(87 days)
Not Found
No
The description focuses on the physical characteristics and mechanical testing of the interbody fusion device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for interbody fusion procedures (arthrodesis) in patients with degenerative disc disease, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is an interbody fusion device intended for use in spinal fusion procedures to provide structural stability, not to diagnose a condition.
No
The device description explicitly states that the device is a physical implant manufactured from titanium alloy, intended for surgical implantation. 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the ASTRAEUS, PROMETHEUS, and THEMIS devices as interbody fusion devices intended for surgical implantation in the spine to aid in spinal fixation and provide structural stability. They are physical implants used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, chemical reactions, or diagnostic testing.
Therefore, the GAIA Lumbar Interbody Fusion Device Family is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ASTRAEUS anterior lumbar interbody fusion device is a member of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous bone graft.
GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach.
The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach.
The THEMIS Transforaminal posterior lumbar is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with disc disease (DDD) at one or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The GAIA Lumbar Interbody Fusion Device (LIFD) Family consists of the ASTRAEUS ALIF, the PROMETHEUS PLIF, and the THEMIS TPLIF.
The ASTRAEUS anterior lumbar interbody fusion (ALIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The ASTRAEUS ALIF devices are to be implanted via an anterior approach.
The PROMETHEUS posterior lumbar interbody fusion (PLIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The PROMETHEUS PLIF devices are to be implanted via a posterior approach.
The THEMIS transforaminal posterior lumbar interbody fusion (TPLIF) implants are interbody fusion devices intended for use an aid in spinal fixation and provided structural stability in skeletally mature patients. THE THEMIS TPLIF devices are to be implanted via a transforaminal or posterior approach.
The GAIA Lumbar Interbody Fusion Device (LIFD) Family implants are manufactured additively from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are offered in a variety of standard sizes (width, length, height, lordotic angle) designed to adapt to many different patient anatomy. Each interbody device has an axial graft window to allow bone grafting material of autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to be placed inside the interbody. Various interbody window lattices are provided to adapt to various bone graft placement methods. High friction surfaces with protrusions on superior and inferior of the interbody fusion device grip the end plates of adjacent vertebrae to resist expulsion or other unintended migration of the implants provide an alternative to autogenous bone graft blocks and assist to reduce complications related to bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
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)
The GAIA Lumbar Interbody Fusion Device (LIFD) Family has been tested in the following test modes:
- o Static and dynamic axial compression per ASTM F2077-18
- Static and dynamic compression shear per ASTM F2077-18 0
- o Subsidence per ASTM F2267-04 (2018)
The results of this non-clinical testing show that the strength of the GAIA Lumbar Interbody Fusion Device (LIFD) Family is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
K170676, K172816, K162496, K143258, K180556, K190483, K111354/K131612
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2020
PrinterPrezz % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201939
Trade/Device Name: GAIA Lumbar Interbody Fusion Device (LIFD) Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 10, 2020 Received: July 13, 2020
Dear Mr. Wright:
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.
1
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 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 medical devices and radiation-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. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
Indications for Use
510(k) Number (if known)
K201939 Device Name
GAIA Lumbar Interbody Fusion Device (LIFD) Family
Indications for Use (Describe)
The ASTRAEUS anterior lumbar interbody fusion device is a member of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous bone graft.
GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach.
The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach.
The THEMIS Transforaminal posterior lumbar is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with disc disease (DDD) at one or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
Type of Use (Select one or both, as applicable)
□ Over-The-Counter Use (21 CFR 801 Subpart C) ∑ Prescription Use (Part 21 CFR 801 Subpart D)
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. 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
Food and Drug Administration
Office of Chief Information Officer
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
5.510(K) SUMMARY
| Submitter's Name: | PrinterPrezz |
|---|---|
| Submitter's Address: | 4110 Clipper Ct. |
| Fremont, CA 94538 | |
| Submitter's Telephone: | 510-225-8412 |
| Contact Person: | Nathan Wright MS |
| Empirical Consulting | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | 10-Jul-2020 |
| Trade or Proprietary Name: | GAIA Lumbar Interbody Fusion Device (LIFD) Family |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The GAIA Lumbar Interbody Fusion Device (LIFD) Family consists of the ASTRAEUS ALIF, the PROMETHEUS PLIF, and the THEMIS TPLIF.
The ASTRAEUS anterior lumbar interbody fusion (ALIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The ASTRAEUS ALIF devices are to be implanted via an anterior approach.
The PROMETHEUS posterior lumbar interbody fusion (PLIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The PROMETHEUS PLIF devices are to be implanted via a posterior approach.
The THEMIS transforaminal posterior lumbar interbody fusion (TPLIF) implants are interbody fusion devices intended for use an aid in spinal fixation and provided structural stability in skeletally mature patients. THE THEMIS TPLIF devices are to be implanted via a transforaminal or posterior approach.
The GAIA Lumbar Interbody Fusion Device (LIFD) Family implants are manufactured additively from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are offered in a variety of standard sizes (width, length, height, lordotic angle) designed to adapt to many different patient anatomy. Each interbody device has an axial graft window to allow bone grafting material of autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to be placed inside the interbody. Various interbody window lattices are provided to adapt to various bone graft placement methods. High friction surfaces with protrusions on superior and inferior of the interbody fusion device grip the end plates of adjacent vertebrae to resist
PrinterPrezz GAIA Lumbar Interbody Fusion Device (LIFD) Family
4
expulsion or other unintended migration of the implants provide an alternative to autogenous bone graft blocks and assist to reduce complications related to bone graft.
INDICATIONS FOR USE
The ASTRAEUS anterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The ASTRAEUS ALIF cage is to be implanted via an anterior approach.
The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The PROMETHEUS PLIF cage is to be implanted via a posterior approach.
5
The THEMIS Transforaminal posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the THEMIS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- o Indications for Use
- O Materials of manufacture
- Structural support mechanism 0
- Sizes
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K170676 | HD Lumbar Interbody System | HD LifeSciences LLC | Primary |
| K172816 | TiGer Shark™ System | Choice Spine, LP | Additional |
| K162496 | Foundation F3 Interbody | CoreLink, LLC | Additional |
| K143258 | PLIF STS, TLIF STS, and OLIF | ||
| STS | 4WEB, Inc. | Additional | |
| K180556 | Foundation 3D Anterior Lumbar | ||
| System | CoreLink, LLC | Additional | |
| K190483 | SPIRA Open Matrix ALIF and | ||
| LLIF | Camber Spine | ||
| Technologies | Additional | ||
| K111354/K131612 | AnyPlus® PEEK Lumbar Fusion | ||
| Cage | GS Medical Co, Ltd. | Additional |
Table 5-1 Predicate Devices
6
PERFORMANCE DATA
The GAIA Lumbar Interbody Fusion Device (LIFD) Family has been tested in the following test modes:
- o Static and dynamic axial compression per ASTM F2077-18
- Static and dynamic compression shear per ASTM F2077-18 0
- o Subsidence per ASTM F2267-04 (2018)
The results of this non-clinical testing show that the strength of the GAIA Lumbar Interbody Fusion Device (LIFD) Family is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the GAIA Lumbar Interbody Fusion Device (LIFD) Family is substantially equivalent to the predicate device.