(108 days)
No
The 510(k) summary describes a physical implant device and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The submission focuses on the material and structural characteristics of the device and its equivalence to a predicate device.
No.
The device, an intervertebral fusion device, is intended to facilitate spinal fusion and provide structural support, which is a reconstructive and supportive function rather than a therapeutic one that actively treats disease.
No
This device is an intervertebral fusion device intended for spinal fusion procedures. While it allows for visualization of the defect site on radiography to assess bone growth, its primary function is not to diagnose a condition, but rather to treat it by performing a surgical fusion.
No
The device description clearly states it is an implant constructed of PEEK and titanium, which are physical materials, not software. The performance studies also focus on mechanical properties of the physical implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as an implant made of PEEK with a titanium coating, designed to be placed between vertebrae. This is a physical device for structural support and fusion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The "radiography" mentioned is for visualizing the implant's position and bone growth in vivo, not for analyzing a sample in vitro.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Octane® Straight Intervertebral Fusion Device, Ti Coated 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
MAX
Device Description
The Exactech® Octane® Straight Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1). The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers to permit verification of position. The device is plasma coated with commercially pure titanium. The Octane Straight Spinal Implant is provided sterile for single use.
The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.
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
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)
The Octane® Straight Intervertebral Fusion Device, Ti Coated has been tested in the following test modes:
- Static axial compression per ASTM F2077 ●
- Static compressive shear per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077 ●
- Dynamic compressive shear per ASTM F2077
- Percent Porosity per ASTM F1854-09
- Coating Thickness per ASTM F1854-09
- Static Shear per ASTM F1044-05 ●
- Static Tensile per ASTM F1147-05
- Shear Fatigue per ASTM F1160-05
- Abrasion per ASTM F1978-00
The results of this non-clinical testing show that the strength of the Octane® Straight Intervertebral Fusion Device, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, overlapping to create a sense of unity and connection. The symbol is meant to represent the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2015
Exactech, Incorporated % Mr. Kenneth C. Maxwell Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K150152
Trade/Device Name: Octane Straight Intervertebral Fusion Device, Ti Coated Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 13, 2015 Received: April 14, 2015
Dear Mr. Maxwell:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Kenneth C. Maxwell
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 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/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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. | |
| Indications for Use | |
| 510(k) Number (if known) | |
| K150152 | |
| Device Name | |
| Octane® Straight Intervertebral Fusion Device, Ti Coated | |
| Indications for Use (Describe) | |
| The Octane® Straight Intervertebral Fusion Device, Ti Coated 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. | |
| 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) | |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| FORM FDA 3881 (9/13) | |
| Page 1 of 2 | PSC Publishing Services (301) 443-6740 EF |
Exactech Octane® Straight Intervertebral Fusion Device, Ti Coated
3
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FORM FDA 3881 (9/13)
Page 2 of 2
4
510(K) SUMMARY
| Submitter's Name: | Exactech, Inc. |
|---|---|
| Submitter's Address: | 2320 NW 66th Court |
| Gainesville, FL 332653 | |
| Submitter's Telephone: | 352.377.1140 |
| Contact Person: | Kenneth C. Maxwell |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 16-Jan-15 |
| Trade or Proprietary Name: | Octane® Straight Intervertebral Fusion Device, |
| Ti Coated | |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Exactech® Octane® Straight Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1). The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers to permit verification of position. The device is plasma coated with commercially pure titanium. The Octane Straight Spinal Implant is provided sterile for single use.
The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.
INDICATIONS FOR USE
The Octane® Straight Intervertebral Fusion Device, Ti Coated 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.
The indications for use for the Octane® Straight Intervertebral Fusion Device. Ti Coated is similar to that of the predicate devices listed in Table 5-1.
5
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness.
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K130434 | Octane® Straight Intervertebral Fusion | ||
| Device | Exactech, Inc. | Primary | |
| K112036 | Calix™ PC Spinal Implant System | X-Spine | Reference |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Octane® Straight Intervertebral Fusion Device, Ti Coated has been tested in the following test modes:
- Static axial compression per ASTM F2077 ●
- Static compressive shear per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077 ●
- Dynamic compressive shear per ASTM F2077
- Percent Porosity per ASTM F1854-09
- Coating Thickness per ASTM F1854-09
- Static Shear per ASTM F1044-05 ●
- Static Tensile per ASTM F1147-05
- Shear Fatigue per ASTM F1160-05
- Abrasion per ASTM F1978-00
The results of this non-clinical testing show that the strength of the Octane® Straight Intervertebral Fusion Device, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Octane® Straight Intervertebral Fusion Device, Ti Coated is substantially equivalent to the predicate device.