(71 days)
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyfi™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation
The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology consists of new interbody implants that are provided sterile and are intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion.
The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
The interbody device is a line extension to add Titan nanoLOCK™ Surface Technology to recently cleared Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021). The subject interbody incorporates Titan Surface Technologies™, where superior and inferior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic roughened surface with nano-scale features. nanoLOCK Surface Technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.
This is a medical device, not an AI/ML device. The provided text describes the regulatory submission for the "Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology," which is an implantable intervertebral body fusion device.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, and ground truth establishment is not applicable in this context. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and biocompatibility testing, not AI/ML performance.
However, I can provide information based on the performance data section of the document, which outlines the verification tests conducted to demonstrate the device's performance characteristics:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a table format, nor does it provide "reported device performance" in terms of numerical results for each test. Instead, it lists the types of verification tests conducted. The underlying assumption for substantial equivalence is that the device met the established acceptance criteria for each test according to the respective ASTM standards or internal protocols, demonstrating comparable safety and effectiveness to the predicate devices.
Here's a re-interpretation of the requested table, focusing on the type of performance evaluated:
| Acceptance Criteria Category (Derived from Test Purpose) | Reported Device Performance (Implied from successful testing) |
|---|---|
| Static and Dynamic Compression Strength (per ASTM F2077-18) | Device demonstrated adequate mechanical strength under static and dynamic compression loads, comparable to predicate devices. |
| Static and Dynamic Compression Shear Strength (per ASTM F2077-18) | Device demonstrated adequate mechanical strength under static and dynamic compression shear loads, comparable to predicate devices. |
| Subsidence Resistance (per ASTM F2267-04(2018)) | Device demonstrated acceptable resistance to subsidence into vertebral endplates, comparable to predicate devices. |
| Expulsion Resistance | Device demonstrated acceptable resistance to expulsion from the intervertebral space, comparable to predicate devices. |
| Wear Debris Generation (per ASTM F1877 (2016)) | Device demonstrated acceptable levels of wear debris generation, comparable to predicate devices. |
| MRI Safety and Compatibility (per ASTM 2503-20, ASTM F2182-19e, ASTM 2052-21, F2213-17, F2219-07) | Device demonstrated acceptable MRI safety characteristics (e.g., heating, artifact, force, torque) consistent with labeled MRI conditions. |
| Titan nanoLOCK™ Surface Technology Performance | In-vitro studies demonstrated the ability of the nano-textured features to elicit an endogenous cellular and biochemical response. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (number of devices tested) for each mechanical or physical test. These tests are typically conducted in a laboratory setting on a representative number of devices and device configurations to ensure statistically sound results. Data provenance would be from internal Medtronic laboratories or accredited third-party testing facilities, likely in the US or similar regulatory environments. The data is prospective for the purpose of the 510(k) submission, meaning the tests were specifically designed and performed for this device to generate the required performance data.
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)
This is not applicable as the device is a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on medical data. Ground truth for mechanical testing would be the physical measurements and observations made during testing according to standard protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to human interpretation/labeling of data in AI/ML studies, not the mechanical and material testing of physical medical devices.
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
Not applicable. This is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI/ML software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical and physical tests, the "ground truth" is established by:
- Physical measurements and data acquisition: Using calibrated instruments and established test methods to measure parameters like load, deformation, wear, etc.
- Adherence to recognized standards: Compliance with ASTM standards (e.g., F2077, F2267, F1877, MRI safety standards) which define precise methodologies and sometimes acceptance criteria.
- In vitro cellular response: For the nanoLOCK™ surface, in vitro studies demonstrated the biological response, with the "ground truth" being the observed cellular and biochemical reactions under controlled laboratory conditions.
8. The sample size for the training set
Not applicable. This concept pertains to AI/ML software development.
