(58 days)
Not Found
No
The 510(k) summary describes a set of orthopedic plates and screws for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies are based on mechanical testing of the implants.
No
This device consists of orthopedic plates and screws used for fixation of fractures and non-unions, which are mechanical interventions rather than therapeutic treatments.
No
The device is described as orthopedic plates and screws intended for fixation of fractures, osteotomies, and non-unions, which are treatment modalities, not diagnostic functions.
No
The device description explicitly states it contains orthopedic plates and screws made of titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fixation of fractures, osteotomies, non-unions, replantations, and fusions of bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of orthopedic plates and screws, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Acumed Small Fragment Base Set contains orthopedic plates and screws indicated for general fragment fixation as described below. Plates and screws are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136, or from commercially pure titanium per ASTM F67. All implants are provided both sterile and non-sterile. The set also contains typical instrumentation for general orthopedic fracture fixation cases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, radius, tibia, fibula, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing between the Acumed Small Fragment Base Set implants and similar devices was conducted as follows:
- Fragment Plate static bending strength and cyclic fatigue testing was performed . per ASTM F382.
- 0 One-Third Tubular Plate static bending strength and cyclic fatigue testing was performed per ASTM F382.
- Hook Plate static bending strength and cyclic fatigue testing was performed per ● ASTM F384
- 0 Locking Peg Hook Plate static bending strength and cyclic fatigue testing was performed per ASTM F384
- 4.0 Cancellous Screw pullout and torque testing was performed per ASTM F543. 0
The results provided in Section 20 demonstrate the substantial equivalence of the Acumed Small Fragment Base Set.
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.
K063049, K082072, K011335, K963192
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
§ 888.3030 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Acumed. LCC Nathan Wolf Regulatory Specialist 5885 NW Cornelius Pass Road Hillsboro, Oregon 97124
Re: K143394 Trade/Device Name: Acumed Small Fragment Base Set 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: December 9, 2014 Received: December 12, 2014
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 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Acumed Small Fragment Base Set 510(k)
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.
K143394 page 1 of 1
510(k) Number (if known)
Device Name
Acumed Small Fragment Base Set
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 |
|-----------------|--------------------------------------------------------------------------------------------------------|
| | Nathan Wolf, Regulatory Specialist
503-726-6622 (Cell)
503-207-1502 (Desk)
503-520-9618 (Fax) |
| Date Prepared: | 05 January 2015 |
| Device Name | |
| Trade Name: | Acumed Small Fragment System |
| Common Name: | Bone Plates and 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 Synthes (USA) Modular Mini Fragment LCP System cleared in 2006 (K063049), Synthes (USA) 3.5mm LCP Hook Plate cleared in 2008 (K082072), Synthes One-Third Tubular DCL Plate cleared in 2001 (K011335), and Synthes Sterile 3.5mm and 4.0mm Cannulated Screws cleared in 1996 (K963192) serve as predicate devices.
Device Description
The Acumed Small Fragment Base Set contains orthopedic plates and screws indicated for general fragment fixation as described below. Plates and screws are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136, or from commercially pure titanium per ASTM F67. All implants are provided both sterile and non-sterile. The set also contains typical instrumentation for general orthopedic fracture fixation cases.
4
Intended Use/Indications for Use
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 Small Fragment Base Set has been determined to be substantially equivalent to its predicate devices, the Synthes (USA) Modular Mini Fragment LCP System (K063049), Synthes (USA) 3.5mm LCP Hook Plate (K082072), Synthes One-Third Tubular DCL Plate (K011335), and Synthes Sterile 3.5mm and 4.0mm Cannulated Screws (K963192). Substantial equivalence was determined due to similarities in materials, technology, function, and dimensions.
Non-clinical Testing
Comparative testing between the Acumed Small Fragment Base Set implants and similar devices was conducted as follows:
- Fragment Plate static bending strength and cyclic fatigue testing was performed . per ASTM F382.
- 0 One-Third Tubular Plate static bending strength and cyclic fatigue testing was performed per ASTM F382.
- Hook Plate static bending strength and cyclic fatigue testing was performed per ● ASTM F384
- 0 Locking Peg Hook Plate static bending strength and cyclic fatigue testing was performed per ASTM F384
- 4.0 Cancellous Screw pullout and torque testing was performed per ASTM F543. 0
The results provided in Section 20 demonstrate the substantial equivalence of the Acumed Small Fragment Base Set.