(50 days)
Not Found
No
The summary describes a physical interbody fusion device with a specific design and material. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interbody fusion device indicated for use in patients with Degenerative Disc Disease, providing mechanical support to the spine and aiding in biologic fusion. This classifies it as a therapeutic device.
No
The device is an implant designed to provide mechanical support and promote fusion, not to diagnose a condition.
No
The device description explicitly states it is a titanium implant designed to provide mechanical support, indicating it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to provide mechanical support and facilitate bone fusion in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a titanium implant with a specific design for spinal support and bone growth. This aligns with a surgical implant, not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
The device is a spinal implant used in surgical procedures, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ALIF STS Interbody Fusion Device is indicated for use 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 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).
The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment with the devices. The devices. The device should be used with supplemental fixation.
The ALIF STS and Cervical STS have the same intended use as the predicate devices of the same name. The only change is that the product is being offered pre-packaged and sterile.
Product codes
MAX, ODP
Device Description
The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. 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 three basic "footprint" sizes, small, medium and large. These sizes are available in 6 and 12 degree lordosis and each of these in 9 heights ranging from 8mm to 16mm in 1mm increments.
The Cervical STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. 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 two basic "footprint" sizes, 17mm x 14mm x 11mm. These sizes are available in zero and 7 degree lordosis and each of these in 8 heights ranging from 5mm to 12mm in 1mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1), cervical spine (C-3 to C-7)
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 includes: Gamma sterilization per ANSI/AAMI/ISO 11137-2 Packaging per ISO 11607-1 Package integrity tests per ASTM F88-09, ASTM F1886-09 and ASTM F1929-12 Shipping performance per ASTM D4169-09 Shelf life tests per ASTM F1980-07
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/1 description: The image is a black and white 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 it. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2014
4Web. Incorporated % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905
Re: K142112
Trade/Device Name: 4Web Spinal Implant Products Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 21, 2014 Received: August 25, 2014
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 - Rich Jansen, Pharm.D.
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" (21 CFR 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.
RonaldFBAJean -S for
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) K142112
Device Name 4Web Spinal Implant Products
Indications for Use (Describe)
The ALIF STS Interbody Fusion Device is indicated for use 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 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).
The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment with the devices. The devices. The device should be used with supplemental fixation.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 K142112
| Date Prepared: | September 22, 2014 |
|---|---|
| Submitter | Jessee Hunt, President |
| 4Web, Inc. | |
| 6170 Research Rd. Suite 219 | |
| Frisco, TX 75033 | |
| Phone: (800) 285-7090 | |
| Fax: 972-488-1816 | |
| Device: | 4Web Spinal Implant Products |
Product Class: Class II Classification: 21 CFR §888.3080 Intervertebral Body Fusion Device Common Name:Interbody Fusion Device Product Codes: MAX, ODP Panel Code: 87
Purpose: The purpose of this submission is to gain clearance of previously cleared devices as sterile, packaged products.
Predicate Device(s):
The 4Web Spinal Implant Products is substantially equivalent to the previously cleared 4Web Spinal Implant Products, ALIF STS (K112316) and the Cervical STS (K121741). Each device is the primary predicate device for the respective proposed change.
Device Description:
The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. 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 three basic "footprint" sizes, small, medium and large. These sizes are available in 6 and 12 degree lordosis and each of these in 9 heights ranging from 8mm to 16mm in 1mm increments.
The Cervical STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. 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.
4
The device is available in two basic "footprint" sizes, 17mm x 14mm x 11mm. These sizes are available in zero and 7 degree lordosis and each of these in 8 heights ranging from 5mm to 12mm in 1mm increments.
Indications for Use:
The ALIF STS Interbody Fusion Device is indicated for use 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 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).
The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.
Intended Use:
The ALIF STS and Cervical STS have the same intended use as the predicate devices of the same name. The only change is that the product is being offered pre-packaged and sterile.
Performance Standards:
Performance testing includes: Gamma sterilization per ANSI/AAMI/ISO 11137-2 Packaging per ISO 11607-1 Package integrity tests per ASTM F88-09, ASTM F1886-09 and ASTM F1929-12 Shipping performance per ASTM D4169-09 Shelf life tests per ASTM F1980-07
Conclusion:
4Web, Inc concludes that these Spinal Implant Products are substantially equivalent to the previously cleared 4Web Spinal Implant Products. The packaging and sterilization processes have been properly validated and raise no new questions of safety or effectiveness.