(62 days)
Not Found
No
The summary describes a mechanical device (a beaded cable) and its intended uses. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a surgical cable used for fixation and stabilization, which is a structural or mechanical function, not a therapeutic one.
No.
The document describes the Dall-Miles Beaded Cable as a device for surgical fixation and stabilization (spinal wiring, sternotomy, cerclage procedures, trauma surgery, supplementary fixation with bone plates and screws, stabilization of bone graft material). Its function is to support and stabilize bones, not to diagnose medical conditions or diseases.
No
The device description clearly describes a physical cable made of stainless steel with a bead formed on one end, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving fixation and stabilization of bone and tissue within the body (spinal wiring, sternotomy, cerclage, trauma surgery, supplementary fixation with plates and screws, bone graft stabilization). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical cable with a bead, designed for mechanical fixation. This is consistent with a surgical implant or instrument, not a diagnostic test performed on samples outside the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Dall-Miles Beaded Cable does not fit this description.
N/A
Intended Use / Indications for Use
The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material.
Product codes (comma separated list FDA assigned to the subject device)
OR(87) JDQ
Device Description
The Dall-Miles Stainless Steel Beaded Cable is a modification of the existing stainless steel cable. A bead is formed on one end of the cable by melting it with an electron beam. This modification allows the cable to be used with a one-sided Tensioner in those applications where a conventional two-sided Tensioner will not fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal, 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 (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.
K844068 & K900926, K953818, K875156, K934557
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
JUN 24 1998
510(k) Summary
Proprietary Name: Dall-Miles Stainless Steel Beaded 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, Requlatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7875 - Phone (201) 507-6870 - Fax
Date Summary Prepared: April 17, 1996
The Dall-Miles Stainless Steel Beaded Cable is a modification of the existing stainless steel cable. A bead is formed on one end of the cable by melting it with an electron beam. This modification allows the cable to be used with a one-sided Tensioner in those applications where a conventional two-sided Tensioner will not fit.
The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material.
The substantial equivalence of the Beaded Cable is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557).