(31 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a powered surgical instrument system, with no mention of AI or ML capabilities. The software update is described as accommodating new circuitry and components, not implementing intelligent algorithms.
No
The device is described as a powered instrument system for cutting soft tissue and bone during surgical procedures. Its function is to facilitate the surgical act rather than directly treating or curing a disease or condition.
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 clearly details hardware components such as a console, handpieces, cords, footswitches, and an irrigation pump. While software is mentioned as being rewritten, it is integral to the function of the hardware system, not a standalone software device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as a "powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone" for various surgical procedures. This clearly indicates a surgical tool used in vivo (within the body) for physical manipulation of tissue.
- Device Description: The description reinforces its use in the surgical field for cutting and irrigation at the surgical site.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such function or interaction with patient specimens.
Therefore, the D4000/D4000A System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The D4000/D4000A 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, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HBC, GEY, ERL
Device Description
The D4000/D4000A Drive System console functions as a powered instrument console for driving powered instruments and accessories used in the cutting of soft tissue and bone at the surgical site.
The D4000/D4000A Drive System console is a non-sterile device and must be located in a non-sterile area of the operating suite. Additionally the D4000A console offers an irrigation pump that, when used with tubing sets, provides a sterile fluid supply to the blades, burs, and drill bits, at the surgical site, for lavage and cooling. The handpiece, handpiece cord, and irrigation tube sets are sterile. The handpiece is used in the sterile field with the cord connected to the console. The irrigation tube set is used on the handpiece in the sterile field with the cassette connected to the console. The footswitch is non-sterile and placed on the floor.
The console provides two handpiece drive ports that are used with a variety of handpieces. Handpiece functionality can be controlled directly by the handpiece, and/or by a corded footswitch or wireless footswitch.
Handpiece speed, direction, user settings, irrigation flow rate, and footswitch settings are controlled with the touch-screen displays.
The D4000/D4000A is a rebranded update to the Advantage Turbo Drive System (D3000), which shares the same intended use, indications for use, conditions of use, and fundamental scientific technology with the predicate device. The D4000/D4000A powers a reduced set of the same handpieces, to the same performance specifications, as the D3000. Where applicable, these handpieces can also be activated by the same footswitches used in the previous system.
The D4000/D4000A software was rewritten in order to accommodate the new internal circuitry layout and to support additional integrated components (i.e. touchscreens, wireless footswitch transceiver, etc.) as well as to send direct signal to 24k when shaver is operating.
Further, the D4000 and D4000A are the same device except for the fact that, like the D3000, the D4000A incorporates a low-flow purpose of optional handpiece irrigation. The D4000A also includes a "Prime Button" on the front panel that is associated with the low-flow pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone
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 verification and validation testing of the D4000/D4000A Drive System included Safety, EMC, software, Electrical system integration, labeling, and packaging/transportation qualifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized crescent shape on the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "LINVATEC" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
RO. FL 33773-4908 · 727-392-6464 · www.limvator.com
510(k) Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K130497
Date Prepared: 28-Mar-2013
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Jonathan Werner Regulatory Affairs Manager Telephone (727) 399-5574 Fax (727) 399-5264
C. Device Name
Trade Name: D4000 Drive System, D4000A Drive System with Irrigation Common Name: Drive System Electric cranial drill motor. (882.4360) Classification Names: Proposed Class/Device: Class II HBC, GEY, ERL Product Codes:
D. Predicate/Legally Marketed Devices
| Device Name: | Advantage Turbo Drive System |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K050519 |
E. Device Description
The D4000/D4000A Drive System console functions as a powered instrument console for driving powered instruments and accessories used in the cutting of soft tissue and bone at the surgical site.
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Module A Page 10
1
Image /page/1/Picture/0 description: The image shows the logo for CONMED Linvatec. The logo features a stylized wave-like graphic to the left of the text "CONMED". Below "CONMED" is the text "LINVATEC" in a smaller font size. The logo is black and white.
11311 Concept Boulevard • Largo, FL 33773-4908 • 727-793-6464 • www.flowtec.com
The D4000/D4000A Drive System console is a non-sterile device and must be located in a non-sterile area of the operating suite. Additionally the D4000A console offers an irrigation pump that, when used with tubing sets, provides a sterile fluid supply to the blades, burs, and drill bits, at the surgical site, for lavage and cooling. The handpiece, handpiece cord, and irrigation tube sets are sterile. The handpiece is used in the sterile field with the cord connected to the console. The irrigation tube set is used on the handpiece in the sterile field with the cassette connected to the console. The footswitch is non-sterile and placed on the floor.
The console provides two handpiece drive ports that are used with a variety of handpieces. Handpiece functionality can be controlled directly by the handbiece. and/or by a corded footswitch or wireless footswitch.
Handpiece speed, direction, user settings, irrigation flow rate, and footswitch settings are controlled with the touch-screen displays.
The D4000/D4000A is a rebranded update to the Advantage Turbo Drive System (D3000), which shares the same intended use, indications for use, conditions of use, and fundamental scientific technology with the predicate device. The D4000/D4000A powers a reduced set of the same handpieces, to the same performance specifications, as the D3000. Where applicable, these handpieces can also be activated by the same footswitches used in the previous system.
The D4000/D4000A software was rewritten in order to accommodate the new internal circuitry lavout and to support additional integrated components (i.e. touchscreens, wireless footswitch transceiver, etc.) as well as to send direct signal to 24k when shaver is operating.
Further. the D4000 and D4000A are the same device except for the fact that. like the D3000, the D4000A incorporates a low-flow purpose of optional handpiece irrigation. The D4000A also includes a "Prime Button" on the front panel that is associated with the low-flow pump.
F. Testing
The verification and validation testing of the D4000/D4000A Drive System included Safety, EMC. software. Electrical svstem integration. labeling. and packaging/transportation qualifications.
G. Intended Use / Indications
The D4000/D4000A 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, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.
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2
Image /page/2/Picture/0 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized graphic to the left of the text "CONMED" in all caps. Below the text is "LINVATEC" in smaller, all-caps letters. There are horizontal lines above and below the word "LINVATEC".
rverd . Largo, FL 33773-4908 . 727-392-6464 . www.liavatel.com 11311 C
H. Substantial Equivalence
The D4000 Drive System/D4000A Drive System with Irrigation has the same intended use, same conditions of use, and utilizes the same fundamental scientific technology as the predicate device, while raising no new issues of safety or The D4000/D4000A is therefore substantially equivalent to the effectiveness. Advantage Turbo Drive System cleared by K050519.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2013
Linvatec Corporation D/B/A Conmed Linvatec % Mr. Jonathan Werner, RAC Regulatory Affairs Manager 11311 Concept Boulevard Largo, Florida 33773
Re: K130497
Trade/Device Name: D4000 Drive System/D4000A Drive System with Irrigation Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill monitor Regulatory Class: II Product Code: HBC, GEY, ERL Dated: February 25, 2013 Received: March 01, 2013
Dear Mr. Werner:
This letter corrects our substantially equivalent letter of March 29, 2013.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 commerce prior 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Mr. Jonathan Werner, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours. FOR FOR FOR
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Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130497
Device Name: D4000 Drive System / D4000A Drive System with Irrigation
Indications For Use:
The D4000/D4000A 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, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.
Prescription Use ਮ (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)
For
Joshua C:
Nipper -S
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(
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130497
Module A Page 13