(103 days)
Not Found
No
The description focuses on mechanical components and an external remote controller for non-invasive lengthening, with no mention of AI or ML.
Yes
The device is used for fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones, which are medical conditions that restore function to a diseased or injured body part.
No
This device is a trauma nail system for fracture fixation and lengthening of bones, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including an implantable rod, locking screws, an external remote controller (ERC), and surgical tools. It is a system with both hardware and software (implied by the ERC's function).
Based on the provided information, the Ellipse PRECICE Trauma Nail System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones." This describes a surgical procedure to treat bone conditions, not a test performed on samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The device is an implantable intramedullary rod, locking screws, and an external controller used for mechanical lengthening. This is a medical device used for treatment, not for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ellipse PRECICE Trauma Nail System is clearly an in vivo (within the body) device used for surgical treatment.
N/A
Intended Use / Indications for Use
The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
Product codes
HSB
Device Description
The Ellipse PRECICE Trauma Nail System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The PRECICE Actuator is supplied sterile by gamma sterilization while the PRECICE Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use.
The External Remote Controller (ERC) is a non-invasive adjustment component of the system. The ERC is electrically powered and is used for non-invasive lengthening of the implanted rod.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
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)
Not Found
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.
Ellipse PRECICE Intramedullary Limb Lengthening System (K101997), Synthes Distraction Osteogenesis Ring System (K092190), Smith and Nephew Trigen Meta-Nail Femoral and Tibial (K061019)
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
: :
March 2012 Product Code: HSB
510(K) SUMMARY
Ellipse PRECICE Trauma Nail System 510(k) Summary - K TBD December 2011
- Ellipse Technologies, Incorporated 1. Company: 13900 Alton Parkway, Suite 123 Irvine, CA 92618
- John McIntyre Contact: Vice President, RA/QA/CA
Proprietary Trade Name: Ellipse PRECICE Trauma Nail System 2.
- Classification Name: Rod, Fixation, Intramedullary and Accessories 3.
(21 CFR 888.3020)
Product Code: HSB 4.
ડ. Product Description:
The Ellipse PRECICE Trauma Nail System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The PRECICE Actuator is supplied sterile by gamma sterilization while the PRECICE Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use.
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
Page 5
(pg 1/3)
1
The External Remote Controller (ERC) is a non-invasive adjustment component of the system. The ERC is electrically powered and is used for non-invasive lengthening of the implanted rod.
Indications 6.
The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
7. Substantial equivalence
Documentation demonstrates substantial equivalence to the following devices:
- Ellipse PRECICE Intramedullary Limb Lengthening System (K101997) .
- . Synthes Distraction Osteogenesis Ring System (K092190)
- Smith and Nephew Trigen Meta-Nail Femoral and Tibial (K061019) .
The purpose of this premarket notification is to provide labeling for this system for use in fracture fixation of long bones. Specifically, the following indication is included in the instructions for use:
The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
Substantial equivalence is based on similar indications for use to both the Smith and Nephew Trigen Meta-Nail and Synthes Distraction Osteogenesis Ring System predicate devices and similar technological characteristics to the Ellipse PRECICE IMLL System, Smith and Nephew Trigen Meta-Nail and Synthes Distraction Osteogenesis Ring System predicates.
The Ellipse PRECICE Trauma Nail System is identical to the Ellipse PRECICE IMLL System, with the exception that the Ellipse PRECICE Trauma Nail is provided extended by approximately 10 mm to allow for compression fracture fixation techniques. Specifically, the Ellipse PRECICE Trauma Nail System and the Ellipse PRECICE IMLL System are both designed to be implanted into the medullary canal of the long bones. These devices are available in a variety of geometrical configurations and diameters and lengths to accommodate a variety of
Page 6
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
2
Ellipse Technologies, Inc. Ellipse PRECICE™ Trauma Nail System Premarket Notification K113695 Response to telephone hold dated March 2, 2012
March 2012 Product Code: HSB
patient anatomies. Both devices are designed as a telescoping rod that can be adjusted in length non-invasively with the use of the ERC.
Review of the product designs and of the labeling demonstrate the equivalence of the Ellipse PRECICE Trauma Nail System to the predicate devices.
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 8 2012
Ellipse Technologies, Inc. % Mr. John McIntyre Vice President, RA/QA/CA 13900 Alton Parkway, Suite 123 Irvine, CA 92618
Re: K113695
Trade/Device Name: Ellipse PRECISE Trauma Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 23, 2012 Received: March 26, 2012
Dear Mr. McIntyre:
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 (reporting of medical
4
Page 2 - Mr. John McIntyre
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,
yours,
{
Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ellipse Technologies, Inc. Ellipse PRECICE™ Trauma Nail System Premarket Notification K113695 Response to telephone hold dated March 2, 2012
March 2012 Product Code: HSB
K113695 (pg 1/1)
510(k) Number: K113695
Device Name: Ellipse PRECICE Trauma Nail System
Indications for Use: The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
Indications for Use
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _
Page 18 of 20
(Diyision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113695
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.