(174 days)
Not Found
No
The summary describes a physical intervertebral body fusion device and its mechanical properties, with no mention of AI or ML in its design, function, or intended use.
Yes
The device is indicated for anterior cervical interbody fusion procedures to treat degenerative disc disease (DDD) and accompanying radicular symptoms. The purpose of fusion is to alleviate pain and symptoms, functioning as a therapeutic intervention.
No
The device is an intervertebral body fusion device used for anterior cervical interbody fusion procedures, not for diagnostic purposes. It is implanted to facilitate fusion, not to diagnose a condition.
No
The device description clearly states the device is manufactured from PEEK or titanium alloy and has a physical form factor (rectangular with a hollow core, ridges). This indicates it is a physical implant, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for anterior cervical interbody fusion procedures. This is a surgical procedure involving the implantation of a device into the body to facilitate bone fusion.
- Device Description: The description details a physical implantable device (a cage) made of PEEK or titanium, designed to be placed between vertebrae.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a therapeutic implant.
The mention of "radiographic studies" in the intended use refers to the use of imaging to confirm the condition (DDD) and potentially to assess the outcome of the fusion after the device is implanted. It does not mean the device itself is performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Alamo® C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
Product codes
ODP
Device Description
The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from either PEEK Optima® LT1 per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization or titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the vertebral end plates. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges (teeth) to improve fixation and stability and prevent back out and migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, 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
Performance testing was conducted on the subject Alamo C device in accordance with ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02 to establish substantial equivalency with the predicate Alamo C device. Testing included static axial compression, dynamic axial compression, static torsion, subsidence, and expulsion. The results obtained demonstrate the subject Alamo C device functions as intended and is substantially equivalent to the predicate Alamo C device.
Key Metrics
Not Found
Predicate Device(s)
K133321, K112361, K161127, K111272, K141993
Reference Device(s)
Not Found
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.
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March 22, 2018
Alliance Partners, LLC Kristiina Gilkey QA/RA Manager 14206 Northbrook Drive San Antonio, Texas 78232
Re: K173128
Trade/Device Name: Alamo® C Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 16, 2018 Received: February 20, 2018
Dear Ms. Gilkey:
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 forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -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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Indications for Use
510(k) Number (if known)
Device Name Alamo® C
Indications for Use (Describe)
The Alamo® C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
| 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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510(k) Summary
Submitter 5.1
| Company: | Alliance Partners, LLC (dba Alliance Spine) |
|---|---|
| 14206 Northbrook Drive | |
| San Antonio, Texas 78232 | |
| Phone: | 210-314-2525 |
| Fax: | 210-314-2524 |
| Contact Person: | Kristiina Gilkey |
| Date Prepared: | March 21, 2018 |
5.2 Device
| Name of Device: | Alamo® C |
|---|---|
| Common Name: | Intervertebral body fusion device, Cervical |
| Classification Name: | Intervertebral body fusion device (21 CFR 888.3080) |
| Regulatory Class: | Class II |
| Product Code: | ODP |
| Review Panel: | Orthopedic |
5.3 Predicate Device
Primary Predicate: Alamo® C [K133321 & K112361] Additional Predicates: Life Spine Small PLATEAU® (PLATEAU-C Ti) Spacer System [K161127] Rhausler Plage™ Anterior Cervical Fusion System [K111272] Alliance Partners Nakoma® ACP [K141993]
5.4 Reason for 510(k) Submission
The purpose of this submission is to expand the Alamo C Interbody Fusion System to include a version of intervertebral body fusion devices manufactured from titanium. This modification does not affect the device's intended used or alter the device's fundamental scientific technology.
5.5 Device Description
The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from either PEEK Optima® LT1 per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization or titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the vertebral end plates. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges (teeth) to improve fixation and stability and prevent back out and migration.
5.6 Indications for Use
The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is
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defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
5.7 Comparison of Technological Characteristics with Predicate Device
The subject Alamo C has the same intended use and similar technological characteristics to the predicate Alamo C in terms of design, dimension, function, and performance characteristics. There are no significant differences between the devices which would adversely affect the use of the product.
Additionally, the subject Alamo C devices are fabricated from similar materials of construction as the predicate Small Plateau-C Ti device, Plage device, and Nakoma ACP device.
5.8 Performance Data / Non-clinical Tests
Performance testing was conducted on the subject Alamo C device in accordance with ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02 to establish substantial equivalency with the predicate Alamo C device. Testing included static axial compression, dynamic axial compression, static torsion, subsidence, and expulsion. The results obtained demonstrate the subject Alamo C device functions as intended and is substantially equivalent to the predicate Alamo C device.
5.9 Clinical Tests
No clinical studies were conducted.
5.10 Conclusions
Submitted data demonstrates that the subject Alamo C device is substantially equivalent to the predicate devices with regard to intended use, indications for use, design, performance, materials and technological characteristics.