(102 days)
The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally 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). These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with spinal deformities as an adjunct to fusion. 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 marrow aspirate. These implants are intended for use with supplemental internal fixation systems.
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.
The Catalyft™ PL Expandable Interbody System consists of implants, instruments, and cases, trays, and lids. The subject implants are expandable lordotic Titanium Alloy (Ti-6Al-4V ELI) interbody fusion implants that are provided in either an inline straight tip, known as the “PL” implant, or a hockey stick-shaped tip, which is known as the “PL40” implant. The implants are expandable and have varying footprints, heights, and lengths that provide surgeons the ability to have better control of the restoration of lordosis in patients and allows more ability to appropriately size the interbody to match patient anatomy. The subject implants are designed with a hollow center region to house autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. In addition to implants, navigated instruments compatible with the StealthStation™ system have been developed. The subject StealthStation™ System compatible instruments are specific to the subject implants, and there are no changes to the StealthStation™ software related to the stereotaxic instruments in this submission. Previously cleared Navigated Rotating Shavers (K150231, S.E. 06/16/2015, K163581, S.E. 04/14/2017; K201267, S.E. 08/26/2020) will be used as disc prep instruments and trials for the Catalyft™ PL system. Cases, trays, and lids have been developed for transportation of the subject instruments.
This document describes the Catalyft™ PL Expandable Interbody System and Navigated Instruments Compatible with StealthStation™ System. The document does not contain information about an AI/ML device. Therefore, it is not possible to describe acceptance criteria and associated studies for an AI/ML device based on this document.
The document discusses the substantial equivalence of the Catalyft™ PL Expandable Interbody System and its navigated instruments to predicate devices. It mentions performance data related to mechanical testing of the implants and verification/validation testing for the navigated instruments.
Here's a breakdown of the type of information presented, which is relevant for a medical device but not an AI/ML system:
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Acceptance Criteria & Device Performance: The document lists various ASTM standards (ASTM 2077, ASTM 2267, ASTM Draft Standard F-04.25.02.02) for mechanical testing (Compression Fatigue, Compression-Shear Fatigue, Static Compression, Static Compression-Shear, Subsidence, Expulsion) of the implants. It also states that testing was completed to ensure the functionality and compatibility of new/existing instruments, and that navigated instruments underwent verification and validation activities. However, specific acceptance criteria values or detailed performance results are not provided in this summary.
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Sample Size, Data Provenance, Ground Truth for Test Set, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type (for Test Set), Training Set Sample Size, and Ground Truth for Training Set: These categories are typically associated with the evaluation of AI/ML algorithms and are not applicable to the information provided in this document, as it concerns a physical medical device and its instruments. The focus is on mechanical integrity and functional compatibility rather than algorithmic performance or diagnostic accuracy.
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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.
May 24, 2021
Medtronic Sofamor Danek, USA Inc. Alex Underberg Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K210425
Trade/Device Name: Catalyft™ PL Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OLO Dated: April 23, 2021 Received: April 26, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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
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Indications for Use
510(k) Number (if known) K210425
Device Name
Catalyft(TM) PL Expandable Interbody System
Indications for Use (Describe)
The Catalyfi™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally 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). These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with spinal deformities as an adjunct to fusion. 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 marrow aspirate. These implants are intended for use with supplemental internal fixation 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Indications for Use
510(k) Number (if known)
Device Name
Navigated Instruments Compatible with StealthStation™ System
Indications for Use (Describe)
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.
| 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.
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."
