(56 days)
Not Found
No
The device description and performance studies sections do not mention any AI or ML components or capabilities. The device is described as a system of bone plates and screws for fixation, which is a traditional mechanical medical device.
No
The device, a plate and screw system, is used for fixation during fractures, fusions, and osteotomies to aid in the healing process, not to provide therapy itself.
No
The device, the Acumed Lower Extremity Congruent Plate System, is described as providing "fixation during fractures, fusions, and osteotomies." This indicates its purpose is for treatment and repair, not for identifying or diagnosing a condition.
No
The device description explicitly states it consists of bone plates and screws, which are hardware components, not software.
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 during fractures, fusions, and osteotomies." This describes a surgical implant used to stabilize bones, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details bone plates and screws made of titanium, used with instruments for insertion. This aligns with a surgical implant, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Acumed Lower Extremity Congruent Plate System is indicated for use in providing fixation during fractures, fusions, and osteolomies. The Acumed Lower Extremity Congruent Plate System includes plates and screws designed specifically for the phalanges, metatarsals, tarsals, tibia and fibula.
The Acumed Lower Extremity Congruent Plate System provides fixation during fractures, fusions, and osteotomies for the phalanges, metatarsals, tibia and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Acumed Lower Extremity Congruent Plate System consists of bone plates and screws for fractures, fusions, and osteotomes: 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. 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
phalanges, metatarsals, tarsals, 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)
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): 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.
K012655, K001941, K974537, K982347, K020401, K981775
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.
Not Found
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).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
acum
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
Tel (503) 627-9957
510(k) Summary
This summary regarding 510(k) salcty and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Acumed LLC Submitter Information: 5885 N.W. Cornelius Pass Road Hillsboro, OR 97124-9432 USA Phone: (503) 627-9957 (503) 686-7102 FAX: 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 Lower Extremity Congruent 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
Synthes USA Modular Foot System K001941
Synthes USA Cannulated Angle Blade Plate System K974537
Depuy Ace Medical Co. Timax Pilon System K982347
Synthes USA Calcaneal Plate K020401
Depuy Ace Medical Co. Timax Calcaneal Peri-Articular Plate
K981775 |
Device Description: The Acumed Lower Extremity Congruent Plate System consists of bone plates and screws for fractures, fusions, and osteotomes: 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. Plates and screws are provided non-sterile.
Intended Use: The Acumed Lower Extremity Congruent Plate System is indicated for use in providing fixation during fractures, fusions, and osteolomies. The Acumed Lower Extremity Congruent Plate System includes plates and screws designed specifically for the phalanges, metatarsals, tarsals, 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 Lower Extremity Congruent Plate System are made out of Titanium as per ASTM F136. The predicates devices listed use cither 316L stainless steel or Titanium as per 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 Lower Extremity Congruent Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Lower Extremity Congruent Plate System is substantially equivalent to the predicate devices referenced.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Mr. Ed Boehmer Regulatory and Documentation Supervisor Acumed LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432
Re: K033639
K035057
Trade/Device Name: Acumed Lower Extremity Congruent Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC Dated: November 14, 2003 Received: November 24, 2003
Dear Mr. Boehmer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tor use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or 10 commerce print to they 20, 1978, are eccordance with the provisions of the Federal Food. Drug. de necs that have boon reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, market and act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to sacer additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that I'DA's issuance of a substantial equivalence determination docs not mean I Toase be advised that I DPT of issuation its your device complies with other requirements of the Act that 1171 has made a sond regulations administered by other Federal agencies. You must or any I outhal bithe Act's requirements, including, but not limited to: registration and listing (21 ClFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 8077, adomig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Ed Boehmer
This letter will allow you to begin marketing your device as described in your Scction 510(k) rms letter with anow your to organization 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 If you desire specific arries 101 ) 594-4659. Also, please note the regulation entitled. Connior the Ories of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrination of your Copymer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark n Millerson
Celia M. Witten, Ph.D., M.D. 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): K033639
Device Name: Acumed Lower Extremity Congruent Plate System
Indications For Use:
The Acumed Lower Extremity Congruent Plate System provides fixation during fractures, fusions, and osteotomies for the phalanges, metatarsals, 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)
f Mark N. Milken
Division of O
Neurological L