(123 days)
The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
The Ellipse PRECICE Trauma Nail System is composed of the PRECICE Trauma 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 PRECICE Trauma 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.
The provided document is a 510(k) premarket notification for the "PRECICE Trauma Nail System". The document states that the device is substantially equivalent to a previously cleared device (K141447) and relies on the testing and data from that predicate device. Therefore, a direct study proving the device meets new acceptance criteria is not presented, as the submission is based on demonstrating equivalence.
Here's an analysis of the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results for this specific 510(k) submission (K142599). Instead, it states that "all testing that was performed on the predicate PRECICE Trauma Nail System is applicable" because there are "no changes to the design of the PRECICE Trauma Nail being made as a result of this submission."
However, the document lists the types of tests performed on the predicate device, which can be inferred as satisfying the acceptance criteria for those tests:
| Acceptance Criteria Type (Inferred from Predicate Testing) | Reported Device Performance (from Predicate) |
|---|---|
| Mechanical Testing (ASTM F1264-03) | Satisfied (implied "applicable" and "conclusions can be drawn") |
| Gamma Radiation Sterilization (ANSI/AAMI/ISO 11137-2) | Provides a sterility assurance level of 10^-6 |
| Design Verification and Validation | Satisfied (implied "applicable" and "conclusions can be drawn") |
| Shelf Life Testing (packaging after accelerated aging) | Satisfied (implied "applicable" and "conclusions can be drawn") |
| O-ring Seal Performance Testing | Satisfied (implied "applicable" and "conclusions can be drawn") |
| Biocompatibility (ISO 10993-1) | Satisfied for the intended use (implied "applicable" and "conclusions can be drawn") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for individual tests. It refers to "mechanical testing according to the methods outlined in the standard ASTM F1264-03." These standards typically define sample size requirements.
- Data Provenance: The data comes from tests performed on the predicate device (K141447). The document doesn't specify the country of origin of this data or if it was retrospective or prospective, but it's implied to be data collected during the development and clearance process of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is typically relevant for studies involving subjective human assessment (e.g., image interpretation for AI algorithms). For physical medical devices undergoing mechanical, sterilization, or biocompatibility testing, ground truth is established by the specified test standards and methodologies themselves (e.g., ASTM, ISO standards), not by human expert consensus in the same way. Therefore, this information is not applicable in this context and is not provided in the document.
4. Adjudication Method for the Test Set
As explained above, for physical device testing against established standards, adjudication methods like 2+1 or 3+1 (common in clinical trials or diagnostic studies) are not applicable. The "ground truth" and "adjudication" are inherent in the test method's specifications and the objective measurements obtained.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is specifically for evaluating the effectiveness of a diagnostic tool, often an AI algorithm, by comparing human reader performance with and without its assistance. The PRECICE Trauma Nail System is an intramedullary fixation rod, a physical implant, and therefore, an MRMC study is not applicable to its evaluation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is also specific to AI/software as a medical device. The PRECICE Trauma Nail System is a physical device, and therefore this type of study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the predicate device's evaluation (and by extension, for this submission's substantial equivalence claim) is based on:
- Compliance with recognized industry standards: ASTM F1264-03 for mechanical testing, ANSI/AAMI/ISO 11137-2 for sterilization, and ISO 10993-1 for biocompatibility.
- Objective measurements and criteria: As defined within these standards for various performance parameters (e.g., strength, sterility assurance level, material compatibility).
8. The Sample Size for the Training Set
Not Applicable. The device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Project Manager 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K142599
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: December 22, 2014 Received: December 23, 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
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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/Resourcesfor You/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 vours.
Lori A. Wiggins -S
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
510(k) Number (if known) K142599
Device Name PRECICE Trauma Nail System
Indications for Use (Describe)
The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and nonunions 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)
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Image /page/4/Picture/1 description: The image shows the logo for Ellipse. The logo consists of three overlapping circles on the left and the word "ELLIPSE" in bold, sans-serif font on the right. The circles are in shades of blue and green, and the word "ELLIPSE" is in dark blue.
13900 Alton Parkway. Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
Ellipse PRECICE Trauma Nail System 510(k) Summary - K TBD September 2014
-
- Ellipse Technologies, Incorporated Company: 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: September 12, 2014
-
- Proprietary Trade Name: Ellipse PRECICE Trauma Nail System
- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 3.
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- Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
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- Product Description: The Ellipse PRECICE Trauma Nail System is composed of the PRECICE Trauma 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 PRECICE Trauma 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 open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
-
- Substantial equivalence: A detailed comparison to the predicate device demonstrates 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 K141447 510(k) Clearance Number:
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Image /page/5/Picture/1 description: The image shows the logo for Ellipse. The logo consists of three overlapping ellipses on the left side of the word "ELLIPSE". The ellipses are in shades of blue and green. The word "ELLIPSE" is in a dark blue sans-serif font.
13900 Alton Parkway. Suite 123 Irvine. California 92618 U Office: 949-837-3600 949-837-3664 www.ellipse-tech.com
Substantial equivalence is based on same intended use, identical technological characteristics and principles of operation.
The Ellipse PRECICE Trauma Nail System and the predicate device have the same intended use. Specifically, the PRECICE Trauma Nail System and the predicate are both designed to treat long bones using compression fracture reduction techniques. The PRECICE Trauma Nail System subject of this premarket notification is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones, specifically.
The Ellipse PRECICE Trauma Nail has the same technological characteristics and principles of operation as that of the predicate. The design of both devices are identical. Both devices are inserted into the intramedullary canal of the long bone and secured with locking screws. Both devices are adjusted non-invasively by the Ellipse External Remote Controller (ERC).
There are no changes to the design of the PRECICE Trauma Nail being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE Trauma Nail System is applicable. These tests include 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 35 methodology as given in ANSI/AAMI/ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6, and design verification and validation, 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 Trauma Nail System for the ERC are applicable.
Conclusions can be drawn from these tests that the PRECICE Trauma Nail System is substantially equivalent to the predicate device.
§ 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.