ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM

K131490 · Ellipse Technologies, Inc. · HSB · Jan 23, 2014 · Orthopedic

Device Facts

• Record ID: K131490
• Device Name: ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Applicant: Ellipse Technologies, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Jan 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

System comprises implantable intramedullary rod (distracting rod), locking screws, and external remote controller (ERC 2P). Rod contains rare earth magnet, telescoping lead screw/nut assembly, and gearing. ERC 2P is handheld, electrically powered unit containing rotating magnets. After surgical implantation of rod into tibia or femur, patient places ERC 2P over actuator site. Rotating magnets in ERC 2P induce rotation of internal rod magnet, causing mechanical lengthening or shortening of rod. Used in home environment by patient per physician prescription stored on SD card. Physician confirms distraction via routine office x-rays. System enables non-invasive, controlled limb lengthening, reducing need for additional surgeries.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), shock/vibration/ingress protection (IEC 60601-1-11), and a usability evaluation performed on 15 participants to confirm suitability for home use by the patient population.

Technological Characteristics

System includes implantable intramedullary rod with rare earth magnet, lead screw, and gearing. ERC 2P is handheld, battery-powered unit with rotating magnets, camera, and LCD display. Connectivity via SD card for prescription data. Tested to IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (home healthcare environment).

Indications for Use

Indicated for limb lengthening of the tibia and femur in patients requiring such procedures.

Regulatory Classification

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.

Predicate Devices

• Ellipse System (K101997)
• Ellipse System (K113219)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### 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

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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

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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 Description | Applicable test standard |
|------------------------------------------------|---------------------------|
| Risk Management Report | EN ISO 14971 |
| Electrical Safety | IEC 60601-1 (3rd edition) |
| Electromagnetic Compatibility and Interference | IEC 60601-1-2 |
| Minimum rated voltage testing | |
| Shock and Vibration Testing | IEC 60601-1-11 |
| Ingress protection | |
| Labeling Readability | n/a |
| Usability evaluation | n/a |

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#### 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

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#### 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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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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