(112 days)
The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures.
The EndoVac Pure™ system builds on the EndoVac System and presents a unique way to irrigate during root canal treatments. The system is an apical negative pressure system that draws fluid apically by way of evacuation, reducing the risk of apical irrigant extrusion during root canal procedures. The vacuum is routed through the system and controlled independently through the dental chair vacuum system. The fluid delivery is controlled by peristaltic pumps. The pumps are driven by Printed Circuit Board Assemblies (PCBA) and controlled by Field Programmable Gate Array (FPGA) configuration files.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the EndoVac Pure device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with direct performance metrics alongside the reported performance of the EndoVac Pure. Instead, it details various "performance tests were conducted as part of design verification" and then provides a comparison table (Table 7.1) outlining technological characteristics between the proposed EndoVac Pure and its predicate device. This comparison implicitly serves as evidence of meeting performance requirements by demonstrating similarity to a legally marketed device.
Therefore, the table below is constructed by interpreting the "Technological Characteristics Non-Clinical Performance Data" section and the "Predicate and Proposed Device Comparison Table" (Table 7.1) as the reported performance, and the fact that these tests were conducted as "design verification" implies they met established internal acceptance criteria for substantial equivalence to the predicate.
| Acceptance Criteria (Implied by Design Verification & Predicate Equivalence) | Reported Device Performance (EndoVac Pure) |
|---|---|
| Functional Performance: | |
| Flow Rate Delivery and Selection | Performed, met design requirements |
| Suction Flow Rate Performance (MicroCannula) | 5ml/min ± 15% |
| Suction Flow Rate Performance (MacroCannula) | 40ml/min ± 20% |
| Unclogging Mechanism | Built-in, allows clearing without disconnecting from vacuum line |
| System Purge (Emptying reservoirs) | Double press purge button to empty each reservoir |
| MicroCannula Working Length Adjustment | Uses rigid hood and ratcheting slider to set working length (prevents inadvertent adjustment) |
| MacroCannula Working Length Adjustment | Can be adjusted by clinician if needed |
| Alarm System | Multiple alarms incorporated (Low fluid: audible alarm/yellow flashing light; System malfunction: red flashing light) |
| Sterility/Biocompatibility: | |
| Cleaning and Disinfection Validation | Meets Requirements |
| Biocompatibility | Meets requirements |
| Sterilization Validation | Meets requirements |
| Shelf Life Validation | Performed, met design requirements |
| Cross contamination | Patient contacting portion is single use and sterile. Handheld controller cleaned/disinfected and covered with cleared dental barrier |
| Adverse Tissue Reaction and Biocompatibility | Meets requirements |
| Electrical/Software: | |
| Electromagnetic Compatibility (EMC) Testing | Meets requirements |
| Electrostatic Discharge (ESD) Suppression | Performed, met design requirements |
| Software Validation | Meets requirements |
| Mechanical/Physical: | |
| MicroCannula Suction Performance | Performed, met design requirements |
| Suction Adapter OD (HVE adapter) | 11.0 ±0.1 mm (0.434 in) |
| MacroCannula OD (on Apex Cartridge) | 0.595 ±0.012 mm (0.023 inch) |
| MicroCannula OD (on Apex Cartridge) | 0.0125 to 0.0118 in |
Study Proving Device Meets Acceptance Criteria
The study primarily relies on non-clinical performance testing and a comparison to a legally marketed predicate device (EndoVac® Apical Negative Pressure Irrigation System K140685) to demonstrate substantial equivalence. The document explicitly states: "The EndoVac Pure™ and the predicate EndoVac System (K140685) perform the same function, which is a method to deliver irrigant, rinse and evacuate during root canal procedures. The following performance tests were conducted as part of design verification:" followed by a list of tests.
The conclusion further reinforces this: "The proposed EndoVac Pure™ is substantially equivalent to the predicate Endo Vac System (K140685) based on design, performance, biocompatibility testing, and the intended use."
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each non-clinical performance test. It lists the types of tests conducted (e.g., Flow Rate Delivery, Suction Flow Rate, Biocompatibility, Sterilization, etc.) but not the number of units or datasets used for each.
