(314 days)
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No
The summary describes a system of electrically powered surgical instruments for bone manipulation, with no mention of AI, ML, image processing, or data-driven decision making.
No
The device is used for cutting, drilling, reaming, decorticating, and smoothing of bone and other bone-related tissue, as well as the placement of screws. While these are surgical procedures, the device itself is an instrument used to perform a physical action on tissue rather than delivering a therapy. A therapeutic device typically delivers energy, substances, or conditions to treat a disease or condition.
No
The device description states its intended use is for "cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue" and "placement of screws" during surgical procedures. These are all interventional or surgical actions, not diagnostic ones.
No
The device description explicitly states it consists of "electrically powered surgical instruments, controls, power source, and other system accessories," indicating it includes hardware components.
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 surgical system for cutting, drilling, and manipulating bone and bone-related tissue during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description confirms it's a system of electrically powered surgical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues by examining these samples.
This device falls under the category of a surgical instrument or system, not an IVD.
N/A
Intended Use / Indications for Use
The Oral Max System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including but not limited to, dental and oral surgery. It is also usable in the placement of screws.
Product codes
LGZ, EJB, HRX
Device Description
The Stryker Oral Max System, consisting of electrically powered surgical instruments, controls, power source, and other system accessories, is equivalent in intended use, safety, and effectiveness to powered instruments, controls, and associated accessories that were marketed by Stryker prior to the 1976 Medical Devices Amendment.
The cutting accessories available to be used with the Oral Max System will be provided sterile. The materials of construction, cutting action, and cutting surface configuration are equivalent to devices distributed by Stryker prior to the 1976 Medical Devices Amendment. As proven in surgical procedures, these designs offer the required precision required for controlling the location and extent of the surgical contact.
The power source/console described in this submission is equivalent to power sources distributed by Aeseptico.
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
bone and other bone related tissue
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
NG 20 199
K954690
stryker®
INSTRUMENIS
4100 East Milham Avenue Kalamazoo, MI 49001-6197 (616) 323-7700 (800) 253-3210
Device Name:
| Classification Names: | Drill, Bone, Powered; 21 CFR 872.4120, Class II
Bur, Dental; 21CFR 872.3240, Class I
Controller, Foot, Handpiece and Cord; 21 CFR 872.4200, Class I | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Electrical Powered Surgical Instruments and
Accessories/Attachments | |
| Proprietary Name: | Stryker Oral Max System | |
| Device Sponsor: | Stryker Corporation
Instruments Division
4100 E. Milham Avenue
Kalamazoo, MI 49001
Registration No: 1811755 | Stryker Puerto Rico
Las Palmas Industrial Park
Highway 3, 130.2
Arroyo, Puerto Rico 00615
Registration No.: 2648666 |
Regulatory Classification: Class II
Summary of Safety and Effectiveness:
The Oral Max System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including but not limited to, dental and oral surgery. It is also usable in the placement of screws.
The Stryker Oral Max System, consisting of electrically powered surgical instruments, controls, power source, and other system accessories, is equivalent in intended use, safety, and effectiveness to powered instruments, controls, and associated accessories that were marketed by Stryker prior to the 1976 Medical Devices Amendment.
The cutting accessories available to be used with the Oral Max System will be provided sterile. The materials of construction, cutting action, and cutting surface configuration are equivalent to devices distributed by Stryker prior to the 1976 Medical Devices Amendment. As proven in surgical procedures, these designs offer the required precision required for controlling the location and extent of the surgical contact.
1
The power source/console described in this submission is equivalent to power sources distributed by Aeseptico. Intended use, function, and safety risks are all substantially equivalent. Safety warnings and operating duty cycles are listed in the Oral Max Operator's Manual. In addition, the Stryker Oral Max System is designed to meet the following Standards: CSA 22.2; UL 544.
The Stryker Oral Max System does not raise any new safety and efficacy concerns when compared to similar devices already being marketed. Therefore, the Stryker Oral Max System is substantially equivalent to these existing devices.
Jimmy Founds
Tammy Lounds Supervisor, Regulatory Affairs Stryker Instruments