(112 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 or ML. The focus is on the material properties and mechanical performance of the device.
Yes.
The device is used to facilitate fusion in the lumbar spine for patients with degenerative disc disease, which is a therapeutic intervention aimed at treating a medical condition.
No.
The device is an implantable intervertebral body fusion device used to support and correct during lumbar interbody fusion surgeries, not to diagnose a condition.
No
The device description clearly states it is an "expandable titanium alloy interbody device" and details its physical characteristics and mechanical testing, indicating it is a hardware implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Catalyft™ LS Expandable Interbody System is a physical implant designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not in vitro (in a lab).
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease and scoliosis by providing structural support and promoting bone fusion in the spine. This is a therapeutic intervention, not a diagnostic test.
The mention of "in vitro" in the device description regarding the nanoLOCK™ surface technology refers to laboratory testing of the material's properties and cellular response, not to the device itself being used as a diagnostic tool.
N/A
Intended Use / Indications for Use
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textures, 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 conditions, additional 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 approaches.
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 Catalyft™ 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.
Product codes
OVD
Device Description
The Catalyft™ LS Expandable Interbody System 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 devices incorporate Titan Surface Technologies™, where exterior 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
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
The subject Catalyft™ LS implants with new subject integrated screws underwent the following mechanical tests to ensure that the main technological differences between the subject and predicate devices do not present a new worst-case:
• Static and Dynamic Compression per ASTM F2077-22
• Static and Dynamic Compression Shear per ASTM F2077-
22
• Subsidence per ASTM F2267-22
• Expulsion per ASTM F-04.25.02.02
• Wear Debris per ASTM F1877 (2016)
• Bone screw push out
• MRI Safety Evaluation per ASTM F2503-23, ASTM F2182-19e2, ASTM F2052-21, F2213-17, F2119-07
Key Metrics
Not Found
Predicate Device(s)
K212653, K091813, K094025, K132897, K142559
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 28, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Medtronic Sofamor Danek USA, Inc. Rose Merlin Jose Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K241992
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: OVD Dated: July 8, 2024 Received: September 12, 2024
Dear Rose Merlin Jose:
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" (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).
1
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 Rule"). 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-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
Submission Number (if known)
Device Name
Catalyft™ LS Expandable Interbody System
Indications for Use (Describe)
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textures, 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 conditions, additional 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 approaches.
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 Catalyft™ 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)
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K241992 Page 1 of 1
4
510(k) Summary
MEDTRONIC Catalyft™ LS Expandable Interbody System
| Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132 |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Rose Merlin Jose
Regulatory Affairs Specialist
Email: rosemerlin.jose@medtronic.com |
| Date Prepared | July 8th 2024 |
| Name of Device | Catalyft™ LS Expandable Interbody System |
| Common Name | Integrated Bone Screws |
| Classification Name | Intervertebral Body Lumbar Fusion Device with Bone Graft (21
CFR 888.3080) |
| Classification | Class II |
| Product Codes | OVD (888.3080) |
| Predicate Devices | Predicate 1 (Primary Predicate): Catalyft™ LS Expandable
Interbody System (K212653, S.E. 11/19/2021)
Predicate 2: SOVEREIGN™ Spinal System (K091813, S.E.
11/17/2009)
Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010)
Predicate 4: Clydesdale™ Spinal System (K132897, S.E.
12/11/2013) |
| Description | The Catalyft™ LS Expandable Interbody System 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 devices incorporate Titan Surface
Technologies™, where exterior 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. |
| Indications for Use | 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 conditions, additional
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 approaches.
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 Catalyft™ 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. |
| Comparison of
Technological
Characteristics with
the Predicate Devices | The subject device has the same fundamental scientific
technology, indications for use, lengths, material, and torx drive as
the predicate devices (Single Lead Cancellous or Dual lead
Cortical/Cancellous thread form). The main technological
difference between the subject and predicate devices are the
diameters and thread form combination. The subject device and
predicates are intended to augment stability during the normal
healing process following surgical correction of disorders of the
spine. |
| Performance Data | The subject Catalyft™ LS implants with new subject integrated
screws underwent the following mechanical tests to ensure that the
main technological differences between the subject and predicate
devices do not present a new worst-case:
• Static and Dynamic Compression per ASTM F2077-22
• Static and Dynamic Compression Shear per ASTM F2077-
22
• Subsidence per ASTM F2267-22
• Expulsion per ASTM F-04.25.02.02
• Wear Debris per ASTM F1877 (2016)
• Bone screw push out
• MRI Safety Evaluation per ASTM F2503-23, ASTM
F2182-19e2, ASTM F2052-21, F2213-17, F2119-07 |
| Conclusion | Based on the supporting evidence provided, Medtronic believes the subject devices are substantially equivalent to the below predicates. |
| | Predicate 1 (Primary Predicate): Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021) |
| | Predicate 2: SOVEREIGN™ Spinal System (K091813, S.E. 11/17/2009) |
| | Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010) |
| | Predicate 4: Clydesdale™ Spinal System (K132897, S.E. 12/11/2013) |
| | Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015) |
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K241992 Page 4 of 4