(54 days)
Not Found
No
The description focuses on the material, design, and mechanical properties of a spinal fusion cage, with no mention of AI or ML capabilities.
No.
The device is an intervertebral cage intended to provide support and structural stability for spinal fusion, not to provide therapy.
No
The provided text describes the "Alamo P" as an intervertebral cage used in spinal fusion procedures to provide support and stability, not to diagnose a condition.
No
The device description clearly states the device is manufactured from PEEK and includes tantalum markers, indicating it is a physical implantable device, not software.
Based on the provided information, the Alamo P device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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 taken from the body.
- Device Description: The device is described as an intervertebral cage made of PEEK and tantalum markers, designed to provide support and stability during spinal fusion. This is a physical implant, not a reagent, instrument, or system intended for the examination of specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a medical device used in vivo (within the body) for a surgical procedure, not in vitro (in glass/outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Alamo P 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 posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Alamo P 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 posterior (PLIF) 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 P is substantially equivalent to the predicate device.
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
510(k) Summary
Summary of 510(k) Safety and Effectiveness
SEP 4 2012
Submitted By:
Alliance Partners. LLC 121 Interpark Blvd. #601 San Antonio, TX 78216
July 6, 2012
Contact Person:
Date:
Contact Telephone:
Device Trade Name: Device Classification Name:
Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device:
Jennifer Palinchik Development and Regulatory Consultant (440) 933-8850
Alamo P Intervertebral Body Fusion Device with Bone Graft, Lumbar Class II Orthopedic 888.3080 MAX Medtronic Sofamor Danek CAPSTONE® Spinal System (K073291)
Device Description:
The Alamo P 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 posterior (PLIF) 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 P 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
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system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a posterior approach.
Substantial Equivalence Information:
The design features, material, and indications for use of the Alamo P device are substantially equivalent to the predicate device 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 P | CAPSTONE® Spinal System |
|---|---|---|
| Product Code | MAX | MAX |
| Classification Name | Intervertebral Body Fusion | |
| Device | Same | |
| Intended Use | degenerative disc disease | |
| (DDD) at one or two | ||
| contiguous levels of the | ||
| lumbosacral spine (L2-S1) | Same | |
| Footprint | Blocks have one width and a | |
| variety of heights and | ||
| lengths with axial and lateral | ||
| openings for bone graft and | ||
| rows of teeth. | Same | |
| Teeth to prevent | ||
| migration | Located on superior and | |
| inferior surfaces. Linear | ||
| pattern | Same | |
| Radiographic markers | Yes | Yes |
| Axial Footprint | ||
| dimensions | 10 x 22mm, 10 x 25mm, 10 | |
| x 28mm | 10 x 22mm, 10 x 26mm, 10 x | |
| 32mm, 10 x 36mm | ||
| Material | PEEK Optima LT1 and | |
| Tantalum (markers) | Same |
Predicate Comparison Summary Table:
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 P is substantially equivalent to the predicate device.
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and a caduceus symbol at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alliance Partners, LLC % Ms. Jennifer Palinchik Development and Regulatory Consultant 121 Internark Boulevard. Suite 601 San Antonio, Texas 78216
SEP 4 2012
Re: K122047
Trade/Device Name: Alamo P Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 10, 2012 Received: July 12, 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 reguirements 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
3
Page 2 - Ms. Jennifer Palinchik
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/CDRH0ffices/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/ReportalProblem/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. Melk son 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): K122047
Device Name: Alamo P
Indications for Use:
The Alamo P 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 posterior approach.
Prescription Use ਮ (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)
Carl-Affi
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122047
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