(112 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of a cervical plate system, with no mention of AI or ML technologies.
No.
The device is an implantable cervical plate system used for spinal fixation, which falls under structural support rather than providing a therapeutic action like healing or prevention of disease.
No
Explanation: The provided text describes the Transom™ as a cervical plate system for anterior cervical fixation (C2-T1), used to treat various spinal conditions like degenerative disc disease, spondylolisthesis, and trauma. It is an implantable device designed for structural support and stabilization, not for diagnosing diseases or conditions.
No
The device description explicitly states that the Transom™ Cervical Plate System consists of bone plates, screws, and locking pins made from titanium alloy, which are physical hardware components. The summary also describes associated instruments for implantation and performance studies involving mechanical testing of these physical components.
Based on the provided information, the Transom™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for anterior cervical fixation to treat various spinal conditions. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a system of bone plates and screws made from titanium alloy, designed for surgical implantation into the vertebral bodies.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. The Transom™ is a surgical implant used inside the body.
N/A
Input text is not a summary of an AI/ML device. Content does not contain the requested information.
The provided text is for a traditional 510(k) spinal implant device, Transom(TM) Cervical Plate System. It does not mention product codes assigned by FDA other than the regulation number and product code for the general device type, nor does it contain information on image processing, AI, DNN, ML, input imaging modality, anatomical site, patient age range, training/test sets, or predetermined change control plans.
Intended Use / Indications for Use
The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Transom™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transom™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transom™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1)
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 Transom™ has been tested in the following test modes:
- Static axial compression bending per modified ASTM F1717-13
- Static torsion per modified ASTM F1717-13
- Dynamic axial compression bending fatigue per modified ASTM F1717-13
The results of this non-clinical testing show that the strength of the Transom™ is sufficient for its intended use and is 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.
K131374, K120515, K974885, K012184, K030595, K050892, K100614
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2014
Neurostructures, Incorporated % Ms. Meredith Mav Senior Manager Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K142060
Trade/Device Name: Transom™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 13, 2014 Received: October 20, 2014
Dear Ms. May:
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
1
Page 2 - Ms. Meredith May
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours. Lori A. Wiggins -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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: December 31, 2013 |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K142060 |
| Device Name | Transom™ Cervical Plate System |
| Indications for Use (Describe) | The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. |
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| FORM FDA 3881 (9/13) | PSC Publishing Services (301) 443-6740 EF |
Neurostructures, Inc. Transom™ Cervical Plate System
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510(K) SUMMARY
| Submitter's Name: | Neurostructures, Inc. |
|---|---|
| Submitter's Address: | 16 Technology Dr. Suite 165 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | 800.352.6103 |
| Contact Person: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was Prepared: | 17-Oct-2014 |
| Trade or Proprietary Name: | Transom™ Cervical Plate System |
| Common or Usual Name: | Spinal intervertebral body fixation orthosis |
| Classification: | Class II per 21 CFR §888.3060 Device Classification |
| Product Code: | KWQ |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Transom™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transom™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transom™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136.
INDICATIONS FOR USE
The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The indications for use for the Transom™ is the same as the Tempus™ Cervical Plate System (K120515, K131374).
TECHNOLOGICAL CHARACTERISTICS
Transom™ Cervical Plate System is made from titanium alloy that conforms to ASTM F136. Titanium alloy has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise
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any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture ●
- Sterilization method ●
- Structural support mechanism .
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K131374 | Tempus™ Cervical Plate System | |
| (Primary Predicate) | Neurostructures, Inc. | |
| K120515 | Tempus™ Cervical Plate System | Neurostructures, Inc. |
| K974885, K012184, | ||
| K030595, K050892, K100614 | Anterior Cervical Plating System | Orthofix |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Transom™ has been tested in the following test modes:
- Static axial compression bending per modified ASTM F1717-13 ●
- Static torsion per modified ASTM F1717-13 ●
- Dynamic axial compression bending fatigue per modified ASTM F1717-13 .
The results of this non-clinical testing show that the strength of the Transom™ is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Transom™ Cervical Plate System is substantially equivalent to the predicate device.