(41 days)
No
The device description focuses on mechanical components and an external remote controller, with no mention of AI/ML terms or functionalities.
Yes
The device is used for limb lengthening of the tibia and femur, which is a therapeutic intervention.
No
The device is described as being indicated for limb lengthening and performs mechanical functions (contains a magnet, lead screw/nut assembly, planetary gearing), not diagnostic functions.
No
The device description explicitly lists hardware components such as the PRECICE nail, locking screws, surgical instruments, and an external remote controller (ERC, ERC2P).
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 therapeutic purpose (limb lengthening).
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 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 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)
In Vitro Testing (Tensile Strength)
FEA Simulations
Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Project Manager 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K150656
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: March 12, 2015 Received: March 13, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic 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) K150656
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)
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PRECICE® Intramedullary Limb Lengthening System 510(k) Summary - K150656 March 2015
-
- Company: Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618
- Contact: Rebecca Shelburne Regulatory Affairs Project Manager Phone: (949) 837-3600 x227 Fax: (949) 837-3664
Date Summary Prepared: March 12, 2015
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- Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System
-
- Common Name: Intramedullary Nail
- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 4.
-
- Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
- The Ellipse PRECICE System is composed of the PRECICE nail Product Description: 6. (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 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 for Use: The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
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- Substantial Equivalence: Documentation that includes a performance assessment and detailed 8. 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, in vitro testing performed and Finite Element Analysis (FEA) Simulations. The Risk Management file was updated to include the design modifications and no new risks were identified.
The additional diameter PRECICE nails that are subject of this premarket notification and the predicate device have the same indications for use. Specifically, both the predicate PRECICE 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 diameter PRECICE nails are available in the same application, screwhole configurations, stroke lengths, and overall lengths. 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:
- Additional diameters added to the product offerings.
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 |
|---|---|
| In Vitro Testing (Tensile Strength) | N/A |
| FEA Simulations | N/A |
There are no changes being made to the ERC, Locking Screws or PRECICE Instruments 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.