(77 days)
Not Found
No
The summary describes a powered surgical instrument system with software modifications primarily focused on controlling motor speed and torque. There is no mention of AI, ML, image processing, or data-driven decision-making.
No
The device is described as a powered instrument system for cutting soft tissue and bone during surgical procedures, which is an interventional rather than a therapeutic function.
No
The device is described as a powered instrument system for cutting soft tissue and bone during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is a "powered instrument system consisting of handpieces and accessories" and mentions a "new motor" and "handpiece," indicating it includes hardware components. While software is mentioned as being modified, it controls the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone" for various surgical procedures. This describes a surgical tool used on the patient, not a device used to examine specimens from the patient to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanical and software aspects of the surgical instrument (motor, speed, torque). It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers or analytes.
Therefore, the Advantage® Turbo Drive System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Advantage® Turbo Drive System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.
Product codes
GEY, HRX, ERL
Device Description
The Advantage® Turbo Drive System device description is identical to the original submission except for the modifications listed below.
The modifications described in this Special 510(K) are listed below:
-
- A new motor has been installed which provides additional torque and speed to the handpiece.
-
- The software, Version 7.0, has been modified to allow Advantage@ Turbo Drive System to run at a maximum forward/reverse speed of 10.000 RMP or 12,000 RPM. This maximum speed is selectable using an appropriate code during the calibration request. All other software parameters used to run the Advantage@ Turbo Drive System operate in the same manner as all pre-existing software versions.
These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The changes made to the Advantage Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol of a human figure with three lines representing the head, body, and legs.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2005
Ms. Elizabeth Paul Manager, Regulatory Affairs ConMed Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K050519
Trade/Device Name: Advantage Turbo® Drive System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: GEY Dated: March 15, 2005 Received: May 2, 2005
Dear Ms. Paul:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o never read above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -- Ms. Elizabeth Paul
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in Jourse FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please It you a the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
s for Use
510(k) Number (if known): K050519
Device Name: Advantage Turbo® Drive System
Indications for Use:
The Advantage® Turbo Drive System functions as a powered instrument system The Advanage® Turbo Dires Bries to perform cutting of soft tissue and bone. The Contisiting of nuridplood and accessoric, Foot, Hand, Medial Sternotomy, Neurosurgical, Trends of upplioution Recognital, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tion Sign-O)
- Restorative
neurological Devices
Page 1 of 1
3
KOSOS 19
February 18, 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the Advantage® Turbo Drive System.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
Revised
C. Device Name
Trade Name:
Advantage@ Turbo Drive System
Common Name:
Drive System
Classification Names:
-
- Ear, Nose and Throat Electrical or Pneumatic Surgical Drill 874.4250
-
- Electric Cranial Drill Motor 882.4250
-
- Bone Cutting Instrument and Accessories 872.4120
-
- Surgical Instrument Motors and Accessories
Proposed Class/Device:
Product Codes:
Class II
HRX ERL
4
PROPRIETARY INFORMATION - LINVATEC CORPORATION
Advantage@ Turbo Drive System Special 510(k) #_ KOSOSS19 February 18, 2005
D. Predicate/Legally Marketed Devices
Advantage Drive System K002523 Linvatec Corporation
E. Device Description
The Advantage® Turbo Drive System device description is identical to the original submission except for the modifications listed below.
The modifications described in this Special 510(K) are listed below:
-
- A new motor has been installed which provides additional torque and speed to the handpiece.
-
- The software, Version 7.0, has been modified to allow Advantage@ Turbo Drive System to run at a maximum forward/reverse speed of 10.000 RMP or 12,000 RPM. This maximum speed is selectable using an appropriate code during the calibration request. All other software parameters used to run the Advantage@ Turbo Drive System operate in the same manner as all pre-existing software versions.
These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.
Intended Use
The Advantage® Turbo Drive System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.
F. Substantial Equivalence
The Advantage® Turbo Drive System is substantially equivalent in intended use, scientific technology and design to the Advantage Drive System. The Advantage Drive System was cleared by FDA under 510(k) K002523. The changes made to the Advantage Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness.