(74 days)
No
The summary describes a passive implantable device (spinal fusion cage) and its associated instruments. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The modifications are described as dimensional changes and line extensions, not technological advancements related to AI/ML.
Yes
The device is used for spinal fusion procedures to treat degenerative disc disease and provide support and structural stability, which are therapeutic actions.
No
The Alamo T device is an intervertebral cage used in spinal fusion procedures to provide support and structural stability. Its purpose is therapeutic (fusion), not diagnostic. While its use is for patients with "degeneration of the disc confirmed by history and radiographic studies," the device itself is not performing the diagnostic function but rather is used once a diagnosis has been made.
No
The device description clearly states the device is manufactured from PEEK Optima® LT1 and includes tantalum markers, indicating it is a physical implant and not software.
Based on the provided text, the Alamo T device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for spinal fusion procedures in skeletally mature patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as an intervertebral cage made from PEEK and tantalum markers, designed to provide support and structural stability during spinal fusion surgery. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a surgical implant used to treat a condition, not a tool for diagnosing or analyzing biological samples.
N/A
Intended Use / Indications for Use
The Alamo T device 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
MAX
Device Description
The Alamo T device 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. Supplemental fixation and autograft is required to facilitate fusion.
The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths 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.
The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.
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)
Non-clinical testing: A failure modes and effects analysis was conducted to evaluate the impact of the design changes. Consideration was also given to FDA's 2007 Special Controls guidance "Intervertebral Body Fusion Devices". Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alliance Partners-ALAMO T (K120401), Life Spine-PLATEAU (K111569), Synthes-OPAL (K072791), Surgical Supplies-Biolign (K130274)
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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· K140303 Page 1 of 3
[As Required by 21 CFR 807.92]
Submitted By: (a)(1)
Phone: Fax:
Date:
Contact Persons Primary: Secondary:
(a)(2) Proprietary Name: Common Name:
Classification Name and Reference:
Product Code:
(a)(3) Predicate Devices: Alliance Partners, LLC 14206 Northbrook Dr. San Antonio, TX 78232 210-314-2525 210-314-2524
Feb 4, 2014/March 31, 2014
Kellen Hills (Orchid Design Consulting) Frank Morris (Alliance Partners, LLC)
Alamo T Interbody Fusion Device Intervertebral body fusion device with bone graft, lumbar 21CFR 888.3080 – Intervertebral body fusion device MAX
Allliance Partners-ALAMO T (K120401) Life Spine-PLATEAU (K111569) Synthes-OPAL (K072791) Surgical Supplies-Biolign (K130274)
Device Description: (a)(4)
The Alamo T device 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. Supplemental fixation and autograft is required to facilitate fusion.
The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths 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.
The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.
Indications for Use: (a)(5)
The Alamo T device 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-
APR 2 1 2014
1
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.
(a)(6) Technological Characteristics:
The fundamental scientific technology remains unchanged between the subject and predicate Alamo T devices. Both are interbody devices, designed to contain autograft material and utilize ancillary fixation in order to achieve fusion between two vertebrae. Both subject and predicate devices are made from PEEK with tantalum markers and incorporate teeth on the inferior and superior surfaces to aid in fixation. Both devices utilize instrumentation common to spinal fusion surgery.
Additionally, Life Spine's PLATEAU system was used as a dimensional predicate to validate the new footprints and heights of the subject Alamo T. Sythes OPAL was used as a predicate for graft volume and Surgical Supplies-Biolign was used as a predicate for graft windows. See table below for a comparison of the subject and predicate devices.
| Subject Device | Predicate Devices | ||
|---|---|---|---|
| Alamo T | Alamo T (K120401) | PLATEAU (K111569) | |
| Product Code | MAX | Same | |
| Classification | 888.3080 | Same | |
| Indications/Intended use | See Sec (a)(5) | Same | |
| Materials | PEEK Optima LT1 and | ||
| Tantalum (markers) | Same | ||
| Graft Opening | Large axial window | Same | |
| Teeth | Superior and Inferior | ||
| surfaces. Pyramid pattern. | Superior and | ||
| Inferior surfaces. | |||
| Pyramid pattern | |||
| and ridge | |||
| Radiographic | |||
| Markers | Yes | Same | |
| Footprint | 11mm x 28mm x 0° | ||
| lordosis | |||
| 11mm x 32mm x 0° | |||
| lordosis | 11mm x 28mm x 0° | ||
| lordosis | 11mm x 27mm x 0° | ||
| lordosis | |||
| 11mm x 32mm x 0° | |||
| lordosis | |||
| Height | 6-14mm (11x28) | ||
| 8-14mm (11x32) | 8-14mm | 6-14mm (11x27) | |
| 8-14mm (11x32) | |||
| Sterilization | End User (Steam) | Same |
2
(b)(1) Non-clinical testing:
A failure modes and effects analysis was conducted to evaluate the impact of the design changes. Consideration was also given to FDA's 2007 Special Controls guidance "Intervertebral Body Fusion Devices". Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary.
(b)(2) Clinical testing:
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
(b)(3) Conclusions:
Based on the information provided in this premarket notification, we believe that the subject Alamo T device and associated instrumentation demonstrates substantial equivalence to the identified predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
April 21, 2014
Alliance Partners, LLC % Orchid Design Mr. Kellen Hills Quality and Regulatory Consultant 4600 East Shelby Drive. Suite 1 Memphis. Tennessee 38118
Re: K140303
Trade/Device Name: Alamo T Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 31, 2014 Received: April 1. 2014
Dear Mr. Hills:
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Kellen Hills
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Reportal?roblem/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/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Ronald-P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ·
5
Indications for Use
510(k) Number (if known) K140303
Device Name
Alamo T Intervertebral Body Fusion Device
Indications for Use (Describe)
The Alamo T device 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 I 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.
Type of Use (Select one or both, as applicable)
2 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)
Anton E. Dmitriev. PhD
Division of
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