(126 days)
The Expanding Innovations X-Pac Expandable LLIF Cage System is indicated for intervertebral body fusion procedures 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 radies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. The X-Pac Expandable LLIF Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Expanding Innovations X-Pac Expandable LLIF Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable LLIF Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are reusable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.
The provided text is a 510(k) summary for the X-Pac Expandable LLIF Cage System, which is a medical device for intervertebral body fusion procedures. It does not describe an AI/ML powered device or an algorithm. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for training or test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.
Here's a summary of the relevant performance data mentioned:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms. | The LLIF Cage System successfully underwent performance testing. Test results demonstrate substantial equivalence to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The testing described is mechanical, not involving patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. The ground truth is based on engineering standards and mechanical test results, not expert interpretation of diagnostic images or clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The testing is mechanical and does not involve adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: Mechanical integrity and performance according to ASTM F2077 standards for intervertebral body fusion devices.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This is not an AI/ML device.
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February 14, 2023
Expanding Innovations, Inc. % Carolyn Guthrie VP of QA/RA Kapstone Medical, LLC. 510 Elliot Street Charlotte, North Carolina 28202
Re: K223174
Trade/Device Name: X-Pac Expandable LLIF Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 12, 2023 Received: January 13, 2023
Dear Carolyn Guthrie:
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.
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
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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 Showalter -S
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
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Indications for Use
510(k) Number (if known) K223174
Device Name X-Pac Expandable LLIF Cage System
Indications for Use (Describe)
The Expanding Innovations X-Pac Expandable LLF Cage System is indicated for intervertebral body fusion procedures 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 radies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. The X-Pac Expandable LLIF Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
| 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)
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Image /page/3/Picture/0 description: The image shows the logo for "Expanding Innovations". The word "Expanding" is in blue with a red dotted line arching over the word. Underneath "Expanding" is the word "Innovations" in a smaller, gray font.
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name, Address, Phone, and Fax Number of Applicant
Expanding Innovations, Inc. 110 Pioneer Way, Suite 1 Mountain View, CA 94041 Phone: (925)-819-2257
Contact Person B.
Carolyn Guthrie Vice President, Regulatory Affairs Kapstone Medical, LLC
C. Date Prepared
November 9, 2022
Device Name and Classification D.
| Trade Name: | X-Pac Expandable LLIF Cage System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| CFR Classification: | 21 CFR§888.3080 |
| Classification Name: | Intervertebral Body Fusion Device |
| Product Code: | MAX |
E. Predicate Device
The Expanding Innovations X-Pac Expandable LLIF Cage System is substantially equivalent to the previously cleared Zavation eZspand Interbody System (K220581).
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Image /page/4/Picture/0 description: The image shows the logo for "Expanding Innovations". The word "Expanding" is in blue with a red dotted line going through it. Underneath "Expanding" is the word "Innovations" in gray.
Device Description ட்
The Expanding Innovations X-Pac Expandable LLIF Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable LLIF Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are reusable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.
Indications for Use / Intended Use G.
The Expanding Innovations X-Pac Expandable LLIF Cages are indicated for intervertebral body fusion procedures 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). These spinal implants are to be used with autogenous bone graft. X-Pac Expandable LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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Image /page/5/Picture/0 description: The image shows the logo for "Expanding Innovations". The word "Expanding" is in blue, with a red dotted arc extending from the "E" to the "g". Below "Expanding" is the word "Innovations", also in blue, but in a smaller font. The logo is simple and modern.
Technological Comparison H.
The technological characteristics of the Expanding Innovations X-Pac Expandable LLIF Cage System implants are substantially equivalent to the predicate in terms of intended use, indications for use, overall design, function, technology, materials, and performance.
. Performance Data
Mechanical testing was conducted to confirm that the Expanding Innovations X-Pac Expandable LLIF Cage System does not introduce new issues of safety or effectiveness. The LLIF Cage System successfully underwent performance testing including mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms. The mechanical performance tests were based on well-recognized test methods for interbody fusion devices, including those outlined in Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Test results demonstrate substantial equivalence to the predicate device.
J. Basis for Substantial Equivalence
The Expanding Innovations X-Pac Expandable LLIF Cage System is identical to the predicate with respect to intended use, indications for use, overall design, function, technology, materials, and performance. The information provided supports the substantial equivalence of the modified X-Pac Expandable LLIF Cage System to the legally marketed predicate devices.
§ 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.