(72 days)
The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4) Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed previous fusions.
The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The REMEDY Cervical Plate System implant components are made from titanium alloy described by ASTM F136.
The REMEDY™ Cervical Plate System is a medical device designed for anterior interbody screw/plate fixation in the cervical spine. The device's acceptance criteria and the study proving its performance are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the REMEDY™ Cervical Plate System are based on demonstrating substantial equivalence to existing predicate devices through non-clinical mechanical testing, adhering to ASTM F1717 standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static Axial Compression Bending per | Demonstrated substantial equivalence to predicate devices, showing comparable or superior performance in Static Axial Compression Bending. |
| ASTM F1717 | |
| Dynamic Axial Compression Bending per | Demonstrated substantial equivalence to predicate devices, showing comparable or superior performance in Dynamic Axial Compression Bending. |
| ASTM F1717 | |
| Static Torsion Tests per ASTM F1717 | Demonstrated substantial equivalence to predicate devices, showing comparable or superior performance in Static Torsion Tests. |
| Material: | Made from titanium alloy described by ASTM F136, which is consistent with predicate devices. |
| Use of titanium alloy (ASTM F136) | |
| Indications for Use: | Identical indications for use as the predicate devices. |
| Identical to predicate device | |
| Principles of Operation: | Employs the same principles of operation as the predicate devices. |
| Same as predicate device | |
| Physical Characteristics: | Prominence on the spine, range of sizes, and screw angulation are at or within the limits of the predicate devices. |
| Prominence, size range, screw angulation within limits of predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical tests (mechanical testing) for the device. For such tests, the "sample size" refers to the number of device samples (plates, screws, and system constructs) subjected to each specific test. The document does not specify the exact number of samples used for each test (e.g., how many plates were tested for static axial compression bending). However, adherence to ASTM F1717 typically involves testing multiple samples to establish statistical validity for the specified mechanical properties.
The data provenance is from laboratory testing, specifically mechanical tests conducted under controlled conditions to simulate physiological loads. There is no information regarding country of origin for the data, but it is standard for medical device testing to follow internationally recognized standards like ASTM. This is a prospective test in the sense that the new device was fabricated and then tested to meet defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to the provided device description. The REMEDY™ Cervical Plate System is a physical medical device (an implantable plate system), not a diagnostic algorithm or imaging device that requires expert interpretation to establish a "ground truth" for a test set. The performance is assessed through objective mechanical testing against established industry standards (ASTM F1717) and comparison to predicate devices, not through expert consensus on medical cases.
4. Adjudication Method for the Test Set
This section is not applicable as the device is a physical implant and its performance is determined by objective mechanical testing, not by human interpretation or clinical adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The REMEDY™ Cervical Plate System is a surgical implant, not a diagnostic tool or AI-assisted system that would involve human readers or image interpretation. Therefore, an MRMC comparative effectiveness study is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The REMEDY™ Cervical Plate System is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the REMEDY™ Cervical Plate System is based on established mechanical performance standards and material specifications as defined by ASTM F1717 and ASTM F136, respectively. The performance of the device samples in various mechanical tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion) serves as the "truth" against which the claims of substantial equivalence to predicate devices are made. The comparative performance against predicate devices, which have a history of safe and effective use, also forms part of this "ground truth."
8. The sample size for the training set
This section is not applicable. As a physical medical device, the REMEDY™ Cervical Plate System does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing process are informed by engineering principles, material science, and the performance characteristics of existing predicate devices, rather than a data-driven training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8. There is no "training set" or corresponding "ground truth" in the context of this physical medical device. The "ground truth" for its design and manufacturing would conceptually relate to foundational engineering principles, biomaterial science, and the performance history of similar devices.
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REMEDY™ Cervical Plate System
510(K) SUMMARY
| Submitter | ArchiMed Inc.50 W 3rd AveCollegeville, PA 19426(800) 991-4559 | Date: | April 7, 2010 |
|---|---|---|---|
| Contact: | Barry AikenArchiMed Inc50 W 3rd AveCollegeville, PA 19426 | ||
| Trade Name | REMEDY™ Cervical Plate System | ||
| Common Name | Cervical Plating Instrumentation | APR - 7 2010 | |
| Classification | KWQ – 888.3060Class II, Spinal Intervertebral Body Orthosis | ||
| Device Description | The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates,screws, and associated instruments. Fixation is provided by bone screws inserted into thevertebral body of the cervical spine using an anterior approach. The REMEDY CervicalPlate System implant components are made from titanium alloy described by ASTM F136. | ||
| Indications for Use | The REMEDY Cervical Plate System is intended for anterior interbody screw/plate fixationfrom C2 to T1. The system is indicated for use in the temporary stabilization of the anteriorspine during the development of cervical spinal fusions in patients with: 1) Degenerative DiscDisease (as defined by neck pain of discogenic origin with degeneration of the disc confirmedby patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4)Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failedprevious fusions. | ||
| WARNING: This device is not intended for screw attachment to the posterior elements(pedicles) of the cervical, thoracic, or lumbar spine. | |||
| Non-Clinical Tests | Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static TorsionTests per ASTM F1717 demonstrate the REMEDY Cervical Plate System is substantiallyequivalent to the predicate devices. | ||
| Predicate Devices | The REMEDY Cervical Plate System has identical indications for use, material, and employsthe same principles of operation as predicate devices. Furthermore, its prominence on thespine, range of sizes, and screw angulation are at or within the limits of the predicate devices.Based on these factors, the REMEDY Cervical Plate System is Substantially Equivalent tothe predicate devices. | ||
| Device | Company | 510(k) Number | |
| Atlantis Vision | Medtronic | K021461 | |
| Venture | Medtronic | K042922 | |
| Premeir | Medtronic | K992110 | |
| Zephir | Medtronic | K030327 | |
| Skyline | Depuy | K052552 | |
| Uniplate | Depuy | K042544 | |
| Swift | Depuy | K040655 | |
| Reflex Hybrid | Stryker Spine | K040261 | |
| Trinica Select | Zimmer | K022344 | |
| Providence | Globus | K070775 |
Vectra-T
Pyrenees
Helix ACP
Gradient Plus
CSLP
Synthes Spine
Synthes Spine
: 彩
K2M
Nuvasive
Nuvasive
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a sans-serif font and is black. To the left of the text is a symbol that appears to be three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
ArchiMed, Inc. % Mr. Barry Aiken Chief Financial Officer 50 West 3rd Avenue Collegeville, Pennsylvania 19426
APR - 7 2010
Re: K100215
Trade/Device Name: REMEDY™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 19, 2010 Received: January 25, 2010
Dear Mr. Aiken:
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. 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
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Page 2 - Mr. Barry Aiken
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Singerely yours.
Mark N. Melkersor Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K100215 |
|---|---|
| Device Name: | REMEDY™ Cervical Plate System |
| Indications for Use: | The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: |
| 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), | |
| 2) Trauma (including fractures), | |
| 3) Tumors, | |
| 4) Deformity (defined as kyphosis, lordosis, or scoliosis), | |
| 5) Pseudarthrosis, and/or | |
| 6) Failed previous fusions. | |
| Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. |
X Prescription Use (Part 21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIDOZIS 510(k) Number_
N/A