(148 days)
None
No
The summary describes a physical implant and its mechanical properties, with no mention of AI or ML in its design, function, or intended use.
Yes
The device is described as an "Interbody Fusion Device" intended for patients with Degenerative Disc Disease, indicating its use in treating a medical condition and restoring function.
No
The device is an interbody fusion device designed for structural support and bone growth in the lumbosacral spine, used as an adjunct to fusion. It does not perform any diagnostic functions by identifying or detecting a disease or condition.
No
The device description clearly states it is a physical implant made from Ti6Al4V alloy, designed for surgical implantation with screws. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is an implantable interbody fusion device used in spinal surgery. It is a physical structure designed to be placed within the body to aid in bone fusion.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples, nor does it provide diagnostic information about a patient's condition based on such tests. Its function is structural and therapeutic (promoting fusion).
Therefore, the Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
Product codes
OVD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
lumbosacral spine at one or two contiguous disc levels; L2 to S1 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 per the following standards:
ASTMF2077 - Static and dynamic axial compression, and static and dynamic compression shear
ASTM F2267-04 - Subsidence Testing
Expulsion testing per accepted industry standard.
MR Conditional testing listed below is from the primary predicate device, the 4WEB ASTS Anterior Spine Truss System (K170851).
ASTM F2119 - MR Image Artifact
ASTM F2052 - MR Induced Displacement Force
ASTM F2213 – MR Induced Torque
ASTM F2182 – RF-induced Heating
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K170851, K190870, K170157, K173535
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 29, 2020
4WEB, Inc. % Rich Jansen, Pharm. D. Consultant Silver Pine Consulting, LLC 3851 Mossy Oak Drive Ft. Myers, Florida 33905
Re: K200002
Trade/Device Name: Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: April 9, 2020 Received: April 10, 2020
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.
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
1
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 (OS) 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 mediation-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,
Brent Showalter, Ph.D. Acting 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) K200002
Device Name
Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device
Indications for Use (Describe)
The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
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."
3
510(k) Summary
| Date Prepared:
Contact: | May 20, 2020
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: | Anterior Spine Truss System - Stand Alone (ASTS-SA)
Interbody Fusion Device |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3080 |
| Common Name: | Intervertebral Body Fusion Device with Integrated Fixation |
| Product Codes: | OVD |
| Panel Code: | 87 |
Indications for Use:
The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a stand-alone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months 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.
4
Predicate Device(s):
The primary predicate device is the 4WEB Anterior Spine Truss System (K170851). Additional predicates include the 4WEB Cervical Spine Truss System - Stand Alone (K190870), Globus INDEPENDENCE Spacers (K170157), and the Titan Endoskeleton TAS Interbody Fusion Device (K173535).
Performance Standards:
Performance testing has been completed per the following standards: ASTMF2077 - Static and dynamic axial compression, and static and dynamic compression shear ASTM F2267-04 - Subsidence Testing Expulsion testing per accepted industry standard.
MR Conditional testing listed below is from the primary predicate device, the 4WEB ASTS Anterior Spine Truss System (K170851). ASTM F2119 - MR Image Artifact ASTM F2052 - MR Induced Displacement Force ASTM F2213 – MR Induced Torque ASTM F2182 – RF-induced Heating
Technological Characteristics:
4WEB, Inc. has compared these devices 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, Inc. concludes that the ASTS-SA devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.