PRECICE Intramedullary Limb Lengthening System

• K Number: K151131
• Device Name: PRECICE Intramedullary Limb Lengthening System
• Manufacturer: Ellipse Technologies, Incorporated
• Date Cleared: 2015-06-19 ( 52 days)
• Product Code: HSB
• Regulation Number: 888.3020
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K141023 , K133289 , K131677
• Predicate For: K160325 , K170169

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 the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific accessories are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing.

AI/ML Overview

This document is a 510(k) summary for the PRECICE® Intramedullary Limb Lengthening System. It describes the device and claims substantial equivalence to previously cleared devices. However, it does not contain the detailed acceptance criteria and study data typically found in a clinical study report or a more comprehensive premarket submission.

Based on the provided text, here's what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance

The document presents in vitro mechanical testing for the device modifications. It doesn't explicitly state "acceptance criteria" as numerical thresholds that were met, but rather implies that the modifications were found substantially equivalent through these tests.

Test Description	Applicable Test Standard	Reported Device Performance
Static Torsion Testing	ASTM F1264	Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications.
Tensile Strength Testing	N/A	Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications.

Missing Information: Specific numerical acceptance criteria and the actual numerical results from these tests are not provided in this summary. The statement "meet the performance specifications" is a general conclusion without supporting data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes in vitro mechanical testing, not a clinical study involving human subjects. Therefore, traditional "sample size," "test set," and "data provenance" as applied to clinical data are not directly applicable.

Missing Information: The number of devices or components tested for Static Torsion and Tensile Strength is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document details in vitro mechanical testing. The concept of "ground truth" established by human experts is not relevant to this type of testing. Engineering standards (ASTM F1264) are used for evaluation.

Missing Information: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to in vitro mechanical testing.

Missing Information: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes a medical device, an intramedullary limb lengthening system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.

Missing Information: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to an intramedullary limb lengthening system.

Missing Information: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the in vitro testing, the "ground truth" would be the established engineering principles and standards (e.g., ASTM F1264) for evaluating the mechanical properties of a medical device.

Missing Information: While the standard is mentioned, specific numerical "ground truth" values for performance are not.

8. The sample size for the training set

This document describes in vitro mechanical testing for a physical medical device, not a machine learning model. Therefore, the concept of a "training set" is not applicable.

Missing Information: Not applicable.

9. How the ground truth for the training set was established

Not applicable, as it's not a machine learning model.

Missing Information: Not applicable.

In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence for modifications to an intramedullary limb lengthening system through in vitro mechanical testing. It does not contain the detailed clinical study data, ground truth establishment, or expert involvement typically associated with AI/diagnostic device evaluations. The reported "performance" is a general statement of meeting specifications rather than specific numerical results against defined acceptance criteria.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2015

Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Project Manager 13900 Alton Parkway, Suite 123 Irvine, California 92618

Re: K151131

Trade/Device Name: PRECICE® Intramedullary Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 1, 2015 Received: June 2, 2015

Dear Ms. Shelburne:

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}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K151131

Device Name

PRECICE® Intramedullary Limb Lengthening 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)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

PRECICE® Intramedullary Limb Lengthening System 510(k) Summarv - K 151131 April 2015

1.	Company:	Ellipse Technologies, Incorporated13900 Alton Parkway, Suite 123Irvine, CA 92618
----	----------	------------------------------------------------------------------------------------------

Rebecca Shelburne Contact: Regulatory Affairs Project Manager Phone: [phone] x227 Fax: [phone]

Date Summary Prepared: April 27, 2015

• 2. Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System
• Common Name: Intramedullary Nail 3.
• 4. Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
• Product Code: HSB (Rod, Fixation, Intramedullary and Accessories) ട്.
• 6. Product Description: The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific accessories are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing.
• 7. Indications for Use: The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
• 8. Substantial Equivalence: Documentation that includes a performance assessment and detailed comparison to the predicate device demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device:

Trade Name: Ellipse PRECICE System Common Name: Intramedullary Nail 510(k) Clearance Number: K141023, K133289, K131677

Substantial equivalence is based on identical indications for use, technological characteristics and in vitro testing performed. The Risk Management file was updated to include the design modifications and no new risks were identified.

The additional length PRECICE nails that are subject of this premarket notification and the predicate device have the same indications for use. Specifically, both the predicate PRECICE

{5}------------------------------------------------

System and the PRECICE System that is subject of this Special 510(k) is indicated for limb lengthening of the tibia or femur. The additional length PRECICE nails are available in the same diameters and application. No changes are being made to the materials, technological characteristics or principles of operation as a result of this premarket notification. Both devices are inserted into the intramedullary canal of the femur or tibia and secured with locking screws. Both devices are adjusted non-invasively by the Ellipse external remote controller (ERC or ERC2P). The differences between the subject device and the predicate device are as follows:

• Shorter overall Nail lengths of 160-190 mm,
• Modified distal screw hole configuration,
• . Modified locking rod interface on the proximal end of the housing tube,
• Chamfered screw holes on the targeting side of the proximal screw holes and a bulleted tip of the distraction rod, and
• Addition of new implantation instruments.

Data relied upon to determine substantial equivalence of the PRECICE System with the device modifications described in this submission to the cleared PRECICE System include the following:

Test Description	Applicable Test Standard
Static Torsion Testing	ASTM F1264
Tensile Strength Testing	N/A

There are no changes being made to the External Remote Controller (ERC or ERC 2P) or Locking Screws as a result of this submission.

Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications.

Regulation Number and Section

§ 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.