(161 days)
Not Found
No
The summary describes a physical interbody fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is implanted in patients to treat degenerative disc disease and facilitate spinal fusion, which are therapeutic interventions.
No
The device, NeoFuse Ti3D, is an intervertebral body fusion device used in surgical procedures to facilitate spinal fusion, not to diagnose medical conditions. Its function is to provide structural support and aid in bone fusion, it does not interpret data to make a diagnosis.
No
The device description explicitly states that the NeoFuse Ti3D devices are made from additive manufactured (AM) Titanium Grade 23, indicating a physical hardware component. The performance studies also detail mechanical testing of the physical implants.
No, 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, or tissue) to provide information about a person's health.
- Device Description: The NeoFuse Ti3D is an implantable intervertebral body fusion device made of titanium. It is surgically placed in the spine to facilitate fusion.
- Intended Use: The intended use is to provide structural support and promote bone fusion in patients with degenerative disc disease. This is a therapeutic use, not a diagnostic one.
The information provided clearly describes a surgical implant used for treatment, not a device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. 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.
When used as a Cervical Interbody Fusion device. NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment with the device. The devices must be used with supplemental fixation and must be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP
Device Description
The NeoFuse Ti3D PLIF/TLIF/Cervical devices are intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F136. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar (L2-S1), Cervical (C2-T1)
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)
FDA performance standards have been established for the NeoFuse Ti3D PLIF/TLIF/Cervical Intervertebral Body Fusion Device. The following tests were independently performed on the lumbar and cervical devices to demonstrate safety based on current industry standards:
- . Static and dynamic axial compression (per ASTM F2077)
- . Static torsion (per ASTM F2077)
- Static compression shear (per ASTM F2077)
- . Subsidence (per ASTM F2267)
- Static Expulsion (per ASTM draft standard F04.25.02.02)
The cervical devices were additionally tested per:
- Dynamic torsion (per ASTM F2077)
The lumbar devices were additionally tested per:
- Dynamic compression shear (per ASTM F2077) ●
The effectiveness of the gamma irradiation as a means of sterilization for the cervical and lumbar devices was validated using AAMI/ANSI/ISO 11137-2 – method VDm%55. This included:
- Bioburden recovery factor testing
- Bacteriostasis and fungistasis
- . Bioburden
- . Verification dose
- . Sterility testing of the verification dose sample
The effectiveness of the final ultrasonic cleaning procedure for gamma sterilization included the following process qualifications:
- Visual verification ●
- . Bioburden testing
- Cytotoxicity testing
- UV/Vis testing
- Total organic carbon (TOC)
- Bacterial Endotoxin (LAL)
The effectiveness of the packaging and shipping of sterile product included the following process qualifications:
- Shipping testing
- . Peel strength testing
- . Bubble emission testing
- . Integrity inspections
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The results of these tests indicated that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is substantially equivalent to the predicate devices.
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.
K160125, K153615, P960025, K120275
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July, 12, 2017
HT Medical, LLC % Mr. Nicholas Cordaro President Additive Innovations. LLC 533 2nd Street. Suite A Encinitas. California 92024
Re: K170318
Trade/Device Name: NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: June 12, 2017 Received: June 14, 2017
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
1
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.
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.
Vincent J. Devlin -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K170318
Device Name
NeoFuse™Ti3D PLIF/TLIF/Cervical Interbody
Indications for Use (Describe)
When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. 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.
When used as a Cervical Interbody Fusion device. NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment with the device. The devices must be used with supplemental fixation and must be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.
| 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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3
510(k) Summary
DATE PREPARED
January 26, 2017
MANUFACTURER AND 510(k) OWNER
HT Medical, LLC 6316 E 102nd Street, Tulsa, OK 74137, USA (918) 995-2090 Telephone: (800) 878-0772 Fax: Official Contact: Robert Compton, Chief Executive Officer
REPRESENTATIVE/CONSULTANT
Nicholas M. Cordaro Additive Innovations, LLC Telephone: Email: nick.cordaro@additiveinnovations.net
PROPRIETARY NAME OF SUBJECT DEVICE
NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody
COMMON NAME Intervertebral body fusion device
DEVICE CLASSIFICATION
Intervertebral body fusion device (21 CFR 888.3080, Product Codes ODP and MAX, Class II)
PREMARKET REVIEW
ODE/DOD/ASDB Orthopedic Panel
INDICATIONS FOR USE
When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. 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 devices must be used with supplemental fixation and must be used with autograft/autologous bone graft to facilitate fusion for each spinal region.
4
When used as a Cervical Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.
DEVICE DESCRIPTION
The NeoFuse Ti3D PLIF/TLIF/Cervical devices are intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F136. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.
PREDICATE DEVICE IDENTIFICATION
The NeoFuse Ti3D PLIF/TLIF/Cervical Interbody will be shown to be substantially equivalent to the following predicates:
| 510(k)
Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|------------------|--------------------------------------|----------------------|
| K160125 | Cascadia Interbody System | ✓ |
| K153615 | NeoFuse HA Enhanced PLIF/TLIF | |
| P960025 | Lumbar I/F Cage | |
| K120275 | DePuy Synthes ACIS | |
SUMMARY OF NON-CLINICAL TESTING
FDA performance standards have been established for the NeoFuse Ti3D PLIF/TLIF/Cervical Intervertebral Body Fusion Device. The following tests were independently performed on the lumbar and cervical devices to demonstrate safety based on current industry standards:
- . Static and dynamic axial compression (per ASTM F2077)
- . Static torsion (per ASTM F2077)
- Static compression shear (per ASTM F2077)
- . Subsidence (per ASTM F2267)
- Static Expulsion (per ASTM draft standard F04.25.02.02)
The cervical devices were additionally tested per:
-
Dynamic torsion (per ASTM F2077)
The lumbar devices were additionally tested per: -
Dynamic compression shear (per ASTM F2077) ●
5
The effectiveness of the gamma irradiation as a means of sterilization for the cervical and lumbar devices was validated using AAMI/ANSI/ISO 11137-2 – method VDm%55. This included:
- Bioburden recovery factor testing
- Bacteriostasis and fungistasis
- . Bioburden
- . Verification dose
- . Sterility testing of the verification dose sample
The effectiveness of the final ultrasonic cleaning procedure for gamma sterilization included the following process qualifications:
- Visual verification ●
- . Bioburden testing
- Cytotoxicity testing
- UV/Vis testing
- Total organic carbon (TOC)
- Bacterial Endotoxin (LAL)
The effectiveness of the packaging and shipping of sterile product included the following process qualifications:
- Shipping testing
- . Peel strength testing
- . Bubble emission testing
- . Integrity inspections
The results of these tests indicated that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is substantially equivalent to the predicate devices.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
HT Medical believes that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody has been shown to be substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimensions, intended use and similar technology characteristics as the devices cleared in K160125, K153615, and P960025. The subject device has an identical manufacturing method as the device cleared in K160125. The device has shown to have equivalent strength characteristics as the cleared predicate devices.
CONCLUSION
The NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicates.