(28 days)
Not Found
No
The description focuses on mechanical components (magnet, lead screw, gearing) and an external remote controller. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is indicated for fixation of fractures, pseudoarthrosis, mal-unions, and non-unions of long bones, which are conditions requiring treatment for healing and stabilization.
No
The device is described as a system for fracture fixation and is composed of a trauma nail, screws, instruments, and a controller. Its purpose is to treat closed fractures, pseudoarthrosis, or mal-unions and non-unions of long bones, which is a therapeutic function, not diagnostic.
No
The device description clearly states that the system is composed of a modified PRECICE Nail, locking screws, surgical instruments, and an external remote controller (ERC). These are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones." This describes a surgical procedure to treat bone conditions, not a test performed on biological samples to diagnose or monitor a disease or condition.
- Device Description: The device is a physical implant (nail, screws) and associated instruments and controller used in vivo (within the body) during surgery. IVDs are typically reagents, instruments, or systems used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, based on the provided information, the Ellipse PRECICE Trauma Nail System is a surgical implant and associated equipment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ellipse PRECICE Truma Nail System is indicated for closed fracture fixution, pseudoarthrosis, or mal-unions of long bones.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Ellipse PRECICE Trauma Nail System is composed of the modified PRECICE Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole 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 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. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones
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)
Substantial equivalence is based on identical indications for use, designs, and on in virro testing performed.
- Mechanical Testing
- Design Verification Testing
- Magnetic Field Safety Testing
- Packaging and Shelf-life Validation
- Sterilization Validation
- Biocompatibility 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
JUN 3 0 2014
May 2014 Product Code: HSB
PRECICE® Trauma Nail System 510(k) Summary - K TBD May 2014
| 1. | Company: | Ellipse Technologies, Incorporated
13900 Alton Parkway, Suite 123
Irvine, CA 92618 |
|----|-------------------------|---------------------------------------------------------------------------------------------------------|
| | Contact: | Rebecca Shelburne
Regulatory Affairs Specialist
Phone: (949) 837-3600 x227
Fax: (949) 837-3664 |
| | Date Summary Prepared: | May 29, 2014 |
| 2. | Proprietary Trade Name: | PRECICE Trauma Nail System |
| 3. | Common Name: | Intramedullary Nail |
| 4. | Classification Name: | Intramedullary Fixation Rod (21 CFR 888.3020) |
| 5. | Product Code: | HSB (Rod, Fixation, Intramedullary and Accessories) |
- Product Description: The Ellipse PRECICE Trauma Nail System is composed of the modified PRECICE Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole 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 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. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.
Indications: The Ellipse PRECICE Trauma Nail System is indicated for closed fracture 7. fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
Substantial equivalence: A detailed comparison to the predicate device demonstrates 8. that the Ellipse PRECICE Trauma Nail System is substantially equivalent to the following 510(k) cleared device:
| Trade Name: | PRECICE® Trauma Nail System |
|---|---|
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K113695 |
Substantial equivalence is based on identical indications for use, designs, and on in virro testing performed.
The modified PRECICE Trauma Nail System and the predicate PRECICE Trauma Nail System have the same intended use. Specifically, the device is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones. In addition to the indication, the
1
| Ellipse Technologies, Inc. | May 2014 |
|---|---|
| PRECICE Trauma Nail System | Product Code: HSE |
| Special 510(k) Application |
principles of operation for the modified PRECICE Trauma Nail System are the same as that of the predicate PRECICE Trauma Nail System. The devices are inserted into the intramedullary canal of the bone and secured with locking screws. These devices contain an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. They both can be adjusted non-invasively by the Ellipse external remote controller (ERC).
The differences between the modified PRECICE Trauma Nail System and the predicate PRECICE Trauma Nail System are as follows:
- The design of the Nail has been modified to incorporate the design changes made to the � PRECICE Intramedullary Limb Lengthening System.
- The addition of an 8.5 mm diameter nail in the PRECICE Trauma Nail System product . offerings.
The design of the modified PRECICE Trauma Nail is identical to the PRECICE Nail in the PRECICE Intramedullary Limb Lengthening System, with the only difference being that the PRECICE Trauma Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques. The modified PRECICE Trauma Nail has the same materials, technological characteristics and principles of operation as that of the modified PRECICE Nail in the referenced PRECICE Intramedullary Limb Lengthening System. Because the design of these two systems are identical, the following tests that were performed on the referenced PRECICE Intramedullary Limb Lengthening System also applies to the PRECICE Trauma Nail System that is subject of this premarket notification:
- Mechanical Testing .
- . Design Verification Testing
- Magnetic Field Safety Testing .
- . Packaging and Shelf-life Validation
- Sterilization Validation .
- . Biocompatibility Testing
Conclusions can be drawn that the modifications to the PRECICE Trauma Nail in the PRECICE Trauma Nail System is substantially equivalent to the predicate device.
2
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Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Specialist 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K141447
Trade/Device Name: PRECICE® Trauma Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 29, 2014 Received: June 2, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Rebecca Shelburne
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 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" (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 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
for 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K141447
Device Name
PRECICE® Trauma Nail System
Indications for Use (Describe)
The Ellipse PRECICE Truma Nail System is indicated for closed fracture fixution, pseudoarthrosis, or mal-unions of long bones.
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)
:
Elizabet标检验Frank -S
Division of Orthopedic Devices
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FORM FDA 3881 (1/14)
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