(80 days)
Not Found
No
The summary describes a mechanical implant (plate) for bone fixation and contains no mention of software, algorithms, or data processing that would suggest AI/ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a plate for fixing fractures, which is a structural support. While it aids in the healing process, it doesn't actively treat the fracture in the same way a drug or therapy device would. Fixation devices are generally considered surgical implants rather than therapeutic devices that deliver therapy.
No
The device is described as a plate intended for fixation of fractures, osteotomies, and non-unions, which is a therapeutic rather than diagnostic function. It is a physical implant, not a tool for identifying or characterizing a medical condition.
No
The device description explicitly states it comprises "two anatomically designed dorsal fixation plate," indicating it is a physical hardware device, not software only.
No, 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, and nonunions of the radius. This describes a surgical implant used to stabilize bone, not a test performed on samples taken from the body.
- Device Description: The device is described as a dorsal fixation plate, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used for mechanical support and stabilization of bone.
N/A
Intended Use / Indications for Use
The Acumed Wrist Spanning Plate is intended for fixation of fractures, osteotomies, and nonunions of the radius.
The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.
Product codes
HRS
Device Description
The Acumed Wrist Spanning Plate comprises two anatomically designed dorsal fixation plate and is provided in sterile packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius
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
The bending strength performance of the Acumed Wrist Spanning Plate was verified to be statistically equivalent to that of the predicate device. A summary of the objective, acceptance criteria, results, and conclusions, as well as the detailed test reports can be found in Section 36.
Key Metrics
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
K131764
Section 4: 510(k) SUMMARY
| Device Trade Name: | Acumed Wrist Spanning Plate |
|---|---|
| Date: | June 14, 2013 |
| Sponsor: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Phone: (503) 627-9957 | |
| Fax: (503) 520-9618 | |
| Contact Person: | Nathan Wolf, Regulatory Specialist |
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Phone: (503) 207 1502 | |
| 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 | |
| Device Regulation Panel: | Orthopedic |
HRS
Device Product Code:
Device Description:
The Acumed Wrist Spanning Plate comprises two anatomically designed dorsal fixation plate and is provided in sterile packaging.
Intended Use:
The Acumed Wrist Spanning Plate is intended for fixation of fractures, osteotomies, and nonunions of the radius.
Indications For Use:
The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and nonunions of the radius.
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Materials:
The Acumed Wrist Spanning Plate is manufactured from titanium alloy (Ti-6AI-4V) as described in ASTM F136.
Technological Characteristics:
There are no technological characteristics that raise new issues of safety or effectiveness.
Assessment of performance data:
The bending strength performance of the Acumed Wrist Spanning Plate was verified to be statistically equivalent to that of the predicate device. A summary of the objective, acceptance criteria, results, and conclusions, as well as the detailed test reports can be found in Section 36.
Legally Marketed Predicate Device:
Synthes 3.5mm Locking Compression Plate standard bone plate (K082807)
Predicate Indications for Use:
The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.
Based upon the similarities of the Acumed Wrist Spanning Plate and the predicate devices studied, the safety and effectiveness of the Acumed Wrist Spanning Plate is substantially equivalent to the predicate devices referenced.
Purpose:
The purpose of this Traditional 510(k) submission is to gain clearance for the Acumed Wrist Spanning Plate.
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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". The eagle is depicted with three curved lines forming its body and wings, creating a sense of movement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
September 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gh() Silver Spring, MD 20993-0002
Mr. Nathan Wolf Regulatory Specialist Acumed. LLC 5885 Northwest Cornelius Pass Road Hillsboro. Oregon 97124
Re: K131764
Trade/Device Name: Acumed Wrist Spanning Plate 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: June 14, 2013 Received: June 17, 2013
Dear Mr. 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 cnactment date of the Medical Device Amendments. or 10 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
3
Page 2 - Mr. Nathan Wolf
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 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/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 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,
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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Section 3: INDICATIONS FOR USE
510(k) Number (if known): K131764
Device Name: Acumed Wrist Spanning Plate
Indications for Use:
The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
AND/OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
| (21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
|---|---|
| ------------------------ | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Elizabeth L. Frank -S
.