(55 days)
Not Found
K/DEN number: Not Found
No
The description focuses on mechanical components and their function, with no mention of AI/ML terms or capabilities.
No
The device is described as surgical equipment for cutting, drilling, and smoothing bone, which are operative functions rather than therapeutic ones.
No
The device description clearly states its intended use is for "cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue," which are surgical procedures, not diagnostic ones. There is no mention of it being used to identify or determine the nature of a disease.
No
The device description clearly details physical components like drill attachments, a drill motor, and a console, indicating it is a hardware device with accessories, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a drill and its attachments used in conjunction with a surgical console. This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the Stryker Universal Drill Attachments and Accessories are surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Stryker Universal Drill Attachments and Accessories are 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, orthopedic, maxillofacial, neuro, and plastics.
Product codes
Not Found
Device Description
The Stryker Universal Drill Attachments are used in conjunction with the previously 510(k) cleared Stryker 75K Drill. The 75K drill motor is powered by DC electric current via the Total Performance System Console. The Extra Long Attachments are up to 400 mm in length. The Hudson Chuck reduces the speed of the 75K drill from 75,000 rom to 700 - 1200 rpm. This chuck with Hudson fitting holds cranial perforators with a standard Hudson shank fitting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and other bone related tissue, cranial
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
962800
Stryker®
SEP | | 1996
4100 East Milham Avenue Kalamazoo, MI 49001-6197 (616) 323-7700 (800) 253-3210
Device Name:
Classification Names: Instrument, Surgical, Orthopedic, DC Powered Motor and Accessories/Attachments: 21 CFR 878.4820, Class I
Bur. Surgical, General and Plastic Surgery 21 CFR 878.4820, Class I
Blade, Surgical, General and Plastic Surgery 21 CFR 878.4820, Class I
Common/Usual Name: Surgical Instrument Motors and Accessories/Attachements
Proprietary Name: Stryker Universal Drill Attachments and Accessories
Device Sponsor: Stryker Corporation Instruments Division 4100 E. Milham Avenue Kalamazoo, MI 49001 Registration No: 1811755
Requiatory Classification: Class I
Summary of Safety and Effectiveness:
The Stryker Universal Drill Attachments and Accessories are 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, orthopedic, maxillofacial, neuro, and plastics.
The Stryker Universal Drill Attachments are used in conjunction with the previously 510(k) cleared Stryker 75K Drill. The 75K drill motor is powered by DC electric current via the Total Performance System Console. The Extra Long Attachments are up to 400 mm in length. The Hudson Chuck reduces the speed of the 75K drill from 75,000 rom to 700 - 1200 rpm. This chuck with Hudson fitting holds cranial perforators with a standard Hudson shank fitting.
1
The Stryker Universal Attachments are equivalent in intended use, safety, and effectiveness to existing powered instrument attachments marketed by companies such as Midas Rex and Codman.
The cutting accessories available will be provided sterile or nonsterile. The materials of construction, cutting action, and cutting surface configuration are equivalent to pre-1976 Medical Device Amendment cutting accessories distributed by Stryker as well as cutting accessories distributed by Midas Rex and Zimmer/Hall.
The Stryker Universal Drill Attachments and Accessories do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Universal Drill Attachments and Accessories are substantially equivalent to these existing devices.
Diane Davis
Diane Davis Requlatory Affairs Representative Stryker Instruments