(55 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the implants and instruments, with no mention of AI or ML technology.
No
This device is a surgical implant designed for internal bone alignment and fixation of fractures, not a therapeutic device that delivers treatment or therapy.
No
The provided text describes a system of implants and instruments used for the internal alignment and fixation of bone fractures. This is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly states that the system consists of implants (plates and screws) and instruments, which are physical hardware components used for internal bone alignment and fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that the Emerge Medical Periarticular and Locking Large Fragment System is an implantable device used for the internal alignment and fixation of bone fractures. It is surgically implanted into the body.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures, fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions.
The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Emerge Medical Periarticular and Locking Large Fragment System consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia and femur. The system features four (4) types of plates (4.5mm Locking Proximal Tibia Plate, 4.5 Locking Condylar Plate, Locking 4.5mm Narrow and Broad Plate, Locking T-Plate), 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 stainless steel (ASTM F139), and offered in various widths, lengths, and thicknesses. 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
proximal tibia, distal femur, long bones (humerus, femur, tibia), proximal humerus, medial tibial plateau, distal tibia
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 Emerge Medical Periarticular and Locking Large Fragment System were evaluated via finite element analysis (FEA) demonstrative the predicate was the worst case scenario. The folloing test modes were emulated on the worst-case plates and screws through FEA:
- Static four-point bending per ASTM F382-99 .
- Dynamic four-point bending per ASTM F382-99 .
- Static screw pull-out per ASTM F543-13 .
- Static torsion per ASTM F543-13 .
The results of this non-clinical testing show that the strength of the Emerge Medical Periarticular and Locking Large Fragment 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.
K082807, K000682, K041911, K000066, K110354, K083025, K062564, K010766, K011978, K002361, K983787
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
MAR 1 Z 2014
K140119 page 1 of 3
| Submitter: | Emerge Medical |
|---|---|
| Submitter's Name: | Michelle Potvin, Vice President of Quality Assurance |
| michelle.potvin@emergemedical.com | |
| Submitter's Address: | 720 S. Colorado Blvd. |
| Suite 550-S | |
| Denver, CO 80246 | |
| Submitter's Telephone: | 720.459.6392 |
| Submitter's Fax: | (800) 698-1440 |
| Contact Person: | Meredith L. May MS, RAC |
| 719.337.7579 | |
| MMay@EmpiricalTesting.com | |
| Date Summary was Prepared: | 15 January 2014 |
| Trade or Proprietary Name: | Emerge Medical Periarticular and Locking Large Fragment |
| 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 and §888.3040 |
| Product Code: | HRS and HWC |
| Classification Panel: | Division of Orthopedic Devices |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Emerge Medical Periarticular and Locking Large Fragment System consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia and femur. The system features four (4) types of plates (4.5mm Locking Proximal Tibia Plate, 4.5 Locking Condylar Plate, Locking 4.5mm Narrow and Broad Plate, Locking T-Plate), 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 stainless steel (ASTM F139), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.
TECHNOLOGICAL CHARACTERISTICS
The Emerge Medical Periarticular and Locking Large Fragment System has the same or similar design, sizes, indications for use, and materials as the predicate systems. The sizes differ slightly, but present no new risks.
INDICATIONS FOR USE
The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems:
1
The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions.
The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.
The Emerge Medical Periarticular and Locking Large Fragment System is not intended for use with 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 is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The indication for use for the Emerge Medical Periarticular and Locking Large Fragment System is similar to that of the predicate devices listed in Table 5-1 Predicate Devices.
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K082807 | 3.5mm and 4.5mm Locking Compression Plate (LCP) | |
| System with Expanded Indications | Synthes | |
| K000682, K041911 | Locking Fragment Dynamic Compression Locking (DCL) | |
| System, LCP Curved Plates | Synthes | |
| K000066 | Locking Condylar Plate (LCP) System | Synthes |
| K110354, K083025 | 4.5mm VA-LCP Curved Condylar Plate System | Synthes |
| K062564 | LCP Distal Femur Plate | Synthes |
| K010766 | Large Fragment Locking Compression Plate (LCP) System |
- T Plate | Synthes |
| K011978, K002361,
K983787 | LCP Proximal Tibia Plate, Locking Proximal Tibia Plating
(L-PTP) System, Proximal Tibia Plating System | Synthes |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Emerge Medical Periarticular and Locking Large Fragment System were evaluated via finite element analysis (FEA) demonstrative the predicate was the worst case scenario. The folloing test modes were emulated on the worst-case plates and screws through FEA:
2
- Static four-point bending per ASTM F382-99 .
- Dynamic four-point bending per ASTM F382-99 .
- Static screw pull-out per ASTM F543-13 .
- Static torsion per ASTM F543-13 .
The results of this non-clinical testing show that the strength of the Emerge Medical Periarticular and Locking Large Fragment 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 Emerge Medical Periarticular and Locking Large Fragment System is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2014
Emerge Medical %.Ms. Meredith May MS. RAC Senior Manager Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K140119
Trade/Device Name: Emerge Medical Periarticular and Locking Large Fragment System 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: January 15, 2014 Received: January 16, 2014
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
4
Page 2 - Ms. Meredith May
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); 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
hup://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html 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/Safetv/RcportalProblem/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.
Sincerely yours.
Lori A. Wiggins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K140119
| 4. INDICATIONS FOR USE STATEMENT | |
|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
| Expiration Date: December 31, 2013 | |
| See PRA Statement on last page. | |
| Indications for Use | |
| 510(k) Number (if known) | K140119 |
| Device Name | Emerge Medical Periarticular and Locking Large Fragment System |
| Indications for Use (Describe) | |
| The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems: | |
| The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures, fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions. | |
| The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions. | |
| 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) | |
| Elizabeth LFB/ank -S | |
| Division of Orthopedic Devices | |
| FORM FDA 3881 (9/13) | PBC Publishing Bervices (301) 443-8740 EF |
Emerge Medical Periarticular and Locking Large Fragment System
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