(51 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a lumbar intervertebral body fusion device indicated for spinal fusion procedures for the treatment of degenerative disc disease (DDD), which aims to address a medical condition.
No.
The device is a surgical implant for spinal fusion, not a device used to diagnose a medical condition.
No
The device description clearly states the system consists of implants manufactured from titanium and cobalt chrome alloys, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "lumbar intervertebral body fusion device" used for "spinal fusion procedures." This is a surgical implant used directly in the body.
- Device Description: The description details a physical implant made of titanium and cobalt chrome alloys, designed to provide structural stability in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine. from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies for surgery should be skeletally mature and have had six months of conservative treatment.
The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The AxCess® Expandable Interbody System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The AxCess® Expandable Interbody System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate per the patient's anatomical needs. AxCess® Expandable Interbody System implant is to be filled with autogenous bone graft and/or allograft.
The AxCess® Expandable Interbody System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) components per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) components per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
Indicated Patient Age Range
skeletally mature patients, skeletally mature
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 AxCess® Expandable Interbody System has been tested in the following test modes:
- Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Compression Shear per ASTM F2077
- Subsidence per ASTM F2267.
The results of this non-clinical testing show that the strength of the AxCess® 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.
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
January 24, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety.
Elliquence LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K243739
Trade/Device Name: AxCess® Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 4, 2024 Received: December 4, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Katherine D. Kavlock -S
for
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
3
Indications for Use
Expiration Date: 07/31/2026 See PRA Statement below.
Form Approved: OMB No. 0910-0120
Submission Number (if known)
Device Name
AxCess® Expandable Interbody System
Indications for Use (Describe)
The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine. from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies for surgery should be skeletally mature and have had six months of conservative treatment.
The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.
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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4
K243739 - 510(K) SUMMARY
| Submitter's Name: | Elliquence LLC | Image: Elliquence logo |
|---|---|---|
| Submitter's Address: | 2455 Grand Avenue | |
| Baldwin, New York 11510 | ||
| Submitter's Telephone: | 516-277-9000 | |
| Contact Person: | Nathan Wright, MS, RAC | |
| Empirical Technologies | ||
| 1-719-351-0248 | ||
| nwright@empiricaltech.com | Image: Empirical Technologies logo | |
| Date Summary was Prepared: | December 4, 2024 | |
| Trade or Proprietary Name: | AxCess® Expandable Interbody System | |
| Device Classification Name: | Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Classification & Regulation #: | Class II per 21 CFR §888.3080 | |
| Product Code: | MAX | |
| Classification Panel: | Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The AxCess® Expandable Interbody System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The AxCess® Expandable Interbody System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate per the patient's anatomical needs. AxCess® Expandable Interbody System implant is to be filled with autogenous bone graft and/or allograft.
The AxCess® Expandable Interbody System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) components per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) components per ASTM F1537.
INDICATIONS FOR USE
The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment.
The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.
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. The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. Specifically, the following characteristics are similar between the subject and predicates:
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- Indications for Use ●
- Structure and Function
- Expandable Feature ●
- Materials
- Sterility ●
- Sizes
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K182877 | HALF DOME Posterior Lumbar Interbody System | Astura Medical, LLC | MAX | Primary |
| K213951 | FORZA XP Expandable Spacer System | Orthofix US LLC | MAX | Additional |
Performance Data
The AxCess® Expandable Interbody System has been tested in the following test modes:
- Static and Dynamic Axial Compression per ASTM F2077 ●
- Static and Dynamic Compression Shear per ASTM F2077
- Subsidence per ASTM F2267 .
The results of this non-clinical testing show that the strength of the AxCess® 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 AxCess® Expandable Interbody System is substantially equivalent to the predicate device.