(49 days)
No
The summary explicitly states "There have been no changes in the design, materials, manufacturing, or operational principles of the Dall-Miles Cable" and there are no mentions of AI, ML, or related concepts.
No
The device is described as a Dall-Miles Homogeneous Cable used for spinal wiring, trochanter reattachment, sternotomy applications, trauma surgery, stabilization of bone graft material, and fracture fixation. These uses are structural and supportive, not for treating a disease or therapeutic condition.
No
The device is described as a surgical cable used for spinal wiring, reattachment, sternotomy, and fracture fixation, which are therapeutic and stabilization procedures, not diagnostic ones.
No
The device description explicitly states "There have been no changes in the design, materials, manufacturing, or operational principles of the Dall-Miles Cable," which is a physical cable used in surgery. This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states this is a "Dall-Miles Homogeneous Cable" used for surgical procedures like spinal wiring, fracture fixation, and reattachment of anatomical structures.
- Intended Use: The intended use is for surgical stabilization and fixation within the body, not for analyzing samples outside the body.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
This submission describes a modification in intended use of the previously released Dall-Miles Homogeneous Cable (K945294). The original Homogeneous cable is intended to be used for spinal wiring, trochanter reattachment, sternotomy applications, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Indications for the stabilization of bone graft material and for fracture fixation when used in conjunction with bone plates and screws have been added.
Product codes
JDQ
Device Description
There have been no changes in the design, materials, manufacturing, or operational principles of the Dall-Miles Cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal, trochanter, sternotomy, shoulder, elbow, knee, hip, ankle
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
2.2 1996
510(k) Summary
Proprietary Name: Dall-Miles Homogeneous Vitallium® Cable
Common Name: Bone Fixation Cerclage
Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010
Proposed Regulatory Class: Class II Device Product Code: OR(87) JDQ
For information contact: Frank Maas
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 4-2-96
This submission describes a modification in intended use of the previously released Dall-Miles Homogeneous Cable (K945294). The original Homogeneous cable is intended to be used for spinal wiring, trochanter reattachment, sternotomy applications, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Indications for the stabilization of bone graft material and for fracture fixation when used in conjunction with bone plates and screws have been added.
There have been no changes in the design, materials, manufacturing, or operational principles of the Dall-Miles Cable.
Substantial equivalence of the additional indications is based on equivalence in intended use to Howmedica's Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System Each of the named devices are currently marketed for (K934557) . . stabilization of bone graft and fracture fixation.