(427 days)
No
The device description and intended use focus solely on the physical characteristics and surgical application of interbody fusion cages and associated instruments. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as "intercalated fusion cages" intended to "facilitate intervertebral body fusion" in the spine to treat degenerative disc disease, directly indicating a therapeutic purpose to alleviate a medical condition.
No
This device, the NITRO Interbody Fusion Cage System Family, is an implantable medical device designed to facilitate spinal fusion. Its purpose is structural support and fusion, not the diagnosis of a medical condition. While its use is predicated on a diagnosis (Degenerative Disc Disease), the device itself does not perform diagnostic functions.
No
The device description clearly states that the device is a system of interbody cages made of silicon nitride material, along with instruments for implantation. These are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to facilitate intervertebral body fusion in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as an interbody fusion cage made of silicon nitride material, designed to hold bone graft material and be implanted surgically. This aligns with a medical device used for treatment, not for diagnosing a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease. Its function is purely mechanical and biological (facilitating fusion).
- Performance Studies: The performance studies described focus on the mechanical properties and stability of the implant (compression, shear, torsion, subsidence, expulsion, pull-off, push-out), which are relevant to a surgical implant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
"CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space).
"LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
Lumbar NTRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Lumbar NTRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX, OVE
Device Description
The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar ) cages offer a complete line of interbody cages for the cervical levels C2-C7 and the lumbar levels L2-S1 to be used with supplemental fixation and bone graft material. The cages are made of silicon nitride material and are available in a variety of widths, lengths, and lordotic angles, (parallel angles to accommodate varying degrees of lordosis and varying patient anatomy). The NITRO Interbody Fusion Cage System Family consists of hollow intervertebral spacers with an axial void designed to hold bone graft material. The bone graft is packed into and around the cage to further facilitate fusion.
Each system includes a complete set of instruments to implant the devices properly. The NITRO Interbody Fusion Cage System Family consists of following systems:
- MATISSE NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System.
- MONET NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System with Supplemental fixation.
- MONDRIAN NITRO Lumbar Interbody Fusion Cage System:
- MONDRIAN NITRO ALIF/OLIF Cage System
- MONDRIAN NITRO DLIF Cage System
- MONDRIAN NITRO PLIF Cage System
- MONDRIAN NITRO TLIF Cage System
The NITRO Interbody Fusion Cage System Family includes implants and instruments. The subject system uses the same instruments and fundamental technology as do their functional counterparts in CTL Medical's already cleared MATISSE, MONET, and MONDRIAN surgical instruments. As with the predicates, the subject device is
implanted using a combination of device-specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C3 disc space to C7-T1 disc space), Lumbar spine (L2 to 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 performance testing of the worst-case subject device MONET NITRO Cervical Cage was compared to the performance testing of the worst-case reference predicate cages (Cervical and Lumbar). Testing included Axial Static Compression, Shear Static Compression, Static Torsion, Axial Dynamic Compression, Subsidence, and Expulsion. Additionally, the Company also conducted Plate Pull-Off, Screw Push Out, and Pyrogenicity testing.
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.
K143518, K161405, K182151, K192863
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.
K121569, K162682, K172212, K172788
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 25, 2023
CTL Medical Corporation Barry E. Sands President and Founder ROMIS Inc. 110 Haverhill Road Suite 524 Amesbury, Massachusetts 01913
Re: K220513
Trade/Device Name: NITRO Interbody Fusion Cage System Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX, OVE Dated: April 12, 2023 Received: April 12, 2023
Dear Mr. Sands:
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.
1
ce determination does not mean that FDA
Page 2
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 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 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 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
Enclosure
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Indications for Use
510(k) Number (if known) K220513
Device Name NITRO Interbody Fusion Cage System Family
Indications for Use (Describe)
"CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space).
"LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
Lumbar NTRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Lumbar NTRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
CTL Medical's NITRO Interbody Fusion Cage System Family (Cervical and Lumbar)
l. SUBMITTER'S ADDRESS, TELEPHONE NUMBER, CONTACT PERSON
CTL Medical Corporation Sean Suh 4550 Excel Parkway, Suite 300 Addison, TX 75001 Phone: (214) 545-5820 Email: ssuh@ctlamedica.com
Contact Person:
Barry E. Sands RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 Phone: (978) 358-7307 Email: barrysands@rqmis.com Facsimile: (978) 477-0206
Date Prepared: April 11, 2023
II. SUBJECT DEVICE
Trade/proprietary name of device:
Common or Usual Name: Classification Name:
Regulation Number: Classification: Product Code(s)
NITRO Interbody Fusion Cage System Family (Cervical and Lumbar)
Intervertebral Body Fusion Device Intervertebral Body Fusion Device with Bone Graft, Cervical and Lumbar 21 C.F.R. §888.3080 Class II ODP, MAX, OVE
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III. PREDICATE DEVICES
Primary Predicate:
- . VALEO Spacer System; VALEO II Interbody Fusion Device System (K143518), (K161405) (primary predicate)
Additional Predicates:
- MATISSE Anterior Cervical Interbody Cage System (K121569, K162682, K172212)
- 0 MONET Anterior Cervical Interbody Fusion Cage System (K172788)
- . MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151), and
- o MONDRIAN Lumbar Interbody Fusion Cage System (K192863)
IV. DEVICE DESCRIPTION
The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar ) cages offer a complete line of interbody cages for the cervical levels C2-C7 and the lumbar levels L2-S1 to be used with supplemental fixation and bone graft material. The cages are made of silicon nitride material and are available in a variety of widths, lengths, and lordotic angles, (parallel angles to accommodate varying degrees of lordosis and varying patient anatomy). The NITRO Interbody Fusion Cage System Family consists of hollow intervertebral spacers with an axial void designed to hold bone graft material. The bone graft is packed into and around the cage to further facilitate fusion.
Each system includes a complete set of instruments to implant the devices properly. The NITRO Interbody Fusion Cage System Family consists of following systems:
- MATISSE NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System.
- MONET NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System with Supplemental fixation.
- MONDRIAN NITRO Lumbar Interbody Fusion Cage System:
- о MONDRIAN NITRO ALIF/OLIF Cage System
- MONDRIAN NITRO DLIF Cage System о
- O MONDRIAN NITRO PLIF Cage System
- о MONDRIAN NITRO TLIF Cage System
The NITRO Interbody Fusion Cage System Family includes implants and instruments. The subject system uses the same instruments and fundamental technology as do their functional counterparts in CTL Medical's already cleared MATISSE, MONET, and MONDRIAN surgical instruments. As with the predicates, the subject device is
6
implanted using a combination of device-specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.
Intended Use/Indications for Use: CERVICAL
"CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space).
Intended Use/Indications for Use: LUMBAR
"LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
Lumbar NITRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
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Lumbar NITRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation.
v. TECHNOLOGICAL CHARACTERISTICS
The NITRO Interbody Fusion Cage System Family is substantially equivalent to the following predicate devices: Primary predicate VALEO Spacer System; VALEO II Interbody Fusion Device System (K143518) and additional predicates MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151), and MONDRIAN Lumbar Interbody Fusion Cage System (K192863).
The NITRO Interbody Fusion Cage System Family has identical intended use and indications, technological characteristics, and principles of operation as the primary and secondary predicates. Additionally, the company also used the additional predicate devices (MATISSE, MONDRIAN, and VALEO II devices above) to demonstrate that some technological characteristics of the subject device do not raise different questions of safety and effectiveness.
VI. PERFORMANCE DATA
The performance testing of the worst-case subject device MONET NITRO Cervical Cage was compared to the performance testing of the worst-case reference predicate cages (Cervical and Lumbar). Testing included Axial Static Compression, Shear Static Compression, Static Torsion, Axial Dynamic Compression, Subsidence, and Expulsion. Additionally, the Company also conducted Plate Pull-Off, Screw Push Out, and Pyrogenicity testing.
VII. CONCLUSION
The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar) has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Thus, the subject device is substantially equivalent to the predicate device.
The technological differences between the subject device and the predicate do not raise new questions of safety and effectiveness. Any minor differences in technological characteristics have been tested and documented.