The data provenance is from non-clinical performance testing, presumably conducted internally by Sybron Dental Specialties. There is no information provided about country of origin of data (apart from the manufacturer being in Orange, CA). The studies are inherently prospective with respect to the device's design verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation is based on non-clinical performance testing against engineering specifications and comparison to a predicate device. There is no mention of human experts establishing "ground truth" for the performance tests in the context of diagnostic accuracy or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical performance testing. Adjudication methods (like N+1 consensus) are typically used in clinical studies where expert reviewers evaluate cases and make subjective judgments, which is not the nature of the tests performed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing has not been performed for EndoVac Pure™" in section 8.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical dental system, not an algorithm or AI software. There is no "standalone" algorithm performance to evaluate. The device's performance is inherently tied to its use by a human operator within a clinical procedure.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was established by engineering specifications, accepted industry standards (e.g., ISO, IEC), and the performance characteristics of the legally marketed predicate device. For instance, flow rates were expected to fall within a specified range, and biocompatibility tests were conducted according to ISO standards.
8. The Sample Size for the Training Set
This information is not applicable. The EndoVac Pure is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with three intertwined snakes and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Kerr Corporation % Mohammad Ansari Regulatory Affairs Specialist II Sybron Dental Specialties 1717 W. Collins Ave. Orange, California 92867
Re: K162436
Trade/Device Name: EndoVac Pure Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: NYL Dated: November 22, 2016 Received: November 25, 2016
Dear Mr. Mohammad Ansari:
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.
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
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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Sincerely,
Susan Runno DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
EndoVac Pure™
Indications for Use (Describe)
The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
× Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K162436 510(k) SUMMARY
-
- Submitter Information:
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867
- Submitter Information:
| Contact Person: | Mohammad Saad Ansari |
|---|---|
| Telephone Number: | 909-962-5644 |
| Fax Number: | 909-962-5694 |
Date Prepared: December 22, 2016
-
- Device Name:
| • Proprietary Name: | EndoVac Pure |
|---|---|
| • Classification Name: | Handheld controller, air-powered, root canal irrigation |
- CFR Number: 872.4200 . Device Class: Class I
- Product Code: . NYL
-
- Predicate Device:
The EndoVac Pure™ product is substantially equivalent to the legally marketed device EndoVac® Apical Negative Pressure Irrigation System (K140685) cleared on July 2nd, 2014, product code NYL.
-
- Description of Device:
The EndoVac Pure™ system builds on the EndoVac System and presents a unique way to irrigate during root canal treatments. The system is an apical negative pressure system that draws fluid apically by way of evacuation, reducing the risk of apical irrigant extrusion during root canal procedures. The vacuum is routed through the system and controlled independently through the dental chair vacuum system. The fluid delivery is controlled by peristaltic pumps. The pumps are driven by Printed Circuit Board Assemblies (PCBA) and controlled by Field Programmable Gate Array (FPGA) configuration files.
- Description of Device:
-
- Intended Use
The EndoVac Pure™ System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
- Intended Use
-
- Indications for Use:
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The EndoVac Pure™ System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures.
-
- Description of Safety and Substantial Equivalence:
The EndoVac Pure™ product is substantially equivalent to the legally marketed device EndoVac® Apical Negative Pressure Irrigation System (K140685) cleared on July 2nd, 2014. product code NYL.
- Description of Safety and Substantial Equivalence:
Technological Characteristics Non-Clinical Performance Data
The technological characteristics of EndoVac Pure™ is very similar to the predicate EndoVac® (K140685) negative pressure irrigation systems. The EndoVac Pure™ and the predicate EndoVac System (K140685) perform the same function, which is a method to deliver irrigant, rinse and evacuate during root canal procedures. The following performance tests were conducted as part of design verification:
- · Flow Rate Delivery and Selection
- · Suction Flow Rate Performance
- Cleaning and Disinfection Validation
- · Biocompatibility
- Sterilization Validation
- Shelf Life Validation
- · Electromagnetic Compatibility (EMC) Testing
- · Electrostatic Discharge (ESD) Suppression
- · MicroCannula Suction Performance
Applicable Standards
- · ISO 14971: 2007 Medical Devices Application of risk management
- · ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing
- · ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5 Tests for in vitro cvtotoxicitv
- · ISO 10093-7:2008: Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
- · ISO 10993-10:2009 Biological Evaluation of Medical Devices Part 10 Tests for irritation and skin sensitization
- IEC 60601-1 Issued: 2005/01/01 Ed: 3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- · IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (3rd Edition)
- · IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for
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safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (4th Edition)
- · IEC 62304:2006/Amd 1:2015 Medical device software Software life cycle processes
- · ISO 11135:2014 Sterilization of healthcare products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- · ISO 14937: 2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
- · ISO 11138:2006 Sterilization of healthcare products Biological indicators –Part 1: General requirements, Part 2: Biological indicators for ethylene oxide sterilization processes
- · ISO 14161:2009 Sterilization of healthcare products Biological indicators -Guidance for the selection, use and interpretation of results.
