(113 days)
No
The summary describes orthopedic plates and screws for bone fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The device is described as orthopedic plates and screws for fixation of fractures, osteotomies, and non-unions, which are used to stabilize bones, not to treat a disease or condition in a therapeutic manner.
No
The device is described as orthopedic plates and screws intended for fixation of fractures, osteotomies, and non-unions, which are surgical interventions, not diagnostic procedures.
No
The device description explicitly states it contains "orthopedic plates and lag screws" and introduces "new 2.7mm and 3.5mm variable angle screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes orthopedic plates and screws intended for the surgical fixation of bone fractures and other bone issues. These are implanted devices used directly on the patient's skeletal system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device described is a surgical implant used for structural support and stabilization of bones.
N/A
Intended Use / Indications for Use
The Acumed Ankle Plating System contains orthopedic plates and lag screws intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Product codes
HRS, HWC
Device Description
The Acumed Ankle and Small Fragment Base Set Update introduces new 2.7mm and 3.5mm variable angle screws for use with previously cleared plates from the Acumed Ankle Plating System (K143385) and Acumed Small Fragment Base Set (K143394).
Additionally, this submission expands the Ankle Plating System to include use of existing 2.7mm and 3.5mm non-locking screws in independent bone fixation, for the K143385 indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia and fibula, ulna, radius, tibia, small bones, small bone fragments, clavicle, scapula, olecranon, humerus, pelvis
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
Non-clinical included:
- ASTM F543 comparative testing
- Cantilever bend comparative testing
- Galvanic corrosion analysis
Test data showed the variable angle screws introduced in this 510(k) submission are substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K143385, K143394, K063875, K081284, K071563
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Acumed, LCC % Mr. Nathan Wolf Regulatory Consultant Wolf Regulatory Consulting LLC P.O. Box 796 Loma Linda, California 92354
October 30, 2015
Re: K151886
Trade/Device Name: Acumed Ankle and Small Fragment Base Set Update Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: September 28, 2015 Received: October 1, 2015
Dear Mr. Nathan 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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.
Mark N. Melkerson -S
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 below.
page 1 of 1
510(k) Number (if known)
Device Name
Acumed Ankle and Small Fragment Base Set Update
Indications for Use (Describe)
The Acumed Ankle Plating System contains orthopedic plates and lag screws intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Contact Details
| Applicant Name: | Acumed LLC
5885 NW Cornelius Pass Road
Hillsboro, OR 97124-9432 |
|--------------------|-------------------------------------------------------------------------------------|
| Applicant Contact: | Ms. Kara Budor, Regulatory Manager
503-207-1413
503-520-9618 (Fax) |
| Correspondent: | Mr. Nathan Wolf, Regulatory Consultant
858-263-0605
nathan@wolfregulatory.com |
| Date Prepared: | July 7, 2015 |
Device Name
| Trade Name: | Acumed Ankle and Small Fragment Base Set Update |
|---|---|
| Common Name: | Bone Plates and Bone Screws |
| Classification: | 21 CFR 888.3030 Single / Multiple component metallic bone |
| fixation appliances and accessories | |
| Class: | Class II |
| Product Code: | HRS HWC |
Legally Marketed Predicate Device(s)
The Acumed Ankle Plating System cleared in 2015 (K143385), Acumed Small Fragment Base Set cleared in 2015 (K143394), Howmedica Osteonics Stryker® Foot Plating System cleared in 2007 (K063875). Howmedica Osteonics VariAx™ Distal Fibula Plate cleared in 2008 (K081284), and Smith & Nephew Peri-Loc'" Periarticular Locked Plating System cleared in 2007 (K071563) serve as the predicate devices for this system.
Device Description
The Acumed Ankle and Small Fragment Base Set Update introduces new 2.7mm and 3.5mm variable angle screws for use with previously cleared plates from the Acumed Ankle Plating System (K143385) and Acumed Small Fragment Base Set (K143394).
4
Acumed Ankle and Small Fragment Base Set Update 510(k) Notification
Additionally, this submission expands the Ankle Plating System to include use of existing 2.7mm and 3.5mm non-locking screws in independent bone fixation, for the K143385 indications.
Intended Use/Indications for Use
The Acumed Ankle Plating System contains orthopedic plates and lag screws intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Substantial Equivalence Comparison
In consideration of the comparisons given herein, the Acumed Ankle and Small Fragment Base Set Update has been determined to be substantially equivalent to its predicate devices. Substantial equivalence was determined due to similarities in materials, technology, function, and dimensions.
Non-clinical Testing
Non-clinical included:
- ASTM F543 comparative testing ●
- Cantilever bend comparative testing .
- . Galvanic corrosion analysis
Test data showed the variable angle screws introduced in this 510(k) submission are substantially equivalent to predicate devices.