(91 days)
No
The document describes a physical intervertebral body fusion device made of PEEK material with hydroxyapatite. There is no mention of software, algorithms, or any computational processing that would involve AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
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 therapeutic intervention aimed at treating a medical condition.
No
The device is an intervertebral body fusion device intended to facilitate fusion in the lumbar spine, not to diagnose a condition.
No
The device description clearly details a physical implant made of PEEK material and associated reusable instruments, indicating it 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 or tissue, to detect diseases, conditions, or infections.
- Device description: The Innovasis® LxHA™ PEEK Lateral IBF is an implantable 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 text clearly describes a surgical implant used for treatment, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Innovasis® LxHA™ PEEK Lateral IBF 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 using a lateral approach.
This device is intended to be used with internal spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant device is intended to be packed with autograft.
Product codes
MAX
Device Description
The LxHA PEEK Lateral IBF System is Innovasis' next generation intervertebral body fusion device with associated instrumentation for use in Lateral Lumbar Interbody Fusion (LLIF) surgeries. The L-Box IBF was initially submitted to FDA under K121581 in September 2012 and was cleared for sale in the USA on October 17, 2012.
The LxHA implants will be manufactured using Invibio PEEK-Optima HA Enhanced. In this material, hydroxyapatite (HA) is integrated with Invibio's PEEK-OPTIMA Natural. The LxHA implants will be manufactured using HA PEEK and are to be sold sterile.
The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients, including 0°, 8°, 12°, and 16° of lordosis. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support LLIF surgeries are provided with the implants in sterilization trays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
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 Data: (Non-clinical)—Performance testing per ASTM F2077-18 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion indicates that the LxHA PEEK Lateral IBF is capable of performing in accordance with its intended use. Testing included simulated aging performed on LxHA PEEK Lateral IBF devices, which then were subjected to testing in accordance with ASTM F2077. The subject LxHA device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal 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.
Innovasis, Inc. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K190684
Trade/Device Name: LxHA™ PEEK Lateral IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 21, 2019 Received: May 22, 2019
Dear Marshall 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 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
June 17, 2019
1
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 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.
for Melissa Hall Assistant Director 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) K190684
Device Name LxHA™ PEEK Lateral IBF System
Indications for Use (Describe)
The Innovasis® LxHA™ PEEK Lateral IBF 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 using a lateral approach.
This device is intended to be used with internal spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant device is intended to be packed with autograft.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/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 "INNOVASIS" is the tagline "INNOVATE / INVOLVE / INVENT". The logo is simple and modern.
510(k) Summary:
LxHA™ PEEK Lateral IBF System
| Company: | Innovasis, Inc.
614 E. 3900 South
Salt Lake City, UT 84107 |
| ---------- | ------------------------------------------------------------------ |
|---|
- Marshall C. McCarty Contact: Phone: (801) 261-2236 x8012 mmccarty@innovasis.com
Trade Name: LxHATM PEEK Lateral IBF System
Common Name: Intervertebral Fusion Device With Bone Graft, Lumbar
- Classification: Requlation No.: 21CFR 888.3080 Class 2 Product Code: MAX Review Panel: 87 - Orthopedic
- Primary Predicate: K121581 Innovasis Box PEEK IBF System This predicate has not been subject to a design-related recall.
Additional Predicate:
| K180078 | Innovasis Px HA® PEEK IBF System |
|---|---|
| --------- | ---------------------------------- |
Reference Device:
| K170395 Meditech Spine Talos®-L (HA) Lumbar PEEK
| Interbody Device |
|---|
| K133455 Pioneer Surgical Technology (RTI Surgical) |
| CrossFuse II IBFD (Labeling Recall Z-1916-2015) |
Device Description:
The LxHA PEEK Lateral IBF System is Innovasis' next generation intervertebral body fusion device with associated instrumentation for use in Lateral Lumbar Interbody Fusion (LLIF) surgeries. The L-Box IBF was initially submitted to FDA under K121581 in September 2012 and was cleared for sale in the USA on October 17, 2012.
The LxHA implants will be manufactured using Invibio PEEK-Optima HA Enhanced. In this material, hydroxyapatite (HA) is integrated with Invibio's PEEK-OPTIMA Natural. The LxHA implants will be manufactured using HA PEEK and are to be sold sterile.
4
Image /page/4/Picture/1 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in a bold, sans-serif font. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller, sans-serif font. The logo is simple and modern, and the use of black gives it a sense of sophistication.
The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients, including 0°, 8°, 12°, and 16° of lordosis. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support LLIF surgeries are provided with the implants in sterilization trays. Performance Data: (Non-clinical)—Performance testing per ASTM F2077-18 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion indicates that the LxHA PEEK Lateral IBF is capable of performing in accordance with its intended use. Testing included simulated aging performed on LxHA PEEK Lateral IBF devices, which then were subjected to testing in accordance with ASTM F2077. The subject LxHA device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions. The LxHA implants are machined from Invibio® PEEK-OPTIMA® Materials: HA Enhanced* polyetheretherketone with hydroxyapatite. The radiographic markers meet ASTM F560 for unalloved Tantalum and ASTM F136 for Ti 6Al 4V ELI respectively. HA is a naturally occurring mineral in bone and is widely used in the orthopedic field. The LxHA instruments/accessories are machined from Surgical Stainless Steel per ASTM F899 and Titanium 6Al-4V ELI per ASTM F136, and have medical grade Silicone handles. The LxHA sterilization trays are comprised of Anodized 5052 Aluminum and have components made of Nylon, Stainless Steel, Polypropylene, and RADEL per ASTM D6394 SP031. Intended Use: The LxHA PEEK Lateral 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. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
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Image /page/5/Picture/1 description: The image shows the logo for Innovasis. The logo is black and consists of the word "INNOVASIS" in all caps, with the letter "V" stylized to include a sharp, angled line extending upwards. Below the main logo, there is a tagline that reads "INNOVATE / INVOLVE / INVENT" in a smaller font size.
Indications for Use: The Innovasis® LxHA™ PEEK Lateral IBF 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 using a lateral approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant device is intended to be packed with autograft.
Comparison of Technological Characteristics with the Predicate Devices:
The LxHA PEEK Lateral IBF 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 devices, K121581 Innovasis Box PEEK IBF System and K180078 Innovasis Px HA® PEEK IBF System.
- Technology is substantially equivalent. —
- -Design is substantially equivalent.
- Sizes are substantially equivalent. —
- -Mechanical strength is substantially equivalent.
- Indications for use are substantially equivalent. —
- Bone graft window/cavity is substantially equivalent. -
- Materials (biocompatibility profile) are substantially equivalent.
- Conclusion: The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices.