(17 days)
Not Found
No
The device description and intended use clearly define a system of physical implants (plates, screws, k-wires) for fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the management of fractures, fusions, and osteotomies, which are therapeutic interventions.
No
The device description indicates it is a system of plates, screws, and k-wires used for managing fractures, fusions, and osteotomies, which are therapeutic interventions rather than diagnostic processes.
No
The device description explicitly lists physical components such as plates, screws, and k-wires, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices." This describes a surgical implant used to fix bones, not a test performed on samples taken from the body.
- Device Description: The description details plates, screws, and k-wires made of titanium, which are physical implants. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
Therefore, the Acumed Hand Plating System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Acumed Hand Fracture System is intended for the management of fractures, fusions, and osteotomies of the distal, middle and proximal phalanges and metacarpals and other bones of appropriate size for the devices.
Product codes
HRS, HWC
Device Description
The Hand Plating System consists of plates, locking screws, lag screws, and k-wires.
Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws have major thread diameters of 1.5 mm to 2.3 mm and are provided in lengths ranging from 5 mm to 20 mm. The lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 8 mm to 18 mm.The lag screws and k-wires are used for fixation.
The plates are made of titanium per ASTM F-67. The screws, lag screws, and the kwires are made of titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.
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)
Engineering analysis was conducted that proved that the 1.5 and 2.3 mm Hexalobe Laq Screws can be used with the Acumed Hand Plates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Acumed Hand Plating System Special 510(k) Notification
JUN 1 3 2014
K141383 page 1 of 2
Section 7 - 510(k) Summary
510(k) Summary
Contact Details
ﻴﺴ
| Applicant Name: | Acumed LLC
5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432 |
|-----------------|---------------------------------------------------------------------|
| | Mariah Knight, Regulatory Specialist
503-207-1530 |
| Date Prepared: | May 22, 2014 |
Device Name
| Trade Name: | Acumed Hand Fracture System |
|---|---|
| ------------- | ----------------------------- |
Common Name: Hand Plating System
Classification: 21 CFR 888. 3030, (Single/multiple component metallic bone fixation appliances and accessories )
Class: ll
HRS, HWC Product Code:
Legally Marketed Predicate Device(s)
The Acumed Hand Plating System cleared in 2013 (K132769) serves as the predicate device.
Device Description
The Hand Plating System consists of plates, locking screws, lag screws, and k-wires.
Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws have major thread diameters of 1.5 mm to 2.3 mm and are provided in
1
Acumed Hand Plating System Special 510(k) Notification
lengths ranging from 5 mm to 20 mm. The lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 8 mm to 18 mm.The lag screws and k-wires are used for fixation.
The plates are made of titanium per ASTM F-67. The screws, lag screws, and the kwires are made of titanium alloy per ASTM F136.
Intended Use/Indications for Use
The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.
Substantial Equivalence Comparison
The Acumed Hand Plating System is substantially equivalent to the predicate K132769. The safety and effectiveness is adequately supported by the substantial equivalence information, materials information, and analysis provided within this Premarket notification.
The proposed Acumed Hand Plating System and the predicate devices consist of same technological characteristics, design features, materials of composition, and intended use.
The proposed Acumed Hand Plating System possesses a modified operating priniciple in that the lag screws may be used with the plates, in addition to being used independently for fixation.
Non-clinical Testing
Enqineering analysis was conducted that proved that the 1.5 and 2.3 mm Hexalobe Laq Screws can be used with the Acumed Hand Plates.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2014
Acumed, LLC Ms. Mariah Knight Regulatory Specialist 5885 NW Cornelius Pass Road Hillsboro, Oregon 97124
Re: K141383 Trade/Device Name: Acumed Hand Fracture System 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: May 22, 2014 Received: May 27, 2014
Dear Ms. Knight:
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
3
Page 2 - Ms. Mariah Knight
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" (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
- for
: ''
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K141383
Device Name Acumed Hand Fracture System
Indications for Use (Describe)
The Acumed Hand Fracture System is intended for the management of fractures, fusions, and osteotomies of the distal, middle and proximal phalanges and metacarpals and other bones of appropriate size for the devices
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
. .
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
・・
Elizabeth动摇rank -S
Division of Orthopedic Devices
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