(72 days)
No
The summary describes a physical implantable device (intervertebral cage) and its materials, design features, and intended use in a surgical procedure. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on mechanical testing of the device itself.
Yes
The device is indicated for anterior cervical interbody fusion procedures to treat degenerative disc disease and facilitate fusion, making it a therapeutic device.
No
Explanation: The document describes a cervical intervertebral body fusion device, which is an implant used in surgical procedures. It is not used to diagnose a medical condition, but rather to treat it by facilitating fusion of the cervical spine. The "radiographic studies" mentioned are for confirming the degeneration of the disc (diagnosis typically performed by imaging machines, not this implant itself) and for post-operative visualization of the implant.
No
The device description clearly states the device is manufactured from PEEK Optima® LT1 and includes tantalum markers, indicating it is a physical implantable device, not software.
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 in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The description details a physical implant made of PEEK and tantalum markers, designed to be placed between vertebrae.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes.
The device is a surgical implant used to facilitate bone fusion in the spine, not a diagnostic tool.
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 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.
Product codes
ODP
Device Description
The Alamo C is designed for use as a cervical intervertebral body fusion device. 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 an anterior (ACIF) surgical approach. 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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical Testing:
Performance testing was conducted to confirm the modification did not alter the worst case scenario of the device. Testing was performed in accordance with ASTM F2077. The device functioned as intended and the performance results show that the modified Alamo C is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alliance Partners, LLC Alamo C (K112361), Depuy Bengal System (K081917), Alphatec Spine Novel Spinal Spacer System (K081730)
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.
0
K133321 page 1 of 2
510(k) Summary
JAN - 9 2014
| Submitted By: | Alliance Partners, LLC
14206 Northbrook Dr.
San Antonio, TX 78232 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 7, 2014 |
| Contact Person: | Jennifer Palinchik
Regulatory Consultant |
| Contact Telephone: | (440) 933-8850 |
| Device Trade Name: | Alamo C |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft,
Cervical |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number: | 888.3080 |
| Product Code: | ODP |
| Predicate Device: | Alliance Partners, LLC Alamo C (K112361)
Depuy Bengal System (K081917)
Alphatec Spine Novel Spinal Spacer System (K081730) |
Device Description:
The Alamo C is designed for use as a cervical intervertebral body fusion device. 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 an anterior (ACIF) surgical approach. 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 to improve fixation and stability and prevent back out and migration.
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 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.
1
Substantial Equivalence Information:
The design features, material, manufacturing process, sterilization process, labeling, and indications for use of the subject device are identical to the previously cleared device except additional axial footprints have been added to the system. These additional sizes are substantially equivalent to the predicate devices listed above. The safety and effectiveness is adequately supported by the documentation provided within this Premarket Notification.
Mechanical Testing:
Performance testing was conducted to confirm the modification did not alter the worst case scenario of the device. Testing was performed in accordance with ASTM F2077. The device functioned as intended and the performance results show that the modified Alamo C is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 representation of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2014
Alliance Partners, LLC % Ms. Jennifer Palinchik Regulatory Consultant JALEX Medical, LLC 33490 Pin Oak Parkway Avon Lake, Ohio 44012
Re: K133321
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: December 12, 2013 Received: December 13, 2013
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. 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
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 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133321
Device Name: Alamo C
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 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.
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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices