(34 days)
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No
The summary describes a bioresorbable plating system made of a specific polymer and its mechanical properties and clinical performance. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used in trauma and reconstructive procedures for comminuted fractures and trauma of the midface and craniofacial skeleton, which indicates a therapeutic purpose.
No
The LactoSorb® Trauma Plating System is used for trauma and reconstructive procedures, meaning it is a therapeutic device for repairing injuries, not for diagnosing conditions.
No
The device description clearly states the device is made of a bioresorbable polymer and is implanted, indicating it is a physical 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 is for surgical procedures (trauma and reconstructive) on the midface and craniofacial skeleton. This involves direct intervention on the patient's body.
- Device Description: The device is an implantable system made of bioresorbable material. It is designed to provide fixation for fractures and reconstructive procedures.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
The LactoSorb® Trauma Plating System is a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton.
- Comminuted fractures of the naso-ethmoidal and l. infraorbital areas.
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- Comminuted fractures of the frontal sinus wall.
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- Trauma of the midface or craniofacial skeleton.
- 4 . Reconstructive procedures of the midface or craniofacial skeleton.
This system is not designed for use in the mandible and/or full load bearing procedures.
Product codes
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Device Description
The LactoSorb® implants are made of bioresorbable and biocompatible polymer that have been used in surqical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in for over 10 years in Poly humans Surqiclip® device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
midface and craniofacial skeleton, naso-ethmoidal and l. infraorbital areas, frontal sinus wall
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The effectiveness of this resorbable system was determined by mechanical testing and an FDA approved clinical study. The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region. This system is as effective as similar metal micro fixation systems on the market. The devices completely resorb by 12 months IN VIVO eliminating the need for long-term removal.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
APR - 8 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
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The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton.
- Comminuted fractures of the naso-ethmoidal and l. infraorbital areas.
-
- Comminuted fractures of the frontal sinus wall.
-
- Trauma of the midface or craniofacial skeleton.
- 4 . Reconstructive procedures of the midface or craniofacial skeleton.
This system is not designed for use in the mandible and/or full load bearing procedures.
The LactoSorb® implants are made of bioresorbable and biocompatible polymer that have been used in surqical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in for over 10 years in Poly humans Surqiclip® device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.
The effectiveness of this resorbable system was determined by mechanical testing and an FDA approved clinical study. The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region. This system is as effective as similar metal micro fixation systems on the market. The devices completely resorb by 12 months IN VIVO eliminating the need for long-term removal.