(362 days)
Not Found
No
The description focuses on mechanical and magnetic components for limb lengthening, with no mention of AI or ML.
Yes
The device is indicated for limb lengthening, which can be considered a therapeutic intervention to address a medical condition (limb length discrepancy).
No
The device is an intramedullary limb lengthening system used for limb lengthening of the tibia and femurs, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists multiple hardware components including an implantable rod, locking screws, and an external remote controller, in addition to mentioning software verification and validation for the external remote controller.
Based on the provided information, the Ellipse Intramedullary Limb Lengthening System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "limb lengthening of the tibia and femurs." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable intramedullary rod, locking screws, and an external controller. These are all components used in a surgical procedure, not for testing samples outside the body.
- No mention of in vitro testing: The description of performance studies focuses on mechanical testing, sterilization, shelf life, biocompatibility, and safety related to the implant and external controller. There is no mention of testing biological samples (blood, urine, tissue, etc.) which is characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ellipse system does not fit this description.
N/A
Intended Use / Indications for Use
The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Ellipse Intramedullary Limb Lengthening System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the IMLL Actuator component and various configurations of IMLL Extension Rods. The IMLL Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The IMLL Actuator is supplied sterile by gamma sterilization while the IMLL Extension Rods, locking screws, and reusable accessories 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, femurs
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 included sterilization, shelf life testing for the packaging and the device functionality, biocompatibility testing, and testing to ASTM F1264-03 for intramedullary rods and F543-07 for metallic medical bone screws. Additional testing to demonstrate the safety of the magnetic fields from both the rare earth magnet included in the IMLL Actuator as well as the External Remote Controller demonstrated that the induced magnetic fields are below established safety guidelines. Testing on the external remote controller also included software verification and validations, electrical safety testing, and electromagnetic interference and compatibility testing.
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. Ellipse Intramedullary Limb Lengthening SystemProduct Code: HSB Original 510(k) Application
JUL 1 2 2011
June 2010
14. 510(K) SUMMARY OR 510(K) STATEMENT
Ellipse Intramedullary Limb Lengthening System 510(k) Summary - K101997 June 2010
-
Ellipse Technologies, Incorporated 1. Company: 13844 Alton Parkway, Suite 130 Irvine, CA 92618
Contact: John McIntyre Vice President, RA/QA/CA -
Proprietary Trade Name: Ellipse Intramedullary Limb Lengthening System 2.
-
Classification Name: 21 CFR 888.3020 -- Intramedullary fixation rod 3.
-
Product Code: HSB Rod, Fixation, Intramedullary and Accessories 4.
-
Product Description: 5.
, j
The Ellipse Intramedullary Limb Lengthening System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the IMLL Actuator component and various configurations of IMLL Extension Rods. The IMLL Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The IMLL Actuator is supplied sterile by gamma sterilization while the IMLL Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use.
6. Indications
The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
1
K101997
June 2010
p213
Ellipse Technologies, Inc. Ellipse Intramedullary Limb Lengthening SystemProduct Code: HSB Original 510(k) Application
Substantial equivalence 7.
.
Documentation that includes mechanical test results and detailed comparison to the predicate device demonstrates that the Ellipse Intramedullary Limb Lengthening System is substantially equivalent to the Orthodyne/Orthofix ISKD device (K010322 and K031219).
Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed.
The Ellipse IMLL System and the predicate device have similar technological characteristics. Specifically, the Ellipse IMLL System and the predicate devices are both designed to be implanted into the medullary canal of the femur or tibia. These devices are available in a variety of geometrical configurations and diameters/lengths to accommodate a variety of patient anatomies. Both devices are designed as a telescoping rod that can be lengthened non-invasively. The ISKD device is lengthened by manual mechanical rotation of the limb while the Ellipse IMLL system is lengthened by the interaction of the rare earth magnet which is contained within the actuator portion of the rod and the external remote controller. The Ellipse IMLL system has the advantage that the length of the rod can be shortened if the rod has been distracted too much. The ISKD device can only be adjusted in one direction (i.e., distraction).
Furthermore, the Ellipse IMLL and the ISKD device have a number of common design features, such as a telescoping Titanium alloy rod that is attached proximally and distally using locking screws. Both devices have telescoping features that are adjustable non-invasively. The Ellipse IMLL gives the user a better level of control of the distraction amount and direction, however.
The Ellipse IMLL device and the predicate device feature similar overall shapes. The various configurations and dimensions are available to accommodate the variety of patient anatomies encountered in limb lengthening procedures.
Testing included sterilization, shelf life testing for the packaging and the device functionality, biocompatibility testing, and testing to ASTM F1264-03 for intramedullary rods and F543-07 for metallic medical bone screws. Additional testing to demonstrate the safety of the magnetic fields from both the rare earth magnet included in the IMLL Actuator as well as the External Remote Controller demonstrated that the induced magnetic fields are below established
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.
2
K101997
June 2010 p313
Ellipse Technologies, Inc. Ellipse Intramedullary Limb Lengthening SystemProduct Code: HSB
Original 510(k) Application
ﺎ ﺃ
safety guidelines. Testing on the external remote controller also included software verification and validations, electrical safety testing, and electromagnetic interference and compatibility testing. The following specific tests have been performed in order to establish equivalence to the predicate device:
| Test Description | Applicable test standard |
|---|---|
| VDmax25 Gamma Radiation Sterilization Validation | ANSI/AAMI/ISO 11137-2: 2007 |
| 6 month shelf life packaging validation | ISO 11607 |
| Biocompatibility testing | ISO 10993-1: 2003 |
| External remote controller software validation testing | IEC 60601-1-4 |
| External remote controller electrical safety testing | IEC 60601-1 |
| External remote controller electromagnetic interference and compatibility | |
| testing | IEC 60601-1-2 |
| Locking screw Static and dynamic three point bend testing | ASTM F1264-03 |
| Locking screw axial pullout testing | ASTM F543-07 |
| Locking screw torque to failure | ASTM F543-07 |
| Implantable rod static and dynamic 4-point bend testing | ASTM F1264-03 |
| Implantable rod torque to failure | ASTM F543-07 |
| Implantable rod torsional stiffness | ASTM F1264-03 |
| Fixture and device compliance | ASTM F1264-03 |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 2 2011
Ellipse Technologies, Inc. % Mr. John McIntyre Vice President. Regulatory. Quality and Clinical Affairs 13844 Alton Parkway, Suite 130 Irvine, California 92618
Re: K101997
Trade Name: Ellipse Intramedullary Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 25, 2011 Received: March 28, 2011
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
4
Page 2 - Mr. John McIntyre
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free nûmber (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Euis Keith
Jo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ellipse Technologies, Inc. Ellipse Intramedullary Limb Lengthening System Original 510(k) Application
Indications for Use
510(k) Number: Unknown K101997
Device Name: Ellipse Intramedullary Limb Lengthening System
Indications for Use: The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _
for m. Melkerm.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101997
Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.