(353 days)
Not Found
No
The description focuses on mechanical and electrical components for limb lengthening and does not mention any AI or ML capabilities.
Yes
The device is used for limb lengthening of the tibia and femurs, which is a therapeutic intervention aimed at treating a physical condition.
No.
The device is used for limb lengthening by non-invasively adjusting an implanted rod, not for diagnostically identifying a medical condition.
No
The device description explicitly lists multiple hardware components including an implantable intramedullary rod, locking screws, an external remote controller (ERC), and surgical implantation tools and accessories.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "limb lengthening of the tibia and femurs." This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is an "implantable intramedullary rod," "locking screws," and an "external remote controller." These are all components used in a surgical and post-surgical process for physical manipulation of bone, not for analyzing biological samples.
- Anatomical Site: The anatomical sites are "tibia and femurs," which are bones within the body. IVDs typically analyze samples like blood, urine, tissue, etc.
- No mention of biological samples or analysis: The entire description focuses on the mechanical aspects of the device and its use in lengthening bone. There is no mention of collecting or analyzing any biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Ellipse PRECICE Intramedullary Limb Lengthening 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 rod is available 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 IMLL 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. The ERC can be used by the physician or by the patient in the home environment to perform lengthening.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia and femurs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or patient in the home environment
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)
Substantial equivalence is focused on the Home Use aspect of the ERC. Testing includes a usability evaluation for the Home Use of the ERC by the patient, minimum rated voltage testing, shock and vibration testing, and ingress protection testing performed in accordance with IEC 60601-1-11;2010. The results of testing demonstrate that the Ellipse PRECICE IMLL System that is the subject of this premarket notification is substantially equivalent to the predicate device.
Usability evaluation: 30 subjects were used to evaluate the usability of the ERC in an equivalent patient population.
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
§ 888.3020 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
Ellipse Technologies, Inc. Ellipse PRECICE Intramedullary Limb Lengthening System Home Use of the External Remote Controller Original 510(k) Application
Ocotber 2011 Product Code: HSB
510(K) SUMMARY ** 6.
OCT 19 2012
Ellipse Intramedullary Limb Lengthening System 510(k) Summary - K TBD October 2011
- Ellipse Technologies, Incorporated Company: 13900 Alton Parkway, Suite 123 Irvine, CA 92618
Contact: John McIntyre Vice President, RA/QA/CA
-
Proprietary Trade Name: Ellipse PRECICE Intramedullary Limb Lengthening System
-
Classification Name: Rod, Fixation, Intramedullary and Accessories
(21 CFR 888.3020)
Product Code: HSB 4.
રે. Product Description:
The Ellipse PRECICE Intramedullary Limb Lengthening 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 rod is available 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
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
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PRECICE IMLL 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. The ERC can be used by the physician or by the patient in the home environment to perform lengthening.
6. Indications
The Ellipse PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.
7. Substantial equivalence
Documentation demonstrates substantial equivalence to the Ellipse Intramedullary Limb Lengthening System cleared under K101997 (cleared on July 12, 2011). The purpose of this premarket notification is to include additional labeling materials for the Home Use of the ERC by the patient. Therefore, data provided in this submission only includes information relevant to the Home Use of the ERC by the patient. Substantial equivalence is based on similar indications for use, designs, in vitro testing, and Usability evaluations performed. The in vitro evaluations included specific tests performed on the ERC to demonstrate the suitability of the ERC for use in the home by the patient. In addition, Usability evaluation of the ERC in a representative population was performed to demonstrate its suitability for use in the proposed patient population and in accordance with the indications.
With the exception of the Home Use of the External Remote Controller by the patient, the implant and the accessories to the system are identical between the Ellipse PRECICE IMLL System and the predicate described in K101997.
No changes in the design of the implant are included in this premarket submission. Specifically, the Ellipse PRECICE IMLL System and the predicate devices are both
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
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designed to be implanted into the medullary canal of the femur or tibia. These devices are available in a variety of geometrical configurations and diameters/lengths to accommodate a variety of patient anatomies. Both devices are designed as a telescoping rod that can be lengthened non-invasively with the use of the ERC.
The Ellipse PRECICE IMLL System was developed and evaluated in accordance with recognized standards and with in-house developed test methodologies. This testing includes risk assessment of the device specific to the home use, additional testing to applicable IEC standards for home use of medical electrical systems for use in the home healthcare environment, and a usability study undertaken on 30 subjects to evaluate the usability of the ERC in an equivalent patient population. Risk analysis for the home use of the device, labeling for the home use of the ERC, and test results are included in this premarket notification. The results of testing demonstrate that the Ellipse PRECICE IMLL System that is the subject of this premarket notification is substantially equivalent to the predicate device.
The following documentation and testing have been included in order to establish equivalence to the predicate device. Substantial equivalence is focused on the Home Use aspect of the ERC. Testing includes a usability evaluation for the Home Use of the ERC by the patient, minimum rated voltage testing, shock and vibration testing, and ingress protection testing performed in accordance with IEC 60601-1-11;2010. The following tests have been performed in order to establish equivalence to the predicate device:
| Test/Document Description | Applicable test standard |
|---|---|
| Risk Management Report | EN ISO 14971:2007 |
| Minimum rated voltage testing | IEC 60601-1-11:2010 |
| Shock and Vibration Testing | IEC 60601-1-11:2010 |
| Ingress protection | IEC 60601-1-11:2010 |
| Usability evaluation | n/a |
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 19 2012
Ellipse Technologies, Inc. % Mr. John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K113219
Trade/Device Name: Ellipse PRECICE Intramedullary Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 28, 2012 Received: October 1, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. John McIntyre .
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/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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
KI13219 510(k) Number: Unknown
Device Name: Ellipse PRECICE Intramedullary Limb Lengthening System
Indications for Use: The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.
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)
Adb
Page 1 of
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113219
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
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