(108 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the cervical plate system, with no mention of AI or ML technology.
No.
The device is for implantation to provide surgical fixation and stability, not to deliver a therapeutic treatment or effect.
No
The device is a cervical plate system used for fixation in the spine. Its purpose is to provide structural support, not to diagnose medical conditions.
No
The device description explicitly states it consists of bone plates, screws, and associated instruments made from titanium alloy, indicating it is a hardware-based implant system, not software.
No, 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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Transept™ Cervical Plate System is a surgical implant used to fix bones in the cervical spine. It is physically implanted into the patient's body.
- Intended Use: The intended use is for anterior cervical fixation for various spinal conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.
The provided information clearly describes a medical device used in surgery, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Transept™ Cervical Plate System 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
KWQ
Device Description
The Transept™ 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 Transept™ 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 Transept™ Cervical Plate System implant components are made from titanium alloy (Ti-6Al-4V ELI) per 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
The Transept™ Cervical Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717-18
- Static torsion per ASTM F1717-18
- Dynamic compression bending per ASTM F1717-18
The results of this non-clinical testing show that the strength of the Transept™ Cervical Plate System is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K142060, K131374, K120515, K133518, K111796, K150666
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the seal of the Department of Health & Human Services-USA, which features an emblem with a stylized caduceus-like symbol encircled by the department's name. To the right of the seal, there is the FDA logo in blue, with the letters "FDA" stacked above the words "U.S. FOOD & DRUG ADMINISTRATION".
Neurostructures. Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs. Colorado 80918
Re: K200927
Trade/Device Name: Transept™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 25, 2020 Received: June 26, 2020
Dear Mr. Wright:
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/cfpmn/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
July 24, 2020
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 (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,
for
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K200927
Device Name
Transept™ Cervical Plate System
Indications for Use (Describe)
The Transept™ Cervical Plate System 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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov " An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
510(K) SUMMARY
| Submitter's Name: | NeuroStructures, Inc. |
|---|---|
| Submitter's Address: | 199 Technology Drive, Suite 110 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | 800-352-6103 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | April 6, 2020 |
| Trade or Proprietary Name: | Transept™ Cervical Plate System |
| Common or Usual Name: | Spinal intervertebral body fixation orthosis |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Transept™ 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 Transept™ 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 Transept™ Cervical Plate System implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The indications for use for the Transept™ Cervical Plate System are the Transom™ Cervical Plate System (K142060).
INDICATIONS FOR USE
The Transept™ Cervical Plate System 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.
TECHNOLOGICAL CHARACTERISTICS
Transept™ 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
4
devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture o
- Manufacturing processes
- Sterilization method ●
- Structural support mechanism ●
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|------------------|--------------------------------------------|--------------------------|-------------------|
| K142060 | Transom™ Cervical Plate System | NeuroStructures, Inc. | Primary |
| K131374, K120515 | Tempus™ Cervical Plate System | NeuroStructures, Inc. | Additional |
| K133518 | MaxAn® Anterior Cervical Plate
System | Biomet Spine, LLC | Additional |
| K111796 | inViZia® Anterior Cervical Plate
System | Zimmer Spine, Inc. | Additional |
| K150666 | uNion™ Cervical Plate System | Ulrich medical USA, Inc. | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Transept™ Cervical Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717-18
- Static torsion per ASTM F1717-18 ●
- Dynamic compression bending per ASTM F1717-18 .
The results of this non-clinical testing show that the strength of the Transept™ Cervical Plate System is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Transept™ Cervical Plate System is substantially equivalent to the predicate device.