(77 days)
Not Found
No
The summary describes standard titanium alloy bone screws and manual instruments, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No.
The device is a bone screw used for fracture fixation, which is a structural support device rather than one that treats or prevents disease.
No
The device described is a bone screw used for fracture fixation, which is a therapeutic device, not a diagnostic one. It does not identify a disease, condition, or state of health.
No
The device description explicitly states it is a titanium alloy bone screw and associated manual orthopedic instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for long and small bone fracture fixation." This describes a surgical implant used in vivo (within the body) to physically stabilize bone fractures.
- Device Description: The device is described as "titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments." These are physical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests in vitro (outside the body) on biological samples. This device is clearly an implant used in vivo for structural support.
N/A
Intended Use / Indications for Use
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.
Product codes
Not Found
Device Description
The subiect of this premarket notification are 4.0mm titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments designed to assist screw fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, fatigue testing was performed on the titanium allov screws; this information is detailed in the application. The Titanium Alloy Bone Screws will be manufactured in accordance with ISO and German Din Standards.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
CULAP. K970549
510(k) Summary of Safety and Effectiveness (in Accordance with SMDA of 1990)
APR 30 1997
Aesculap Titanium Alloy Bone Screws
Submitted by:
Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080
Contact: Victoria Mackinnon Phone: (415) 876-7000 x346 (415) 589-3007 FAX:
Product Name
Trade Name: Bone Screws Common Name Classification Name:
Aesculap Titanium Alloy Bone Screws Screw, Fixation, Bone
Predicate Device
The titanium allov bone screws from Aesculap are identified as predicate devices.
Device Description
The subiect of this premarket notification are 4.0mm titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments designed to assist screw fixation.
Intended Use
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.
Summary of Technological Characteristics
Aesculap's Titanium Alloy Bone Screws represent no change in technological characteristics. There have been only minor modifications to product design.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, fatigue testing was performed on the titanium allov screws; this information is detailed in the application. The Titanium Alloy Bone Screws will be manufactured in accordance with ISO and German Din Standards.
1
Image /page/1/Picture/0 description: The image shows the logo for AESCULAP. The logo consists of a symbol on the left and the word "AESCULAP" on the right. The symbol is a rod with a snake wrapped around it, inside of a circle, which is inside of a square.
510(k) Summary of Safety and Effectiveness
Aesculap Titanium Alloy Bone Screws, page 2 of 2.
Substantial Equivalence
Aesculap believes that the Titanium Alloy Bone Screws presented in this submission are substantially equivalent in design, function, and intended use to Aesculap's current line of bone screws and other existing legally marketed bone screws such as: