(86 days)
Not Found
No
The description details a digitally-controlled fluid delivery system with a pump, reservoir, tubing, and footswitch. It mentions electronic operation and adjustable flow rate via buttons and an LCD display. There is no mention of AI, ML, image processing, or any learning or adaptive capabilities. The control is based on user input and a simple digital control system.
Yes
The device is intended to deliver irrigation (sodium hypochlorite solution) during endodontic procedures, which can be considered a form of treatment for dental issues.
No
The device is a fluid delivery system for irrigation during endodontic procedures, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description clearly outlines multiple hardware components including a pump unit console, irrigation reservoir, tubing, footswitch, LCD display, and rechargeable battery.
Based on the provided information, the VATEA system is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to deliver irrigation during endodontic procedures. This is a therapeutic/procedural function, not a diagnostic one. IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a fluid delivery unit. It pumps irrigation fluid into the tooth during a dental procedure. It does not analyze any biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device operates on the tooth, which is the site of the procedure, not a sample being analyzed.
The VATEA system is a medical device used in a clinical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.
Product codes (comma separated list FDA assigned to the subject device)
NYL
Device Description
The VATEA device is a self contained, digitally-controlled fluid delivery unit consisting of a pump unit console, irrigation reservoir and tubing intended to be connected to an endodontic file. The device consists of a positive pressure peristaltic pump console with control panel, LCD display, irrigation reservoir, disposable silicone tubing, and a footswitch control to provide irrigation during endodontic rocedures. One end of the silicone tubing connects to the VATEA and the other end connects to the dental handpiece using a silicone ring. The silicone ring is elastic, and may be stretched to the domar handpiece as my of dental handpieces used in endodontic procedures. The irrigation reservoir is filled as needed with sodium hypochlorite solution for irrigation during endodontic rocedures. The irrigation fluid is pumped from the reservoir and then out of the silicone tubing, proodation: the internet of the tooth. The silicone tubing for the delivery of the iring the lumand the silicone ring connecting the pump to the dental handpiece are disposable and replaced after each treatment.
The irrigation fluid flow may be switched on and off with a footswitch that is connected to the VATEA. The fingulon had now his his of the device are displayed on the LCD screen on the control r no how rate and operation is 0, and the user must increase the flow rate using the - / + buttons on panel. The using for face of the irrigation fluid. The irrigation fluid flow rate may be adjusted the control parter in increments of 1 ml/min using the - /+ push-button control on the control panel.
The VATEA is an electronically operated device, powered by a rechargeable battery.
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 company performed the following testing to evaluate the safety and performance of the device:
- IEC 60601-1 Medical Electrical Equipment Part 1, General Requirements for Safety.
- IEC 60601-1-2 Medical Electrical Equipment, General Requirements for Safety. Collateral.Standard: Electromagnetic Compatibility- requirements and tests.
- Performance validation:
- Verification of flow rate Actual irrigant flow rate matched the displayed flow rate
- Battery indication and life time With batteries fully charged, the system can operate without the charger for 4 continuous hours at maximum output.
Performance data establishes that the VATEA has comparable performance and safety as compared to its claimed predicate device.
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
510(k) SUMMARY REDENT NOVA's VATÈÁ Endodontic Irrigation System
Submitter's Name, Address, Telephone Number, Contact Person: and Date Prepared
Hogan Lovells US LLP Phone: (202) 637-5794 Facsimile: (202) 637-5910 Contact Person: Jonathan S. Kahan
Date Prepared: May 25, 2010
MAY 2 8 2010
Name of Device and Name/Address of Sponsor:
VATEA Endodontic Irrigation System
ReDent Nova Ltd. 15 Hataasia street P.O.B 4159 Raanana 43000, Israel
r
Common or Usual Name
VATEA Endodontic Irrigation System
Classification Name
| Name: | Dental Handpiece & Accessories |
|---|---|
| ------- | -------------------------------- |
Product code: NYL
872.4200 Classification panel:
-Class:
Dental Panel:
Predicate Devices
Quantec-E Irrigation System (K991035), Sybron Dental Specialties Inc., CA, US.
1
Intended Use / Indications for Use
The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.
Technological Characteristics
The VATEA device is a self contained, digitally-controlled fluid delivery unit consisting of a pump unit console, irrigation reservoir and tubing intended to be connected to an endodontic file. The device consists of a positive pressure peristaltic pump console with control panel, LCD display, irrigation reservoir, disposable silicone tubing, and a footswitch control to provide irrigation during endodontic rocedures. One end of the silicone tubing connects to the VATEA and the other end connects to the dental handpiece using a silicone ring. The silicone ring is elastic, and may be stretched to the domar handpiece as my of dental handpieces used in endodontic procedures. The irrigation reservoir is filled as needed with sodium hypochlorite solution for irrigation during endodontic rocedures. The irrigation fluid is pumped from the reservoir and then out of the silicone tubing, proodation: the internet of the tooth. The silicone tubing for the delivery of the iring the lumand the silicone ring connecting the pump to the dental handpiece are disposable and replaced after each treatment.
The irrigation fluid flow may be switched on and off with a footswitch that is connected to the VATEA. The fingulon had now his his of the device are displayed on the LCD screen on the control r no how rate and operation is 0, and the user must increase the flow rate using the - / + buttons on panel. The using for face of the irrigation fluid. The irrigation fluid flow rate may be adjusted the control parter in increments of 1 ml/min using the - /+ push-button control on the control panel.
The VATEA is an electronically operated device, powered by a rechargeable battery.
Performance Characteristics
The company performed the following testing to evaluate the safety and performance of the device:
- IEC 60601-1 Medical Electrical Equipment Part 1, General Requirements for Safety .
- IEC 60601-1-2 Medical Electrical Equipment, General Requirements for Safety. Collateral . Standard: Electromagnetic Compatibility- requirements and tests.
- Performance validation: .
- o Verification of flow rate Actual irrigant flow rate matched the displayed flow rate
- Battery indication and life time With batteries fully charged, the system can operate o without the charger for 4 continuous hours at maximum output.
Performance data establishes that the VATEA has comparable performance and safety as compared to its claimed predicate device.
2
3873
Substantial Equivalence
The VATEA has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the VATEA and its predicate device raise no new issues of safety or effectiveness. Preclinical performance data demonstrates that the VATEA is as safe and effective as the Quantec-E. Thus, it can be concluded that the VATEA is substantially equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ReDent Nova Limited C/O Jonathan S. Kahan Hogan & Hartson LLP Columbia Square, 555 13" Street, NW Washington, District of Columbia 20004
Re: K100606
Trade/Device Name: VATEA Endontic Irrigation System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: NYL Dated: May 25, 2010 Received: May 25, 2010
Dear Mr. Kahan:
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, listing 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.
MAY 2 8 2010
4
Page 2-Mr. Jonathan S. Kahan
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); 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/Safety/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use Statement
510(k) Number (if known): _
Device Name:
VATEA Endodontic Irrigation System
Indications for Use:
The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.
Prescription Use _ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rai Mulay for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100606
Page __ of