(88 days)
The Catalyft™ LS 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). Additionally, the Catalyf(™ 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 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 Catalyfi™ LS Expandable interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable interbody 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 consists of implants, instruments, and trays. The implants 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.
Catalyft™ LS Expandable Interbody System implants are expandable height & lordotic titanium interbody fusion implants. The subject interbody implants have double curved endcaps geometry that will allow the implants to seat inside the vertebral endplate curvature. The interbody implants are made of titanium alloy (Ti-6Al-4V Eli) and they expand for adjustable height and adjustable lordosis. The purpose of the adjustable height and lordosis is to allow the surgeons to have better control and restoration of spinal alignment and lordosis in patients and to appropriately size the interbody to match the patient anatomy.
The provided text is a 510(k) summary for the Medtronic Catalyft™ LS Expandable Interbody System. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through the evaluation of mechanical and safety performance data, rather than performance studies related to AI or clinical outcomes in the traditional sense.
Therefore, many of the requested elements for an AI/clinical study acceptance criteria and performance description (e.g., sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone AI performance) are not applicable to the information contained in this FDA 510(k) summary.
The document primarily describes:
- Device Description: The Catalyft™ LS Expandable Interbody System is an implant used for intervertebral body fusion in the lumbar spine. It is made of titanium alloy and is designed for adjustable height and lordosis.
- Intended Use: For skeletally mature patients with degenerative disc disease at one or two contiguous levels of the lumbar spine (L2-S1), and as an adjunct to fusion for multilevel degenerative scoliosis and sagittal deformities.
- Substantial Equivalence: The submission claims substantial equivalence to several predicate devices based on fundamental scientific technology, indications for use, design, material, and levels of attachment.
- Performance Data: This section details the engineering/mechanical verification tests conducted on the device, not clinical performance or AI algorithm performance.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a table with numerical thresholds for clinical outcomes or AI performance. Instead, it lists the verification tests performed, implying that the device met the requirements of these standard tests for spinal implants. The "reported device performance" in this context refers to the successful completion of these mechanical and safety tests, demonstrating that the device functions as intended and is safe.
| Test Category | Specific Test Performed | Reported Device Performance (Implied Acceptance) |
|---|---|---|
| Mechanical Performance | Static and Dynamic Compression per ASTM F2077-18 | Met the requirements of the ASTM standard for static and dynamic compression. |
| Static and Dynamic Compression Shear per ASTM F2077-18 | Met the requirements of the ASTM standard for static and dynamic compression shear. | |
| Subsidence per ASTM F2267-04(2018) | Met the requirements of the ASTM standard for subsidence. | |
| Expulsion per ASTM F-04.25.02.02 Bone Screw Push Out | Met the requirements for expulsion and bone screw push out. | |
| Safety and Compatibility | MRI Safety Evaluation per ASTM F2052-15, F2213-17, F2219-07, F2182-19e | Demonstrated MRI safety as per the specified ASTM standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text, as this refers to mechanical testing of the device units, not a clinical trial or AI test set with patient data. These ASTM standards typically specify the number of samples required for testing.
- Data Provenance: Not applicable in the context of mechanical device testing. The data originates from laboratory testing, not patient observations. There is no mention of clinical data (retrospective or prospective) for performance evaluation.
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)
Not applicable. The "ground truth" for a mechanical device like this is established through engineering specifications and adherence to recognized ASTM (American Society for Testing and Materials) standards. There are no radiologists or clinical experts involved in establishing ground truth for the performance of the device in this document, as it's not an AI or diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image analysis where expert consensus is needed. Mechanical testing follows standardized protocols, not 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
Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance, as per this 510(k) summary, is based on engineering specifications and adherence to recognized mechanical testing standards (ASTM). The device's physical properties and mechanical behavior under simulated loads are compared against the requirements of these standards. There is no clinical outcomes data, pathology, or expert consensus used for the device's immediate performance evaluation as described here.
8. The sample size for the training set
Not applicable. This is not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. Since there is no AI training set, there is no ground truth establishment for one.
In summary, the provided 510(k) summary for the Catalyft™ LS Expandable Interbody System focuses on demonstrating substantial equivalence through standard mechanical and safety testing for an orthopedic implant. It does not contain information related to AI performance, clinical trial outcomes, or diagnostic accuracy, which are the typical contexts for the detailed acceptance criteria and study designs you've asked about.
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December 27, 2022
Medtronic Sofamor Danek USA, Inc. Madhuvanthi Soundirarajan Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K212653
Trade/Device Name: Catalyft™ LS Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD
Dear Madhuvanthi Soundirarajan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 19, 2021. Specifically, FDA is updating this SE Letter to correct the product code as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.
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
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Image /page/1/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 and 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.
November 19, 2021
Medtronic Sofamor Danek USA, Inc. Madhuvanthi Soundirarajan Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K212653-S001
Trade/Device Name: Catalyft™ LS Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, KWQ, OVD Dated: November 8, 2021 Received: November 10, 2021
Dear Madhuvanthi Soundirarajan:
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 medical devices and radiation-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 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)
Device Name Catalyft™ LS Expandable Interbody System
Indications for Use (Describe)
The Catalyfi™ LS 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). Additionally, the Catalyf(™ 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 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 Catalyfi™ LS Expandable interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable interbody 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
to be used with 4 screws and supplemental fixation.
