(133 days)
Not Found
No
The 510(k) summary describes a mechanical implant (intramedullary nail system) and does not mention any software, image processing, AI, or ML capabilities. The performance studies are mechanical and dimensional testing.
No.
The device, an intramedullary nail system, is intended for temporary stabilization of bone fractures and tumor resections, not for directly treating a disease or improving health.
No
The device is an intramedullary nail system intended for the temporary stabilization of long bone fractures; it does not diagnose medical conditions.
No
The device description explicitly states that the system consists of titanium alloy intramedullary nails, locking screws, and end caps, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures". This describes a surgical implant used to treat bone fractures.
- Device Description: The description details "titanium alloy intramedullary (IM) nails locking screws and end caps". These are physical components designed to be implanted in the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such testing.
The information provided describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones.
Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint.
Specific Humeral indications according to AO classification may include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The System consists of titanium alloy intramedullary (IM) nails locking screws and end caps. The rigid, cannulated IM nails are inserted into the medullary canal and available in a variety of styles and lengths with proximal and distal holes for locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones including the femur, tibia and humerus
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)
Dimensional analysis and mechanical testing (ASTM F-1264 and ASTM F-543) demonstrated that the device performs as well as or better than the predicate device. Clinical data were not needed to demonstrate substantial equivalence.
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.
K081152, K003018, K043404, K122489, K140119
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2014
Emerge Medical Ms. Michelle Potvin Vice President of Quality Assurance 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246
Re: K141347
Trade/Device Name: Emerge Medical IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 29, 2014 Received: September 2, 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 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
1
Page 2 – Ms. Michelle Potvin
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 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/Resourcesfor You/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 vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K141347
Device Name: Emerge Medical IM Nail System
Indications for Use:
The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones.
Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint.
Specific Humeral indications according to AO classification may include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.
| Prescription Use | X | or Over-The-Counter Use |
|---|---|---|
| (21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
| 510(k) Summary | |
|---|---|
| NAME OF FIRM: | Emerge Medical |
| 720 S. Colorado Blvd. | |
| Suite 550-S | |
| Denver, CO 80246 | |
| DATE PREPARED: | September 18, 2014 |
| 510(K) CONTACT: | Michelle Potvin |
| Vice President of Quality Assurance | |
| Tel: (720) 459-6392 | |
| PROPOSED TRADE NAME: | Emerge Medical IM Nail System |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 888.3020 |
| CLASSIFICATION NAME: | Intramedullary fixation rod |
| PRODUCT CODE: | HSB |
| DEVICE DESCRIPTION: | The System consists of titanium alloy intramedullary (IM) nails |
| locking screws and end caps. The rigid, cannulated IM nails are | |
| inserted into the medullary canal and available in a variety of styles | |
| and lengths with proximal and distal holes for locking screws. | |
| INDICATIONS FOR USE: | The Emerge Medical IM Nail System is intended to provide |
| temporary stabilization in long bones including the femur, tibia and | |
| humerus of various types of open or closed fractures including | |
| malunions, nonunions (pseudoarthrosis), correction osteotomy | |
| including malalignment, pathologic fractures, impending pathologic | |
| fractures, and tumor resections of specific bones. |
Specific Femoral indications may include supracondylar fractures
including those with intra-articular extension, Ipsilateral femur
fractures, fractures proximal to a total knee arthroplasty, and
fractures distal to a hip joint. |
| MATERIALS: | Specific Humeral indications according to AO classification may
include Type A-Fractures, dislocated, Type B Fractures, dislocated,
Type C-Fractures, with intact calotte, or Humeral Fractures
according to Neer-Classification.
Titanium alloy (ASTM F136) |
| PREDICATE DEVICES: | Stryker IM Nails (K081152, K003018, K043404);
Emerge Medical Screws (K122489, K140119) |
| TECHNOLOGIC CHARACTERISTICS: | The fundamental scientific principles and technological
characteristics, including the intended use, material, general
design, and sizes of the devices are equivalent to the predicate
devices. |
| PERFORMANCE DATA: | Dimensional analysis and mechanical testing (ASTM F-1264 and
ASTM F-543) demonstrated that the device performs as well as or
better than the predicate device. Clinical data were not needed to
demonstrate substantial equivalence. |