(83 days)
Not Found
No
The description focuses on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an intramedullary rod/nail intended for fixation of bone fractures, which is a structural support device rather than a device that treats or prevents a disease or condition.
No
The device, an intramedullary nail system, is intended for fracture fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a titanium alloy intramedullary rod/nail, which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures (fibula and ulna). This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is an intramedullary rod/nail made of titanium alloy, designed to be implanted into bone.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The Acumed Small Bone IM Nail System is a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula, and ulna, radius
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)
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and connection.
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
1
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 LLC
5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432 |
|--------------------|--------------------------------------------------------------------------------------------------------|
| | Nathan Wolf, Regulatory Specialist
503-726-6622 (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.
4
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.