- · ISO 11607-1:2006 Packaging for Terminally Sterilized Medical Devices
- · ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices Part 2: Validation requirements for forming, sealing and assembly processes
| Element | PredicateEndoVac System | ProposedEndoVac Pure |
|---|---|---|
| 510(k) | K140685 | K162436 |
| Trade Name | EndoVac Apical NegativePressure Irrigation System | EndoVac Pure™ |
| Class | Class 1 | Class 1 |
| Product Code | NYL | NYL |
| Classification Name | Handheld controller, Air-Powered, Root Canal Irrigation | Handheld controller, Air-Powered,Root Canal Irrigation |
| Target Users | Licensed Dental Professionals | Licensed Dental Professionals |
| Intended Use | The EndoVac system is intendedfor the delivery and evacuationof endodontic irrigation solutionsduring root canal procedures. | The EndoVac Pure™ system isintended for the delivery andevacuation of endodontic irrigationsolutions during root canalprocedures. |
| Indications For Use | The EndoVac system is intendedfor the delivery and evacuationof endodontic irrigation solutionsduring root canal procedures. | The EndoVac Pure™ System isintended for the delivery andevacuation of endodontic irrigationsolutions and removing debris ofinjured or necrotic pulp tissueduring root canal procedures. |
| Device Components | Syringes, Multi-Port Adapter,Master Delivery Tip,Fingerpiece, Handheld | Base Unit, HVE Adapter, Handheldcontroller, Apex Cartridge (withMicroCannula and MacroCannula). |
| Element | PredicateEndoVac System | ProposedEndoVac Pure |
| Suction Adapter | controller, MicroCannula andMacroCannula, Connectiontubing,The Multi-Port Adaptercritical to functionality dimensionin this component is the OuterDiameter (OD) due tocompatibility with dental chairhigh evacuation line OD = 0.434in) | AC Supply, Universal Latches,Connection tubing,HVE adapter:Critical to functionality dimensionin this component is the OuterDiameter (OD) due to compatibilitywith dental chair High evacuationline (OD = 11.0 ±0.1 mm) (0.434in) |
| Fluid DeliveryFeature | Delivery Needle in MasterDelivery Tip and Luer LockConnection | Delivery Needle in Apex Cartridgeand Handheld controllerConnection |
| MacroCannulaDimensions | The MacroCannulacritical to functionalitydimension in this component isthe OD due to the clinicalapplication into the root canalcleaning procedure (OD = 0.020±0.001 in) | MacroCannula on Apex Cartridgecritical to functionality dimensionin this component is the OD due tothe clinical application into the rootcanal cleaning procedure (OD =0.595 ±0.012 mm) (0.023 inch) |
| MacroCannulamaterial | Titan Petchem SM598 (EthylenePropylene Copolymer) / colorant(BLMT 2070) | Polyamide (PI) |
| MicroCannulaDimensions | MicroCannula critical tofunctionality dimension in thiscomponent is the OD due to theclinical application into the rootcanal cleaning procedure (OD =0.0125 to 0.0118 in) | MicroCannula on Apex Cartridgecritical to functionality dimensionin this component is the OD due tothe clinical application into the rootcanal cleaning procedure (OD =0.0125 to 0.0118 in) |
| MicroCannulaMaterial | AISI 304 Stainless Steel | AISI 304 Stainless Steel |
| Mounting System | None | Universal Latch |
| Mode of Operation | Manually Operated | Manually Operated |
| Fluid Delivery System | Manual operation of syringeplunger | Base Unit contains two peristalticpumps that are manually operatedby fluid delivery buttons in thehandheld controller |
| AC SupplyConnection | None | 100-240V AC, 1.0-0.5A, 50-60Hz |
| Element | PredicateEndoVac System | ProposedEndoVac Pure |
| Flow Uptake | MicroCannula uptake flow5ml/min ± 15%MacroCannula uptake flow40ml/min ± 20% | MicroCannula uptake flow5ml/min ± 15%MacroCannula uptake flow40ml/min ± 20% |
| MicroCannula,Working Length | MicroCannula working length isfrom 14 to 30 mm ±0.5 mm | MicroCannula working length isfrom 14 to 30 mm ±0.5mm |
| System Purge | Remove syringe plunger andempty each syringe, manuallypush the plunger to empty eachsyringe | Double press purge button to emptyeach reservoir |
| Hood Design | 1 ConfigurationsMaster Delivery Tip Hood | 2 ConfigurationsMacroCannula HoodApex Irrigation Hood |
| Vacuum EvacuationSystem | MicroCannula andMacroCannula are twoindependent single usecomponents | Single Use, sterile Apex Cartridgeincludes coaxial MicroCannula andMacroCannula |
| Vacuum Connection | Multi-Port Adapter | HVE Adapter |
| Liquid Storage | Syringes20 ml syringe NaOCl3 ml syringe EDTA | Liquid Reservoirs100 ml NaOCl25 ml EDTA |
