(192 days)
No
The summary describes a physical implant device and its mechanical testing, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is indicated for treating Degenerative Disc Disease (DDD) and is designed to provide structural support for fusion, which aims to alleviate pain and restore function in patients. These are therapeutic goals.
No
Explanation: The device is an implantable medical device (spinal interbody fusion device) for structural support, not for diagnosing medical conditions.
No
The device description clearly states the device is an implant made from Ti6Al4V alloy, which is a hardware component. The summary also describes mechanical performance studies on the physical device.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Lateral Spine Truss System is a physical implant designed to be surgically placed in the spine (L2-L5) to provide structural support and promote bone fusion in patients with Degenerative Disc Disease. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and biological (promoting fusion).
Therefore, this device falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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 at the involved level(s).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The device is available in a variety of sizes to accommodate the patient's anatomy. The implant is made from Ti6Al4V alloy (ASTM F-1108).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-L5
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)
Validated FEA, comparing the subject device to PLIF STS (K143258), was conducted to evaluate the mechanical performance of the devices under different loading scenarios, including pure compression and combined compression and shear. Other mechanical tests included subsidence per ASTM F2267-04 and expulsion testing per an industry accepted methodology.
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.
K112316, K143258, K083894, K132897
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 is a black and white seal for the Department of Health and Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2016
4WEB. Incorporated % Rich Jansen, Ph.D. Consultant Silver Pine Consulting, LLC. 11821 Bramble Cove Drive Ft. Myers, Florida 33905
Re: K153436
Trade/Device Name: LATERAL Spine Truss System Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MAX Dated: May 9, 2016 Received: May 10, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K153436
Device Name LATERAL Spine Truss System
Indications for Use (Describe)
The Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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 at the involved level(s).
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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510(k) Summary
| Date Prepared: | June 2, 2016 |
|---|---|
| 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: | LATERAL 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 Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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 device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The device is available in a variety of sizes to accommodate the patient's anatomy. The implant is made from Ti6Al4V alloy (ASTM F-1108).
Predicate Device(s):
The 4WEB LATERAL STS is substantially equivalent to the primary predicate, the 4WEB ALIF STS (K112316). Additional predicated devices are the 4WEB PSTS (K143258), 4WEB ALIF STS (K083894), and Medtronic Clydesdale Spinal System (K132897).
Performance Standards:
Validated FEA, comparing the subject device to PLIF STS (K143258), was conducted to evaluate the mechanical performance of the devices under different loading scenarios, including pure
4
compression and combined compression and shear. Other mechanical tests included subsidence per ASTM F2267-04 and expulsion testing per an industry accepted methodology.
Technological Characteristics:
4Web, Inc. has compared the Lateral STS to the 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 these LATERAL STS devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.