(78 days)
Not Found
No
The device description and the lack of any mention of AI, ML, or related concepts strongly suggest this is a purely mechanical device.
No.
The device is an orthopedic repair component (a crimp sleeve for cerclage wire) used in surgical procedures, but it does not directly provide therapy for a disease or condition. It is a tool for mechanical stabilization.
No
Explanation: The device description clearly states its purpose is for "general orthopedic repairs wherever cerclage wire is indicated," and it details a physical mechanism for securing bones. This points to a therapeutic or surgical function, not a diagnostic one. There is no mention of analysis, measurement, or assessment of a medical condition.
No
The device description clearly states it is a "block with two holes" used with "cerclage wire," indicating a physical, hardware-based 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Acumed Wire Crimp Sleeve is a physical device used in orthopedic surgery to secure cerclage wire around bone. It is used directly on the patient's body during a surgical procedure.
- Intended Use: The intended use is for "general orthopedic repairs wherever cerclage wire is indicated," which is a surgical application, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant/accessory, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable. It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable.
The sleeve is manufactured from titanium per ASTM F 136. It is intended for use with titanium or cobalt chromium cerclage wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
K931246, Osteo-Clage Cable System, Howmedica Dall-Miles Cable System
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for ACUMED. The logo is in black and white, with the word "ACUMED" in large, bold letters. There is a line underneath the word "ACUMED". The letters are blocky and sans-serif.
Ouality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary
MAY - 3 1996
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable. It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.
The sleeve is manufactured from titanium per ASTM F 136. It is intended for use with titanium or cobalt chromium cerclage wire.
Information regarding implantation, packaging, and labeling have been provided.
This medical device is identical except for material type to the Acumed Cerclage Wire Crimp (K931246). Both the Acumed Cerclage Wire Crimp and the Richards Orthopedic Cable System are manufactured from titanium. In addition, the Acumed Cerclage Wire Crimp may be found substantially equivalent to the Osteo-Clage Cable System and the Howmedica Dall-Miles Cable System, is safe and effective, and is expected to perform as well as similar devices.
e well engine edic problem is backed by
Randall Hu ident, Acume
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- 10950 SW 5th St., Suite 170 ◆ Beaverton, OR 97005 ◆ (503) 627-9957 ◆ Fax: (503) 643-1909 ◆ Form # FOCL-22 02/09/96 Page 8 of 9 © 1995, Acumed, Inc.