(141 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is indicated for use in treating patients with DDD and for facilitating fusion in the lumbar spine, which are therapeutic interventions.
No
The device description clearly states it is an "intervertebral body fusion device" and its intended use is to facilitate fusion. It is a surgical implant, not a tool for diagnosing medical conditions.
No
The device description clearly states it is an intervertebral body fusion device made from PEEK-OPTIMA HA Enhanced, with optional titanium inserts and radiographic markers. This is a physical implant, not software.
Based on the provided information, 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. It is used in the body to facilitate bone growth and stabilize the spine.
- Device Description: The device is described as an intervertebral body fusion device made of PEEK and titanium, designed to be implanted surgically.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information about a patient's health status. IVDs typically involve analyzing blood, urine, tissue, or other samples.
- Performance Studies: The performance studies described are mechanical tests (compression, shear, torsion, etc.) relevant to the structural integrity and function of a surgical implant, not analytical performance metrics associated with IVDs (like sensitivity, specificity, etc.).
Therefore, the NeoFuse device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device.
The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The NeoFuse™ HA Enhanced PLIF/TLIF devices are intervertebral body fusion devices made from PEEK-OPTIMA HA Enhanced (HA PEEK). Each device may include an optional Titanium Insert containing through holes to increase graft volume. The implants are available in various heights to accommodate patients' anatomy. The implants are provided non-sterile with surgical instruments to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), or titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (Lumbar Spine)
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)
The interbody fusion system was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear, static torsion, subsidence, and expulsion.
Test results demonstrated that the devices are substantially equivalent to the predicate devices.
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.
P960025, K142345, K142026, K150321
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized representation of three faces in profile, stacked one above the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
HT Medical, LLC % Nicholas Cordaro President Additive Innovations, LLC 533 2nd Street, Suite A Encinitas, California 92024
Re: K153615
Trade/Device Name: NeoFuse™ HA Enhanced PLIF/TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 16, 2016 Received: April 18, 2016
Dear Mr. Cordaro:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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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Indications for Use
510(k) Number (if known) K153615
Device Name NeoFuse™ HA Enhanced PLIF/TLIF
Indications for Use (Describe)
When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device.
The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
HT Medical LLC's
NeoFuse™ HA Enhanced PLIF/TLIF
Intervertebral Body Fusion System
| Trade Name: | NeoFuse™ HA Enhanced PLIF/TLIF |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Product Class: | Class II |
| Classification: | 888.3080 |
| Product Code: | MAX (Lumbar) |
| Panel Code: | 87 Orthopedic |
| Date Prepared: | May 5, 2016 |
Sponsor / Manufacture Information:
HT Medical, LLC Attn: Robert Compton 6316 E 102nd Street Tulsa, OK 74137 Phone: 417-309-9457 Registration Number: PENDING
Contact Information:
Additive Innovations, LLC Attn: Nicholas Cordaro 533 2nd Street, Suite A Encinitas, CA 92024 Phone: 760-525-9900
Device Description
The NeoFuse™ HA Enhanced PLIF/TLIF devices are intervertebral body fusion devices made from PEEK-OPTIMA HA Enhanced (HA PEEK). Each device may include an optional Titanium Insert containing through holes to increase graft volume. The implants are available in various heights to accommodate patients' anatomy. The implants are provided non-sterile with surgical instruments to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), or titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.
Predicate Device
The interbody fusion system is substantially equivalent to legally marketed predicate devices. The primary predicate devices is Depuy/AcroMed Lumbar I/F Cage per P960025, with additional predicates including Meditech Spine Talos-C per K142345, SpineFrontier, Inc., Arena-C HA PEEK Cervical Interbody Fusion Device per K142026, and Cutting Edge Spine, LLC's EVOS Lumbar Interbody System per K150321.
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Intended Use / Indications for Use
When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device.
The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.
Technology Characteristics
The technological characteristics of the NeoFuse are equivalent or similar to the predicate devices, including the materials. Identical to K142345, K142026, and K150321 the hydroxyapatite filled polyetheretherketone (HA PEEK ) contains HA which is a naturally occurring mineral in bone and is widely used in the orthopedic field. Similar to K142026, the devices are supplied non-sterile for steam sterilization. NeoFuse has the same technology characteristics and intended use as the intervertebral body fusion predicate devices P960025, K142345, K142026, and K150321.
Summary of Non-clinical Testing
The interbody fusion system was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear, static torsion, subsidence, and expulsion.
Test results demonstrated that the devices are substantially equivalent to the predicate devices.
Conclusion
Performance bench testing and comparisons have demonstrated NeoFuse is substantially equivalent to the predicate devices in regards to Indications for Use, Dimensions, Function, Materials, Mechanical Testing, and Technology Characteristics. The NeoFuse does not raise new questions of safety and effectiveness; and NeoFuse demonstrates substantial equivalence to legally marketed predicate devices.