(102 days)
Not Found
No
The description focuses on mechanical components and the external remote controller for controlling the lengthening process. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
This device is designed to lengthen the residual limb of the femur, which is a therapeutic intervention aimed at improving a patient's physical condition or function.
No
Explanation: The device is indicated for lengthening of the residual limb, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists hardware components such as an intramedullary nail, locking screws, surgical instruments, and an external remote controller.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "lengthening of the residual limb of the femur." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable intramedullary nail with mechanical components and an external controller. This is a physical device used for structural support and manipulation within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with biological specimens in this way.
The Ellipse Residual Limb Lengthening System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Ellipse Residual Limb Lengthening System is indicated for lengthening of the residual limb of the femur.
Product codes
HSB
Device Description
The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments 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. The Ellipse RLL System is a non-weight bearing device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
residual limb of the 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)
Non-clinical testing on the RLL System included mechanical testing according to the methods outlined in the standard ASTM F1264-03, validation of the gamma radiation sterilization cycle in accordance with the VDmax 3 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6, and design verification and validation.
The following specific performance tests were completed on the RLL System in order to establish equivalence to the predicate device:
| Test Description | Applicable Test Standard |
|---|---|
| Static Four Point Bend | ASTM F1264-03 |
| Dynamic Four Point Bend | ASTM F1264-03 |
| Static Torque to Failure | ASTM F1264-03 |
| Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose | ANSI/AAMI/ISO 11137-2 |
| Device functionality and verification | N/A |
Tests that were performed on the predicate PRECICE System which are applicable to the RLL System include shelf life testing for the packaging after accelerated aging, O-ring seal performance testing and biocompatibility in accordance with ISO 10993-1 for the intended use of the device.
There are no changes to the design of the ERC being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE System for the ERC are applicable to the RLL System.
Conclusions can be drawn from these tests that the RLL 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.
Ellipse PRECICE® Intramedullary Limb Lengthening System (K141023)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Specialist 13900 Alton Parkway, Suite 123 Irvine, California 92618-0000
October 7, 2014
Re: K141739
Trade/Device Name: Residual Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 9, 2014 Received: July 10, 2014
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/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,
Mark N. Melkerson -S
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) K141739
Device Name Residual Limb Lengthening System
Indications for Use (Describe)
The Ellipse Residual Limb Lengthening System is indicated for lengthening of the residual limb of the 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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Image /page/4/Picture/0 description: The image shows the Ellipse logo. The logo consists of three overlapping circles on the left and the word "ELLIPSE" in a bold, sans-serif font on the right. The circles are in shades of blue and green, while the word "ELLIPSE" is in a dark blue color.
13900 Alton Parkway. Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
Ellipse Residual Limb Lengthening System 510(k) Summary - K141739 June 2014
-
- Company: Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618
- Rebecca Shelburne Contact: Regulatory Affairs Specialist Phone: (949) 837-3600 x227 Fax: (949) 837-3664
Date of Submission: June 26, 2014
-
- Proprietary Trade Name: Ellipse Residual Limb Lengthening System
- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 3.
-
- Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
- Product Description: The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments 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. The Ellipse RLL System is a non-weight bearing device.
Indications: The Ellipse Residual Limb Lengthening System is indicated for lengthening of 6. residual limb of the femur.
- Substantial equivalence: Documentation that includes mechanical test results, design verification and detailed comparison to the predicate devices demonstrates that the Ellipse RLL System is substantially equivalent to the following 510(k) cleared device:
● Ellipse PRECICE® Intramedullary Limb Lengthening System (K141023)
Substantial equivalence is based on similar indications for use, technological characteristics, principles of operation, designs, and on in vitro testing performed.
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Image /page/5/Picture/0 description: The image shows the logo for Ellipse. The logo consists of a circular design on the left and the word "ELLIPSE" on the right. The circular design is made up of three overlapping circles in different shades of blue and green. The word "ELLIPSE" is written in a bold, sans-serif font in a dark blue color.
3900 Alton Parkwav. Suite 123 vine California 92618 ffice: 949-837-3600 949-837-3664 www.ellipse-tech.com
The Ellipse RLL System and the predicate device have the same intended use. Specifically, the RLL System and the predicate PRECICE System are both designed for limb lengthening. The RLL System is indicated for lengthening of the residual limb of the femur, specifically.
The Ellipse RLL Nail has similar technological characteristics and the same principles of operation as that of the predicate. Both the RLL Nail and the predicate PRECICE Nail are titanium intramedullary nails with a telescoping portion that can adjust the length of the limb using principles of distraction osteogenesis. 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).
Non-clinical testing on the RLL System included mechanical testing according to the methods outlined in the standard ASTM F1264-03, validation of the gamma radiation sterilization cycle in accordance with the VDmax 3 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6, and design verification and validation.
The following specific performance tests were completed on the RLL System in order to establish equivalence to the predicate device:
| Test Description | Applicable Test Standard |
|---|---|
| Static Four Point Bend | ASTM F1264-03 |
| Dynamic Four Point Bend | ASTM F1264-03 |
| Static Torque to Failure | ASTM F1264-03 |
| Sterilization of healthcare products - Radiation - | |
| Part 2: Establishing the sterilization dose | ANSI/AAMI/ISO 11137-2 |
| Device functionality and verification | N/A |
Tests that were performed on the predicate PRECICE System which are applicable to the RLL System include shelf life testing for the packaging after accelerated aging, O-ring seal performance testing and biocompatibility in accordance with ISO 10993-1 for the intended use of the device.
There are no changes to the design of the ERC being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE System for the ERC are applicable to the RLL System.
Conclusions can be drawn from these tests that the RLL System is substantially equivalent to the predicate device.