(97 days)
No
The summary describes a physical intervertebral body fusion device made of PEEK material, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to treat degenerative disc disease and facilitate fusion in the lumbar spine, which are medical conditions, thus making it a therapeutic device.
No
Explanation: The provided text describes the Innovasis PEEK IBF System as an intervertebral body fusion device and implant used to facilitate spinal fusion in patients with degenerative disc disease. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is an intervertebral body fusion device made of PEEK material with associated instrumentation, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intervertebral body fusion device" used in surgical procedures to facilitate fusion in the lumbar spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics of the implant (material, shape, features) and the associated surgical instruments. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of providing information about a patient's health status or disease state based on in vitro analysis.
In vitro diagnostics are devices used to perform tests on samples taken from the human body to detect diseases, conditions, or infections. This device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
The Innovasis PEEK IBF System (Px, Px HA and TxHA) 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 level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Innovasis TxHA PEEK IBF Spinal System is a line extension of the Px Posterior Spinal IBF System, an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The Px IBF was submitted to FDA under K150500 in February 2015, and was cleared for sale in the USA on June 19, 2015. The Px HA design manufactured using Invibio® PEEK-Optima® HA Enhanced was cleared under K151785 on October 14, 2015. In this material, hydroxyapatite (HA), is integrated with Invibio's PEEK-OPTIMA Natural.
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 have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support PLIF/TLIF surgeries are provided with the implants in sterilization trays.
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)
(Non-clinical)—Performance testing per ASTM F2077-14 and Performance Data: F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion indicates that the Px, Px HA, TxHA PEEK IBF is capable of performing in accordance with its intended use. Testing included simulated aging performed on Px HA PEEK IBF and TxHA PEEK IBF Devices, which then were subjected to testing in accordance with ASTM F2077.
The Px/Px HA PEEK IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards on new and artificially aged devices and the worst-case size has been demonstrated to be substantially equivalent to the predicate device, K151785 and K150500 when tested singly (not in pairs).
The TxHA PEEK IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards on new and artificially aged devices and has been shown to be substantially equivalent to the predicate device, K151785 Innovasis Px HA PEEK IBF System.
The technological characteristics were found to be substantially equivalent in terms of design, sizes, materials (biocompatibility profile and processing), and mechanical strength.
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.
K151785, K143740, K150500, K171633, K171519
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.
Not Found
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
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April 17, 2018
Innovasis, Inc. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K180078
Trade/Device Name: Px® PEEK IBF System, Px HA® PEEK IBF System, TxHA™ PEEK IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 16, 2018 Received: March 19, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S 2018.04.17 14:12:14 -04'00'
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) K180078
Device Name
Px® PEEK IBF System, Px HA® PEEK IBF System, TxHA™ PEEK IBF System
Indications for Use (Describe)
The Innovasis PEEK IBF System (Px, Px HA and TxHA) 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 level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) 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.
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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Image /page/3/Picture/1 description: The image shows the logo for Innovasis. The logo is in black and white and features the word "INNOVASIS" in bold letters. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in smaller letters.
5.0 510(k) Summary Report:
Px®/Px HA®/TxHA™ PEEK IBF 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: Px® PEEK IBF System Px HA® PEEK IBF System TxHA™ PEEK IBF System
- Common Name: Intervertebral fusion device with bone graft
- Classification: Regulation No.: 21CFR 888.3080 Class 2 Product Code: MAX Review Panel: Orthopedic PSDB
Innovasis Px HA® PEEK IBF System Primary Predicate Device: K151785 This predicate has not been subject to a design-related recall.
Additional Predicates:
| K143740 | Alphatec Battalion Universal Spacer System |
|---|---|
| K150500 | Innovasis Px PEEK IBF System |
| K171633 | NuVasive TLX Interbody System |
| K171519 | EOI FLXfit™ 15 |
Device Description:
The Innovasis TxHA PEEK IBF Spinal System is a line extension of the Px Posterior Spinal IBF System, an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The Px IBF was submitted to FDA under K150500 in February 2015, and was cleared for sale in the USA on June 19, 2015. The Px HA design manufactured using Invibio® PEEK-Optima® HA Enhanced was cleared under K151785 on October 14, 2015. In this material, hydroxyapatite (HA), is integrated with Invibio's PEEK-OPTIMA Natural.
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K180078 - Page 2 of 3
Image /page/4/Picture/1 description: The image shows the logo for Innovasis. The logo is in black and white and features the word "INNOVASIS" in bold, sans-serif font. Below the word "INNOVASIS" is the tagline "INNOVATE / INVOLVE / INVENT" in a smaller font. The letter "V" in Innovasis is stylized with a line extending upwards from the right side of the letter.
Px®/Px HA®/TxHA™ PEEK IBF
510(k)
April 16, 2018
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 have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support PLIF/TLIF surgeries are provided with the implants in sterilization trays.
(Non-clinical)—Performance testing per ASTM F2077-14 and Performance Data: F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion indicates that the Px, Px HA, TxHA PEEK IBF is capable of performing in accordance with its intended use. Testing included simulated aging performed on Px HA PEEK IBF and TxHA PEEK IBF Devices, which then were subjected to testing in accordance with ASTM F2077.
The Px implants are machined from medical grade Solvay Zeniva Materials: ZA-500 or Evonik VESTAKEEP i4R PEEK. The Px HA and TxHA implants are machined from Invibio® PEEK-OPTIMA® HA Enhanced* polyetheretherketone with hydroxyapatite. The radiographic markers meet ASTM F560 for unalloyed Tantalum. HA is a naturally occurring mineral in bone and is widely used in the orthopedic field.
Intended Use: The Innovasis PEEK IBF System (Px, Px HA and TxHA) 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.
*Invibio® and PEEK-OPTIMA® are registered trademarks of Invibio Limited. All rights reserved.
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April 16. 2018
Indications for Use: The Innovasis PEEK IBF System (Px, Px HA and TxHA) 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 level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) 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 is intended to be packed with autograft.
Basis for Substantial Equivalence:
The Px/Px HA PEEK IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards on new and artificially aged devices and the worst-case size has been demonstrated to be substantially equivalent to the predicate device, K151785 and K150500 when tested singly (not in pairs).
The TxHA PEEK IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards on new and artificially aged devices and has been shown to be substantially equivalent to the predicate device, K151785 Innovasis Px HA PEEK IBF System.
The technological characteristics were found to be substantially equivalent in terms of design, sizes, materials (biocompatibility profile and processing), and mechanical strength.
- Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device.