(59 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on mechanical components and an external remote controller for limb lengthening.
Yes
The device is indicated for limb lengthening of the tibia and femur, which is a therapeutic intervention.
No
Explanation: The device is indicated for limb lengthening, which is a therapeutic intervention, not a diagnostic one. It is used to treat a condition (limb length discrepancy), not to identify or characterize it.
No
The device description explicitly lists hardware components such as the PRECICE Nail, locking screws, end cap, surgical instruments, and an external remote controller (ERC, ERC2P).
Based on the provided information, the PRECICE Intramedullary Limb Lengthening System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "limb lengthening of the tibia and femur." This is a surgical procedure performed in vivo (within the living body) to modify bone structure.
- Device Description: The device consists of implants (nail, screws, end cap), surgical instruments, and an external controller. These are all components used in a surgical procedure, not for testing biological samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to test blood, urine, tissue, or any other biological sample to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The PRECICE system is a surgical implant and associated tools used for a physical modification of the body.
N/A
Intended Use / Indications for Use
The PRECICE Intramedullary Limb Lengthening 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 Intramedullary Limb Lengthening System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, 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 surgical instruments are supplied non-sterile and must be sterilized prior to use.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Documentation that includes a performance assessment, mechanical test results and detailed comparison to the predicate device demonstrates that the PRECICE Intramedullary Limb Lengthening System is substantially equivalent to the following 510(k) cleared device:
- Ellipse PRECICE Intramedullary Limb Lengthening System (K151131)
Testing performed on the predicate Ellipse PRECICE Intramedullary Limb Lengthening System included sterilization validation, shelf life testing for the packaging and the device functionality, biocompatibility testing, and testing to ASTM F1264 for intramedullary rods. These results are also applicable to the subject PRECICE Intramedullary Limb Lengthening System.
The following additional tests have been performed on the subject PRECICE Intramedullary Limb Lengthening System in order to establish equivalence to the predicate device:
Test Description: Static Torque to Failure, Applicable Test Standard: ASTM F1264
Test Description: Device functionality and verification, Applicable Test Standard: none
Conclusions can be drawn from the testing performed that the PRECICE Intramedullary Limb Lengthening System is substantially equivalent to the predicate device.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2016
Ellipse Technologies, Incorporated Ms. Cora Sim Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
Re: K160325
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: February 4, 2016 Received: February 5, 2016
Dear Ms. Sim:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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" (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/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 -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
PRECICE Intramedullary Limb Lengthening System
Indications for Use (Describe)
The PRECICE Intramedullary Limb Lengthening 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)
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Image /page/3/Picture/0 description: The image shows the word "ELLIPSE" in a bold, sans-serif font, with the letters in a dark blue color. To the left of the word is a logo consisting of three overlapping circles, each outlined in the same dark blue color. The circles are arranged in a way that they form a larger, rounded shape, and there is a gradient of green and yellow within the circles, adding a touch of color to the design. The overall impression is clean, modern, and professional.
101 Enterprise. Suite 100 Aliso Viejo, CA 92656-2604 949-837-3600 Office: 949-837-3664 Fax: www.ellipse-tech.com
510(k) Summary Ellipse PRECICE® Intramedullary Limb Lengthening System 510(k) Summary - K160325 February 4, 2016
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- Ellipse Technologies, Incorporated Company: 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
Contact: Cora Sim Regulatory Affairs Specialist Phone: (949) 837-3600 x221 Fax: (949) 837-3664
- Ellipse Technologies, Incorporated Company: 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
Date of Submission: February 4, 2016
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- Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System
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- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
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- Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
-
- Product Description: The Ellipse PRECICE Intramedullary Limb Lengthening System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, 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 surgical instruments are supplied non-sterile and must be sterilized prior to use.
-
- Indications: The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.
-
- Substantial equivalence: Documentation that includes a performance assessment, mechanical test results and detailed comparison to the predicate device demonstrates that the PRECICE Intramedullary Limb Lengthening System is substantially equivalent to the following 510(k) cleared device:
- Ellipse PRECICE Intramedullary Limb Lengthening System (K151131)
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In addition, the PRECICE Intramedullary Limb Lengthening System designates the following 510(k) cleared reference device:
- . Pega Medical, Incorporated Simple Locking IntraMedullary (SLIM) System (K143355)
Substantial equivalence is based on identical indications for use, technological characteristics, and on in vitro testing performed.
The PRECICE Intramedullary Limb Lengthening System and the predicate device have the same indications for use, similar technological characteristics, and the same principles of operation. Specifically, the subject PRECICE Intramedullary Limb Lengthening System and the predicate are both designed to lengthen the femur or tibia. This submission is for a line extension to the Ellipse PRECICE Intramedullary Nail to include additional shorter models with different locking screw hole patterns to the product line. An additional contraindication has also been added to the labeling for these models.
There are no changes to the design of the ERC or ERC2P being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE Intramedullary Limb Lengthening System with regard to the ERC and ERC 2P are applicable.
Testing performed on the predicate Ellipse PRECICE Intramedullary Limb Lengthening System included sterilization validation, shelf life testing for the packaging and the device functionality, biocompatibility testing, and testing to ASTM F1264 for intramedullary rods. These results are also applicable to the subject PRECICE Intramedullary Limb Lengthening System.
The following additional tests have been performed on the subject PRECICE Intramedullary Limb Lengthening System in order to establish equivalence to the predicate device:
| Test Description | Applicable Test Standard |
|---|---|
| Static Torque to Failure | ASTM F1264 |
| Device functionality and verification | none |
Conclusions can be drawn from the testing performed that the PRECICE Intramedullary Limb Lengthening System is substantially equivalent to the predicate device.