(240 days)
Not Found
No
The summary describes a passive intervertebral cage made of PEEK with tantalum markers. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an intervertebral cage intended for spinal fusion procedures to treat degenerative disc disease, which clearly indicates a therapeutic purpose to alleviate a medical condition.
No
The Alamo T is an intervertebral cage used for spinal fusion procedures, providing support and structural stability. It is a therapeutic device, not one used for diagnosis.
No
The device description clearly states the device is manufactured from PEEK Optima® LT1 and includes tantalum markers, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Alamo T is a physical implant (an intervertebral cage) used in spinal fusion surgery. It provides structural support and stability.
- Intended Use: The intended use is for spinal fusion procedures in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample.
- Device Description: The description details the material, design, and function of a physical implant.
- Performance Studies: The performance studies focus on mechanical testing of the implant's structural integrity, not on the accuracy or reliability of a diagnostic test.
The device is a surgical implant used in the body, not a test performed on a sample from the body.
N/A
Intended Use / Indications for Use
The Alamo T is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Alamo T is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization.
The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a transforaminal (TLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges 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
lumbosacral spine (L2-S1)
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)
Performance testing was conducted via the following mechanical tests per ASTM F2077 and F2267 using the worst case device: Static Compression, Dynamic Compression, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the Alamo T is 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.
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
K|2α40|
ОСТ
5 2012
510(k) Summary
Summary of 510(k) Safety and Effectiveness
| Submitted By: | Alliance Partners, LLC
121 Interpark Blvd, #601
San Antonio, TX 78216 | |
|-----------------------------|---------------------------------------------------------------------------------------------------|--|
| Date: | July 11, 2012 | |
| Contact Person: | Jennifer Palinchik
Development and Regulatory Consultant | |
| Contact Telephone: | (440) 933-8850 | |
| Device Trade Name: | Alamo T | |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft,
Lumbar | |
| Device Classification: | Class II | |
| Reviewing Panel: | Orthopedic | |
| Regulation Number: | 888.3080 | |
| Product Code: | MAX | |
| Predicate Device: | Globus Medical Signature TLIF Spacer (K072970)
Genesys Spine Interbody Fusion System (K103034) | |
Device Description:
The Alamo T is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization.
The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a transforaminal (TLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.
Intended Use:
The Alamo T is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.
page 1 of 2
1
Substantial Equivalence Information:
The design features, material, and indications for use of the Alamo T device are substantially equivalent to the predicate devices listed above. The safety and effectiveness is adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.
| Item | Alamo T | Globus TLIF Spacer | Genesys TLIF System |
|---|---|---|---|
| Product Code | MAX | MAX | MAX, ODP, MQP |
| Classification Name | Intervertebral Body | ||
| Fusion Device | Same | Same | |
| Intended Use | degenerative disc disease | ||
| (DDD) at one or two | |||
| contiguous levels of the | |||
| lumbosacral spine (L2- | |||
| S1) | Same | Same. Also intended | |
| for vertebral body | |||
| replacement | |||
| Footprint | Blocks have one length | ||
| and width, and a variety | |||
| of heights with axial and | |||
| lateral openings for bone | |||
| graft and rows of teeth. | |||
| No pivoting mechanism | Blocks in a variety of | ||
| lengths, widths, and | |||
| heights with axial and | |||
| lateral openings for bone | |||
| graft and rows of teeth. | |||
| Pivoting mechanism for | |||
| controlled articulation | |||
| during insertion | Blocks have one length | ||
| and width, and a | |||
| variety of heights with | |||
| axial and lateral | |||
| openings for bone graft | |||
| and rows of teeth. No | |||
| pivoting mechanism | |||
| Graft Opening | Large axial graft window | Same plus anterior graft | |
| windows | Same | ||
| Teeth to prevent | |||
| migration | Located on superior and | ||
| inferior surfaces. | |||
| Pyramid pattern | Same | Same, but linear pattern | |
| Radiographic | |||
| markers | Yes | Yes | Yes |
| Axial Footprint | |||
| dimensions | 10 x 28mm | 10 x 28mm and 11 x | |
| 33mm | 14 x 35mm | ||
| Device Height | 8mm-14mm (1mm | ||
| increments) | 7mm-17mm (1mm | ||
| increments), excluding | |||
| 14mm | 6mm-15mm (1mm | ||
| increments) | |||
| Material | PEEK Optima LT1 and | ||
| Tantalum (markers) | Same | Same |
Mechanical Testing:
Performance testing was conducted via the following mechanical tests per ASTM F2077 and F2267 using the worst case device: Static Compression, Dynamic Compression, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the Alamo T is substantially equivalent to the predicate devices.
K120401 Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alliance Partners, LLC % RP+M, LLC Ms. Jennifer Palinchik Development and Regulatory Consultant 33490 Pin Oak Parkway Avon Lake, Ohio 44012
Re: K120401
Trade/Device Name: Alamo T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 26, 2012 Received: September 27, 2012
Dear Ms. Palinchik:
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
OCT
5 2012
3
Page 2 - Ms. Jennifer Palinchik
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K12 0401
Device Name: Alamo T
Indications for Use:
The Alamo T is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.
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-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of Surgical, Orthopedic, |
| and Restorative Devices |
510(k) Number K1206401
Page 1 of 1