(27 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and the performance studies are based on engineering calculations and bench testing, with no mention of AI/ML terms or functionalities.
No
The device, a plate and screw system, is intended for wrist arthrodesis and fracture fixation, not for delivering therapeutic substances or energy.
No
Explanation: The device is a plate system used for wrist arthrodesis and fracture fixation, which are surgical interventions, not diagnostic procedures. It is designed to provide structural support rather than to identify or characterize medical conditions.
No
The device description clearly states it contains plates and screws, which are physical hardware components, not software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The Acumed Wrist Arthrodesis Plate System is a surgical implant. It is a physical device designed to be surgically placed within the body to stabilize bones in the wrist and other small bones.
- Intended Use: The intended use clearly states it's for "wrist arthrodesis and fractures of other small bones," which are surgical procedures.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
The device is a surgical implant used in orthopedic procedures, not a diagnostic test performed outside the body.
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 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.
Product codes
HRS, HWC
Device Description
The Acumed Total Wrist Fusion Plating System contains plates which are pre-contoured with an anatomic design. The plates have a combination of distal and proximal holes which utilize 2.3 mm and 3.5 mm cortical locking screws and non-locking screws. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the previously cleared Acumed Wrist Arthrodesis Plate System including modifications to existing plates, the addition of the Neutral plate and the modified 2.3 mm screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
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 rationales including calculations of moments of inertia and cross-sectional area were conducted to prove that the subject plates and screws are substantially equivalent to the predicate plates and screws.
Distal screw construct pull-out bench testing was also performed to prove that the distal subject screw-plate construct is substantially equivalent to the distal predicate screw-plate construct.
A discussion of clinical tests is not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100123, K042355, K023870, K011458, K000558, K052754, K991873
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
K131380
Section 4: 510(k) SUMMARY
| Device Trade Name: | Acumed Wrist Arthrodesis Plate System: Acumed Total Wrist
Fusion Plating System |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 10, 2013 |
| Sponsor: | Acumed, LLC
5885 NW Cornelius Pass Road
Hillsboro, OR 97124
Phone: (503) 627-9957
Fax: (503) 520-9618 |
| Contact Person: | Brittany Cunningham, Regulatory Specialist 2 |
| Manufacturer: | Acumed, LLC
5885 NW Cornelius Pass Road
Hillsboro, OR 97124
Phone: (503) 207-1467
Fax: (503) 520-9618 |
| Common Name: | Plate, Fixation, Bone |
| Device Classification: | Class II |
| Classification Name: | Plate, Fixation, Bone |
| Regulation: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener |
| Device Regulation Panel: | Orthopedic |
| Device Product Code: | HRS, HWC |
Device Description:
The Acumed Total Wrist Fusion Plating System contains plates which are pre-contoured with an anatomic design. The plates have a combination of distal and proximal holes which utilize 2.3 mm and 3.5 mm cortical locking screws and non-locking screws. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the previously cleared Acumed Wrist Arthrodesis Plate System including modifications to existing plates, the addition of the Neutral plate and the modified 2.3 mm screw.
Intended Use:
Wrist arthrodesis and fractures of other small bones
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
JUN 1 0 2013
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K131380
arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.
Materials:
The Acumed Total Wrist Fusion Plating System components are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136.
Technological Characteristics:
The plates and screws are made of titanium alloy (Ti-6AI-4V) per ASTM F136. The predicate devices share these dimensional and material characteristics. There are no technological characteristics that raise new issues of safety or effectiveness.
Performance Data:
Engineering rationales including calculations of moments of inertia and cross-sectional area were conducted to prove that the subject plates and screws are substantially equivalent to the predicate plates and screws.
Distal screw construct pull-out bench testing was also performed to prove that the distal subject screw-plate construct is substantially equivalent to the distal predicate screw-plate construct.
A discussion of clinical tests is not applicable.
Predicate Device: (modified to subject device) Acumed Wrist Arthrodesis Plate System - K100123
Previous Predicates: (For modified device)
Synthes LCP Wrist Fusion Plate - K042355 Synthes Small Titanium Wrist Fusion Plate - K023870 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 Total Wrist Fusion Plating Device and the predicate devices studied, the safety and effectiveness of the Acumed Total Wrist Fusion Plating System is substantially equivalent to the predicate devices referenced.
The term "substantial equivalence" as used in this Special 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and applied under 21 CFR 807, Subpart E, under which a device can be marketed without the pre-approval or classification.
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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 two main elements: the department's name encircling the symbol on the left and the symbol itself on the right. The symbol is a stylized representation of a human figure embracing a globe, conveying the department's mission of protecting and promoting the health and well-being of people in the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2013
Acumed. LLC % Ms. Brittany Cunningham Regulatory Specialist II 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124
Re: K131380
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, HWC Dated: May 10, 2013 Received: May 14, 2013
Dear Ms. Cunningham:
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 mav 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. Brittany Cunningham
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 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 yours.
Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif font. The middle initial and last name, "DKeith," are written in a more decorative font with outlines and patterns within the letters.
For
Mark Melkerson Director Division of Orthonedic Devices Office of-Device Evaluation-Center for Devices and
Radiological Health
Enclosure
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Section 3: INDICATIONS FOR USE
510(k) Number (if known): K131380
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 | X |
|---|---|
| ------------------ | --- |
AND/OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(21 CFR 801 Subpart D)
Subpart C)
(21 CFR 807(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Elizabeth L. Frank -S
Division of Orthopedic Devices