(65 days)
Not Found
No
The description focuses on increasing motor speed and modifying oscillation through software and a computer chip upgrade, which are standard control system modifications, not indicative of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
No
The device is used for surgical tissue and bone shaving, which is an operative procedure, not a therapeutic treatment in itself. Its function is to facilitate surgical removal, not to treat a disease or conditiondirectly.
No.
The device is described as a surgical tool used for shaving soft tissue and bone, which is a treatment or modification function, not a diagnostic one.
No
The device description explicitly lists hardware components (drive console, micro handpiece, blades/burrs/routers, foot switches) and the modification involves upgrading a computer chip within the drive console power unit. While software is being modified, the device itself is a system with 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 states the device is used for "shaving of soft tissue and bone during otolaryngological and reconstructive surgery." This describes a surgical procedure performed directly on a patient, not a test performed on a sample (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The components listed (drive console, handpiece, blades/burrs/routers, foot switches) are all tools used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable.
Product codes
Not Found
Device Description
The Apex Universal Drive system contains a drive console, micro handpiece, blades/burrs/routers and foot switches.
The forward/reverse speed is being increased to reduce The oscillation speed is the incidence of bur chatter. being modified to increase the rate of resection.
The modification will take place within the drive console power unit software. A computer chip will be upgraded to allow the handpiece to run at a higher maximum rpm in forward/reverse and oscillate mode.
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
Testing has been done to prove safety and effectiveness of the devices.
Key Metrics
Not Found
Predicate Device(s)
K944476, K862807, K954796, K960856, K954989
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a black geometric shape on the left and the word "Linvatec" in black, bold letters on the right. The geometric shape appears to be a stylized representation of a medical device or tool.
11311 Concept Boulevard Largo, Florida 34643 813 399-5334 Fax: 813 399-5264
Carol A. Weideman, Ph.D.
Manager, Resulatory and Clinical Alfairs
November 12, 1996
JAN. 17, 1997
510(k) SUMMARY OF SAFETY AND KFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Spinal System, 96 4546
Submitter ..
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs
C. Device Mame
| Trade Name: | : Apex™ Universal Drive System |
|---|---|
| Common Name | : Drive System |
| Classification Name | : Surgical, ENT (electric or |
| pneumatic), including handpiece |
Predicate/Legally Marketed Devices D.
Apex™ Universal Drive System Linvatec Corporation
XPS Straightshot Micro Resector System Xomed Endoscopy
Dyonics® EP1 Surgical Drive System Smith and Nephew Endoscopy
Image /page/0/Picture/17 description: The image shows a black and white drawing of a hexagon. Inside the hexagon, there are six triangular shapes that are arranged in a circular pattern. The triangular shapes are connected to each other at their vertices, forming a star-like shape in the center of the hexagon. The overall design is symmetrical and intricate.
3
$$\partial \mathcal{I}$$
1
Summary of Safety and Effectiveness Apex™ Universal Drive System 510 (k) + November 12, 1996 Page 2 of 3
Device Description は。
The Apex Universal Drive system contains a drive console, micro handpiece, blades/burrs/routers and foot switches.
The forward/reverse speed is being increased to reduce The oscillation speed is the incidence of bur chatter. being modified to increase the rate of resection.
The modification will take place within the drive console power unit software. A computer chip will be upgraded to allow the handpiece to run at a higher maximum rpm in forward/reverse and oscillate mode.
Intended Use .
The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and The drive system is reusable. reconstructive surgery.
Substantial Equivalence 6.
is substantially Drive System ADOX Universal 1924 equivalent in design, function and intended use to the Apex" Universal Drive System (Linvatec Corporation) , XPS Straightshot Micro Resector System (Xomed Endoscopy) and Dyonics® KP1 Surgical Drive System (Smith and Nephew Endoscopy) .
Testing has been done to prove safety and offectiveness of the devices.
The similarities/dissimilarities to the prodicates are shown in the attached table.
$\mathscr{H}$
2
Summary of Safety and Effectiveness Apex™ Universal Drive System 510 (k) #
November 12, 1996 Page 3 of 3
Class Controller
CHART OF SIMILARITIES AND DISSINILARITIES
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Device Name | Intended Use | Design | |
|---|---|---|---|
| NEW PRODUCT | |||
| Linvatec | Apex™ Universal | ||
| Drive System | ENT and | ||
| Reconstructive | |||
| Surgery | Micro Handpiece Speed | ||
| Maximum Forward/Reverse: 5,000 rpm | |||
| Maximum Oscillate: 2,500 rpm | |||
| PREDICATE | |||
| Linvatec |
510(k) #
K944476 | Apex™ Universal
Drive System | ENT and
Reconstructive
Surgery | Micro Handpiece Speed
Maximum Forward/Reverse: 3,500 rpm
Maximum Oscillate: 1,500 rpm |
| PREDICATE
Xomed
Endoscopy
510(k) #
K862807
K954796
K960856 | XPS™
Straightshot™
Micro Resector
System | ENT | Handpiece Speed
Maximum Forward/Reverse: 6,000 rpm
Maximum Oscillate: 3,000 rpm |
| PREDICATE
Smith and
Nephew
Endoscopy
510(k) #
K954989 | Dyonics® EP1
Surgical Drive
System | ENT | Handpiece Speed:
Maximum Forward/Reverse: 8, 000 rpm
Maximum Oscillate: 3,000 rpm |
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