(160 days)
Not Found
No
The document describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is an intervertebral body fusion device used to promote spinal fusion in patients with degenerative disc disease, which is a therapeutic intervention.
No
The device is described as an implantable system for spinal fusion procedures, specifically intervertebral body fusion devices, rather than a tool used for diagnosis. Its purpose is to facilitate fusion by allowing bone graft packing and providing stability, not to identify or assess a condition.
No
The device description clearly states the device is comprised of physical implants made from Titanium Alloy, including spacers, screws, and barbs. It also describes the physical characteristics and intended use of these hardware components. There is no mention of software as a component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this is a surgical implant (an intervertebral body fusion device) intended for spinal fusion procedures. It is physically implanted into the patient's body to provide structural support and promote bone growth.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical and biological (promoting fusion) within the body.
Therefore, the Stand-Alone ALIF Titanium System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stand-Alone ALIF Tianium System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to allow packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.
The Stand-Alone ALIF Titanium System is intended for use with three titanium alloy screws which are provided with the system. If the physician chooses to use fewer than three of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used. When used with Barbs (Anchors), these devices are intended for use with supplemental fixation (e.g. Pedicle screws or posterior fixation).
Product codes
MAX, OVD
Device Description
The Stand-Alone ALIF Titanium System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6Al-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/ or migration. The anterior face of the spacer has integrated screw holes to allow for placement of three titanium alloy screws that anchor the implant to the adjacent vertebrae. Additionally, the barbs may be inserted through the screw holes in place of screws. The barbs are intended to provide additional stability to the cage but require supplementary fixation, such as pedicle screws. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Stand-Alone ALIF Titanium System components with components from any other system or manufacturer. The components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar and sacral 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
The Stand-Alone ALIF Titanium System was tested according to ASTM F2077-14 which included Static and Dynamic compression Test and Dynamic Compressive Shear and was presented to demonstrate the substantial equivalency to predication.
Key Metrics
Not Found
Predicate Device(s)
Life Spine Dyna-Link Elite System (K180215), Life Spine Stand-Alone Spacer System (K091301), NuVasive BASE Interfixated System (K170592)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 16, 2019
Life Spine, Inc. Angela Batker RA/QA Specialist 13951 S. Quality Drive Huntley, Illinois 60142
Re: K191834
Trade/Device Name: Stand-Alone ALIF Titanium System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: November 14, 2019 Received: November 15, 2019
Dear Angela Batker:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191834
Device Name Stand-Alone ALIF Titanium System
Indications for Use (Describe)
The Stand-Alone ALIF Tianium System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to allow packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.
The Stand-Alone ALIF Titanium System is intended for use with three titanium alloy screws which are provided with the system. If the physician chooses to use fewer than three of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used. When used with Barbs (Anchors), these devices are intended for use with supplemental fixation (e.g. Pedicle screws or posterior fixation).
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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3
510(k) Summary Stand-Alone ALIF Titanium System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | December 16th, 2019 |
| Trade Name: | Stand-Alone ALIF Titanium System |
| Common Name: | Intervertebral body fusion device |
| Classification: | OVD CFR 888.3080, Class II
MAX CFR 888.3080, Class II |
| Primary Predicate: | Life Spine Dyna-Link Elite System (K180215) |
| Additional Predicate: | Life Spine Stand-Alone Spacer System (K091301)
NuVasive BASE Interfixated System (K170592) |
Device Description:
The Stand-Alone ALIF Titanium System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6Al-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/ or migration. The anterior face of the spacer has integrated screw holes to allow for placement of three titanium alloy screws that anchor the implant to the adjacent vertebrae. Additionally, the barbs may be inserted through the screw holes in place of screws. The barbs are intended to provide additional stability to the cage but require supplementary fixation, such as pedicle screws. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Stand-Alone ALIF Titanium System components with components from any other system or manufacturer. The components should never be reused under any circumstances.
4
Intended Use of the Device:
The Stand-Alone ALIF Titanium System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to allow packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.
The Stand-Alone ALIF Titanium System is intended for use with three titanium alloy screws which are provided with the system. If the physician chooses to use fewer than three of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used. When used with Barbs (Anchors), these devices are intended for use with supplemental fixation (e.g. Pedicle screws or posterior fixation).
Technological Characteristics:
The Stand-Alone ALIF Titanium System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. This this is the same material used in the predicate devices NuVasive BASE Interfixated System (K170592).
Performance Data:
The Stand-Alone ALIF Titanium System was tested according to ASTM F2077-14 which included Static and Dynamic compression Test and Dynamic Compressive Shear and was presented to demonstrate the substantial equivalency to predication.
Substantial Equivalence:
The Stand-Alone ALIF Titanium System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of The Stand-Alone ALIF Titanium System.