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
MEDTRONIC Catalyft™ LS Expandable Interbody System
August 2021
| Submitter | Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738 |
|---|---|
| Contact Person | Madhuvanthi SoundirarajanRegulatory Affairs SpecialistEmail: madhuvanthi.soundirarajan@medtronic.comTelephone: (352)-433-9130 |
| Date Prepared | August 2021 |
| Name of Device | Catalyft™ LS Expandable Interbody System |
| 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) – SOVEREIGNT™ SpinalSystem (K172328, S.E 11/02/2017) and (K091813, S.E11/17/2009).Predicate 2 – BASE Interfixated Titanium (K201820, S.E09/25/2020)Predicate 3-CRESCENT™ PEEK (K094025, S.E. 04/26/2010)Predicate 4 – ELEVATE™ Spinal System (K142559, S.E06/09/2015)Predicate 5- CLYDESDALE™ Spinal System (K132897, S.E12/11/2013) |
| Predicate 6 - CATALYFT™ PL Expandable InterbodySystem (K210425, S.E 05/24/21) | |
| The Catalyft™ LS Expandable Interbody system consists ofimplants, instruments, and trays. The implants are provided sterile | |
| Description | and are intended to be surgically implanted between two lumbar orlumbosacral vertebral bodies to give support and correction duringlumbar intervertebral body fusion. |
| Catalyft™ LS Expandable Interbody System implants areexpandable height & lordotic titanium interbody fusionimplants. The subject interbody implants have double curvedendcaps geometry that will allow the implants to seat inside thevertebral endplate curvature. The interbody implants are made oftitanium alloy (Ti-6Al-4V Eli) and they expand foradjustable height and adjustable lordosis. The purpose of theadjustable height and lordosis is to allow the surgeons to havebetter control and restoration of spinal alignment and lordosis inpatients and to appropriately size the interbody to match thepatient anatomy. | |
| Indications for Use | The Catalyft™ LS Expandable Interbody System is indicated foruse as an intervertebral body fusion device in skeletally maturepatients with degenerative disc disease (DDD - defined bydiscogenic back pain with degeneration of the disc confirmed bypatient history and radiographic studies) at one or two contiguouslevels of the lumbar spine (L2-S1). Additionally, the Catalyft™LS Expandable Interbody System can be used with patientsdiagnosed with spinal multilevel degenerative scoliosis andsagittal deformities as an adjunct to fusion. When used in patientsas an adjunct to fusion in patients diagnosed with multileveldegenerative scoliosis and sagittal deformity conditions, additionalsupplemental fixation (e.g posterior fixation) must be used. Thesepatients should be skeletally mature and have undergone 6 monthsof non-operative treatment prior to surgery. Implants are used tofacilitate fusion in the lumbar spine using autogenous bone graftand/or allograft bone graft comprised of cancellousand/or corticocancellous bone, and/or demineralized allograftbone with bone marrow aspirate. These implants may beimplanted via a variety of open or minimally invasive approaches.These approaches include anterior and or oblique approach.The Catalyft™ LS Expandable interbody system cages used with4 titanium alloy screws may be used as a stand-alone device up to20°lordosis. If the physician chooses to use less than 4 or none ofthe provided screws, additional supplemental fixation in the |
| Comparison ofTechnologicalCharacteristics withthe Predicate Devices | lumbar spine must be used to augment stability. Implants withlordosis angles greater than 20° are intended to be used with 4screws and supplemental fixationCatalyft™ LS Expandable Interbody System has the samefundamental scientific technology, indications for use, design,material, and levels of attachment as the predicate devices. Thepredicate and the subject devices are intended for stabilization useand to promote bone fusion during the normal healing processfollowing surgical correction of disorders of the spine.The subject interbody implant has a similar expansion mechanismas the Predicate 4 ELEVATE™ Spinal System implant. However,the subject implant has expandable height and lordosis movingboth the endcaps during the expansion, whereas the ELEVATE™implant's bottom endcap remains in fixed position. |
| Performance Data | The subject Catalyft™ LS implants underwent the followingverification 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 per ASTM F-04.25.02.02 Bone Screw Push Out MRI Safety Evaluation per ASTM F2052-15, F2213-17, F2219-07, F2182-19e |
| Conclusion | Based on the supporting evidence provided, Medtronic believes thesubject devices are substantially equivalent to the below predicates.Predicate 1 (Primary Predicate) – SOVEREIGN™Spinal System (K172328, S.E11/02/2017) and (K091813, S.E 11/17/2009). Predicate 2 – BASE Interfixated Titanium (K201820,S.E 09/25/2020) Predicate 3 – CRESCENT™ PEEK (K094025, S.E.04/26/2010) Predicate 4 - ELEVATE™ Spinal System (K142559,S.E 06/09/2015) Predicate 5- CLYDESDALE™ SpinalSystem (K132897, S.E 12/11/2013) Predicate 6 - CATALYFT ™ PL Expandable InterbodySystem (K210425, S.E 05/24/21) |
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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.