(143 days)
Not Found
No
The summary describes a physical interbody fusion implant and associated instruments, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical testing, not related to AI/ML performance metrics.
No
The TranS1 Interbody Fusion System is an implant designed for spinal fusion procedures, providing structural support and not actively treating a condition in a therapeutic manner.
No
Explanation: The device is an interbody fusion system designed for spinal fusion procedures, specifically as an implant, not for diagnosing conditions.
No
The device description clearly states it is a "radiolucent PEEK interbody fusion implant comprised of various heights and footprints," which is a physical implant, not software. It also mentions "access instruments and disc preparation instruments" and "mechanical testing," all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The TranS1 Interbody Fusion System is a physical implant designed to be surgically placed in the spine to facilitate fusion. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
- Device Description: The description details a physical implant made of PEEK and surgical instruments, not equipment for analyzing biological samples.
- Performance Studies: The performance studies focus on mechanical testing of the implant's structural integrity, which is relevant for a surgical device, not an IVD.
The mention of "radiographic studies" in the intended use refers to the diagnostic information used to identify patients who are candidates for the surgical procedure, not the device itself performing a diagnostic function.
N/A
Intended Use / Indications for Use
The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing for the TranS1 Interbody Fusion System was performed per ASTM standards and included:
| Test | Standard |
|---|---|
| Static Compression | ASTM F2077-11 |
| Static Compression Shear | ASTM F2077-11 |
| Static Torsion | ASTM F2077-11 |
| Subsidence | ASTM F2267-04 |
| Expulsion | N/A |
| Dynamic Compression | ASTM F2077-11 |
All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. The results demonstrated that the subject TranS1 Interbody Fusion System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
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
§ 888.3080 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
K12 0991
AUG 2 3 2012
Trant
Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
July 2012
Submitter: Contact Person:
TranS1. Inc. 301 Government Center Drive Wilmington, NC 28403
Cheryl L Waqoner Director of Regulatory 910-332-1703 (phone), 910-233-1701 (fax)
Proprietary Name: TranS1® Interbody Fusion System Classification: 888.3080: Intervertebral Fusion Device (MAX) Predicate Device: Life Spine Plateau Spacer System: K111569
Indications and Intended use:
The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
Device Description
The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.
Technological Characteristics and Substantial Equivalence
Documentation was provided to demonstrate that the TranS1® Interbody Fusion System is substantially equivalent to the Predicate Life Spine Plateau Spacer System (K111569). The Subject device is substantially equivalent to the Predicate devices in intended use, level of attachment, materials, labeling, sterilization, and technological characteristic. These devices
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have the same intended use and indications and rely on the same fundamental scientific technology; therefore the Subject device is substantially equivalent to the Predicate devices.
Summary of Testing
Mechanical testing for the TranS1 Interbody Fusion System was performed per ASTM standards and included:
| Test | Standard |
|---|---|
| Static Compression | ASTM F2077-11 |
| Static Compression Shear | ASTM F2077-11 |
| Static Torsion | ASTM F2077-11 |
| Subsidence | ASTM F2267-04 |
| Expulsion | N/A |
| Dynamic Compression | ASTM F2077-11 |
All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. The results demonstrated that the subject TranS1 Interbody Fusion System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
Conclusion
Based on the indications for use, technological characteristics, and comparison to predicate device, the subject TranS1 Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
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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 depiction of an eagle or bird-like figure, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Trans1 Incorporated % Ms. Cheryl L Wagoner Director of Regulatory 301 Government Center Drive Wilmington, North Carolina 28403
AUG 2 3 2012
Re: K120991
Trade/Device Name: TranS1® Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 23, 2012 Received: July 23, 2012
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2- Ms. Cheryl L Wagoner
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.
Sincerely yours,
For
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number: K120991
Device Name: TranS1® Interbody Fusion System
Indications for Use:
The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and These DDD patients may also have up to Grade 1 spondylolisthesis or radiographic studies. retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
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)
Col-S
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
长120991 510(k) Number_
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