(45 days)
K 131677
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 indicated for limb lengthening of the tibia and femur, which is a therapeutic intervention.
No
The device is indicated for limb lengthening (a treatment), not for diagnosing a condition or disease.
No
The device description explicitly lists hardware components such as the PRECICE nail, locking screws, surgical instruments, and an external remote controller (ERC). The performance studies also focus on mechanical testing of these hardware components.
Based on the provided information, the Ellipse PRECICE System is not an IVD (In Vitro Diagnostic) device.
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 composed of a nail, screws, surgical instruments, and an external controller. These are all components used in a surgical setting for a physical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Ellipse PRECICE System does not interact with or analyze such specimens.
Therefore, the Ellipse PRECICE System is a surgical implant and associated instrumentation, not an in vitro diagnostic device.
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). 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.
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
Mechanical testing, Design functionality and performance testing
Key Metrics
Not Found
Predicate Device(s)
Ellipse Intramedullary Limb Lengthening System (K 131677)
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.
0
November 2013
Ellipse PRECICE® System
DEC 9 2013
510(k) Summary
November 11, 2013
- Company: Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618
Contact: John McIntvre
Vice President, RA/QA/CA Phone: (949) 837-3600 x203 Fax: (949) 837-3664
-
- Proprietary Trade Name: Ellipse PRECICE® System
Common Name: Intramedullary Nail 3.
- Proprietary Trade Name: Ellipse PRECICE® System
- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
Product Code: HSB (Rod, Fixation, Intramedullary and Accessories) રો
Product Description: The Ellipse PRECICE System is composed of the PRECICE nail (supplied 6. sterile), locking screws, surgical instruments and an external remote controller (ERC). 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.
-
Indications: The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
-
Substantial equivalence: Documentation that includes mechanical test results and detailed comparison to the predicate devices demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device:
. Ellipse Intramedullary. Limb Lengthening System (K 131677)
1
and the control of the control of the control of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the c
Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed. Where specific dimensional differences exist, bench testing has shown that these differences do not present new risks.
The 8.5 mm PRECICE Nail and the predicate device have intended use. Specifically, to lengthen the femur or tibia. The 8.5 mm diameter nail and the predicate are available in the same application, screw hole configurations, stroke lengths, and overall lengths. The 8.5 PRECICE Nail has the same materials, technological characteristics and principles of operation as that of the predicate. 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). The differences between the modified PRECICE System and the predicate device are as follows:
- . Addition of an 8.5 mm diameter nail which has a tapered 10.7 mm proximal end for compatibility with the 5.0 mm locking screws and implantation tools.
- . Addition of a 3.5 mm diameter locking screw, which will be used to secure the distal end of the 8.5 mm implant to the bone.
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 performance testing .
The following specific tests have been performed in order to establish equivalence to the predicate devices:
| Test Description | Applicable Test Standard . |
|---|---|
| PRECICE Nail, Static Four Point Bend | ASTM F1264-03 |
| PRECICE Nail, Dynamic Four Point Bend | ASTM F1264-03 |
| PRECICE Nail, Static Torque to Failure | ASTM F1264-03 |
| PRECICE Locking Screw, Static Three Point Bend | ASTM F1264-03 |
| PRECICE Locking Screw, Dynamic Three Point Bend | ASTM F1264-03 |
| PRECICE Locking Screw, Axial Pullout Strength | ASTM F543-07 |
| PRECICE Locking Screw, Torque to Failure | ASTM F543-07 |
| Device functionality and verification | None |
Based on the non-clinical testing performed, the 8.5 mm PRECICE Nail in this Special 510(k) is as safe, effective, and performs as well as the predicate device (K131677).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wave-like lines extending from the right side.
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2013
Ellipse Technologies, Incorporated Mr. John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K133289
Trade/Device Name: Ellipse PRECICE® System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Codes: HSB Dated: November 11, 2013 Received: November 12, 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
3
Page 2 - Mr. John Meintyre
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYowIndustry/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S 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: December 31, 2013 See PRA Statemant on last page.
510(k) Number (if known) K133289
Device Nama Ellipse PRECICE® System
TAR
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 601 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 Hisatth (CDRH) (Signature)
Casey L Hanley, Ph.D.
Division of Orthopedic Devices
FORM FDA 3881 (8/13)
Pago for (Page 1/1)
PRC Publishing Borden (180 AD-4040 C