(30 days)
No
The summary describes a physical intervertebral body fusion device and its associated instrumentation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML for image processing, diagnosis, treatment planning, or any other function. The performance studies focus on mechanical properties and surface integrity, not algorithmic performance.
Yes.
The device facilitates fusion in the lumbar spine to treat degenerative disc disease, which is a therapeutic function.
No
This device is an intervertebral body fusion device intended to facilitate fusion in the lumbar spine, not to diagnose a condition. It is a surgical implant used for treatment.
No
The device description clearly states that the device is an "intervertebral body fusion device" made from titanium alloy, which is a physical implant. It also mentions associated instrumentation. This is a hardware medical device, not software only.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The text clearly describes the Innovasis® TxTiHA™ IBF System and AxTiHA™ Stand-Alone ALIF System as intervertebral body fusion devices. These are implants designed to be surgically placed in the lumbar spine to facilitate bone fusion.
- Lack of Diagnostic Activity: The intended use and device description do not mention any testing of biological samples or diagnostic procedures. The device's function is mechanical support and facilitation of bone growth, not the detection or diagnosis of a condition through in vitro analysis.
Therefore, the Innovasis® TxTiHA™ IBF System and AxTiHA™ Stand-Alone ALIF System are medical devices (specifically, implants), but they are not IVDs.
N/A
Intended Use / Indications for Use
The Innovasis® TxTiHA™ IBF 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 Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.
This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.
The Innovasis® AxTiHA™ 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 AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD
Device Description
TxTiHA™ IBF System: The TxTiHA system is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implant is an additive manufactured device made from the titanium alloy Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6AI-4V ELI) conforming to the ASTM F3001 specifications and features a Promimic HAM® Surface® ! Implants are available in various lengths, widths, heights, and degrees of lordosis to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth. Implants are supplied sterile. Reusable instruments to support the TLIF surgery are provided with the implants in sterilization trays.
AxTiHA™ Stand-Alone ALIF System: The AxTiHA system is for Anterior Lumbar Interbody Fusion (ALIF). The implants are an additive manufactured device comprised of Ti-6Al-4V ELI per ASTM F3001 and feature a Promimic HA®®® Surface. Implants are available in multiple size options to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth.
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
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
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 per ASTM F2077-17 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Subsidence and Expulsion testing performed on the predicates applies to the modified devices because there is no difference in size, dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite (a naturally occurring substance in the body in the area of the spine and other bone) applied to the surface.
(Non-clinical)—Performance testing performed per Promimic protocol accepted by FDA for the testing of HAN® Surface integrity for the clearance of the reference devices (K190025, Cutting Edge Spine EVOL SI Joint Fusion System) and (K170392, S.I.N Dental Implant System).
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.
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/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2020
Innovasis, Inc. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K201614
Trade/Device Name: TxTiHA™ IBF System, AxTiHA™ Stand-Alone ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: June 12, 2020 Received: June 15, 2020
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. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name TxTiHA™ IBF System
Indications for Use (Describe)
The Innovasis® TxTiHA™ IBF 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 Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.
This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Indications for Use
510(k) Number (if known)
Device Name AxTiHA™ Stand-Alone ALIF System
Indications for Use (Describe)
The Innovasis® AxTiHA™ 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 AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
4
Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and white and features the word "INNOVASIS" in bold, sans-serif font. The letter "V" in the logo is stylized with a line extending upwards and to the right, creating a sense of movement. Below the main logo, the words "INNOVATE / INVOLVE / INVENT" are written in a smaller, sans-serif font.
Special 510(k)
June 12, 2020
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
1. Submitted by:
Marshall C. McCarty Director QA/RA Innovasis, Inc. 614 E 3900 S Salt Lake City, Utah 84107 Telephone: (801) 261-2236
2. Device Information
Device Names: Innovasis® TxTiHA™ IBF System
Innovasis® AxTiHA™ Stand-Alone ALIF System
Common Names:
Intervertebral Fusion Device with Bone Graft (TxTiHA)
Intervertebral Fusion Device with Integrated Fixation, Lumbar (AxTiHA)
Product Code: MAX (TxTiHA); OVD (AxTiHA) Classification Name: Intervertebral body fusion device (21 CFR 888.3080) Review Panel: 87 - Orthopedic Devices (OHT6) Regulatory Class: Class II
3. Predicate Devices
Primary Predicate Devices:
K183064 - Innovasis TxTi'M IBF System Add'I Predicate Devices:
K182139 – Innovasis AXTi™ Titanium Stand-Alone ALIF System Reference Devices:
K190025 - Cutting Edge Spine EVOL® - SI Joint Fusion System
K170392 – S.I.N Dental Implant System
K101225 – Promimic Dental Implant
4. Indications for Use
TxTiHA™ IBF System
The Innovasis® TxTiHA™ IBF 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 Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The implant is intended to be packed with autograft.
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Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is black and white and features the word "INNOVASIS" in bold letters. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in smaller letters.
Special 510(k) June 12, 2020
AxTiHA™ Stand-Alone ALIF System
The Innovasis® AxTiHA™ 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 AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
5. Device Description
TxTiHA™ IBF System
The TxTiHA system is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implant is an additive manufactured device made from the titanium alloy Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6AI-4V ELI) conforming to the ASTM F3001 specifications and features a Promimic HAM® Surface® ! Implants are available in various lengths, widths, heights, and degrees of lordosis to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth. Implants are supplied sterile. Reusable instruments to support the TLIF surgery are provided with the implants in sterilization trays.
AxTiHA™ Stand-Alone ALIF System
The AxTiHA system is for Anterior Lumbar Interbody Fusion (ALIF). The implants are an additive manufactured device comprised of Ti-6Al-4V ELI per ASTM F3001 and feature a Promimic HA®®® Surface. Implants are available in multiple size options to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth.
6. Intended Use
TxTiHA™ IBF System
The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
1 HAmano is a registered trademark of Promimic AB, Mölndal Sweden
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Image /page/6/Picture/1 description: The image shows the logo for Innovasis. The logo is black and white and features the word "INNOVASIS" in bold, sans-serif font. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller, sans-serif font. The logo is simple and modern.
Special 510(k)
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
AxTiHA™ Stand-Alone ALIF System
The Innovasis AxTiHA Titanium Stand-Alone ALIF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
7. Technological Characteristics
Innovasis has leveraged 3D printing techniques to develop Patent-Pending Tetracell™ Technology. Tetracell is a titanium, open-cellular matrix of tetrahedrons providing:
- . Large inner volume for graft material.
- o TxTiHA has up to 28% more graft volume than a traditional implant
- o AxTiHA has up to 41% more graft volume than a traditional implant
- Micro-textured surface geometry ●
- Large endplate contact surface area to distribute compressive loads ●
- Tetracell™ structure reduces the radiographic signature ●
- HAnano Surface2 ●
8. Performance Data
Performance testing per ASTM F2077-17 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Subsidence and Expulsion testing performed on the predicates applies to the modified devices because there is no difference in size, dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite (a naturally occurring substance in the body in the area of the spine and other bone) applied to the surface.
(Non-clinical)—Performance testing performed per Promimic protocol accepted by FDA for the testing of HAN® Surface integrity for the clearance of the reference devices (K190025, Cutting Edge Spine EVOL SI Joint Fusion System) and (K170392, S.I.N Dental Implant System).
9. Conclusions
The subject TxTiHA IBF System and AxTiHA Stand-Alone ALIF System have been shown to be substantially equivalent to legally marketed predicate devices for their intended uses.
2 Promimic AB, Mölndal Sweden