(91 days)
Not Found
No
The summary describes a physical implant and its mechanical properties, with no mention of AI/ML in its design, function, or intended use.
Yes
The device is described as an "Interbody Fusion Device" indicated for degenerative disc disease to provide structural support and promote fusion in the cervical spine, which directly treats a medical condition.
No
This device is an interbody fusion device, indicated for treating Degenerative Disc Disease by promoting fusion in the cervical spine. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an implant made from Ti6Al4V alloy, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is an implantable medical device designed to provide structural support and promote fusion in the cervical spine. It is surgically placed within the body.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose or monitor a condition. Its function is entirely therapeutic and structural.
Therefore, the Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with deqeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. When using the CTST-SA interbody with fixation anchors, the device must be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws or fixation anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
cervical spine at one level or two contiguous disc levels, C2 to T1 disc levels
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has been completed on the CSTS-SA implants per the following standards:
- . ASTM F2077 – Static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion testing
- . ASTM F-04.25.02.02 - Expulsion testing
- ASTM F2267 - Subsidence testing
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 2, 2023
4WEB Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, Florida 33905
Re: K223362
Trade/Device Name: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: December 13, 2022 Received: December 14, 2022
Dear Richard Jansen:
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.
1
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 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.
Katherine D. Kavlock -S
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223362
Device Name
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
Indications for Use (Describe)
The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with deqeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. When using the CTST-SA interbody with fixation anchors, the device must be used with supplemental fixation.
| 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) |
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3
510(k) Summary
| Date Prepared: | February 2, 2023 |
|---|---|
| Contact: | Jessee Hunt, President |
| 4WEB, Inc. | |
| 2801 Network Blvd., Suite 620 | |
| Frisco, TX 75034 | |
| Phone: (800) 285-7090 | |
| Fax: 972-488-1816 | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC | |
| richj@s-pineconsulting.com | |
| Trade Name: | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3080 |
| Common Name: | Intervertebral Body Fusion Device |
| Product Codes: | OVE |
| Panel Code: | 87 |
Purpose:
The purpose of this submission is to update the Cervical Spine Truss System – Stand Alone (CSTS-SA) implant offering with the addition of fixation anchors.
Indications for Use:
The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. When using the CTST-SA interbody with fixation anchors, the device must be used with supplemental fixation.
Device Description:
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's
4
anatomy. Screws or fixation anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
Predicate Device(s):
The primary predicate device is the 4WEB Medical Cervical Spine Truss System – Stand Alone (K190870). Additional predicates for this submission is the 4WEB Medical Cervical Spine Truss System (K173159) and the 4WEB Medical Lateral Spine Truss System – Plating Solution (K203065).
Performance Standards:
Performance testing has been completed on the CSTS-SA implants per the following standards:
- . ASTM F2077 – Static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion testing
- . ASTM F-04.25.02.02 - Expulsion testing
- ASTM F2267 - Subsidence testing
Technological Characteristics:
4WEB, Inc. has compared these devices to the previously cleared predicate devices regarding indications for use, materials, function, sizes and testing. These comparisons demonstrate substantial equivalence to the predicate devices.
Conclusion:
4WEB, Inc. concludes that the CSTS-SA device is substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.