(33 days)
Not Found
No
The document describes a surgical drill system with basic controls (speed, direction, irrigation) and does not mention any features related to data analysis, learning, or adaptive behavior typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is used for controlled incision or removal of bone in surgical procedures, directly acting on the body to treat or alter health conditions.
No
The device description indicates its purpose is for the controlled incision or removal of bone, which is a surgical or treatment function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a console, electric motor handpiece, and foot pedal, indicating it is not a software-only device.
Based on the provided information, the ACE System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the ACE System is for the controlled incision or removal of bone in various parts of the body (ear, nose, throat, head, neck, neurosurgery, hand surgery, plastic surgery). This is a surgical procedure performed directly on a patient.
- Device Description: The device description details a system with a console, handpiece, foot pedal, and accessories used for surgical procedures involving bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The ACE System does not perform this function. It is a surgical tool used on the body.
Therefore, the ACE System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)
Product codes
77ERL, 77EQJ
Device Description
The ACE System is made up of a console, electric motor handpiece, foot pedal and various accessories. The Console is designed to mount onto an IV pole or to set on a cart and provides control of various functions such as handpiece speed and direction and irrigation. It has the ability to operate one or two handpieces (one selected at a time), angled and straight, and incorporates irrigation capability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, nose, throat and other areas of the head and neck, cervical, hand, facial, mandibular
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(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 the limitations in § 874.9.
0
¥960853
APR - 3 996
510(k) Summary ACE System
1.0 Date Prepared
February 27, 1996
2.0 Submitter (Contact)
David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
| Proprietary Name: | ACE System |
|---|---|
| Common Name: | Electric Surgical Drill System |
| Classification Name: | ENT electric or pneumatic surgical drill AND |
| ENT bur |
4.0 Device Classification
Currently marketed products of this type have been classified by the Ear, Nose and Throat Panel as follows:
ENT electric or pneumatic surgical drill Class II 874.4250 77ERL
77EQJ Class I* 874.4140 ENT bur *ENT burs have been exempted from premarket notification.
5.0 Device Description
The ACE System is made up of a console, electric motor handpiece, foot pedal and various accessories. The Console is designed to mount onto an IV pole or to set on a cart and provides control of various functions such as handpiece speed and direction and irrigation. It has the ability to operate one or two handpieces (one selected at a time), angled and straight, and incorporates irrigation capability.
6.0 Intended Use
The ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)
1
Image /page/1/Picture/0 description: The image shows the text 'K960853' in a handwritten style. The characters are connected, giving it a cursive appearance. The text is black against a white background, making it easily readable.
7.0 Substantial Equivalence
The new ACE System is substantially equivalent to the following currently marketed surgical drills in that it has the same intended use (controlled incision of bone) and equivalent features (irrigation, handpiece styles, etc.) and performance characteristics (speed and torque):
| DEVICEMicro-Craft® Power System | ManufacturerXomed | 510K NumberK791407 |
|---|---|---|
| Synergy™ | Smith & Nephew - Richards | unknown |
| Jedmed Otologic Drill | Bien-Aire | |
| (Marketed by Jedmed) | unknown | |
| UltraPower™Complete | ||
| Drill System | Hall Surgical / Zimmer | unknown |
| Bone Dissecting System | Mednext | K926547 |
7.1 Discussion of Differences
There are no substantial differences between the ACE System and the equivalent electrical drill systems other than in device performance, as noted by the enhanced speed and torque with the ACE System. The improved performance of the ACE System is equivalent to the performance of pneumatic drills currently on the market. The ACE System combines the speed and torque of the equivalent Pneumatic drills with the design and controls of the equivalent electrical systems.