(109 days)
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No
The document describes a bone plate system and screws, focusing on mechanical properties and materials. There is no mention of AI, ML, or any software-driven analytical capabilities.
No
The device, a bone plate system, is used for fixation of fractures, fusions, or ostectomies, which are surgical procedures. This functionality aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition rather than diagnose or prevent one.
No.
The device is a bone plate system designed for fixation of fractures, fusions, or ostectomies, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the device is a bone plate system and includes components made of titanium alloy, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a bone plate system and screws used for fixation of fractures, fusions, or ostectomies. These are implanted devices used to stabilize bones.
- Intended Use: The intended use is to provide fixation for fractures, fusions, or ostectomies in various bones. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is clearly an implantable orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or ostectomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Acu-Loc 2 Plate is a volar plate which is intended to provide fixation for distal radius fractures.
The purpose of this Special 510(k) is to add 2.3mm Locking Variable Angle Screws for use with the Acu-Loc 2 Plate. All components are made of titanium alloy conforming to ASTM F136.
This addition does not affect the intended use of the device or alter the fundamental scientific technology of the device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical Testing:
The new screws were subjected to mechanical testing to characterize the screw/plate interface. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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
k |20903
JUL 1 3 2012
5. 510(k) Summary
Device Trade Name: Acumed Congruent Bone Plate System: Acu-Loc 2 Plate Acumed, LLC Manufacturer: 5885 NW Cornelius Pass Road Hillsboro, OR 97124 Contact: Ms. Brittany Cunningham Regulatory Specialist Phone: 503.207.1467 Fax: 503.686.7102 Prepared by: Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 Phone: (202) 552-5800 Fax: (202) 552-5798 March 23, 2012 Date Prepared: 21 CFR 888.3030, Single/multiple component metallic Classifications: bone fixation appliances and accessories 21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener Class: II
Product Codes:
Indications For Use:
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or ostectomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
HRS: HWC
Device Description:
The Acu-Loc 2 Plate is a volar plate which is intended to provide fixation for distal radius fractures.
The purpose of this Special 510(k) is to add 2.3mm Locking Variable Angle Screws for use with the Acu-Loc 2 Plate. All components are made of titanium alloy conforming to ASTM F136.
This addition does not affect the intended use of the device or alter the fundamental scientific technology of the device.
1
Predicate Device:
The subject 2.3mm Variable Angle Locking Screws are substantially equivalent to predicate screws and pegs (K102998) with respect to indications, design, function, and materials.
Preclinical Testing:
The new screws were subjected to mechanical testing to characterize the screw/plate interface. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acumed, LLC % Ms. Brittany Cunningham Regulatory Specialist 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124-9432
JUL 13 2012
Re: K120903
Trade/Device Name: Acumed Congruent Bone Plate System: 2.3 mm Variable Angle Locking Screw for Use with Acu-Loc2 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, HWC Dated: June 14, 2012 Received: June 15, 2012
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.
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 r read be action and a determination that your device complies with other requirements of the Act that I Dri has interes and regulations administered by other Federal agencies. You must or any I vith 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 - Ms. Brittany Cunningham
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 yours,
Mark N. Melkerson VIT Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): _ V 12 09 03
Device Name: Acumed Congruent Bone Plate System
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
ど Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) :
Concurrence of CDRH, Office of Device Evaluation (ODE)
Asin
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120903