(264 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) and its performance through engineering analysis and mechanical testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets typically associated with AI/ML devices.
Yes
The device is intended to treat and restore function in various wrist conditions, such as post-traumatic arthritis, rheumatoid wrist deformities, and complex carpal instability, which are therapeutic applications.
No
The device, a wrist arthrodesis plate system, is an implantable medical device used for treatment (fusion of the wrist and fixation of fractures), not for diagnosis. Its purpose is to physically stabilize the wrist, not to identify or characterize a disease or condition.
No
The device description clearly states it is a "Wrist Arthrodesis Plate System" and describes physical plates and screws, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for wrist arthrodesis and fractures of other small bones, which are surgical procedures performed directly on the patient's body.
- Device Description: The device is a plate and screw system designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. This device is a surgical implant used for structural support and fusion in vivo.
N/A
Intended Use / Indications for Use
The Acumed Wrist Arthrodesis Plate System is intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis r frame wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, turnor resection, and spastic deformities.
Product codes
HRS
Device Description
Device Book prist Arthrodesis Plates are pre-contoured with an anatomic design with multiple rric Acaned Which will be a combination of distal and proximal holes which utilize 2.3 mm and 3.5 mm cortical locking and non-locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, carpal
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)
An engineering analysis of plate strength was conducted to compare the Acumed Wrist Arthrodesis Plate to the predicate device. Calculations based on cross-sect6ional area and plate material showed that the Acumed Wrist Arthrodesis Plate is able to withstand more load than the predicate device before plastic deformation.
Mechanical testing of distal screw pull-out strength was conducted comparing the Acumed Wrist Arthrodesis Plate to the predicate device. The results showed that the Acumed Wrist Arthrodesis Plate required equivalent force and significantly more energy to cause distal screw pull-out than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes LCP Wrist Fusion Plate - K042355, Synthes Small Titanium Wrist Fusion Plate - K023879, Synthes Straight Wrist Fusion Plate - K011458, Synthes Wrist Fusion Plate - K000558, DVO Wrist Fusion Plate - K052754, KMI Wrist Fusion System - K991873
Reference Device(s)
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
Innovative Solustions
15100123
OCT 6 2010
| 510(k) Summary | |
|---|---|
| Contact: | Lino Tsai |
| Acumed, LLC | |
| 5885 NW Cornelius Pass Rd. | |
| Hillsboro, OR 97124-9432 | |
| (503) 627-9957 x 1370 | |
| FAX: (503) 686-7102 | |
| Device Trade Name: | Acumed Wrist Arthrodesis Plate System |
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Rd. | |
| Hillsboro, OR 97124-9432 | |
| Common Name: | Plate, Fixation, Bone |
| Classification: | 21 CFR 888.3030 |
| Class: | II |
| Product Code: | HRS |
| Date: | September 24, 2010 |
Indications for Use:
The Acumed Wrist Arthrodesis Plate System is intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis r frame wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, turnor resection, and spastic deformities.
Device Description:
Device Book prist Arthrodesis Plates are pre-contoured with an anatomic design with multiple rric Acaned Which will be a combination of distal and proximal holes which utilize 2.3 mm and 3.5 mm cortical locking and non-locking screws.
1
Innovative Solustions
Technological Characteristics:
The plates and screws are made of titanium alloy, Ti 6Ai 4V, per ASTM F136. The plates are supplied in multiple wrist positions. The predicate devices share these dimensional and material characteristics. There are no technological characteristics that raise new issues of safety or effectiveness.
An engineering analysis of plate strength was conducted to compare the Acumed Wrist Arthrodesis Plate to the predicate device. Calculations based on cross-sect6ional area and plate material showed that the Acumed Wrist Arthrodesis Plate is able to withstand more load than the predicate device before plastic deformation.
Mechanical testing of distal screw pull-out strength was conducted comparing the Acumed Wrist Arthrodesis Plate to the predicate device. The results showed that the Acumed Wrist Arthrodesis Plate required equivalent force and significantly more energy to cause distal screw pull-out than the predicate device.
Predicate Device(s):
Synthes LCP Wrist Fusion Plate - K042355 Synthes Small Titanium Wrist Fusion Plate - K023879 Synthes Straight Wrist Fusion Plate - K011458 Synthes Wrist Fusion Plate - K000558 DVO Wrist Fusion Plate - K052754 KMI Wrist Fusion System - K991873
Based upon the similarities of the Acumed Wrist Arthrodesis Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Wrist Arthrodesis Plate System is substantially equivalent to the predicate devices referenced.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acumed LLC % Ms. Lino Tsai Regulatory Specialist 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124-9432
OCT 6 2010
Re: K100123
Trade/Device Name: Acumed Wrist Arthrodesis Plate 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 Dated: August 26, 2010 Received: August 27, 2010
Dear Ms. Tsai:
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. Iisting 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
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Page 2 - Ms. Lino Tsai
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours,
ely yours,
for
N. Malkerson
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "ACUMED" in all caps with a registered trademark symbol. The font is blocky and sans-serif. The letters are black and the background is white.
Innovative Solutions
Indications for Use
510(k) Number (if known): K100123
Device Name: Acumed Wrist Arthrodesis Plate System
Indications for Use:
The Acumed Wrist Arthrodesis Plate System is intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the wrist, · rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.
Prescription Use _ × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soutte for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100123
Acumed LLC
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