(126 days)
Not Found
No
The description focuses on the mechanical components (plates, screws, instruments) and their material properties and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an implant system for fixation of bones and bone fragments, which is a structural support device rather than a device intended to treat or cure a disease or condition.
No
Explanation: The device is an implantable system for fracture fixation and osteotomies, not for diagnosing medical conditions. Its intended use is to provide fixation and stability to bones and bone fragments.
No
The device description explicitly states it consists of implants (plates and screws) and instruments, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bones and bone fragments in the foot and ankle. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of implants (plates and screws) and instruments for surgical installation and removal. This is consistent with a surgical fixation system, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically stabilize bone structures.
N/A
Intended Use / Indications for Use
The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Eminent Foot Plate System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features twenty four (24) types of plates (Evans, Metatarsal, Metatarsal Left, Metatarsal Right, Metatarsal Step Left, Metatarsal Step Right, PMO Right, PMO Right, PMO Wedge Left, PMO Wedge Right, Osteotomy Left, Osteotomy Right, Osteotomy Wedge Left, Osteotomy Wedge Right, Osteotomy L Left, Osteotomy L Right, Peanut Slotted, Utility, Utility Long, Lis' Franc, Calcaneus, Calcaneus Long, and Forefoot H), bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade titanium (ASTM F136), and offered in various widths and lengths. Plates and screws are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.
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)
The Eminent Foot Plate System has been tested in the following test modes:
- Static Three-point Bending Test per ASTM F382
- Dynamic Three-point Bending Test per ASTM F382
- Torsion Testing per ASTM F543
- Static Axial Pullout Test per ASTM F543
The results of this non-clinical testing show that the strength of the Eminent Foot Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
K131722, K071105, K091614, K131445, K133437
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
Eminent Spine % Ms. Meredith May Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K143365
Trade/Device Name: Eminent Foot Plate Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 20, 2015 Received: February 25, 2015
Dear Ms. May:
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
1
Page 2 - Ms. Meredith May
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. | |
| Indications for Use | |
| 510(k) Number (if known) | |
| Device Name | |
| Eminent Foot Plate System | |
| Indications for Use (Describe) | |
| The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle. | |
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| FORM FDA 3881 (9/13) | |
| Page 1 of 2 | PSC Publishing Services (301) 443-6740 EF |
3
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."
FORM FDA 3881 (9/13)
Page 2 of 2
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5.510(K) SUMMARY
| Submitter's Name: | Eminent Spine |
|---|---|
| Submitter's Address: | 7200 N. IH 35 Bldg. #1 |
| Georgetown, TX 78626 | |
| Submitter's Telephone: | 512.868.5980 |
| Contact Person: | Meredith L. May MS, RAC |
| Empirical Consulting LLC | |
| 719.337.7579 | |
| Date Summary was Prepared: | 04-Nov-14 |
| Trade or Proprietary Name: | Eminent Foot Plate System |
| Common or Usual Name: | Single/multiple component metallic bone fixation |
| appliances and accessories (§888.3030) | |
| Smooth or threaded metallic bone fixation fastener | |
| (§888.3040) | |
| Classification: | Class II per 21 CFR §888.3030 |
| Class II per 21 CFR §888.3040 | |
| Product Code: | HRS, HWC |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Eminent Foot Plate System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features twenty four (24) types of plates (Evans, Metatarsal, Metatarsal Left, Metatarsal Right, Metatarsal Step Left, Metatarsal Step Right, PMO Right, PMO Right, PMO Wedge Left, PMO Wedge Right, Osteotomy Left, Osteotomy Right, Osteotomy Wedge Left, Osteotomy Wedge Right, Osteotomy L Left, Osteotomy L Right, Peanut Slotted, Utility, Utility Long, Lis' Franc, Calcaneus, Calcaneus Long, and Forefoot H), bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade titanium (ASTM F136), and offered in various widths and lengths. Plates and screws are provided non-sterile.
INDICATIONS FOR USE
The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.
CONTRAINDICATIONS
Active or latent infection. Osteoporosis, insufficient quantity or quality of bone/soft tissue. Material sensitivity. If suspected, tests should be performed prior to implantation. Sepsis. Patients who are unwilling or incapable of following postoperative care instructions. This device
5
is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:
- . Indications for Use
- Materials of manufacture ●
- Structural support mechanism ●
- . Principles of Operation
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Type |
|---------------------------------------|---------------------------------------|--------------|------------|
| K131722 | Extremity Fixation Systems | I.T.S. | Primary |
| K071105, K091614,
K131445, K133437 | FPS – Foot Plate System | Osteomed | Additional |
Performance Data
The Eminent Foot Plate System has been tested in the following test modes:
- . Static Three-point Bending Test per ASTM F382
- Dynamic Three-point Bending Test per ASTM F382 ●
- . Torsion Testing per ASTM F543
- . Static Axial Pullout Test per ASTM F543
The results of this non-clinical testing show that the strength of the Eminent Foot Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Eminent Foot Plate System is substantially equivalent to the predicate device.