(29 days)
The OlecraNail® Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
The OlecraNail® intramedullary nail is a fixation device that has been previously cleared for marketing (K090091). Accessories are being added to the system that will offer optional advantages in terms of how the procedure is accomplished, specifically how the bone is cut, the drill holes are measured, and how the nail is removed.
The provided text describes a Special 510(k) application for accessories to an already cleared device, the OlecraNail® Intramedullary Fixation System. The focus of the submission is on demonstrating the substantial equivalence of the new accessories to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design of accessories for the OlecraNail® Intramedullary Fixation System. | Validated through human cadaveric testing. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "human cadaveric testing," but does not provide the number of cadavers or specimens used.
- Data Provenance: The origin of the cadavers (e.g., country) is not specified. The testing was likely conducted in a controlled environment as part of the regulatory submission process. It is a prospective study in the sense that the testing was conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth Establishment
This information is not provided in the text. Human cadaveric testing implies the involvement of experts for setup, performance, and evaluation, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the text. For mechanical or functional testing like cadaveric studies, adjudication methods similar to those for clinical trials (e.g., 2+1, 3+1) are not typically applicable. The evaluation would likely involve objective measurements and expert assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No.
- The device is a physical fixation system (intramedullary nail and accessories), not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance is not relevant or applicable to this type of medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in a sense.
- The "human cadaveric testing" can be considered a standalone performance evaluation of the device accessories' design and function. This testing evaluates the device's physical performance independent of an "AI algorithm" or human interpretation of data generated by the device in a clinical setting (since it's a surgical implant). The "standalone" here refers to the device's functional integrity as a physical product.
7. Type of Ground Truth Used
The ground truth for the cadaveric testing would be based on direct observation and objective measurements of the mechanical performance and functional integrity of the OlecraNail® accessories during surgical simulation or testing on human cadavers. This would include assessing proper bone cutting, accurate drill hole measurement, and effectiveness of nail removal, as implied by the stated purpose of the accessories. It is essentially an engineering-based ground truth related to mechanical performance and surgical technique.
8. Sample Size for the Training Set
This information is not applicable. The device is a surgical implant system, not a machine learning model that requires a "training set" of data. The development of the device's design would be based on engineering principles, predicate device designs, and expert surgical knowledge, rather than a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set in the context of this device. The design and validation relied on established engineering standards, biomechanical principles, and comparison to legally marketed predicate devices.
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K 110322(1/2)
MAR - 4 2011
Section 3: 510(k) Summary
Submitter's Name and Address
Mylad Orthopedic Solutions, LLC 8803 Windy Creek Way McLean, Virginia 22102 Phone: (793)738-6547 Facsimile: (661)885-4447
OlecraNail® Intramedullary Fixation
Rod, Fixation, Intramedullary and
Accessories per 21 CFR section 888.3020
Acumed ulna shortening osteotomy guide
Biomet Premier Total Knee Instrumentation Acumed Congruent Bone Plate System
Mylad OlecraNail® Intramedullary Fixation
Scott Edwards, M.D.
January 20, 2011
Intramedullary nail
System
(K063460)
System (K090091)
Date of Summary:
Contact Person
Proprietary Name of Device:
Common/Usual Name:
Classification Name:
Legally Marketed Equivalent Devices:
Summary of Device:
The OlecraNail® intramedullary nail is a fixation device that has been previously cleared for marketing (K090091). Accessories are being added to the system that will offer optional advantages in terms of how the procedure is accomplished, specifically how the bone is cut, the drill holes are measured, and how the nail is removed.
Intended Use:
The OlecraNail® Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
Technological Characteristics of the Device Compared to the Predicate Devices: The material, design, and intended use of the accessories for the OlecraNail® I he macerial, 2017-11, are identical or similar to at least one of the listed predicates. There are no technological characteristics that raise new issues of safety or effectiveness.
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K11032(2/2)
Non-Clinical Tests:
• ﺳﺮ
t
Human cadaveric testing validated the design of accessories for the OlecraNail® Intramedullary Fixation System. Details of these tests are included in this Special 510(k) application.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mylad Orthopedic Solutions, LLC % Scott Edwards, M.D. 8803 Windy Creck Way McLean, Virginia 22102
MAR - 4 2011
Re: K110322
Trade/Device Name: OlecraNail® Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, NDE Dated: January 24, 2011 Received: February 03, 2011
Dear Dr. Edwards:
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
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Page 2 - Scott Edwards, M.D.
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if anplicable, 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 number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Aliz B. R.h
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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(P. 1 of 1)
| Section 2: Statement of Indications for Use | |
|---|---|
| 510(k) Number _ | K11 0322 |
OlecraNail® Intramedullary Fixation System Device Name:
Indications for Use:
The OlecraNail® Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
X Prescription Use __ (21 CFR 801 Subpart D) 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)
M. Mucken
Division Orthopedic, .JUS
510(k) Number K110322. -9-
§ 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.