(320 days)
Device Name: Auxein Nailing system
Indications for Use (Describe)
Device Name: Auxein Nailing System are categorized to the following system:
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Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE:
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AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.
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AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
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AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
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AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.
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The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures .
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AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
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AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
Auxein Brand of Expert Tibia Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 8 mm to 12 mm; the length varies from 255 mm to 375 mm.
The screw implants are in corresponding diameter of 4.4 mm & 4.8 mm diameters with lengths varying as per the requirements and minimum length: 18 mm to maximum length 90 mm.
Auxein Brand of Expert Femoral Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking screw & Anti-rotation screw of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 9 mm to 13 mm; the length varies from 320 mm to 440 mm.
The screw implants are in corresponding diameter of 4.8 mm, 6.4 mm diameters with lengths varying as per the requirements and minimum length: 25 mm to maximum length 130 mm.
Auxein Brand of Ga-mma Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, Inner screw, locking bolts, Antirotation screw & Cephalic screw of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 9 mm to 13 mm; the length varies from 180 mm to 440 mm.
The screw implants are in corresponding diameter of 4.8 mm, 6.4mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm.
Auxein Brand of Humeral Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolt, compression screw, and proximal screw of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 7mm to 9 mm; the length varies from 180 mm to 320 mm.
The screw implants are in corresponding diameter of 3.5 mm & 4.5 mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 70mm.
Auxein Brand of AJAX Advance Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolts, Cephalic screw, inner screw of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 9 mm to 12 mm; the length varies from 170 mmto 420 mm.
The screw implants are in corresponding diameter of 4.9 mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm.
Auxein Brand of Elastic Nailing system consists of various shape and sizes of nails featuring end cap of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 1.5 mm to 4.0 mm; the total length of 440 mm.
The end caps are in corresponding diameter ranges from 1.5 mm to 4.0 mm diameters with length of 14 mm & 25 mm.
Auxein Brand of Retrograde Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 10 mm to 12 mm; the length varies from 180 mm to 360 mm.
The screw implants are in corresponding diameter of 5.0 mm diameters with lengths varying as per the requirements and minimum length: 32 mm to maximum length 80 mm.
These implants are sold non-sterile, the products have to be sterilized prior to use.
This document is a 510(k) Premarket Notification from Auxein Medical Private Limited for their "Auxein Nailing System". The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria by comparing the proposed device against predicate devices and relevant ASTM standards. The reported performance is often stated as "Equivalent" to the predicate.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Similar intended use to predicate device. | Similar intended use in New Device and Predicate device. (Equivalent) |
| Material | Same material used as predicate device and compliance with ASTM F 136 and ASTM F899-12b. | Same material used in New Device and Predicate device. (Equivalent) |
| Performance Standards | Compliance with ASTM F 1264, ASTM F 384, ASTM F 543. | Same performance standards used in both New Device as well as predicate device. (Equivalent) |
| Sterilization | Same method of sterilization as predicate device (Autoclaving to achieve SAL of 10-6). | Same method of sterilization used in both New Device as well as Predicate device. (Equivalent) |
| Dimensional Verification | Similar dimensions to predicate device. | Similar dimensions found in both New Device as well as Predicate device. (Equivalent) |
| Mechanical Test Performance | Compliance with ASTM F 1264, ASTM F 384, ASTM F 543 for nails and screws. | As per ASTM F 1264, ASTM F 384, ASTM F 543 Standard Specification and Test Methods for Intramedullary Fixation Devices. (Same) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a test set that would typically be associated with clinical performance or accuracy studies. This submission is for a medical device (intramedullary fixation rod) and relies heavily on bench testing (non-clinical testing) and substantial equivalence to predicate devices. The data provenance is primarily from bench tests conducted by Auxein Medical Private Limited, presumably in India where the manufacturing unit is located. There is no mention of retrospective or prospective clinical data for the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable in the context of this 510(k) submission. The submission focuses on substantial equivalence for a physical medical device based on engineering and material standards, not an AI/software device requiring expert adjudication of outputs.
4. Adjudication Method for the Test Set:
This section is not applicable as the submission describes an intramedullary fixation rod, not an AI/software device that would involve human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
This section is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted systems where human readers interpret medical images or data. This submission is for a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
This section is not applicable. This describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device is based on:
- Engineering and Material Standards: Compliance with ASTM F 136, ASTM F899-12b (material standards), and ASTM F 1264, ASTM F 384, ASTM F 543 (performance standards).
- Comparison to Predicate Devices: The dimensional and performance characteristics of the new device are compared to established predicate devices (which have already demonstrated safety and efficacy).
Essentially, the "ground truth" is that the device meets the established performance and material specifications demonstrated by predicate devices and recognized consensus standards.
8. The Sample Size for the Training Set:
This section is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.