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February 10th, 2021
| Submitter | Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133 |
|---|---|
| Contact Person | Alex UnderbergRegulatory Affairs SpecialistTelephone: (901) 344-1443 (Direct) |
| Date Prepared | February 10th, 2021 |
| Name of Device | Catalyft™ PL Expandable Interbody System |
| Common Name | Interbody Cages; Navigated Instruments |
| Classification Name | Intervertebral fusion Device with Bone Graft,Lumbar (21 CFR 888.3080);Stereotaxic Instruments (21 CFR 882.4560) |
| Regulatory Classification | Class II |
| Product Codes | MAX, OLO |
| Predicate Devices | Predicate 1 (Primary Predicate): Artic-L™ 3D TiSpinal System and Artic-XL™ 3D Ti Spinal System(K171689, S.E. 10/05/2017; K190959, S.E.07/03/2019)Predicate 2: Elevate™ Spinal System (K142559,S.E. 06/09/2015)Predicate 3: Crescent™ Spinal System (K094025,S.E. 04/26/2010; K133216, S.E. 11/22/2013;K171031, S.E. 07/06/2017)Predicate 4: Clydesdale™ Spinal System(K100175, S.E. 06/02/2010; K132897, S.E.12/11/2013; K133577, 09/26/2014)Medtronic Navigated Manual ReusableInstruments for Use with StealthStation™SystemNavigated Elevate™ Inserter (K163581, S.E.04/14/2017) |
| Description of Devices | Navigated Capstone™ Trials (K131425, S.E. 08/14/2013; K150231, S.E. 06/16/2015) |
| Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015, K163581, S.E. 04/14/2017; K201267, S.E. 08/26/2020) | |
| The Catalyft™ PL Expandable Interbody System consists of implants, instruments, and cases, trays, and lids. | |
| The subject implants are expandable lordotic Titanium Alloy (Ti-6Al-4V ELI) interbody fusion implants that are provided in either an inline straight tip, known as the “PL” implant, or a hockey stick-shaped tip, which is known as the “PL40” implant. The implants are expandable and have varying footprints, heights, and lengths that provide surgeons the ability to have better control of the restoration of lordosis in patients and allows more ability to appropriately size the interbody to match patient anatomy. | |
| The subject implants are designed with a hollow center region to house autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate | |
| In addition to implants, navigated instruments compatible with the StealthStation™ system have been developed. The subject StealthStation™ System compatible instruments are specific to the subject implants, and there are no changes to the StealthStation™ software related to the stereotaxic instruments in this submission. | |
| Previously cleared Navigated Rotating Shavers (K150231, S.E. 06/16/2015, K163581, S.E. 04/14/2017; K201267, S.E. 08/26/2020) will be used as disc prep instruments and trials for the Catalyft™ PL system. | |
| Indications for Use | Cases, trays, and lids have been developed fortransportation of the subject instruments.Catalyft™ PL Expandable Interbody SystemThe Catalyft™ PL Expandable Interbody System isindicated for use as an intervertebral body fusiondevice in skeletally mature patients withdegenerative disc disease (DDD-defined bydiscogenic back pain with generation of the discconfirmed by patient history and radiographicstudies) at one or two contiguous levels of thelumbar spine (L2-S1). These DDD patients mayalso have up to Grade 1 spondylolisthesis orretrolisthesis at the involved levels. Additionally,the Catalyft™ PL Expandable Interbody Systemcan be used with patients diagnosed with spinaldeformities as an adjunct to fusion. Thesepatients should be skeletally mature and haveundergone 6 months of non-operative treatmentprior to surgery. Implants are used to facilitatefusion in the lumbar spine using autogenous bonegraft and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone, and/ordemineralized allograft bone with bone marrowaspirate. These implants are intended for use withsupplemental internal fixation systems.Medtronic Navigated Manual ReusableInstruments for Use with StealthStation™SystemMedtronic Navigated Surgical Instruments areintended to be used during preparation andplacement of Medtronic implants during spinalsurgery to assist the surgeon in precisely locatinganatomical structures in either open or minimallyinvasive procedures. Medtronic NavigatedReusable Instruments can be compatible withvarious Medtronic spinal implant systems.Navigated surgical instruments are specificallydesigned for use with the StealthStation™System, which is indicated for any medicalcondition in which the use of stereotacticsurgery may be appropriate, and wherereference to a rigid anatomical structure, such |
| identified relative to a CT or MR-based model,fluoroscopy images, or digitized landmarks of | |
| the anatomy. An instrument may incorporate a | |
| measuring function, which has uses as | |
| described on the label and the instruments. | |
| Comparison of TechnologicalCharacteristics with the PredicateDevices | Catalyft™ PL Expandable Interbody System hasthe same fundamental scientific technology,indications for use, intended use, design, andmaterial levels of attachment as the predicatedevices. The predicate and subject devices areintended for stabilization use and to promotebone fusion during the normal healing processfollowing surgical correction of disorders of thespine. |
| The subject device has a similar expansionmechanism to that of the predicate Elevate™Spinal System device. However, the Catalyft™ PLimplant's bottom endplate moves duringexpansion, whereas the Elevate™ implant'sbottom endplate remains in a fixed position. | |
| Navigated instruments are non-sterile, reusableinstruments. The navigated disc prep instrumentsare existing devices that are not undergoing anydesign changes. The navigated disc prepinstruments are being extended to be used as discprep instruments and trials for Catalyft™ PLExpandable Interbody System. | |
| Performance Data | Testing on implants was completed in accordancewith ASTM 2077 (Compression Fatigue,Compression-Shear Fatigue, Static Compression,and Static Compression-Shear), ASTM 2267(Subsidence), and ASTM Draft Standard F-04.25.02.02 (Expulsion). Testing was alsocompleted to ensure functionality andcompatibility of new/existing instruments. |
| Navigated Instruments underwent verificationand validation activities per the BenchPerformance Testing section and are compatibleto be used with Catalyft™ PL ExpandableInterbody System and StealthStation™ System. | |
| Conclusion | |
| Based on the information contained in thissubmission, Medtronic believes that the subjectdevices are substantially equivalent to thepredicate devices. |
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§ 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.