparison of Technological Characteristics
Both predicate and proposed devices have the same intended use, basic fundamental scientific technology, and share the following similarities:
- the same indications for use .
- similar design features .
- the same materials .
- . the same 8-year shelf life
- packaging and sterilization using the same materials and processes .
The proposed Octane Straight components are not being submitted as the result of a recall or any corrective action related to the Octane product lines.
Non-Clinical Performance Data
Table 1 shows non-clinical performance data provided, cited, or referenced in this submission to support a conclusion of substantial equivalence:
| Evaluation | Activities Performed |
|---|---|
| Loss of mechanical integrity: fracture/breakage | Static compression testing per ASTM F2077 |
| Dynamic compression testing per ASTM F2077 | |
| Static compressive shear testing per ASTM F2077 | |
| Implant subsidence | Subsidence Yield Force per ASTM F2267 |
Table 1: Octane Straight Non-Clinical Performance Data
2
Exactech® Octane® Straight Intervertebral Fusion Device 510(k) Summary
ئ
Substantial Equivalence Conclusion:
Comparison analysis and results of engineering studies referenced in this 510(k) submission demonstrate proposed Octane Straight Intervertebral Fusion Device implants are substantially equivalent to cited predicate devices cleared for US distribution.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2013
Exactech®, Incorporated % Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K130434
Trade/Device Name: Exactech® Octane® Straight Intervertebral Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 18, 2013 Received: March 19, 2013
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 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
4
Page 2 - Mr. Patrick Hughes
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. 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.
Image /page/4/Picture/8 description: The image shows the name "Erin Keith" in a stylized font. The letters "E", "r", "i", and "n" are in a bold, sans-serif font. The letters "K", "e", "i", "t", and "h" are in a similar font, but with a more decorative design.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech® Octane® Straight Intervertebral Fusion Device Special 510(k) - Indications for Use
· 510(k) Number: K130434
Device Name: Exactech® Octane® Straight Intervertebral Fusion Device
INDICATIONS
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 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 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
| Prescription Use X
(Part 21 CFR 801 Subpart D) | and/or | 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)
RonaldiP: Jean -S
(Division Sign-Off)
Division of Orthopedic Devices
510(k) Number: K130434