(67 days)
Not Found
No
The summary describes a mechanical implant (screws) and focuses on material properties and mechanical testing for substantial equivalence, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for "fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis," which are therapeutic interventions.
No
The device is a screw system intended for fusion of the sacroiliac joint, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states the device consists of screws manufactured from Ti-6Al-4V ELI, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Advanced Research Medical Trident SI Screw System is a surgical implant (screws) used for the fusion of the sacroiliac joint. It is a physical device implanted into the body.
- Intended Use: The intended use is for surgical fusion of a joint, not for testing samples from the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Advanced Research Medical Trident SI Screw System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The Advanced Research Medical Trident SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
Not Found
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)
Non-Clinical Testing:
The implants, instruments, and case are supplied non-sterilized prior to use. These components of the system were adopted into a validated cleaning procedure and steam sterilization protocol.
Biocompatibility testing was not required for this device. The screw system is manufactured from Ti-6Al-4V ELI per ASTM F136, while the associated instrumentation is manufactured from medical grade stainless steel per ASTM F899, A269, and F138, silicone, and polyphenylsulfone (PPSU). The screw system material is recognized by the FDA and cleared for implantation. The predicate device is also made from the same material cleared for implantation. The type and duration of patient contact (permanent >30 days) is identical to the predicate device. Steam sterilization, which is an industry standard for these types of implants and instruments, does not adversely affect the raw materials. Biocompatibility is therefore not adversely affected.
Clinical testing was not required for this device. Substantial equivalence to the predicate device was determined through comparison of mechanical testing results, indications and intended uses, and device function.
Substantial equivalence is supported by the results of mechanical testing including static and dynamic cantilever bending per ASTM F2193 and axial pullout, driving torque, and torsional strength per F543. Mechanical testing methods, data, and reports are provided in this submission.
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.
L&K Biomed Co., Ltd. PathLoc-SI Joint Fusion System (K153656)
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
January 22, 2021
Image /page/0/Picture/1 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Advanced Research Medical, LLC % Kyle Kovach Quality and Regulatory Engineer JALEX Medical 27865 Clemens Rd., Suite #3 Westlake, Ohio 44145
Re: K203373
Trade/Device Name: Advanced Research Medical Trident SI Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: November 11, 2020 Received: November 16, 2020
Dear Kyle Kovach:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known) K203373
Device Name
Advanced Research Medical Trident SI Screw System
Indications for Use (Describe)
The Advanced Research Medical Trident SI Screw System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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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3
Image /page/3/Picture/0 description: The image is a logo for Advanced Research Medical (ARM). The logo features the letters ARM in a dark blue color, with a light blue line running through the middle of the letters. Below the letters, the words "ADVANCED RESEARCH" are written in a smaller font, and below that, the word "MEDICAL" is written in a light blue color with a line above it.
510(k) Summary
| Submitted By: | Advanced Research Medical, LLC
1515 Hwy 13 East
Burnsville, MN 55337 |
|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 11/11/2020 |
| Contact Person:
Contact Telephone:
Contact Fax: | Kyle Kovach, Quality and Regulatory Engineer
(440) 787-5832
(440) 933-7839 |
| Device Trade Name:
Device Classification Name:
Device Classification:
Reviewing Panel:
Product Code: | Advanced Research Medical Trident SI Screw System
Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Class II
Orthopedic
OUR |
| Primary Predicate Device: | L&K Biomed Co., Ltd. PathLoc-SI Joint Fusion System (K153656) |
Device Description:
The Advanced Research Medical Trident SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.
Indications for Use:
The Advanced Research Medical Trident SI Screw System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.
Summary of Technological Characteristics:
The Advanced Research Medical Trident SI Screw System and the same intended use and fundamental scientific technology. A comparison table of the subject device and predicate device technological characteristics is provided in this submission XIV Substantial Equivalence. A condensed comparison table is also presented below. There are no differences in technological characteristics that raise questions of safety and efficacy.
| Item | Advanced Research Medical Trident SI
Screw System | L&K Biomed Co., Ltd. PathLoc-SI
Joint Fusion System (K153656) |
|------------------------|-------------------------------------------------------|------------------------------------------------------------------|
| Classification
Name | Smooth or threaded metallic bone fixation
fastener | Smooth or threaded metallic bone fixation
fastener |
| Regulation | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Product Code | OUR | OUR |
| Screw
Lengths | 30 – 90 mm in 5 mm increments | 30 – 70 mm in 5 mm increments |
Table 1: Dimensions and Technological Characteristics Comparison
4
Image /page/4/Picture/1 description: The image shows the logo for Advanced Research Medical. The logo consists of the letters "ARM" in a bold, sans-serif font, with a blue line running horizontally through the middle of the letters. Below the letters, the words "ADVANCED RESEARCH MEDICAL" are printed in a smaller font. The logo is simple and modern, and the use of blue suggests a connection to science or medicine.
| Screw
Diameters | Ø6.0, 13.0 mm | Ø6.0, 7.0, 12.0 mm |
---|---|---|
Material | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 |
Non-Clinical Testing:
The implants, instruments, and case are supplied non-sterilized prior to use. These components of the system were adopted into a validated cleaning procedure and steam sterilization protocol.
Biocompatibility testing was not required for this device. The screw system is manufactured from Ti-6Al-4V ELI per ASTM F136, while the associated instrumentation is manufactured from medical grade stainless steel per ASTM F899, A269, and F138, silicone, and polyphenylsulfone (PPSU). The screw system material is recognized by the FDA and cleared for implantation. The predicate device is also made from the same material cleared for implantation. The type and duration of patient contact (permanent >30 days) is identical to the predicate device. Steam sterilization, which is an industry standard for these types of implants and instruments, does not adversely affect the raw materials. Biocompatibility is therefore not adversely affected.
Clinical testing was not required for this device. Substantial equivalence to the predicate device was determined through comparison of mechanical testing results, indications and intended uses, and device function.
Substantial equivalence is supported by the results of mechanical testing including static and dynamic cantilever bending per ASTM F2193 and axial pullout, driving torque, and torsional strength per F543. Mechanical testing methods, data, and reports are provided in this submission.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.