(71 days)
The Emerge Medical Large Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone.
The Emerge Medical Small Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osetopenic bone.
The Emerge Medical Small and Large Non-Locking Fragment Plate System consists of stainless steel components. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The plates are provided non-sterile.
Here's a breakdown of the acceptance criteria and the study details for the Emerge Medical Small and Large Non-Locking Fragment Plate System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance (Test Results) |
|---|---|
| Strength sufficient for intended use. | The results of non-clinical testing show that the strength of the Emerge Medical Small and Large Non-Locking Fragment Plate System is sufficient for its intended use. |
| Substantially equivalent to legally marketed predicate devices in terms of strength. | The device is substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text describes non-clinical mechanical testing and does not refer to human subject data or a "test set" in the context of clinical trials or AI/algorithm performance. Therefore, details about sample size (patients/cases) or data provenance (country, retrospective/prospective) are not applicable here. The testing was performed on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Ground truth, in this context, would relate to the established standards or methods for evaluating the mechanical properties of bone plates. The text does not mention human experts involved in establishing a "ground truth" for the mechanical tests. The testing was performed according to a modification of a recognized standard (ASTM F382-99 (2008)).
4. Adjudication Method for the Test Set:
Not applicable, as this was mechanical testing, not a clinical study involving human assessment or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This is a medical device (bone plate) and the performance data consists of mechanical strength testing, not an assessment of human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical bone plate, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.
7. Type of Ground Truth Used:
The ground truth used for evaluating the device's performance was the modified ASTM F382-99 (2008) standard for dynamic four-point bending. This standard provides a recognized methodology for assessing the mechanical strength of bone fixation devices.
8. Sample Size for the Training Set:
Not applicable. This device is a physical bone plate, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of medical device.
In summary, the provided document focuses on the mechanical performance of a bone plating system, demonstrating its equivalence to existing predicate devices through non-clinical laboratory testing. The evaluation does not involve clinical studies with human participants, AI algorithms, or the associated concepts of test sets, training sets, or expert ground truth as typically applied in AI/clinical performance assessments.
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5.510(K) SUMMARY
| Submitter's Name: | Emerge Medical |
|---|---|
| Submitter's Address: | 720 S. Colorado Blvd.Suite 550-SDenver, CO 80246 |
| Submitter's Telephone: | (866) 553-0376 |
| Submitter's Fax: | (800) 698-1440 |
| Contact Name: | Michelle Potvin, Vice President of Quality Assurance |
| Contact's Telephone: | 720.459.6392 |
| Contact's Email: | michelle.potvin@emergemedical.com |
| Date Summary was Prepared: | November 15th, 2013 |
| Trade or Proprietary Name: | Emerge Medical Small and Large Non-Locking Fragment PlateSystem |
| Common or Usual Name: | Bone plating system |
| Classification: | Class II per 21 CFR §888.3030 |
| Product Codes: | HRS |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Synthes Small Fragment Dynamic Compression Locking(DCL) System (K000684)Synthes Modular Foot System (K001941)Synthes Large Fragment Locking Compression Plate (LCP) -T-Plate (K010766)Synthes 3.5mm Broad LC-DCP Plates (K020872)Synthes 3.5and 4.5mm Locking Compression Plate LCP with ExpandedIndications (K082807)Synthes 3.5 and 4.5 Curved Narrow and Broad LCP (K092609)Synthes Medial Distal Tibia Plates (K001945)Synthes Calcaneal Plate (K020401, K010518)Synthes Reconstructive Y-Plate (K792291)Synthes LCP Distal Tibia Plates (K013248)OrthoPro Ankle Trauma System (K122936) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The Emerge Medical Small and Large Non-Locking Fragment Plate System consists of stainless steel components. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The plates are provided non-sterile.
The device description for the Emerge Medical Small and Large Non-Locking Fragment Plate System is similar to that of the predicate devices listed above.
Emerge Medical Small and Large Non-Locking Fragment Plate System
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TECHNOLOGICAL CHARACTERISTICS
The fundamental scientific principles and technological characteristics, including the intended use, material, general design, and sizes of the device are equivalent to the predicate devices.
INDICATIONS FOR USE
The Emerge Medical Large Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone.
The Emerge Medical Small Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osetopenic bone.
The indications for use for the Emerge Medical Small and Large Non-Locking Fragment Plate System is similar to that of the predicate devices listed above.
PERFORMANCE DATA
The Emerge Medical Small and Large Non-Locking Fragment Plate System has been tested in the following test modes:
- Dynamic four-point bending per modified ASTM F382-99 (2008) .
The results of this non-clinical testing show that the strength of the Emerge Medical Small and Large Non-Locking Fragment 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 Emerge Medical Small and Large Non-Locking Fragment Plate System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
January 28, 2014
Emerge Medical, Incorporated Ms. Michelle Potvin Vice President of Quality Assurance 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246
Re: K133541
Trade/Device Name: Emerge Medical Small and Large Non-Locking Fragment Plate 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 Dated: January 7, 2014 Received: January 8, 2014
Dear Ms. Potvin:
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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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 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
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Vincent Javlin -S
for Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Since States and Charles of the Spirit
4. INDICATIONS FOR USE STATEMENT
Device Name: Emerge Medical Small and Large Non-Locking Fragment Plate System
The Emerge Medical Large Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone.
The Emerge Medical Small Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus. including in osetopenic bone.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth动公Frank -S
Division of Orthopedic Devices
Emerge Medical Small and Medium Bone Plate Line Extension
§ 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.