(26 days)
Not Found
No
The 510(k) summary describes a system of bone plates and screws for fracture fixation, which are purely mechanical devices. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
Yes
The device is described as providing "fixation for fractures, fusions, or osteotomies," which are medical interventions aimed at treating or alleviating a condition, thus making it a therapeutic device.
No
Explanation: The device description states that the Acumed Congruent Bone Plate System "provides fixation for fractures, fusions, or osteotomies." This indicates a therapeutic or reconstructive function, not a diagnostic one. There is no mention of the device being used to identify or determine the nature of a condition.
No
The device description explicitly states it consists of bone plates, screws, and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "fixation for fractures, fusions, or osteotomies" for various bones. This is a surgical implant used directly on the patient's body to stabilize bone structures.
- Device Description: The description details bone plates and screws made of materials like Titanium, Stainless Steel, and Cobalt Alloy. These are physical implants.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve any testing of biological samples.
The information provided describes a surgical implant system, not an in vitro diagnostic device.
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, metatarsal, malleolus, tibia, and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Acumed 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 plates and screws are manufactured from Titanium in conformance with ASTM F136, Stainless Steel in conformance with ASTM F138 and ASTM F2229, and Cobalt Alloy in conformance with ASTM F90. 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
clavicle, humerus, radius, ulna, metatarsal, malleolus, tibia, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
AGUMED.
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 | JUL 1 8 2007 | |
| FAX: (503) 686-7102 | ||
| Contact: Ed Boehmer, Regulatory Compliance Officer |
| Classification Name: | Single/multiple Component Metallic Bone Fixation Appliances and
Accessories |
|----------------------------------------|--------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone |
| Proprietary Name: | Acumed 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 |
Device Description: The Acumed 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 plates and screws are manufactured from Titanium in conformance with ASTM F136, Stainless Steel in conformance with ASTM F138 and ASTM F2229, and Cobalt Alloy in conformance with ASTM F90. Plates and screws are provided non-sterile.
Intended Use: The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metatarsal, malleolus, tibia, and fibula.
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Congruent Bone Plate System is made out of Titanium as per ASTM F67 and ASTM F136, Stainless Steel ASTM F138 and ASTM F2229, Cobalt Alloy per ASTM F90. The predicates devices listed use similar materials
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 Congruent Bone Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Congruent Bone Plate System is substantially equivalent to the predicate devices referenced.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping lines forming the head and upper body. The figure is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2007
Acumed LLC % Mr. Ed Boehmer Regulatory Compliance Officer 5885 N.W. Cornelius Pass Road Hillsboro, OR 97124
Re: K071715
Trade/Device Name: Acumed 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: June 20, 2007 Received: June 22, 2007
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 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.
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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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Voulare Mueller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
1071715 510(k) Number (if known):
Device Name: Acumed Congruent Bone Plate System
Indications For Use:
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ultra, metacarpol, metatarsal, malleolus, tibia and fibula.
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)
Daibare Buen
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K071705
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Acumed LLC