(190 days)
TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.
The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.
The TranS1® AxiaLIF® 2L 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 tract to the LC-1.5-S 1 disc spaces. The track and the device's instruments are used for distracting the L4 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes implantable anterior fixation rods that are implanted through the same tract.
The provided text is a 510(k) Premarket Notification for the TranS1 AxiaLIF 2L System. This document describes a medical device (spinal intervertebral body fixation orthosis) and its intended use, but it does not contain information about acceptance criteria, study methodologies, or performance data comparing the device to these criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The document focuses on establishing substantial equivalence to a predicate device (TranS1 AxiaLIF II, K073643) rather than presenting detailed clinical or performance study results against specific acceptance criteria.
The FDA's letter states that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This determination is typically based on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, often without requiring extensive new clinical studies that establish performance against explicit acceptance criteria in the way you've outlined.
**To answer your request, I would need a different type of document, such as a full clinical study report, a specific performance testing report, or a more detailed submission that includes: **
- Performance goals or acceptance criteria for the device.
- The methodology of a study designed to test these criteria.
- Results of that study.
- Details about sample sizes, ground truth establishment, expert qualifications, etc.
Based on the provided text, I can only extract these general facts:
- Device: TranS1 AxiaLIF 2L System
- Intended Use: Anterior stabilization of L4-S1 spinal segments as an adjunct to spinal fusion; minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.
- Indications for Use: Patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease.
- Predicate Device: TranS1 AxiaLIF II (K073643)
The document explicitly states: "The technological characteristics of the TranS1® AxiaLIF® 2L System have not changed," which is a key part of demonstrating substantial equivalence to the predicate device in a 510(k) submission. This usually implies that the performance is expected to be similar to the predicate, but it does not detail specific performance studies of the new device against new acceptance criteria.
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TranS1 AxiaLIF 2L System
Image /page/0/Picture/2 description: The image shows the logo for "Trans1". The logo is in black and white and features a stylized font. The "1" in "Trans1" has a curved line extending from the bottom, and a circled R symbol is located to the right of the "1".
JAN 2 1 2010
Premarket Notification [510(K)] Summary
(per 21 CFR 807.92)
7/14/2009
| Submitter: | Contact Person: |
|---|---|
| TranS1, Inc.411 Landmark DriveWilmington, NC 28412 | Cheryl L WagonerQuality and Regulatory Manager910-332-1703 (phone)910-233-7105 (fax) |
| Proprietary Name: | TranS1® AxiaLIF® 2L System |
| Classification: | Spinal Intervertebral Body Fixation Orthosis21 CFR 888.3060Product Code: KWQ |
| Predicate Device: | TranS1® AxiaLIF® II, K073643 |
Intended use:
TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.
The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.
Device Description
The TranS1® AxiaLIF® 2L 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 tract to the LC-1.5-S 1 disc spaces. The track and the device's instruments are used for distracting the L4 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes implantable anterior fixation rods that are implanted through the same tract.
Technological Characteristics and Substantial Equivalence
The technological characteristics of the TranS1® AxiaLIF® 2L System have not changed.
ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ
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Image /page/1/Picture/1 description: The image contains a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, rendered in black. The emblem is composed of curved lines and shapes, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN 2 1 2010
TranS1. Inc. % Ms. Cheryl L. Wagoner Quality and Regulatory Manager 411 Landmark Drive Wilmington, North Carolina 28412
Re: K092124
Trade/Device Name: TranS1® AxiaLIF® 2L System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: November 20, 2009 Received: November 23, 2009
Dear Ms. Wagoner:
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.
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
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Page 2 - Ms. Cheryl L. Wagoner
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely vours.
Harbare bouchem
Mark N. Me kerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
Page 1 of 1
K092114 510(k) Number: _
Device Name: TranS1® AxiaLIF® 2L System
Indications for Use:
TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The Axial.IF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny, or for assistance in the performance of L4-S1 interbody fusion.
The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.
Over-The-Counter Use Prescription Use × Prescription 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_________________________________________________________________________________________________________________________________________________________________
ੰ
§ 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.