(324 days)
No
The summary describes a physical interbody fusion cage and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an intervertebral body fusion cage intended for spinal fusion procedures to treat degenerative disc disease, which is a therapeutic intervention.
No
The MONDRIAN™ Lumbar Interbody Fusion Cage is an implantable device used for spinal fusion procedures, not for diagnosing medical conditions.
No
The device description explicitly states the device consists of physical components made of PEEK, Tantalum, and Titanium alloy, which are hardware materials.
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 MONDRIAN™ Lumbar Interbody Fusion Cage 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 (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, use of reagents, or diagnostic testing.
Therefore, the MONDRIAN™ Lumbar Interbody Fusion Cage is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The MONDRIAN™ Lumbar Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain lumbar intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA LT1 –or- PEEK VESTAKEEP i-Grade with Tantalum marker pins; titanium alloy; or a combination of PEEK, Titanium Alloy, or both.
The MONDRIAN™ Lumbar Interbody Fusion Cage System consists of cages made out of PEEK with marker pins made of Tantalum or Titanium alloy, both of which are identical to its predicate device. All of the heights, lengths, and widths are similar and/or within ranges covered by its predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Performance Data:
Static Axial Compression
Static Compression Shear
Dynamic Axial & Compression Shear
Expulsion
Subsidence
The subject lumbar devices demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions.
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.
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.
K091278, K142347, K143518, K121892, K143158, K161405, K171633
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 26, 2020
CTL Medical Corporation % Mr. Barry E. Sands President and Founder RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K192863
Trade/Device Name: MONDRIAN 114 Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 17, 2020 Received: July 27, 2020
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.
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. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192863
Device Name
MONDRIANTM Lumbar Interbody Fusion Cage System
Indications for Use (Describe)
The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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
510(k) SUMMARY
CTL Medical Corporation's MONDIRAN™ Lumbar Interbody Fusion Cage System
| Submitter: | Sean Suh |
|---|---|
| CTL Medical Corporation | |
| 4550 Excel Parkway Suite 300 | |
| Addison, TX 75001 | |
| Phone: 214-545-5820 | |
| Fax: 888-831-4892 | |
| Contact Person: | Barry Sands |
| RQMIS, Inc. | |
| 110 Haverhill Road, Suite 526 | |
| Amesbury, MA 01913 | |
| Phone: 978-358-7307 | |
| Date Prepared: | Thursday, July 16, 2020 |
| Name of Device: | MONDRIAN™ Lumbar Interbody Fusion Cage System |
| Regulation: | 21 CFR 888.3080 |
| Class: | Class II |
| Name/Address of Sponsor: | Sean Suh |
| CTL Medical Corporation | |
| 4550 Excel Parkway Suite 300 | |
| Addison, TX 75001 | |
| Common or Usual Name | Intervertebral Body Fusion Device |
Intervertebral Body Fusion Device, Lumbar (Product code MAX)
4
Predicate Device
| Primary Predicate Device | |
|---|---|
| • CEZANNE Lumbar Interbody Fusion Cage System, | K121567 |
| Additional Predicate Devices | |
| • CEZANNE-II Lumbar Interbody Fusion Cage System, | K131981 |
| • PHANTOM PLUS Cage System, | K082801 |
| • VALEO Spacer System | K091278, K142347, K143518 |
| • VALEO-II IBF Device System | K121892, K142347, K143518 |
| • VALEO-II IBF Device System, LL | K161405 |
| • VALEO-II AL System | K143158 |
| • VALEO-II OL/PL System | K143518 |
| • Nuvasive TLX Interbody System | K171633 |
Intended Use / Indications for Use
Indications for Use:
The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.
These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage
Intended Use:
The MONDRIAN™ Lumbar Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain lumbar intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA LT1 –or- PEEK VESTAKEEP i-Grade with Tantalum marker pins; titanium alloy; or a combination of PEEK, Titanium Alloy, or both.
Technological Characteristics
The MONDRIAN™ Lumbar Interbody Fusion Cage System consists of cages made out of PEEK with marker pins made of Tantalum or Titanium alloy, both of which are identical to its predicate device. All of the heights, lengths, and widths are similar and/or within ranges covered by its predicate
5
devices. Material composition profiles are provided below with their associated standards in Table 1.
| Material | Standards |
|---|---|
| Polyetheretherketone (PEEK) | ASTM F2026: Standard Specification for Polyetheretherketone |
| (PEEK) Polymers for Surgical Implant Applications | |
| Titanium alloy (Ti-6Al-4V) | ASTM F136: Standard Specification for Wrought Titanium- |
| 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical | |
| Implant Applications (UNS R56401) | |
| Tantalum | ASTM F560: Standard Specification for Unalloyed Tantalum for |
| Surgical Implant Applications (UNS R05200, UNS R05400) | |
| Stainless steel | |
| (Instrument shafts) | ASTM F899: Standard Specification for Wrought Stainless Steels for |
| Surgical Instruments | |
| Aluminum | |
| (Handles) | ASTM B211: Standard Specification for Aluminum and Aluminum- |
| Alloy Rolled or Cold Finished Bar, Rod, and Wire | |
| ASTM B221: Standard Specification for Aluminum and Aluminum- | |
| Alloy Extruded Bars, Rods, Wire, Profiles, and Tubes |
Table 1 Material Profile with Associated Standard(s)
Performance Data
Table 2 shows the mechanical testing performed on the MONDRIAN™ Lumbar Interbody Fusion Cage System to establish substantial equivalence with predicate devices and demonstrate structural and functional efficacy.
| Testing Performed | |
|---|---|
| Static Axial | |
| Compression | X |
| Static | |
| Compression Shear | X |
| Dynamic Axial & | |
| Compression Shear | X |
| Expulsion | X |
| Subsidence | X |
Table 2 Performance Testing
The subject lumbar devices demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions.
6
Substantial Equivalence
The MONDRIAN™ Lumbar Interbody Fusion Cage System is as safe and effective as the predicate CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems (K121567, K131981, K082801). The MONDRIAN™ Lumbar Interbody Fusion Cage System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The technological differences between the MONDRIAN™ Lumbar Interbody Fusion Cage System and its predicate devices raise no new issues of safety or effectiveness. Thus, MONDRIAN™ Lumbar Interbody Fusion Cage System is substantially equivalent.
The MONDRIAN™ Lumbar Interbody Fusion Cage System is as safe and effective as the CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems (K121567, K131981, K082801). The MONDRIAN™ Lumbar Interbody Fusion Cage System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the MONDRIAN™ Lumbar Interbody Fusion Cage System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the MONDRIAN™ Lumbar Interbody Fusion Cage System is as safe and effective as the CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems (K121567, K131981, K082801). Thus, the MONDRIAN™ Lumbar Interbody Fusion Cage System is substantially equivalent.