(84 days)
Not Found
No
The description focuses on the mechanical components and materials of an external fixation system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use to provide treatment for long bone and pelvic fractures that require external fixation," which directly points to a therapeutic purpose.
No
The Emerge External Fixation system is a treatment device, not a diagnostic one. It is used to stabilize fractures and soft tissues, perform osteotomies, manage non-unions, and assist with reductions and bone transport, all of which are treatment-oriented actions. There is no mention of it being used to detect, identify, or monitor a medical condition.
No
The device description explicitly lists physical components such as clamps, rods, pins, and screws, all fabricated from medical-grade materials, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the mechanical stabilization and treatment of bone fractures and related conditions. This is a surgical/orthopedic device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details components like clamps, rods, pins, and screws made from materials like stainless steel and titanium. These are typical components of external fixation systems used in surgery.
- 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 health status based on in vitro testing.
In summary, the Emerge External Fixation System is a medical device used for surgical treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The system can be used for:
Stabilization of soft tissues and fractures
Polytrauma/multiple orthopedic trauma
Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
Arthrodeses and osteotomies with soft tissue problems; failures of total joints
Neutralization of fractures stabilized with limited internal fixation
Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction
Unilateral rectilinear bone segment transport or leg lengthening
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone and pelvic
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)
Performance testing was conducted per ASTM 1451-02 (2001). In all instances, the Emerge External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device.
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.
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
510(k) SUMMARY Emerge Medical External Fixation System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: Emerge Medical, Inc.
720 S Colorado Blvd., Suite 550-S Denver. CO 80246
Contact Person:
JUN 1 0 2014
Michelle Potvin, Vice President of Quality Assurance Phone: 720-459-6392 Facsimile: 800-698-1440 Email: Michelle.Potvin@EmergeMedica.com
Date Prepared:
March 14, 2014
Common or Usual Name: Emerge External Fixation System Device Classification: Class II; 21 CFR 888.3030
Classification Name:
Single/multiple component metallic bone fixation appliances and accessories
Product Code: KTT
Device Description:
The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.
Indications For Use:
The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The system can be used for:
Stabilization of soft tissues and fractures
Polytrauma/multiple orthopedic trauma
Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints
Neutralization of fractures stabilized with limited internal fixation
Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening
6-1
1
510(k) SUMMARY Emerge Medical External Fixation System
Predicate Device:
Synthes: Large External Fixation, MR Conditional (K082650)
Performance Data:
Performance testing was conducted per ASTM 1451-02 (2001). In all instances, the Emerge External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device.
Technological Characteristics and Substantial Equivalence:
The Emerge External Fixation System is substantially equivalent to the legally marketed predicate, K082650, based on intended use, basic design, materials, sizing and performance. The systems utilize the same principles of operation allowing for unilateral, stacked, bilateral or modular frame configurations.
The systems contain similar components including large combination clamp (rod to pin clamp), rod-to-rod clamp. rods, pins. and Schanz screws: but have slight geometric differences in clamp designs. The large combination clamp and the rod-to rod clamp of the subject device use different geometrical features to lock the rotation of the clamp bodies with respect to each other when compared to the same style predicate clamps. Additionally, the subject and predicate devices have different shaped clamp body styles.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions, positioned to the right. To the left of the figure, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2014
Emerge Medical, Incorporated Ms. Michelle Potvin Vice President of Quality Assurance 720 South Colorado Boulevard Suite 550-S Denver, Colorado 80246
Re: K140675
Trade/Device Name: Emerge External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 27, 2014 Received: March 28, 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 reguirements 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 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Michelle Potvin
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,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known) | K140675 | ||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Device Name: Emerge External Fixation System
Indications for Use:
The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The system can be used for:
Stabilization of soft tissues and fractures Polytrauma/multiple orthopedic trauma Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening
Prescription Use × (Part 21 CFR 801 Subpart D)
OR
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)
なる。
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices