(88 days)
Not Found
No
The summary describes a mechanical expandable interbody fusion device and its associated instruments. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies listed are mechanical tests, not performance metrics related to AI/ML.
Yes
The device is a medical implant intended to treat degenerative disc disease and facilitate fusion in the lumbar spine, which are therapeutic actions.
No
The device is an expandable interbody fusion system designed to facilitate fusion in the lumbar spine, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of implants, instruments, and trays, which are physical hardware components. The performance studies also focus on the mechanical properties and safety of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Catalyft™ LS Expandable Interbody System is a surgically implanted device used to facilitate fusion in the lumbar spine. It is a physical implant, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, laboratory procedures, or diagnostic information derived from such analysis.
Therefore, the Catalyft™ LS Expandable Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 to be used with 4 screws and supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, KWQ, OVD
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject Catalyft™ LS implants underwent the following 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 per ASTM F-04.25.02.02 Bone Screw Push Out MRI Safety Evaluation per ASTM F2052-15, F2213-17, F2219-07, F2182-19e
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K172328, K091813, K201820, K094025, K142559, K132897, K210425
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Madhuvanthi Soundirarajan
Regulatory Affairs Specialist
Email: madhuvanthi.soundirarajan@medtronic.com
Telephone: (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 (21
CFR 888.3080) |
| Classification | Implants: Class II |
| Product Codes | MAX (888.3080)
OVD (888.3080) |
| Predicate Devices | Predicate 1 (Primary Predicate) – SOVEREIGNT™ Spinal
System (K172328, S.E 11/02/2017) 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™ Spinal System (K132897, S.E
12/11/2013) |
| | Predicate 6 - CATALYFT™ PL Expandable Interbody
System (K210425, S.E 05/24/21) |
| | The Catalyft™ LS Expandable Interbody system consists of
implants, instruments, and trays. The implants are provided sterile |
| Description | 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. |
| Indications for Use | The Catalyft™ LS Expandable Interbody System 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 spinal 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 approaches.
These approaches include anterior and or oblique approach.
The Catalyft™ LS Expandable interbody system cages used with
4 titanium alloy screws may be used as a stand-alone device up to
20°lordosis. If the physician chooses to use less than 4 or none of
the provided screws, additional supplemental fixation in the |
| Comparison of
Technological
Characteristics with
the Predicate Devices | 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
Catalyft™ LS Expandable Interbody System has the same
fundamental scientific technology, indications for use, design,
material, and levels of attachment as the predicate devices. The
predicate and the subject devices are intended for stabilization use
and to promote bone fusion during the normal healing process
following surgical correction of disorders of the spine.
The subject interbody implant has a similar expansion mechanism
as the Predicate 4 ELEVATE™ Spinal System implant. However,
the subject implant has expandable height and lordosis moving
both 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 following
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 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 the
subject devices are substantially equivalent to the below predicates.
Predicate 1 (Primary Predicate) – SOVEREIGN™
Spinal System (K172328, S.E
11/02/2017) 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™ Spinal
System (K132897, S.E 12/11/2013) Predicate 6 - CATALYFT ™ PL Expandable Interbody
System (K210425, S.E 05/24/21) |
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