(29 days)
Not Found
No
The device description focuses on mechanical components and an external remote controller, with no mention of AI or ML. The performance studies also focus on mechanical and functional testing, not algorithmic performance.
Yes
The device is indicated for limb lengthening of the tibia and femur, which is a therapeutic intervention.
No
The provided text describes the Ellipse PRECICE System as a device for limb lengthening, specifically of the tibia and femur, and details its components and sterilization. There is no mention of it being used to diagnose conditions or processes.
No
The device description explicitly lists hardware components such as the PRECICE nail, locking screws, surgical instruments, and an external remote controller (ERC).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 nail, screws, surgical instruments, and an external controller. These are all components used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a surgical intervention.
N/A
Intended Use / Indications for Use
The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters. Iengths and screwhole 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.
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
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)
Mechanical testing
Design functionality and verification testing .
Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications. The following specific tests have been performed in order to establish equivalence to the predicate devices:
Static Four Point Bend, Dynamic Four Point Bend, Static Torque to Failure, Magnet Holding Torque, Device functionality and verification
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
MAY 2 0 2014
Ellipse Technologies, Inc. PRECICE Intramedullary Limb Lengthening System Special 510(k) Application
April 2014 Product Code: HSB
PRECICE® Intramedullary Limb Lengthening System 510(k) Summary - K TBD April 2014
- Company: Ellipse Technologies. Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618
Rebecca Shelburne Contact: Regulatory Affairs Specialist Phone: (949) 837-3600 x227 Fax: (949) 837-3664 Date Summary Prepared: April 17, 2014
Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System 2.
Common Name: Intramedullary Nail 3.
- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
న. Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
Product Description: The Ellipse PRECICE System is composed of the PRECICE nail 6. (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters. Iengths and screwhole 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.
- Indications: The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
Substantial equivalence: Documentation that includes mechanical test results and 8. detailed comparison to the predicate devices demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device:
Ellipse PRECICE System (K131677 and K133289) .
Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed. The Risk Management file was updated to include the design modifications and no new risks were identified.
The modified Ellipse PRECICE System and the predicate device have the same intended use. Specifically, to lengthen the femur or tibia. The modified PRECICE nail and the predicate are available in the same application, screwhole configurations, stroke lengths, and overall lengths. The PRECICE Nail has the same patient contacting materials, technological characteristics and principles of operation as that of the predicate. Both devices are inserted into the intramedullary
1
canal of the femur or tibia and secured with locking screws. Both devices are adjusted noninvasively by the Ellipse external remote controller (ERC). The differences between the modified PRECICE System and the predicate device are as follows:
- The magnet stabilizer feature is being modified and re-located to the proximal end of the . housing tube for ease of manufacturing, and
- The anti-rotation lug feature is being modified to be press-fit into the internal diameter of . the housing tube, eliminating the tack welding process.
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:
- . Mechanical testing
- Design functionality and verification testing .
Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications. The following specific tests have been performed in order to establish equivalence to the predicate devices:
| Test Description | Applicable Test Standard |
|---|---|
| Static Four Point Bend | ASTM F1264-03 |
| Dynamic Four Point Bend | ASTM F1264-03 |
| Static Torque to Failure | ASTM F1264-03 |
| Magnet Holding Torque | None |
| Device functionality and verification | None |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Specialist 13900 Alton Parkway, Suite 123 Irvine. California 92618
Re: K141023
Trade/Device Name: Ellipse PRECICE® System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 17, 2014 Received: April 21. 2014
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 notc: 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
3
Page 2 - Ms. Rebecca Shelburne
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 (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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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) K141023
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)
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.
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Casey antev-Division of Orthopedle D vices
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