(147 days)
Not Found
No
The summary describes a mechanical spinal implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a Spine Truss System intended for use in patients with Degenerative Disc Disease, designed to provide mechanical support to the spine while biological fusion occurs, which directly addresses a medical condition and aims to improve patient health.
No
The device is described as an implant designed to provide mechanical support to the spine for fusion, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device consists of "a series of titanium implants" and is made from "Ti6Al4V alloy," indicating it is a physical hardware device, not software only.
No, 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, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The description clearly states that the 4WEB PLIF STS, TLIF STS, and OLIF STS are "titanium implants that are designed to provide mechanical support to the spine while biologic fusion occurs." These are surgically implanted devices that remain within the body.
- Intended Use: The intended use is for treating Degenerative Disc Disease by providing structural support and facilitating bone fusion in the spine. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) consists of a series of titanium implants that are designed to provide mechanical support to the spine while biologic fusion occurs. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy. The device is available in multiple sizes to accommodate varied patient's anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (spine)
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)
Preclinical testing performed on the 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) included static axial compression, static compression shear, dynamic axial compression, and dynamic compressive shear mechanical testing per ASTM F2077. The other mechanical test included subsidence per ASTM F2267-04 as well as expulsion testing to demonstrate substantial equivalence.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
4WEB, Incorporated % Richard Jansen, Pharm. D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Ft. Myers, Florida 33905
Re: K143258
Trade/Device Name: PLIF STS, TLIF STS and OLIF STS (Spine Truss System) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 6, 2015 Received: March 9, 2015
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. 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 - Dr. Richard Jansen
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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143258
Device Name PLIF STS, TLIF STS and OLIF STS (Spine Truss System)
Indications for Use (Describe)
The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
K143258 510(k) Summary
| Date Prepared: | April 4, 2015 |
|---|---|
| Contact: | Jessee Hunt, President |
| 4WEB, Inc. | |
| 6170 Research Rd. Suite 219 | |
| Frisco, TX 75033 | |
| Phone: (800) 285-7090 | |
| Fax: 972-488-1816 | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC | |
| richj@s-pineconsulting.com | |
| Trade Name: | PLIF STS, TLIF STS and OLIF STS (Spine Truss System) |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3080 |
| Common Name: | Intervertebral Body Fusion Device |
| Product Codes: | MAX |
| Panel Code: | 87 |
Indications for Use:
The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from 12-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Device Description:
The 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) consists of a series of titanium implants that are designed to provide mechanical support to the spine while biologic fusion occurs. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy. The device is available in multiple sizes to accommodate varied patient's anatomy.
4
Predicate Device(s):
The 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) is substantially equivalent to the Primary Predicate, the 4WEB ALIF STS (K112316). Additional predicates include the K2M Aleutian (K133614) and the Orthofix Forza (K103111).
Performance Standards:
Preclinical testing performed on the 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) included static axial compression, static compression shear, dynamic axial compression, and dynamic compressive shear mechanical testing per ASTM F2077. The other mechanical test included subsidence per ASTM F2267-04 as well as expulsion testing to demonstrate substantial equivalence.
Technological Characteristics
The 4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System) is exactly the same as the primary predicate device in Indications for Use, materials, manufacturing and design. It is substantially equivalent to the additional predicate devices in sizes, surgical approaches risks.
Conclusion:
4WEB, Inc. concludes that the PLIF STS, TLIF STS and OLIF STS (Spine Truss System) devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.