9. How the ground truth for the training set was established
Not applicable. This concept pertains to AI/ML software development.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2022
Medtronic Sofamor Danek USA, Inc. Alex Underberg Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K223153
Trade/Device Name: Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: October 4, 2022 Received: October 6, 2022
Dear Alex Underberg:
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
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology
Indications for Use (Describe)
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyfi™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
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 of information. 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 Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
MEDTRONIC
Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology
December 8th, 2022
| Submitter | Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132 |
|---|---|
| Contact Person | Alex UnderbergSenior Regulatory Affairs SpecialistEmail: alex.r.underberg@medtronic.comTelephone: (901) 344-1443Fax: (901) 346-9738 |
| Date Prepared | December 8th, 2022 |
| Name of Device | Catalyft™ LS Expandable Interbody System with TitannanoLOCK™ Surface Technology |
| Common Name | Interbody Cages |
| Classification Name | Intervertebral Body Lumbar Fusion Device with Bone Graft (21CFR 888.3080) |
| Classification | Implants: Class II |
| Product Codes | MAX (888.3080)OVD (888.3080) |
| Predicate Devices | Predicate 1 (Primary Predicate): Catalyft™ LS ExpandableInterbody System (K212653, S.E. 11/19/2021)Predicate 2: Anteralign LS™ Interbody System with TitannanoLOCK™ Surface Technology (K214010, S.E. 04/12/2022)Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010;K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017) |
| 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) | |
| Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015) | |
| The Catalyft™ LS Expandable Interbody System with TitannanoLOCK™ Surface Technology consists of new interbodyimplants that are provided sterile and are intended to be surgicallyimplanted between two lumbar or lumbosacral vertebral bodies togive support and correction during lumbar intervertebral bodyfusion. | |
| Description | The Catalyft™ LS Expandable Interbody System with TitannanoLOCK™ Surface Technology is an expandable titanium alloyinterbody device consisting of expandable interbodies of variouswidths, lengths, heights, and lordotic angles to accommodatepatient anatomy. These devices can be inserted between twolumbar or lumbosacral vertebral bodies to give support andcorrection during lumbar interbody fusion surgeries. Implantshave a central cavity that allows them to be packed withautogenous bone graft and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone, and/or demineralizedallograft bone with bone marrow aspirate. |
| The interbody device is a line extension to add TitannanoLOCK™ Surface Technology to recently cleared Catalyft™LS Expandable Interbody System (K212653, S.E. 11/19/2021).The subject interbody incorporates Titan Surface Technologies™,where superior and inferior surfaces include nanoLOCK™ surfacetreatments designed to improve bone fixation to adjacent bone.nanoLOCK™ surface technology provides a microscopicroughened surface with nano-scale features. nanoLOCK SurfaceTechnology is specifically engineered to have nano texturedfeatures at a nanometer (10-9) level, which has demonstrated theability to elicit an endogenous cellular and biochemical responseattributed to these nanotextured features in vitro . nanoLOCKsurface technology demonstrates elements to be considerednanotechnology as outlined in the FDA nanotechnology guidancedocument. | |
| Indications for Use | The Catalyft™ LS Expandable Interbody System device,including those with or without micro- and nano-roughenedsurface textured features, is indicated for use as anintervertebral body fusion device in skeletally mature patientswith degenerative disc disease (DDD - defined by discogenicback pain with degeneration of the disc confirmed by patienthistory and radiographic studies) at one or two contiguouslevels of the lumbar spine (L2-S1). Additionally, theCatalyft™ LS Expandable Interbody System can be used withpatients diagnosed with multilevel degenerative scoliosis andsagittal deformities as an adjunct to fusion. When used inpatients as an adjunct to fusion in patients diagnosed withmultilevel degenerative scoliosis and sagittal deformityconditions, additional supplemental fixation (e.g. posteriorfixation) must be used. These patients should be skeletallymature and have undergone 6 months of non-operativetreatment prior to surgery. Implants are used to facilitate fusionin the lumbar spine using autogenous bone graft and/orallograft bone graft comprised of cancellous and/orcorticocancellous bone, and/or demineralized allograft bonewith bone marrow aspirate.These implants may be implanted via a variety of open orminimally invasive anterior or oblique approach.The Catalyft™ LS Expandable Interbody System device maybe used as a stand-alone device or in conjunction withsupplemental fixation. When used as a stand-alone device, theCatalyft™ LS Expandable Interbody System device isintended to be used with 4 titanium alloy screws. If thephysician chooses to use less than 4 or none of the providedscrews, additional supplemental fixation in the lumbar spinemust be used to augment stability. Implants with lordosisangles greater than 20° are intended to be used with 4 screwsand supplemental fixation. |
| Comparison ofTechnologicalCharacteristics withthe Predicate Devices | The subject device has the same or similar fundamental scientifictechnology, indications for use, design, material, and levels ofattachment as the predicate devices. The subject device andpredicates are intended for stabilization use and to promote bonefusion during the normal healing process following surgicalcorrection of disorders of the spine.The subject interbody implant has an identical expansionmechanism and size range as that of the primary predicate. |
| The only difference between the subject device and the primarypredicate device is that the CatalyftTM LS nanoLOCKTM interbodyhas Titan nanoLOCKTM Surface Technology. | |
| Performance Data | The subject CatalyftTM LS nanoLOCKTM implants underwent thefollowing verification tests:Static and Dynamic Compression per ASTM F2077-18 Static and Dynamic Compression Shear per ASTM F2077-18 Subsidence per ASTM F2267-04(2018) Expulsion testing Wear Debris per ASTM F1877 (2016) MRI Safety Evaluation per ASTM 2503-20, ASTMF2182-19e, ASTM 2052-21, F2213-17, F2219-07 |
| Conclusion | Based on the supporting evidence provided, Medtronic believes thesubject devices are substantially equivalent to the below predicates.Predicate 1 (Primary Predicate): CatalyftTM LS ExpandableInterbody System (K212653, S.E. 11/19/2021)Predicate 2: Anteralign LSTM Interbody System with TitannanoLOCKTM Surface Technology (K214010, S.E. 04/12/2022)Predicate 3: CrescentTM PEEK (K094025, S.E. 04/26/2010;K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017)Predicate 4: ClydesdaleTM Spinal System (K100175, S.E.06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014)Predicate 5: ElevateTM Spinal System (K142559, S.E. 06/09/2015) |
{4}------------------------------------------------
{5}------------------------------------------------
{6}------------------------------------------------
§ 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.