(303 days)
No
The device description focuses on mechanical components (rods, hooks, screws, cross links) for spinal stabilization and fusion. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is intended to treat medical conditions such as spondylolisthesis, fractures, dislocations, scoliosis, kyphosis, and spinal tumors by providing immobilization and stabilization of spinal segments as an adjunct to fusion. This aligns with the definition of a therapeutic device.
No.
The Aaxter A3 Posterior Spinal System is an implantable device designed for spinal stabilization and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, and cross links made from titanium alloy, which are hardware implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Aaxter A3 Posterior Spinal System is a surgical implant used for stabilizing the spine. It is a physical device implanted into the body to provide structural support and promote fusion.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens.
Therefore, based on the provided information, the Aaxter A3 Posterior Spinal System clearly falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication: spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Aaxter A3 Posterior Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Fracture of the vertebral body
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWP
Device Description
The Aaxter A3 Posterior Spinal System is a posterior spinal system which is a top loading multiple components, posterior pedicle and hook fixation system intended to provide segmental stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
The Aaxter A3 Posterior Spinal System consists of variety of rods, hooks, screws, and cross links used to build a spinal construct for stabilization and promotion of spinal fusion in the thoracic-lumbar and sacral regions.
The Aaxter A3 Posterior Spinal System implant system components are supplied non-sterile for single use and are made from medical titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Specialized instruments made from surgical grade stainless steel are used for all the operations of the Aaxter A3 Posterior Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine, L5-S1 vertebra, lumbar and sacral spine, thoracic, lumbar and sacral spine
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)
Static compression bending, static torsion and dynamic compression bending testing per ASTM F1717 and pullout testing per ASTM F1798 were performed on the Aaxter A3 Posterior Spinal System. Test results were substantially equivalent to legally marketed 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.
OPTIMATM, Spinal System MNI. MNH-(K031585)
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.
U&I America, Spinal Hook System™, KWP-(K031595)
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
1.4 510(k) SUMMARY
MAR 166 2011
510(K) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a)
Submission Information:
.
:
-
- i
| Contact: | Kason Tsai
R&D Dept. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Aaxter Co., Ltd
Address:No. 8-3, Sec. 1, Jhongsing Rd.,
Wugu Township, Taipei County 24872, Taiwan
(886)-2-8976-9238 (TEL)
(886)-2-8976-9287 (FAX)
E-Mail: kason@aaxter.com |
| Contact(In USA): | Eric Kung
4905 Washtenaw Avenue Ann Arbor MI 48108, USA
734-645-8888(TEL)
734-470-6076(FAX)
E-Mail:erickung@comcast.net |
| Data Prepared: | May 11, 2010 |
| Device Identification | |
| Trade Name:
Common Name: | Aaxter A3 Posterior Spinal System
Pedicle Screw Spinal System |
| Classification Name: | a) Appiliance, Fixation, Spinal Interlaminal
(KWP per 21 CFR) § 888.3050
b) Spinal Pedicle Fixation Orthosis (MNI)
Per 21 CFR § 888.3070
c) Spondylolisthesis Spinal Fixation
Orthosis (MNH) per 21 CFR § 888.3070 |
1-14
page 1 of 3
1
Substantially Equivalent Predicate Legally Marketed Devices:
The Subject Aaxter A3 Posterior Spinal System is substantially equivalent in function materials, design, operational principles, composition, labeling, and intended use to:
OPTIMATM, Spinal System MNI. MNH-(K031585) U&I America, Spinal Hook System™, KWP-(K031595)
Device Description:
The Aaxter A3 Posterior Spinal System is a posterior spinal system which is a top loading multiple components, posterior pedicle and hook fixation system intended to provide segmental stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
The Aaxter A3 Posterior Spinal System consists of variety of rods, hooks, screws, and cross links used to build a spinal construct for stabilization and promotion of spinal fusion in the thoracic-lumbar and sacral regions.
The Aaxter A3 Posterior Spinal System implant system components are supplied non-sterile for single use and are made from medical titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Specialized instruments made from surgical grade stainless steel are used for all the operations of the Aaxter A3 Posterior Spinal System.
Indications for Use:
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication: spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Aaxter A3 Posterior Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
· Degenerative spondylolisthesis with objective evidence of neurological impairment
· Fracture of the vertebral body
· Dislocation
page 2 of 3
2
- Scoliosis
- Kyphosis
- Spinal tumor
Statement of Technological Comparison:
The subject spinal implant system is substantially equivalent to the above listed predicate device in terms of material, design, indications for use and operational principles.
Performance data:
Static compression bending, static torsion and dynamic compression bending testing per ASTM F1717 and pullout testing per ASTM F1798 were performed on the Aaxter A3 Posterior Spinal System. Test results were substantially equivalent to legally marketed predicate devices.
page 3 of 3
I-16
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2011
Aaxter Co., Ltd. % Mr. Eric Kung 4905 Washtenaw Avenue Ann Arbor, Michigan 48108
Re: K101374
Trade/Device Name: Aaxter A3 Posterior Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: March 11, 2011 Received: March 11, 2011
Dear Mr. Kung:
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
4
Page 2 - Mr. Eric Kung
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 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
A
B-2t
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K101374 Device Name: Aaxter A3 Posterior Spinal System Indications for Use:
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication: spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
İn addition, the Aaxter A3 Posterior Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
· Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Fracture of the vertebral body
- · Dislocation
- · Scoliosis
- Kyphosis
- Spinal tumor
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 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 | K101374 |
|---|---|
| --------------- | --------- |
| 4-25 | |
|---|---|
| page 1 of 1 |