(51 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its associated instruments. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is intended to provide anterior stabilization of spinal segments as an adjunct to spinal fusion, treating conditions like pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease. This directly addresses medical conditions and aims to improve patient health, which is the definition of a therapeutic device.
No
Explanation: The device description states it is a multi-component system including implantable devices and instrumentation used to provide anterior stabilization of spinal segments as an adjunct to spinal fusion. It is used for surgical procedures, not for identifying or diagnosing a disease or condition.
No
The device description explicitly states it is a "multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel," indicating it is a hardware-based medical device.
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 stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion." This describes a surgical implant and its purpose in treating spinal conditions.
- Device Description: The description details implantable devices (titanium alloy rod) and surgical instruments used to prepare the surgical site and insert the implant and bone graft. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to perform tests on samples to diagnose diseases or conditions.
The device is a surgical implant system used for spinal fusion, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
TranS1 AxiaLIF Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. The AxiaLIF Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The TranS1 AxiaLIF Plus system is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 - S1 or L4-S1 disc space(s). The device's instruments are used for distracting the L5 – S1 or L4-S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 or L4-S1 spinal segment(s), lumbar spine
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)
The TranS1 AxiaLIF System was evaluated via an engineering analysis and V&V performance testing according to the predicate device. The results demonstrate the performance of the device 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
§ 888.3060 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
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November 20, 2019
TranS1, Inc. Ms. Kristen Allen Director of Compliance and Regulatory Affairs 3804 Park Avenue, Suite C Wilmington, North Carolina 28403
Re: K192792
Trade/Device Name: TranS1 AxiaLIF Plus System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 27, 2019 Received: September 30, 2019
Dear Ms. Allen:
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/cdrh/cfdocs/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192792
Device Name TranS1 AxiaLIF Plus System
Indications for Use (Describe)
TranS1 AxiaLIF Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. The AxiaLIF Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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/1 description: The image shows the logo for TRAN1. The logo is in blue and green. The word "TRAN" is in blue, and the number "1" is in blue. There is a green dotted line between the letters and the number.
510(k) Summary
TranS1 AxiaLIF Plus System
| Submitter: | TranS1, Inc.
3804 Park Avenue, Suite C
Wilmington, NC 28403 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Allen
Director of Compliance and Regulatory Affairs
910-612-4153 (P)
Kristen@trans1.com (e-mail) |
| Date Prepared: | September 27, 2019 |
| Trade Name: | TranS1 AxiaLIF Plus System |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Device Product Code
and Classification: | Regulation Number: 21 CFR 888.3060
KWQ, Class II, Spinal Intervertebral Body Fixation Orthosis |
| Primary Predicate: | TranS1 AxiaLIF Plus System (K102334) |
Device Description:
The TranS1 AxiaLIF Plus system is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 - S1 or L4-S1 disc space(s). The device's instruments are used for distracting the L5 – S1 or L4-S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.
Indications and Intended use:
TranS1 AxiaLIF Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. The AxiaLIF Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF.
Summary of Technological Characteristics:
The subject devices are substantially equivalent to the predicate device as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through
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Image /page/4/Picture/1 description: The image shows the logo for TRAN1. The logo is in blue and green. The word "TRAN" is in blue, and the number "1" is in blue with a green design to the right of the letter N.
comparison of characteristics including design, intended use, material composition, performance specifications and function.
Summary of Performance Testing:
The TranS1 AxiaLIF System was evaluated via an engineering analysis and V&V performance testing according to the predicate device. The results demonstrate the performance of the device is substantially equivalent to the predicate device.
Conclusion:
Based on the comparison to predicate device, the Subject Device has been shown to be substantially equivalent to the legally marketed predicate device.