(123 days)
Not Found
No
The device description focuses on mechanical components and an external remote controller, with no mention of AI/ML terms or functionalities. Performance studies are based on mechanical and sterilization testing, not algorithmic performance.
Yes
The device is indicated for limb lengthening, which is a therapeutic intervention.
No
The device description indicates it is a system for limb lengthening of the tibia and femur, composed of a nail, screws, instruments, and a remote controller. This is an interventional device, not a diagnostic one.
No
The device description explicitly lists hardware components such as a modified PRECICE nail, locking screws, surgical instruments, and an external remote controller (ERC). The performance studies also focus on testing these physical 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 an implantable nail, screws, surgical instruments, and an external controller. These are all components used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The Ellipse PRECICE System does not perform any such analysis of 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 (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Ellipse PRECICE System is composed of the modified Ellipse 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 modified 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, 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)
Testing on the modified PRECICE System included functional testing according to the methods outlined in the standard ASTM F1264-03, O-ring seal performance testing, shelf life testing for the packaging after 6-months of accelerated aging and additional biocompatibility testing. Tests that were performed on the original PRECICE nail which are applicable to the modified device include validation of the gamma radiation sterilization cycle in accordance with the VDms35 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10°, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device. Conclusions can be drawn from these tests that the modified PRECICE System is safe and effective and meets the performance specifications.
The following specific tests have been performed in order to establish equivalence to the predicate devices:
- PRECICE, Static Four Point Bend (ASTM F1264)
- PRECICE, Dynamic Four Point Bend (ASTM F1264)
- PRECICE, Static Torque to Failure (ASTM F1264)
- 6 Month Shelf Life Packaging Validation (ISO 11607-1)
- Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose (ANSI/AAMI/ISO 11137-2)
- Biocompatibility (ISO 10993-1)
- Device functionality and verification (none)
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
Ellipse Technologies, Inc. Modifications to the Ellipse PRECICE Nail Original 510(k) Application
July 2013 Product Code: HSB
5. 510(K) SUMMARY OR 510(K) STATEMENT
Ellipse PRECICE® System 510(k) Summary - K 131677 July 2013
Ellipse Technologies, Incorporated 1. Company: 13900 Alton Parkway, Suite 123 Irvine, CA 92618
Contact: John Melntyre Vice President, RA/QA/CA Phone: (949) 837-3600 x203 Fax: (949) 837-3664
OCT 1 1 2013.
Proprietary Trade Name: Ellipse PRECICE System 2.
Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 3.
- Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
Product Description: The Ellipse PRECICE System is composed of the modified ડ. 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 modified 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 6. and femur.
Substantial equivalence: Documentation that includes mechanical test results and 7. 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 (K101997) .
Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed.
1
The modified Ellipse PRECICE Nail and the predicate device have the same intedned use. Specifically, the modified Ellipse PRECICE Nail and the predicate are both designed to lengthen the femur or tibia. These devices are both available in a variety of screw hole patterns and geometrical configurations to accommodate different patient anatomies and implantation methods.
The modified Ellipse PRECICE Nail has similar technological characteristics and principles of operation as that of the predicate. Both the modified PRECICE Nail and the predicate are Titanium intramedullary nails with a telescoping portion that can adjust the length of the implant. 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 overall length of the modified Ellipse PRECICE System is similar to the overall length of the predicate.
The differences between the modified PRECICE System and the predicate device are as follows:
- . Addition of tibia-specific models
- Two new screw-hole configurations .
- Stroke Lengths of 50 mm and 80 mm .
- Start length 195 mm to 365 mm .
- . Non-modular device
- Addition of 3 new biocompatible materials .
- New style package to accommodate the non-modular design .
Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed. Testing on the modified PRECICE System included functional testing according to the methods outlined in the standard ASTM F1264-03, O-ring seal performance testing, shelf life testing for the packaging after 6-months of accelerated aging and additional biocompatibility testing. Tests that were performed on the original PRECICE nail which are applicable to the modified device include validation of the gamma radiation sterilization cycle in accordance with the VDms35 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10°, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device. Conclusions can be drawn from these tests that the modified PRECICE System is safe and effective and meets the performance specifications.
2
Ellipse Technologies, Inc. Modifications to the Ellipse PRECICE Nail Original 510(k) Application
July 2013 Product Code: HSB
The following specific tests have been performed in order to establish equivalence to the predicate devices:
| Test Description | Applicable Test Standard |
|---|---|
| PRECICE, Static Four Point Bend | ASTM F1264 |
| PRECICE, Dynamic Four Point Bend | ASTM F1264 |
| PRECICE, Static Torque to Failure | ASTM F1264 |
| 6 Month Shelf Life Packaging Validation | ISO 11607-1 |
| Sterilization of healthcare products - Radiation - | |
| Part 2: Establishing the sterilization dose | ANSI/AAMI/ISO 11137-2 |
| Biocompatibility | ISO 10993-1 |
| Device functionality and verification | none |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administrution 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
October 11, 2013
Ellipse Technologies, Incorporated Mr. John Meintyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K131677
Trade/Device Name: Ellipse PRECICE® System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 15, 2013 Reccived: July 16, 2013
Dear Mr. Mr. Meintyre:
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 cither 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
4
Page 2 - Mr. John McIntyre
forth in the quality systems (QS) regulation (2) 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/McdicalDevices/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/Reportal?roblem/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.
Erini Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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 Statement on last page.
510(k) Number (if known) K131677
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.
TEN FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR F ン:
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/5/Picture/13 description: The image contains the words "Casey Hanley Ph.D." on the top line. There is a horizontal line underneath this text. The second line of text says "Division of Orthopedic Devices."