(131 days)
The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device 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 which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. 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 with the devices.
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 are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
The provided text is a 510(k) summary from the FDA for a medical device called the Cervical Spinal Truss System-Stand Alone (CSTS-SA). It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove performance against specific acceptance criteria for an AI/software device.
Therefore, many of the requested categories for AI/software device studies are not applicable or cannot be extracted from this document, as this is a hardware device submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the typical sense for an AI/software device (e.g., sensitivity, specificity, AUC thresholds). Instead, it refers to performance standards for a physical medical implant.
| Acceptance Criteria (Performance Standards) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F2077 (Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion) | Testing completed per standard |
| ASTM F2267-04 (Subsidence Testing) | Testing completed per standard |
| Expulsion testing | Testing completed per accepted industry standard |
| MR Conditional testing (from predicate K173159): | |
| ASTM F2119 (MR Image Artifact) | Testing completed per standard |
| ASTM F2052 (MR Induced Displacement Force) | Testing completed per standard |
| ASTM F2213 (MR Induced Torque) | Testing completed per standard |
| ASTM F2182 (RF-induced Heating) | Testing completed per standard |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The "test set" would refer to the physical devices tested according to the ASTM standards. The document doesn't provide details on the number of devices or units tested for each standard. Data provenance is not relevant in the context of device mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in this context, would be the physical properties and structural integrity of the device, established through standardized engineering tests, not expert human review of data.
4. Adjudication method for the test set
Not applicable. Testing is based on objective measurements against engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical interbody fusion device, not an AI/software product that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by the specified ASTM and industry standards for mechanical and MR conditional testing. Compliance with these standards indicates the device performs as expected for its intended physical function.
8. The sample size for the training set
Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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4Web, Inc. % Dr. Rich Jansen Consultant Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers, Florida 33905
Re: K190870
Trade/Device Name: Cervical Spinal Truss System-Stand Alone (CSTS-SA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 11, 2019 Received: July 15, 2019
Dear Dr. 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.
August 12, 2019
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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.
for Melissa Hall 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
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Indications for Use
510(k) Number (if known) K190870
Device Name
Cervical Spine Truss System-Stand Alone (CSTS-SA)
Indications for Use (Describe)
The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device 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 which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. 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 with the devices.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared: | April 2, 2019 |
|---|---|
| Contact: | Jessee Hunt, President4WEB, Inc.2801 Network Blvd., Suite 620Frisco, TX 75034Phone: (800) 285-7090Fax: 972-488-1816 |
| Regulatory Contact: | Rich Jansen, Pharm. D.Silver Pine Consulting, LLCrichj@s-pineconsulting.com |
| Trade Name: | Cervical Spine Truss System-Stand Alone (CSTS-SA) |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3080 |
| Common Name: | Intervertebral Body Fusion Device |
| Product Codes: | OVE |
| Panel Code: | 87 |
Indications for Use:
The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device 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 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.
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 are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
Predicate Device(s):
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K190870 Page 2 of 2
The primary predicate device is the 4WEB CSTS (K173159). Additional predicates include the Spinal USA Vault-C Standalone Cervical Interbody Fusion System (K132029) and the Globus Medical Coalition Spacers (K151939).
Performance Standards:
Performance testing has been completed per the following standards: ASTMF2077 - Static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion ASTM F2267-04 - Subsidence Testing Expulsion testing per accepted industry standard.
MR Conditional testing listed below is from the primary predicate device, the 4WEB CSTS Cervical Spine Truss System (K173159). ASTM F2119 — MR Image Artifact ASTM F2052 - MR Induced Displacement Force ASTM F2213 - MR Induced Torque ASTM F2182 - RF-induced Heating
Technological Characteristics:
4Web Medical, Inc. has compared this device to the previously cleared predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.
Conclusion:
4WEB Medical, Inc. concludes that the CSTS-SA is substantially equivalent to the predicate devices.
§ 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.