(37 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a spinal fixation system made of titanium alloy, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat various spinal conditions (degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, trauma, spinal stenosis, unsuccessful previous fusion surgery, deformities, tumor) by providing temporary fixation until fusion is achieved, thus alleviating symptoms and improving patient health.
No
This device is a spinal fixation system, intended for temporary fixation in the lumbar spine to aid bone graft healing and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "non-sterile, single-use plates and screws" and "Class I manual instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The Aspida Anterior Lumbar Plating System is described as a spinal fixation system consisting of plates and screws made from titanium alloy. These are implants designed to be surgically placed within the body.
- Intended Use: The intended use is for anterior lumbar spine fixation as a temporary fixation device until fusion is achieved. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
The device is clearly an implantable surgical device used for structural support and stabilization within the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Aspida Anterior Lumbar Plating System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the great vessels. The device is intended as a temporary fixation device until fusion is achieved.
The Aspida Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:
-
Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
-
Pseudoarthrosis
-
Spondylolysis
-
Spondylolisthesis
-
- Trauma (i.e., fracture or dislocation)
-
- Spinal stenosis
-
- Unsuccessful previous fusion surgery
-
- Deformities or curvatures (i.e., scoliosis,
- kyphosis, and/or lordosis)
-
- Tumor
Product codes
KWQ
Device Description
The Aspida Anterior Lumbar Plating System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136. The system also contains Class I manual instruments. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior lumbar spine (L1-S1)
Indicated Patient Age Range
Not Found
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)
Nonclinical testing performed on the Aspida Anterior Lumbar Plating System supports substantial equivalence to other predicate devices. The following testing was performed:
- Static compression testing per ASTM F1717
- Static torsion testing per ASTM F1717 ●
- . Dynamic compression testing per ASTM F1717
The results demonstrate that the subject Aspida Anterior Lumbar Plating System is substantially equivalent to other predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2018
Alphatec Spine, Inc. Ms. Ruby Zheng Regulatory Affairs Compliance Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K182808
Trade/Device Name: Aspida® Anterior Lumbar Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 2, 2018 Received: October 3, 2018
Dear Ms. Zheng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Ronald P. Jean -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)
K182808
Device Name Aspida® Anterior Lumbar Plating System
Indications for Use (Describe)
The Aspida Anterior Lumbar Plating System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the great vessels. The device is intended as a temporary fixation device until fusion is achieved.
The Aspida Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:
-
Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
-
Pseudoarthrosis
-
Spondylolysis
-
Spondylolisthesis
-
- Trauma (i.e., fracture or dislocation)
-
- Spinal stenosis
-
- Unsuccessful previous fusion surgery
-
- Deformities or curvatures (i.e., scoliosis,
- kyphosis, and/or lordosis)
-
- Tumor
| 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) | ✓ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white letter "a" inside of it. To the right of the square is the word "tec" in white font, with a trademark symbol above the "c".
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
Phone: (760) 431-6884
Fax: (760) 431-0289 |
|----|------------------------|-------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Ruby Zheng
Regulatory Affairs Compliance Specialist
Contact Phone: (760) 494-6884 |
| | Date Summary Prepared: | November 8, 2018 |
II. DEVICE
| Name of Device: | Aspida® Anterior Lumbar Plating System |
|---|---|
| Common or Usual Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body |
| (21 CFR 888.3060) | |
| Regulatory Class: | Class II |
| Product Code: | KWQ |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K101255 | KWQ | Alphatec Spine Anterior Lumbar | |
| Plating System | Alphatec Spine | ||
| Additional Predicate Device | |||
| K090222 | KWQ | Pioneer Lumbar Plate System | Pioneer Surgical |
| Technology |
IV. DEVICE DESCRIPTION
The Aspida Anterior Lumbar Plating System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136. The system also contains Class I manual instruments. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
4
Image /page/4/Picture/0 description: The image shows the logo for a company called "atec". The logo consists of a green square with a white stylized "a" inside of it. To the right of the square is the word "tec" in white sans-serif font. The letters are connected to each other. The background of the image is a dark blue color.
V. INDICATIONS FOR USE
The Aspida Anterior Lumbar Plating System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved.
The Aspida Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
-
- Pseudoarthrosis
-
- Spondylolysis
-
- Spondylolisthesis
-
- Trauma (i.e., fracture or dislocation)
-
- Spinal stenosis
-
- Unsuccessful previous fusion surgery
-
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Tumor
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Nonclinical testing performed on the Aspida Anterior Lumbar Plating System supports substantial equivalence to other predicate devices. The following testing was performed:
- Static compression testing per ASTM F1717
- Static torsion testing per ASTM F1717 ●
- . Dynamic compression testing per ASTM F1717
The results demonstrate that the subject Aspida Anterior Lumbar Plating System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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Image /page/5/Picture/0 description: The image is a logo for a company called "atec". The logo consists of a green square with rounded corners on the left side, and the word "atec" in white letters on the right side. The "a" in "atec" is stylized with a curved line that resembles the Greek letter alpha. There is a trademark symbol after the "c" in "atec".
K182808 Page 3 of 3
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.