(113 days)
P960025 Jaguar IF / Brantigan Cage
No
The summary describes a physical implant device and surgical instruments, 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 treat degenerative disc disease and facilitate fusion in the lumbar spine, which are therapeutic interventions.
No
Explanation: The device is an intervertebral body fusion device and is intended for therapeutic use (to facilitate fusion in the lumbar spine), not for diagnosing a condition. Its use is based on existing diagnoses from "history and radiographic studies."
No
The device description explicitly states it is manufactured from implant grade polyetheretherketone (PEEK) and includes tantalum spheres, indicating it is a physical implant, not software.
Based on the provided information, 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 Function: The Innovasis Px™ PEEK IBF System is a physical implant designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for treating degenerative disc disease by providing structural support and promoting fusion. It does not involve analyzing biological samples for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics of the implant (material, shape, features) and its surgical use.
- Performance Studies: The performance studies mentioned are related to the mechanical properties and stability of the implant, not the accuracy of a diagnostic test.
Therefore, the Innovasis Px™ PEEK IBF System falls under the category of a medical device (specifically, a surgical implant), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Innovasis Px™ PEEK 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 a 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 either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.
This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px implant is intended to be packed with autograft.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Innovasis Px™ PEEK IBF is designed for use in a posterior (PLIF) approach to the lumbar spine. Manufactured by Innovasis from implant grade polyetheretherketone (PEEK) conforming to ASTM F2026, the Px has excellent strength, stiffness and dimensional stability, with a modulus of elasticity similar to human vertebral bone. The device is radiolucent allowing straightforward assessment of the fusion process, while tantalum spheres are located around the periphery of the device to allow implant visualization during the procedure.
The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone in-growth, as well as a convex shape 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. Reusable instruments to support the PLIF surgery are provided with the implants in custom 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 F2077-11 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion, indicates that the Px PEEK IBF is capable of performing in accordance with its intended use.
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.
K073177 Pioneer Bullet Tip IBF
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.
P960025 Jaguar IF / Brantigan Cage
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Innovasis, Incorporated Mr. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K150500
Trade/Device Name: Px™ PEEK IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 19, 2015 Received: May 20, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Mr. Marshall McCarty
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
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) K150500
Device Name Px™ PEEK IBF System
Indications for Use (Describe)
The Innovasis Px™ PEEK 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 a 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 either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.
This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px implant 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is in black and features the word "INNOVASIS" in a bold, sans-serif font. Below the main wordmark are the words "INNOVATE / INVOLVE / INVENT" in a smaller font size. The logo has a modern and clean design.
510(k) Summary Report:
Px™ PEEK IBF System
| Company: | Innovasis, Inc.
614 E. 3900 South
Salt Lake City, UT 84107 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Marshall C. McCarty
Phone: (801) 261-2236
mmccarty@innovasis.com | |
| Trade Name: | Px™ PEEK IBF System | |
| Common Name: | Intervertebral body fusion device | |
| Classification: | Regulation No.: 21CFR 888.3080
Class 2
Product Code: MAX
Review Panel: Orthopedic ASDB
Applicable Standards: | |
| | • ASTM F560-13 | Standard Specification for Unalloyed Tantalum for
Surgical Implant Applications |
| | • ASTM F983-86 | (Reapproved 2013) Standard Practice for
Permanent Marking of Orthopedic Implant
Components |
| | • ASTM F2026-12 | Standard Specification for Polyetheretherketone
(PEEK) Polymers for Surgical Implant
Applications |
| | • ASTM F2077-11 | Test Methods for Intervertebral Body Fusion
Devices |
| | • ASTM F2267-04 | (Reapproved 2011) Standard Test Method for
Measuring Load Induced Subsidence of
Intervertebral Body Fusion Device Under Static
Axial Compression |
| | • ISO 17665-1: 2006 | (Reapproved 2013) Sterilization of Healthcare
Products - Moist Heat - Part 1 Requirements for
the Development, Validation and Routine Control
of a Sterilization Process for Medical Devices |
| | The Innovasis Px™ PEEK IBF is designed for use in a posterior
(PLIF) approach to the lumbar spine. Manufactured by Innovasis
from implant grade polyetheretherketone (PEEK) conforming to
ASTM F2026, the Px has excellent strength, stiffness and
dimensional stability, with a modulus of elasticity similar to human
vertebral bone. The device is radiolucent allowing straightforward
assessment of the fusion process, while tantalum spheres are
located around the periphery of the device to allow implant
visualization during the procedure. | |
| | The single use implant devices feature an open cavity in the
interior geometry to accommodate bone graft and maximize bone
in-growth, as well as a convex shape 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. Reusable
instruments to support the PLIF surgery are provided with the
implants in custom sterilization trays. | |
| Performance Data: | (Non-clinical)—Performance testing per ASTM F2077-11 and
F2267-04 for Static Axial Compression, Dynamic Axial
Compression, Subsidence and Expulsion, indicates that the Px
PEEK IBF is capable of performing in accordance with its intended
use. | |
| Materials: | The implants are machined from medical grade Solvay Zeniva ZA-
500 and Evonik VESTAKEEP i4R polyetheretherketone per ASTM
F2026. The radiographic markers meet ASTM F560 for unalloyed
Tantalum. | |
| Intended Use: | The Innovasis Px PEEK 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. | |
| Indications for Use: | The Innovasis Px™ PEEK 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 | |
Primary Predicate: K073177 Pioneer Bullet Tip IBF This predicate has not been subject to a design-related recall.
4
Image /page/4/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".
Add'I Predicate: P960025 Jaguar IF / Brantigan Cage
Device Description: $Px^{TM}$ PEEK IBF System
5
Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the company name in a bold, sans-serif font. The "V" in Innovasis is stylized to look like a check mark. Below the company name is the tagline "Innovate / Involve / Invent."
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 and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.
This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px implant is intended to be packed with autograft.
Basis for Substantial Equivalence:
The Px PEEK 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 device, K073177 Pioneer Surgical Technology Interbody Fusion Bullet Tip IBF and reference device P960025 Depuy Spine Jaguar IF/Brantigan Cage.
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Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe and as effective, and performs as well as or better than the legally marketed predicate device.