(89 days)
Not Found
No
The summary describes a physical implantable device (spinal cage) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is a lumbar interbody fusion device intended to treat degenerative disc disease and fuse vertebral bodies, which is a therapeutic intervention.
No
The device is an intervertebral body fusion device intended to replace lumbar interbody discs and fuse adjacent vertebral bodies in spinal fusion procedures. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an implantable cage system made of PEEK, titanium, and tantalum, which are hardware components. The performance studies also focus on the mechanical properties of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, not a test performed on biological samples outside the body to diagnose a condition.
- Device Description: The device is described as an implantable cage made of PEEK and titanium, designed to replace discs and fuse vertebrae. This is a medical device for surgical intervention, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a surgical implant used in a procedure to treat a condition (degenerative disc disease), not a test to diagnose it.
N/A
Intended Use / Indications for Use
The Australis Spinal System is indicated for use as lumbar intervertebral body fusion devices for spinal fusion procedures in skeletally mature patients with symptomatic 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. The Australis Spinal System is intended to be used with autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Australis ALF cage. The Australis Spinal System is indended for use with supplemental fixation, such as the Prism Surgical Aurora® Anterior Lumbar Plate System.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Prism Surgical Designs Australis® Anterior Lumbar Interbody Fusion (ALIF) Cage System (also referred to as Australis® Spine System and Australis® Spinal System) implants are intended to replace lumbar interbody discs and to fuse adjacent vertebral bodies following anterior lumbar discectomy stabilization and/or alignment of the lumbar spine. The Australis® ALIF cage is designed to be implanted via an anterior approach to the spine. The devices consist of wedge-shaped geometry to restore lordosis of the fused vertebral bodies and serrated teeth with three titanium pins on the inferior and superior surfaces to resist expulsion The center of the device is hollow to accept autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft to promote arthrodesis. The Australis® ALIF Cage System is to be used in conjunction with supplemental fixation.
The Australis® ALIF is offered in a variety of footprints and heights to accommodate the anatomical needs of patients. The Australis® ALIF is manufactured from PEEK per ASTM F2026 with titanium pins per ASTM F136 and ISO 5832-3 and tantalum marker beads per ASTM F560 and ISO 13782.
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 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 Australis® Anterior Lumbar Cage has been tested in the following test modes:
- Static axial compression per ASTM F2077 ●
- Static compression shear per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077 ●
- Dynamic compression shear per ASTM F2077 ●
- . Subsidence per ASTM F2267
The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage 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.
K122639, K172349, K200541, K183705, K200352
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 contains the logo of the U.S. Food and 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.
December 22, 2020
Prism Surgical Designs Pty Ltd % Nathan Wright, M.S. Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K202820
Trade/Device Name: Australis® Anterior Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 23, 2020 Received: October 28, 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 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 L. 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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K202820
Device Name
Australis® Anterior Lumbar Cage System
Indications for Use (Describe)
The Australis Spinal System is indicated for use as lumbar intervertebral body fusion devices for spinal fusion procedures in skeletally mature patients with symptomatic 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. The Australis Spinal System is intended to be used with autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Australis ALF cage. The Australis Spinal System is indended for use with supplemental fixation, such as the Prism Surgical Aurora® Anterior Lumbar Plate System.
| 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
510(K) SUMMARY
| Submitter's Name: | Prism Surgical Designs Pty Ltd |
|---|---|
| Submitter's Address: | 15/43 Lang Parade |
| Milton, Queensland 4064 Australia | |
| Submitter's Telephone: | +61 7 3720 8882 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | September 23, 2020 |
| Trade or Proprietary Name: | Australis® Anterior Lumbar Cage System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Prism Surgical Designs Australis® Anterior Lumbar Interbody Fusion (ALIF) Cage System (also referred to as Australis® Spine System and Australis® Spinal System) implants are intended to replace lumbar interbody discs and to fuse adjacent vertebral bodies following anterior lumbar discectomy stabilization and/or alignment of the lumbar spine. The Australis® ALIF cage is designed to be implanted via an anterior approach to the spine. The devices consist of wedge-shaped geometry to restore lordosis of the fused vertebral bodies and serrated teeth with three titanium pins on the inferior and superior surfaces to resist expulsion The center of the device is hollow to accept autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft to promote arthrodesis. The Australis® ALIF Cage System is to be used in conjunction with supplemental fixation.
The Australis® ALIF is offered in a variety of footprints and heights to accommodate the anatomical needs of patients. The Australis® ALIF is manufactured from PEEK per ASTM F2026 with titanium pins per ASTM F136 and ISO 5832-3 and tantalum marker beads per ASTM F560 and ISO 13782.
INDICATIONS FOR USE
The Australis Spinal System is indicated for use as lumbar intervertebral body fusion devices for spinal fusion procedures in skeletally mature patients with symptomatic 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. The Australis Spinal System is intended to be used with autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Australis ALIF
Prism Surgical Designs Australis® Anterior Lumbar Cage System
4
cage. The Australis Spinal System is intended for use with supplemental fixation, such as the Prism Surgical Aurora® Anterior Lumbar Plate System.
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 similar between the subject and predicates:
- Indications for Use
- Technological Characteristics ●
- Materials of manufacture ●
- Sizes
| Table 5-1 Predicate Devices | ||||
|---|---|---|---|---|
| -- | -- | -- | ----------------------------- | -- |
| 510k
Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|----------------|-------------------------------------------------------|-----------------------------|-------------------|
| K122639 | SynCage Evolution Spacer | DePuy Synthes Spine | Primary |
| K172349 | InFill® Interbody Fusion Device | Pinnacle Spine Group, LLC | Additional |
| K200541 | Hive™ Stand-alone Anterior
Lumbar Interbody System | HD LifeSciences LLC | Additional |
| K183705 | IndentiTi Porous Ti Interbody
System | Alphatec Spine, Inc. | Additional |
| K200352 | Axis Spine Technologies ALIF | Axis Spine Technologies Ltd | Additional |
PERFORMANCE DATA
The Australis® Anterior Lumbar Cage has been tested in the following test modes:
- Static axial compression per ASTM F2077 ●
- Static compression shear per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077 ●
- Dynamic compression shear per ASTM F2077 ●
- . Subsidence per ASTM F2267
The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage 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 Australis® Anterior Lumbar Cage System is substantially equivalent to the predicate device.