K Number
K131490
Device Name
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Date Cleared
2014-01-23

(245 days)

Product Code
Regulation Number
888.3020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
Device Description
The Ellipse PRECICE System is composed of an 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 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 second generation External Remote Controller (ERC 2P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 2P is an electrically powered handheld unit. The ERC 2P contains two large rareearth magnets that are rotated using gears. After the rod has been implanted into the patient, the external device can be placed over the actuator portion of the implant and activated. When activated, the magnets within the ERC 2P rotate, which causes the magnet in the implantable device to rotate, lengthening or shortening the rod. Periodic lengthening (typically daily) of the rod is performed after the primary implantation surgery to lengthen the limb. The physician writes the patient prescription on an SD card which is placed in the ERC 2P. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis.
More Information

No
The device description focuses on mechanical and magnetic principles for limb lengthening, and there is no mention of AI or ML in the provided text.

Yes
The device is indicated for limb lengthening of the tibia and femur, which is a therapeutic intervention.

No.

The device is designed for limb lengthening by adjusting an implanted rod, not for diagnosing medical conditions. While x-rays are used to confirm the distraction, the device itself does not perform any diagnostic function.

No

The device description clearly outlines multiple hardware components including an implantable rod, locking screws, and an external remote controller (ERC 2P), which is an electrically powered handheld unit. While there is mention of software validation, the device is fundamentally a system with significant hardware components.

Based on the provided information, the Ellipse PRECICE System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is "limb lengthening of the tibia and femur." This is a surgical procedure performed directly on the patient's body.
  • Device Description: The device is an implantable rod and an external controller used to physically lengthen the bone. It does not involve testing samples of human origin (like blood, urine, tissue, etc.) outside of the body to provide diagnostic information.
  • Function: The device's function is mechanical manipulation of bone, not diagnostic testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Ellipse PRECICE System does not fit this definition.

N/A

Intended Use / Indications for Use

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

Product codes

HSB

Device Description

The Ellipse PRECICE System is composed of an 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 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 second generation External Remote Controller (ERC 2P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 2P is an electrically powered handheld unit. The ERC 2P contains two large rare-earth magnets that are rotated using gears. After the rod has been implanted into the patient, the external device can be placed over the actuator portion of the implant and activated. When activated, the magnets within the ERC 2P rotate, which causes the magnet in the implantable device to rotate, lengthening or shortening the rod. Periodic lengthening (typically daily) of the rod is performed after the primary implantation surgery to lengthen the limb. The physician writes the patient prescription on an SD card which is placed in the ERC 2P. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis.

The ERC 2P was designed to improve ergonomic handling and user interfaces, and has the same methods and principles of operation as the first generation ERC. The ERC 2P incorporates the controller and hand piece into one unit, to be more ergonomic and user friendly. The ERC 2P contains a camera and colored LCD-display screen to assist the patient in proper alignment with the implant location.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tibia and Femur

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home environment (patient), office (physician).

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 based on similar indications for use, designs, in vitro testing, software validation, and Usability and labeling readability evaluations performed. The in vitro evaluations included specific tests performed on the ERC 2P to demonstrate the suitability of the device for its intended use, and electrical safety and electromagnetic compatibility tests. Usability evaluation of the ERC 2P in a representative population was performed to demonstrate its suitability for use by the proposed patient population in the home environment and in accordance with the indications.

The second generation ERC for the Ellipse PRECICE 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, testing to applicable IEC standards, and a usability study undertaken on 15 participants to evaluate the usability of the ERC 2P in an equivalent patient population. Risk analysis, draft labeling, and test results are included in this premarket notification. The results of testing demonstrate that the ERC 2P for the Ellipse PRECICE System that is the subject of this premarket notification is substantially equivalent to the predicate External Remote Controller device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101997

Reference Device(s)

K113219

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

August 2013 Product Code: HSB

510(K) SUMMARY OR 510(K) STATEMENT

JAN 2 3 2014

Ellipse PRECICE® System 510(k) Summary - K131490 July 2013

Company:

Eilipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618 Phone: (949) 837-3600 Fax: (949) 837-3664

FDA Establishment Registration No: 3006179046

Contact: John McIntyre Vice President, RA/QA/CA

Proprietary Trade Name: Ellipse PRECICE® System

Common Name: Intramedullary Fixation Rod

Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)

Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)

Product Description:

The Ellipse PRECICE System is composed of an 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 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 second generation External Remote Controller (ERC 2P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The

1

August 2013 Product Code: HSB

ERC 2P is an electrically powered handheld unit. The ERC 2P contains two large rareearth magnets that are rotated using gears. After the rod has been implanted into the patient, the external device can be placed over the actuator portion of the implant and activated. When activated, the magnets within the ERC 2P rotate, which causes the magnet in the implantable device to rotate, lengthening or shortening the rod. Periodic lengthening (typically daily) of the rod is performed after the primary implantation surgery to lengthen the limb. The physician writes the patient prescription on an SD card which is placed in the ERC 2P. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis.

Indications:

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

Substantial Equivalence:

Documentation demonstrates substantial equivalence to the Ellipse System cleared under K101997 (cleared on July 12, 2011) and K113219 (cleared on October 19, 2012). The purpose of this premarket notification is to include a second generation External Remote Controller (ERC 2P) into the PRECICE® system. Data provided in this submission includes information relevant to the second generation ERC (ERC 2P). Substantial equivalence is based on similar indications for use, designs, in vitro testing, software validation, and Usability and labeling readability evaluations performed. The in vitro evaluations included specific tests performed on the ERC 2P to demonstrate the suitability of the device for its intended use, and electrical safety and electromagnetic compatibility tests. Usability evaluation of the ERC 2P in a representative population was performed to demonstrate its suitability for use by the proposed patient population in the home environment and in accordance with the indications.

The ERC 2P was designed to improve ergonomic handling and user interfaces, and has the same methods and principles of operation as the first generation ERC. The ERC 2P incorporates the controller and hand piece into one unit, to be more ergonomic and user friendly. The ERC 2P contains a camera and colored LCD-display screen to assist the

2

patient in proper alignment with the implant location. The second generation ERC for the Ellipse PRECICE 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, testing to applicable IEC standards, and a usability study undertaken on 15 participants to evaluate the usability of the ERC 2P in an equivalent patient population. Risk analysis, draft labeling, and test results are included in this premarket notification. The results of testing demonstrate that the ERC 2P for the Ellipse PRECICE System that is the subject of this premarket notification is substantially equivalent to the predicate External Remote Controller device.

The following documentation and testing have been included in order to establish equivalence to the predicate device. Testing includes a usability evaluation for the Home Use of the ERC 2P 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 DescriptionApplicable test standard
Risk Management ReportEN ISO 14971
Electrical SafetyIEC 60601-1 (3rd edition)
Electromagnetic Compatibility and InterferenceIEC 60601-1-2
Minimum rated voltage testing
Shock and Vibration TestingIEC 60601-1-11
Ingress protection
Labeling Readabilityn/a
Usability evaluationn/a

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

January 23, 2014

Ellipse Technologies, Incorporated Mr. John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway, Suite 123 Irvine, California 92618

Re: K131490

Trade/Device Name: Ellipse PRECICE® System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 19, 2013 Received: December 20, 2013

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 Meintyre

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 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/ResourcesforYou/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/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/ResourcesforYou/Industrv/default.htm.

Sincerely vours.

Ronald##Jean -S for

  • Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
    Enclosure

5

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

. Indications for Use

510(k) Number (if known) K131490

Device Name

Ellipse PRECICE® System

Indications for Use (Describe)

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

Type of Use (Select one or both, as applicable)

父 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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