(51 days)
Not Found
No
The summary describes a system of physical bone plates and screws for surgical fixation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device provides fixation for fractures, fusions, and osteotomies, which are structural supports rather than therapeutic actions that treat or mitigate a disease.
No
The device is a bone plate system used for fixation during fractures, fusions, and osteotomies, which are surgical interventions, not diagnostic procedures.
No
The device description explicitly states it consists of bone plates and screws, which are hardware components.
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 Rib Congruent Bone Plate System is a system of bone plates and screws designed for surgical implantation to fix fractures, fusions, and osteotomies of the rib. It is a physical implant used directly on the patient's bone.
- Intended Use: The intended use is to provide fixation during surgical procedures on the rib, not to analyze biological samples for diagnostic purposes.
The description clearly indicates a surgical implant used for structural support, which is fundamentally different from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib. The Acumed Rib Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the rib.
Product codes
HRS
Device Description
The Acumed Rib Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All nlates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rib
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 assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
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
Ko51410
JUL 2 1 2005
구로 디
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
Tel (503) 627-9957
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Information: | Acumed LLC
5885 N.W. Cornelius Pass Road
Hillsboro, OR 97124-9432
USA
Phone: (503) 627-9957
FAX: (503) 686-7102
Contact: Ed Boehmer, Regulatory & Documentation Supervisor |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Single/multiple Component Metallic Bone Fixation Appliances and
Accessories |
| Common Name: | Plate, Fixation, Bone |
| Proprietary Name: | Acumed Rib Congruent Bone Plate System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3030 |
| Device Product Code: | HRS |
| Legally Marketed Equivalent Device(s): | Acumed LLC Congruent Bone Plate System K012655
KLS-Martin Sternal Plating System K032413
MacroPore OS Trauma K024169 |
Device Description: The Acumed Rib Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All nlates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.
Intended Use: The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Rib Congruent Bone Plate System plates are made out of Titanium as per ASTM F136. The predicates devices listed use Titanium as per ASTM F67 and ASTM F136.
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Based upon the similarities of the Acumed Rib Congruent Bone Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Rib Congruent Bone Plate System is substantially equivalent to the predicate devices referenced.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" encircling the eagle. The text is arranged in a circular fashion around the eagle, with the words "DEPARTMENT OF HEALTH" at the bottom and "SERVICES. USA" at the top.
JUL 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ed Boehmer Regulatory & Documentation Supervisor Acumed, LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432
Re: K051410
Trade/Device Name: Acumed Rib Congruent Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 20, 2005 Received: May 31, 2005
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, 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 such 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); good manufacturing practice requirements as set
2
Page 2 - Mr. Ed Boehmer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Brown
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known):
Device Name: Acumed Rib Congruent Bone Plate System
Indications For Use:
;
The Acumed Rib Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the rib.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 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 (ODE)
. Fion Sign-Off) Asion of General. Restorative J Neurological Devices
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