(102 days)
No
The document describes a spinal implant system and navigated surgical instruments used with a stereotactic system. While navigation systems use image processing and spatial tracking, there is no mention of AI or ML being used for analysis, decision support, or any other function within the described device or its associated navigation system. The document explicitly states "there are no changes to the StealthStation™ software related to the stereotaxic instruments in this submission."
Yes
The device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease and spinal deformities to facilitate fusion, which is a therapeutic purpose.
No
Explanation: The provided text describes the Catalyft™ PL Expandable Interbody System as a fusion device (implant) and tools used for its placement, specifically Medtronic Navigated Surgical Instruments that assist in locating anatomical structures. These tools are used during surgery to aid in implant placement, not to diagnose a medical condition. While the indication for use mentions diagnosing Degenerative Disc Disease (DDD) through "patient history and radiographic studies" before the device is used, the device itself (the interbody system and its instruments) does not perform diagnostic functions.
No
The device description explicitly states that the system consists of implants, instruments, and cases, trays, and lids, which are all hardware components. While it mentions compatibility with the StealthStation™ System (which includes software), the subject device itself is primarily hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Catalyft™ PL Expandable Interbody System is an implantable device used in spinal surgery to facilitate fusion. The navigated instruments are used to guide the placement of these implants. Neither the implants nor the instruments are designed to perform tests on biological samples.
- Lack of Mention of Biological Samples or Testing: The description focuses on the physical characteristics of the implants, the surgical procedure, and the use of imaging for navigation. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Catalyft™ PL Expandable Interbody System and its associated navigated instruments fall under the category of surgical implants and surgical navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
MAX, OLO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR-based model, fluoroscopy images
Anatomical Site
Lumbar spine (L2-S1)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Surgeon, specifically during spinal surgery in either open or minimally invasive procedures.
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)
Testing on implants was completed in accordance with 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 also completed to ensure functionality and compatibility of new/existing instruments.
Navigated Instruments underwent verification and validation activities per the Bench Performance Testing section and are compatible to be used with Catalyft PL Expandable Interbody System and StealthStation System.
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.
K171689, K190959, K142559, K094025, K133216, K171031, K100175, K132897, K133577, K163581
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.
K131425, K150231, K150231, K163581, K201267
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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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
1
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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."
4
February 10th, 2021
| Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133 |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Alex Underberg
Regulatory Affairs Specialist
Telephone: (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 Ti
Spinal 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 Reusable
Instruments for Use with StealthStation™
System
Navigated 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 for
transportation of the subject instruments.
Catalyft™ PL Expandable Interbody System
The Catalyft™ PL 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 generation 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 or
retrolisthesis at the involved levels. Additionally,
the Catalyft™ PL Expandable Interbody System
can be used with patients diagnosed 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 with bone marrow
aspirate. These implants are intended for use with
supplemental internal fixation systems.
Medtronic Navigated Manual Reusable
Instruments for Use with StealthStation™
System
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 |
| | 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 Technological
Characteristics with the Predicate
Devices | Catalyft™ PL Expandable Interbody System has
the same fundamental scientific technology,
indications for use, intended use, design, and
material levels of attachment as the predicate
devices. The predicate and 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 device has a similar expansion
mechanism to that of the predicate Elevate™
Spinal System device. However, the Catalyft™ PL
implant's bottom endplate moves during
expansion, whereas the Elevate™ implant's
bottom endplate remains in a fixed position. |
| | Navigated instruments are non-sterile, reusable
instruments. The navigated disc prep instruments
are existing devices that are not undergoing any
design changes. The navigated disc prep
instruments are being extended to be used as disc
prep instruments and trials for Catalyft™ PL
Expandable Interbody System. |
| Performance Data | Testing on implants was completed in accordance
with 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 also
completed to ensure functionality and
compatibility of new/existing instruments. |
| | Navigated Instruments underwent verification
and validation activities per the Bench
Performance Testing section and are compatible
to be used with Catalyft™ PL Expandable
Interbody System and StealthStation™ System. |
| Conclusion | |
| | Based on the information contained in this
submission, Medtronic believes that the subject
devices are substantially equivalent to the
predicate devices. |
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