(88 days)
No
The 510(k) summary describes a system of bone plates and screws for fracture fixation and mentions modifications to existing components and the addition of a new component. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies described are mechanical tests, not studies related to algorithmic performance.
Yes
The device is a bone plate system used for fixation of fractures, fusions, or osteotomies, which are therapeutic interventions.
No
The device, a bone plate system, is used to provide fixation for fractures and other bone conditions. It does not diagnose medical conditions.
No
The device description explicitly states it consists of bone plates and screws made of titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide fixation for fractures, fusions, or osteotomies of various bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of bone plates and screws, which are implanted medical devices used for structural support and fixation within the body.
- Anatomical Site: The device is used on bones within the human body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is clearly an implantable surgical device used for orthopedic procedures, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS
Device Description
The predicate Congruent Bone Plate System (K012655) consists of bone plates and screws which provide fixation for fractures, fusions, and osteotomies of the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
The purpose of this 510(k) is to modify two components of the Congruent Bone Plate System and to add one component to this predicate system. These modifications are intended to allow the operating surgeon to better accommodate various patient anatomies when treating distal and midshaft fractures of the radius. All components are made of titanium alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
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)
Preclinical Testing: The new components were subjected to static and dynamic 4-point bend testing in accordance with ASTM F382, Standard Specification and Test Method for Metallic Bone The results demonstrate that the modified components are substantially Plates. equivalent to the predicate. .
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
510(k) Summary
| Device Trade Name: | Congruent Bone Plate System |
|---|---|
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Contact: | Mr. Ed Boehmer |
| Global Regulatory and Quality Director | |
| Chief Compliance Officer | |
| Phone: (503) 627-9957 | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | December 14, 2010 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic |
| bone fixation appliances and accessories | |
| Class: | II |
| Product Code: | HRS |
| JAN - 4 2011 |
Indications For Use:
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.
Device Description:
The predicate Congruent Bone Plate System (K012655) consists of bone plates and screws which provide fixation for fractures, fusions, and osteotomies of the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
The purpose of this 510(k) is to modify two components of the Congruent Bone Plate System and to add one component to this predicate system. These modifications are intended to allow the operating surgeon to better accommodate various patient anatomies when treating distal and midshaft fractures of the radius. All components are made of titanium alloy conforming to ASTM F136.
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Predicate Device:
The modified Congruent Bone Plate System is substantially equivalent to the predicate Congruent Bone Plate System previously cleared in K012655 with respect to indications, design, function, and materials.
Preclinical Testing:
The new components were subjected to static and dynamic 4-point bend testing in accordance with ASTM F382, Standard Specification and Test Method for Metallic Bone The results demonstrate that the modified components are substantially Plates. equivalent to the predicate. .
2
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 representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acumed, LLC % Mr. Ed. Boehmer 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124
JAN - 4 2011
Re: K102998 Trade/Device Name: Congruent Bone Plate System Regulation Number: 21 CRF 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: October 6, 2010 Received: October 8, 2010
Dear Mr. Boehmer:
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
3
Page 2 - Mr. Ed. Boehmer
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/ReportalProblem/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.
A. B. R. to
D. fr.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
JAN - 4 2011
510(k) Number (if known): Kloa798
Device Name: 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.
KIDZ998
Prescription Use ﺳﮯ Prescription Ose _____________________________________________________________________________________________________________________________________________________________
ND/OR
Ove
(21
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)
for M. Melleran
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102998
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