(301 days)
No
The 510(k) summary describes a physical medical device (spinal fusion cage, plate, and screws) and its intended use and materials. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an implant for spinal fusion and provides structural stability, which is not considered a therapeutic function that actively treats or cures a disease in the way a pharmaceutical or energy-based device might.
No
Explanation: The device is an interbody fusion device intended for spinal fusion procedures, providing structural stability. Its purpose is treatment, not diagnosis, as it does not analyze or interpret patient data to identify a disease or condition.
No
The device description explicitly states it is comprised of physical components like spacers, plates, screws, and instruments, which are made from materials like PEEK, Titanium Alloy, and Stainless Steel. This indicates it is a hardware medical device, not software-only.
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 for spinal fusion. It is used in the body to provide structural stability and facilitate bone growth.
- Device Description: The device is described as a system of spacers, plates, screws, and instruments made from materials like PEEK and Titanium Alloy. These are physical components implanted during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
The device described is a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.
The MONDRIAN ALIF Cage with Supplementary Fixation Plate System is intended for use with either two or four titanium alloy screws which are provided with the system. When used with screws and implants with lordotic angles ≤20°, the MONDRIAN ALIF Cage with Supplementary Fixation Plate System is a stand-alone interbody fusion device. If the physician chooses to use fewer than the number of screws compatible with the plate, then a supplemental spinal fixation system that is cleared for use in the lumbosacral spine must be used. Hyperlordotic cage offerings (>20°) require the use of a supplemental fixation system (e.g. facet screws or posterior fixation).
Product codes
MAX, OVD
Device Description
The MONDRIAN ALIF Cage with Supplemental Fixation Plate System are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals. The system is comprised of spacers, plates, screws and instruments to facilitate the installation of the implants. The spacers are manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136, plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, L2-S1
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Tests:
- Axial Dynamic Compression (per ASTM F2077)
- Screw Push-Out Testing
- Plate-Cage Disassembly Testing
Key results: Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.
Clinical Tests: Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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September 15, 2022
CTL Medical Corporation % Dhaval Saraiya Regulatory/Quality Consultant Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington, District of Columbia 20003
Re: K213641
Trade/Device Name: MONDRIAN ALIF Cage with Supplementary Fixation Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: September 6, 2022 Received: September 6, 2022
Dear Dhaval Saraiya:
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
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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213641
Device Name
MONDRIAN ALIF Cage with Supplemental Fixation Plate System
Indications for Use (Describe)
The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.
The MONDRIAN ALIF Cage with Supplementary Fixation Plate System is intended for use with either two or four titanium alloy screws which are provided with the system. When used with screws and implants with lordotic angles ≤20°, the MONDRIAN ALIF Cage with Supplementary Fixation Plate System is a stand-alone interbody fusion device. If the physician chooses to use fewer than the number of screws compatible with the plate, then a supplemental spinal fixation system that is cleared for use in the lumbosacral spine must be used. Hyperlordotic cage offerings (>20°) require the use of a supplemental fixation system (e.g. facet screws or posterior fixation).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the MONDRIAN ALIF Cage with Supplemental Fixation Plate System 510(k) premarket notification.
| Sponsor: | CTL Medical Corporation
Sean Suh
4550 Excel Pkwy
Ste 300
Addison, TX 75001 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dhaval Saraiya
Omni Strategic Solutions, LLC.
Regulatory/Quality Consultant
Email: omniregsolutions@gmail.com |
| Date: | November 15, 2021 |
| Subject Device: | Trade Name: MONDRIAN ALIF Cage with Supplemental Fixation Plate
System |
| | Common Name: Lumbar Intervertebral Fusion Device
Classification Name:
MAX - Intervertebral Fusion Device with Bone Graft, Lumbar
(21 CFR 888.3080)
OVD - Intervertebral Fusion Device with Integrated Fixation, Lumbar
(21 CFR 888.3080) |
| Predicate Device(s): | |
| | Primary Predicate: K192863 MONDRIAN™ Lumbar Interbody Fusion Cage System CTL Medical Corporation |
| | Reference Device: K160597 INDEPENDENCE® Spacers Globus Medical Inc. |
| Purpose and
Device Description: | The purpose of this submission is to request clearance for the new
MONDRIAN ALIF Cage with Supplemental Fixation Plate System.
The MONDRIAN ALIF Cage with Supplemental Fixation Plate System
are anterior lumbar interbody fusion devices used to provide structural
stability in skeletally mature individuals. The system is comprised of
spacers, plates, screws and instruments to facilitate the installation of
the implants. The spacers are manufactured from PEEK per ASTM
F2026 and/or Titanium Alloy per ASTM F136, plates and screws are
manufactured from Titanium Alloy per ASTM F136. The instruments
are manufactured from Stainless Steel per ASTM F899. Implants and
instruments will be provided in non-sterile configuration and will require
steam sterilization prior to use. |
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Intended Use and Indications for Use:
The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.
The MONDRIAN ALIF Cage with Supplementary Fixation Plate System is intended for use with either two or four titanium alloy screws which are provided with the system. When used with screws and implants with lordotic angles ≤20°, the MONDRIAN ALIF Cage with Supplementary Fixation Plate System is a stand-alone interbody fusion device. If the physician chooses to use fewer than the number of screws compatible with the plate, then a supplemental spinal fixation system that is cleared for use in the lumbosacral spine must be used. Hyperlordotic cage offerings (>20°) require the use of a supplemental fixation system (e.g. facet screws or posterior fixation).
Summary of Technological Characteristics:
- The rationale for substantial equivalence is based on consideration of . the following characteristics:
- .
- . Intended Use: The intended use is similar to the intended use cleared in K160597 and K192863.
- Indications for Use: The indications for use are similar to the indications for use cleared in K160597 and K192863.
- . Materials: The MONDRIAN ALIF Cage with Supplemental Fixation Plate implants are manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136 and instruments are manufactured from Stainless Steel per ASTM F899 which are commonly used materials in orthopedic implants and instruments and similar to materials used in K160597 and K192863.
- . Design Features: The design features for the MONDRIAN ALIF Cage with Supplemental Fixation Plate System implants and instruments are similar to those in currently marketed devices cleared in K160597 and K192863. The design differences have not identified any issues that would impact the safety and effectiveness of the device.
- Sterilization: The MONDRIAN ALIF Cage with Supplemental Fixation ● Plate implants and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use is similar to the devices cleared in K160597 and K192863.
- Summary of Performance Data (Nonclinical and/or Clinical):
Substantial Equivalence Conclusion:
- Non-Clinical Tests: .
- o Axial Dynamic Compression (per ASTM F2077)
- o Screw Push-Out Testing
- o Plate-Cage Disassembly Testing
- Clinical Tests: ●
- o
The MONDRIAN ALIF Cage with Supplemental Fixation Plate System has shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.