(83 days)
The Acumed Small Bone IM Nail System is intended for fixation of fractures of the fibula, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.
The Acumed Small Bone IM Nail is a titanium alloy (Ti-6Al-4V) intramedullary rod/nail manufactured in multiple lengths (110mm to 270mm) and diameters (2.6mm to 4.0mm). The nails have openings used in conjunction with titanium alloy cortical screws, which lock them in place. The nails are compatible with an optional far-end locking (FEL) bushing and set screw that provide a locking option at the distal end of the nail. The nails are also compatible with optional end caps that thread into the proximal portion of the nail to provide additional length if desired. All implants are provided both sterile and non-sterile.
The provided text describes a 510(k) premarket notification for the "Acumed Small Bone IM Nail System," which is an intramedullary fixation rod. The document details the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, specific device performance metrics, detailed study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.
The non-clinical testing section only states that:
"Comparative testing between the Acumed Small Bone IM Nailing system and a predicate device was conducted as per ASTM F1264-03. The test data showed the Acumed Small Bone IM Nail was substantially equivalent to the predicate device in a static four-point bend test, static torsion test, and bending fatigue test as described herein."
This statement confirms that testing was done to demonstrate substantial equivalence, but it does not provide the quantitative acceptance criteria or the specific performance results in a way that allows for the creation of the requested table. It also lacks all other requested information about sample sizes, ground truth, experts, and study types.
Therefore, I cannot fulfill the request to provide the table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The document focuses on regulatory approval through substantial equivalence, which often relies on demonstrating similar physical and mechanical properties to existing devices rather than extensive clinical performance studies with acceptance criteria in the manner requested for AI or diagnostic devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2015
Acumed, LLC Mr. Nathan Wolf Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124
Re: K143276
Trade/Device Name: Acumed Small Bone IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 12, 2014 Received: November 14, 2014
Dear Mr. Wolf:
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 - Mr. Nathan Wolf
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) K143276
Device Name
Acumed Small Bone IM Nail System
Indications for Use (Describe)
The Acumed Small Bone IM Nail System is intended for fixation of fractures of the fibula, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.
| 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)
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510(k) Summary
Contact Details
| Applicant Name: | Acumed LLC5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432 |
|---|---|
| Nathan Wolf, Regulatory Specialist503-726-6622 (Cell)503-207-1502 (Desk)503-520-9618 (Fax) | |
| Date Prepared: | 12 November 2014 |
| Device Name | |
| Trade Name: | Acumed Small Bone IM Nail System |
| Common Name: | Intramedullary Fixation Rod/Pin |
| Classification: | 21 CFR 888.3020, Intramedullary Fixation Rod |
| Class: | Class II |
| Product Code: | HSB |
Legally Marketed Predicate Device(s)
The Synthes Elastic Intramedullary Nail (EIN), cleared in 1997 (K971783), the Synthes EIN End Cap, cleared in 2008 (K082148), and the Acumed Small Bone Locking Rod System II, cleared in 2003 (K031438) serve as the predicate devices.
Device Description
The Acumed Small Bone IM Nail is a titanium alloy (Ti-6Al-4V) intramedullary rod/nail manufactured in multiple lengths (110mm to 270mm) and diameters (2.6mm to 4.0mm). The nails have openings used in conjunction with titanium alloy cortical screws, which lock them in place. The nails are compatible with an optional far-end locking (FEL) bushing and set screw that provide a locking option at the distal end of the nail. The nails are also compatible with optional end caps that thread into the proximal portion of the nail to provide additional length if desired. All implants are provided both sterile and non-sterile.
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Intended Use/Indications for Use
The Acumed Small Bone IM Nail System is intended for fixation of fractures and osteotomies of the fibula, radius, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.
Substantial Equivalence Comparison
In consideration of the comparisons given herein, the Acumed Small Bone IM Nail System has been determined to be substantially equivalent to its predicate devices, the Synthes EIN (K971783), Synthes EIN End Cap (K082148), and Acumed Small Bone Locking Rod System II (K031438). Substantial equivalence was determined due to similarities in materials, technology, function, and dimensions.
Non-clinical Testing
Comparative testing between the Acumed Small Bone IM Nailing system and a predicate device was conducted as per ASTM F1264-03. The test data showed the Acumed Small Bone IM Nail was substantially equivalent to the predicate device in a static four-point bend test, static torsion test, and bending fatigue test as described herein.
§ 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.