(254 days)
No
The document describes a physical medical implant (intervertebral body fusion device) and its mechanical properties and intended use. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes.
The device is an intervertebral body fusion device used to facilitate fusion in the lumbar spine for patients with degenerative disc disease, which is a condition treated in healthcare.
No
The device is an intervertebral body fusion device and is used for treatment, not diagnosis. It's an implant to facilitate fusion in the lumbar spine.
No
The device description clearly outlines a physical implant (intervertebral body fusion device) made of HA PEEK or titanium, including screws, a locking mechanism, and instruments. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Innovasis Ax Stand-Alone ALIF System is an implantable medical device designed to be surgically placed in the lumbar spine to facilitate fusion. It is a physical device, not a test performed on a sample.
- Intended Use: The intended use is to treat degenerative disc disease by providing structural support and promoting bone fusion in the spine. This is a therapeutic intervention, not a diagnostic test.
The description clearly indicates a surgical implant used for treatment, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Innovasis Ax Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The Ax Stand-Alone interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
Product codes
OVD
Device Description
The Innovasis Ax Stand-Alone ALIF implant will be provided in two configurations. The first is an HA PEEK caqe with an integrated titanium faceplate. The second is an all titanium version of the same implant. Both designs will feature screws, a locking mechanism, and instruments. The implant is a stand-alone anterior intervertebral body fusion device indicated for use in patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
The interior of the device will be packed with autograft.
Intended to support restoration of the sagittal balance.
It is intended to be used with bone screws and will not require additional supplementary fixation for implants with a lordotic angle less than 20°.
Implants with a lordotic angle ≥20° are indicated for use with supplementary fixation, such as the Excella Spinal System.
It is intended for use with the standard anterior approach
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Prescription Use
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
Non-clinical—Performance testing per ASTM F2077-14 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence, Expulsion and side by side antibackout testing indicates that the Ax Stand-Alone ALIF is substantially equivalent to the predicates.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2017
Innovasis, Inc. Marshall McCarty Director OA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K162236
Trade/Device Name: Ax™ Stand-Alone ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 8, 2017 Received: March 21, 2017
Dear Mr. McCarty:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K162236
Device Name AxTM Stand-Alone ALIF System
Indications for Use (Describe)
The Innovasis Ax Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The Ax Stand-Alone interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is black and white and features the word "INNOVASIS" in large, bold letters. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in smaller letters. The logo is simple and modern.
510(k) Summary Report: 4.0
K162236 Page 1 of 3
Ax™ Stand-Alone ALIF System
Company: Innovasis, Inc. 614 E. 3900 South Salt Lake City, UT 84107
- Marshall C. McCarty Contact: Phone: (801) 261-2236 mmccarty@innovasis.com
- Trade Name: Ax™ Stand-Alone ALIF System
Common Name: Intervertebral fusion device with bone graft
- Classification: Requlation No.: 21CFR 888.3080 Class 2 Product Code: OVD Review Panel: Division of Orthopedic Devices (DOD) - Anterior Spine Devices Branch (ASDB)
- Integra Vu a•POD™ Prime System Primary Predicate: K121211 (SeaSpine has separated from Integra and now owns this product line.) This predicate has not been subject to a design-related recall.
Additional Predicates:
Nuvasive® Brigade™ Hyperlordotic Implant System K123045 Innovasis® Px HA™ PEEK IBF System K151785
- Device Description: The Innovasis Ax Stand-Alone ALIF implant will be provided in two configurations. The first is an HA PEEK caqe with an integrated titanium faceplate. The second is an all titanium version of the same implant. Both designs will feature screws, a locking mechanism, and instruments. The implant is a stand-alone anterior intervertebral body fusion device indicated for use in patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
- The interior of the device will be packed with autograft.
- Intended to support restoration of the sagittal balance.
- It is intended to be used with bone screws and will not require additional supplementary fixation for implants with a lordotic angle less than 20°.
- Implants with a lordotic angle ≥20° are indicated for use with supplementary fixation, such as the Excella Spinal System.
- It is intended for use with the standard anterior approach
4
Image /page/4/Picture/21 description: The image shows the word "INNOVASIS" in a bold, sans-serif font. The letter "A" in the word is stylized with a diagonal line extending upwards and to the right, creating a dynamic and modern look. The overall design is clean and professional, suggesting a company or brand focused on innovation.
April 18, 2017
K162236 Page 2 of 3
Performance Data: (Non-clinical)—Performance testing per ASTM F2077-14 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence, Expulsion and side by side antibackout testing indicates that the Ax Stand-Alone ALIF is substantially equivalent to the predicates.
Materials: Implants
- *Invibio® PEEK-OPTIMA® HA Enhanced . Polyetheretherketone with hydroxyapatite for surgical implant
- Unalloyed Tantalum per ASTM F560 ●
- . Titanium-6-Aluminum-4-Vanadium ELI (Extra Low Interstitial) Allov
Instruments
- 465 Stainless Steel per ASTM F899 ●
- 17-4 Stainless Steel per ASTM F899 ●
- Silicone Handles (Tested for biocompatibility)
- o Radel Handle per ASTM D6394
Sterilization Trays
- Anodized 5052 Aluminum ●
- Polvpropylene ●
- Radel
*Invibio and PEEK-OPTIMA® are registered trademarks of Invibio Limited. All rights reserved.
Indications for Use: The Innovasis Ax Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The Ax Stand-Alone interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
5
Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo is simple and modern.
April 18, 2017
Basis for Substantial Equivalence:
K162236 Page 3 of 3
The Ax Stand-Alone ALIF System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate device, K121211 Integra Vu a•POD, and reference devices, K151785 Innovasis Px HA PEEK IBF System and K123045 NuVasive Brigade HL.
- -Materials (biocompatibility profile and processing) are substantially equivalent to predicate device.
- -Technology is substantially equivalent to predicate device.
- Design is substantially equivalent to predicate device. -
- -Sizes are substantially equivalent to predicate device.
- Bone graft window/cavity is substantially equivalent to predicate device.
- -Mechanical strength is substantially equivalent to predicate device.
- -Indications for use are substantially equivalent to predicate device.
Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the leqally marketed predicate device.