(49 days)
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.
The provided text is a 510(k) summary for a medical device (Dall-Miles Homogeneous Vitallium® Cable) seeking approval for expanded indications. It is a regulatory submission focused on demonstrating substantial equivalence to predicate devices for these new indications.
**Crucially, this document does not describe:
- An AI/ML device.
- Acceptance criteria for algorithm performance.
- A study proving device performance against such criteria.**
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details.
The document discusses substantial equivalence for new intended uses of an existing physical device (a bone fixation cable), not the performance of a diagnostic or predictive algorithm.
{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.
§ 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.