(67 days)
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No
The summary describes a system of electrically powered surgical instruments for mechanical manipulation of bone and tissue. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an electrically powered surgical instrument intended for cutting, drilling, reaming, decorticating, and smoothing bone, as well as placing or cutting fixation devices. These actions are surgical interventions, not therapeutic treatments.
No
The device is described as a surgical tool for cutting, drilling, reaming, decorticating, and smoothing bone, as well as placing or cutting fixation devices. Its function is to perform physical modifications during surgery, not to diagnose conditions or diseases.
No
The device description explicitly states it consists of "electrically powered surgical instruments, controls, power source, and other system accessories," indicating it is a hardware system with electrical components, not a software-only device.
Based on the provided information, the Command2 MicroElectric System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving the cutting, drilling, and manipulation of bone and related tissues. This is a direct surgical intervention on the patient's body.
- Device Description: The description confirms it's a system of electrically powered surgical instruments.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health status. The provided information does not mention any analysis of specimens or diagnostic purposes.
Therefore, the Command2 MicroElectric System falls under the category of a surgical instrument or system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Command2 MicroElectric 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: ENT, dental, orthopedic, maxiofacial, spinal, and plastics. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices.
Product codes
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Device Description
The Stryker Command2 MicroElectric 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.
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
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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
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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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§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
K961970
stryker
INSTRUMENTS
4100 East Milham Avenue Kalamazoo, MI 49001-0107 010) 323 1700 (800) 253-3210
Jul 26 1996
Device Name:
Classification Names: Surgical Instrument Motors and Accessories/Attachments: 21 CFR 878.4820, Class I and Class II
Common/Usual Name: Surgical instrument Motors and Accessories/Attachements
Proprietary Name: Stryker Command2 MicroElectric Surgical 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 Command2 MicroElectric 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: ENT, dental, orthopedic, maxiofacial, spinal, and plastics. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices.
The Stryker Command2 MicroElectric 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 Command2 MicroElectric 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 additional power source/console feature described in this submission is equivalent to existing power sources distributed by MicroAire. Intended use, function, and safety risks are all substantially equivalent. Safety warnings, malfunction troubleshooting, and operating duty cycles are listed in the Command2 MicroElectric System Operator's Manual. In addition, the Stryker Command2 MicroElectric System is designed to meet the following Standards: CSA 22.2 No. 601.1-M90, UL 2601-1 First Edition, IEC 601-1 with amendments, IEC 601-1-2, CISPR 11, IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4, IEC 1000-4-5.
The Stryker Command2 MicroElectric System does not raise any new safety and efficacy concerns when compared to similar devices already being marketed. Therefore, the Stryker Command2 MicroElectric System is substantially equivalent to these existing devices.
Diane Davis
Diane Davis Regulatory Affairs Representative Stryker Instruments