| UncloggingMechanism | Requires MacroCannula andMicroCannula to be disconnectedfrom the vacuum line. TheMacroCannula andMicroCannula are independentlyconnected to another syringe andpositive pressure is applied todislodge and unclog any debris. | Built-in unclogging mechanismallows MacroCannula andMicroCannula withoutdisconnecting from the vacuumline. The MicroCannula can beused to drive out any cloggeddebris in the MacroCannula bysliding in and out of it. TheMicroCannula can be pulled backinto the MacroCannula removingany debris on the external sides ofthe MicroCannula. TheMicroCannula can also be pulledback into the head of the ApexCartridge system allowingmaximum vacuum pressure todislodge any clogged debris on theinside of the MicroCannula. |
| MicroCannula andMacroCannula | Negative pressure used to cleanroot canal on both MicroCannulaand MacroCannula.MacroCannula doesn't require | Negative pressure used to cleanroot canal on both MicroCannulaand MacroCannula.MacroCannula doesn't require any |
| Element | PredicateEndoVac System | ProposedEndoVac Pure |
| any working length measurementbut can be adjusted by clinicianif needed.MicroCannula working lengthutilizes a sliding rubber stop as adatum and can be used to set theworking length. The rubber stopmay move accidentally ifpressure is applied to it. | working length measurement butcan be adjusted by clinician ifneeded.MicroCannula working lengthutilizes a rigid hood as a datum anda ratcheting slider to set theworking length. The ratchet on theslider prevents the working lengthfrom being adjusted inadvertently. | |
| Cross contamination(cleaning,disinfection,sterilization) | Meets RequirementsPatient contacting portion isAutoclaveable | Meets RequirementsPatient contacting portion is singleuse and sterile.Handheld controller is cleanedand disinfected between uses,then covered with an FDAcleared dental barrier sleevewhich is non-sterile and intendedfor single patient use only. |
| Alarm System | None | Alarm at Device Malfunction.Multiple alarms have beenincorporated in the EndoVacPureTM system to alert the user incase of issues that may affect theclinical outcome.- Issue #1 - Low fluid with anaudible alarm and yellow flashinglight- Issue #2 - System malfunctionwith a red flashing light |
| Adverse TissueReaction andBiocompatibility | Meets requirements | Meets requirements |
| ElectromagneticCompatibility | None | Meets requirements |
| SterilizationValidation | Meets requirements | Meets requirements |
| Software Validation | Not Applicable | Meets requirements |
Table 7.1: Predicate and Proposed Device Comparison Table
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8. Clinical Performance Data
Clinical performance testing has not been performed for EndoVac Pure™
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9. Conclusion as to Substantial Equivalence
The EndoVac System (K140685) and the proposed EndoVac Pure™ have the same Intended Use: for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. The proposed Indications for Use statement adds "and removing debris of injured or necrotic pulp tissue" to better describe root canal cleaning and the setting and use-site environment where the system is used. The EndoVac Pure™ is a less-complex non-automated technology. The technological characteristics of EndoVac Pure™ are very similar to the predicate EndoVac System (K140685). The proposed EndoVac Pure™ has similarities in select performance characteristics and design features as compared to the predicate. The technological characteristics of EndoVac Pure™ are very similar to the predicate EndoVac (K140685) negative pressure irrigation systems. The EndoVac Pure™ and the predicate EndoVac System (K140685) perform the same function, which is a method to deliver irrigant, rinse and evacuate during root canal procedures. The proposed Endo Vac Pure™ is substantially equivalent to the predicate Endo Vac System (K140685) based on design, performance, biocompatibility testing, and the intended use. Any noted differences in technological characteristics between the proposed and predicate products do not raise new questions of safety and effectiveness. The EndoVac Pure™ and the predicate EndoVac System (K140685) perform the same function. which is a method to deliver irrigant, rinse and evacuate during root canal procedures. Based on biocompatibility studies, identical intended use, and performance characteristics, the Endo Vac Pure™ is substantially equivalent to the predicate EndoVac System (K140685).
§ 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.