EndoVac Pure

K162436 · Kerr Corporation · NYL · Dec 21, 2016 · Dental

Device Facts

• Record ID: K162436
• Device Name: EndoVac Pure
• Applicant: Kerr Corporation
• Product Code: NYL · Dental
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

Device Story

EndoVac Pure is an apical negative pressure irrigation system for root canal procedures; used by licensed dental professionals in clinical settings. System inputs include irrigation solutions (NaOCl, EDTA) stored in reservoirs; vacuum pressure routed from dental chair system. Device transforms inputs via peristaltic pumps driven by PCBA and FPGA-controlled logic; delivers fluid to root canal while simultaneously evacuating fluid and debris apically to reduce risk of irrigant extrusion. Output is a cleaned root canal. Features include built-in unclogging mechanism, ratcheting slider for working length, and alarm system for low fluid or malfunction. Benefits include improved debris removal and reduced risk of apical extrusion compared to manual methods. Healthcare providers operate the handheld controller to manage fluid delivery and suction.

Clinical Evidence

No clinical data; bench testing only. Performance testing included flow rate delivery, suction flow rate, cleaning/disinfection validation, biocompatibility, sterilization validation, shelf life, EMC, ESD, and microcannula suction performance.

Technological Characteristics

Apical negative pressure irrigation system. Materials: AISI 304 stainless steel (microcannula), Polyamide (macrocannula). Energy: 100-240V AC, 50-60Hz. Connectivity: Standalone. Sterilization: Ethylene oxide. Software: FPGA-controlled peristaltic pumps. Standards: ISO 14971, ISO 10993 series, IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 11135, ISO 14937, ISO 11138, ISO 14161, ISO 11607.

Indications for Use

Indicated for delivery and evacuation of endodontic irrigation solutions and removal of debris of injured or necrotic pulp tissue during root canal procedures in patients requiring endodontic treatment.

Regulatory Classification

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.

Predicate Devices

• EndoVac Apical Negative Pressure Irrigation System (K140685)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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

- 1. Submitter Information:
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867

| Contact Person: | Mohammad Saad Ansari |
|-------------------|----------------------|
| Telephone Number: | 909-962-5644 |
| Fax Number: | 909-962-5694 |

Date Prepared: December 22, 2016

- 2. 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
- 3. 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.

- 4. 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.

- 5. Intended Use
The EndoVac Pure™ System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

- 6. 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.

- 7. 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.

## 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 | Predicate<br>EndoVac System | Proposed<br>EndoVac Pure |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K140685 | K162436 |
| Trade Name | EndoVac Apical Negative<br>Pressure Irrigation System | EndoVac Pure™ |
| Class | Class 1 | Class 1 |
| Product Code | NYL | NYL |
| Classification Name | Handheld controller, Air-<br>Powered, Root Canal Irrigation | Handheld controller, Air-Powered,<br>Root Canal Irrigation |
| Target Users | Licensed Dental Professionals | Licensed Dental Professionals |
| Intended Use | The EndoVac system is intended<br>for the delivery and evacuation<br>of endodontic irrigation solutions<br>during root canal procedures. | The EndoVac Pure™ system is<br>intended for the delivery and<br>evacuation of endodontic irrigation<br>solutions during root canal<br>procedures. |
| Indications For Use | The EndoVac system is intended<br>for the delivery and evacuation<br>of endodontic irrigation solutions<br>during root canal procedures. | The EndoVac Pure™ System is<br>intended for the delivery and<br>evacuation of endodontic irrigation<br>solutions and removing debris of<br>injured or necrotic pulp tissue<br>during root canal procedures. |
| Device Components | Syringes, Multi-Port Adapter,<br>Master Delivery Tip,<br>Fingerpiece, Handheld | Base Unit, HVE Adapter, Handheld<br>controller, Apex Cartridge (with<br>MicroCannula and MacroCannula). |
| Element | Predicate<br>EndoVac System | Proposed<br>EndoVac Pure |
| Suction Adapter | controller, MicroCannula and<br>MacroCannula, Connection<br>tubing,<br>The Multi-Port Adapter<br>critical to functionality dimension<br>in this component is the Outer<br>Diameter (OD) due to<br>compatibility with dental chair<br>high evacuation line OD = 0.434<br>in) | AC Supply, Universal Latches,<br>Connection tubing,<br>HVE adapter:<br>Critical to functionality dimension<br>in this component is the Outer<br>Diameter (OD) due to compatibility<br>with dental chair High evacuation<br>line (OD = 11.0 ±0.1 mm) (0.434<br>in) |
| Fluid Delivery<br>Feature | Delivery Needle in Master<br>Delivery Tip and Luer Lock<br>Connection | Delivery Needle in Apex Cartridge<br>and Handheld controller<br>Connection |
| MacroCannula<br>Dimensions | The MacroCannula<br>critical to functionality<br>dimension in this component is<br>the OD due to the clinical<br>application into the root canal<br>cleaning procedure (OD = 0.020<br>±0.001 in) | MacroCannula on Apex Cartridge<br>critical to functionality dimension<br>in this component is the OD due to<br>the clinical application into the root<br>canal cleaning procedure (OD =<br>0.595 ±0.012 mm) (0.023 inch) |
| MacroCannula<br>material | Titan Petchem SM598 (Ethylene<br>Propylene Copolymer) / colorant<br>(BLMT 2070) | Polyamide (PI) |
| MicroCannula<br>Dimensions | MicroCannula critical to<br>functionality dimension in this<br>component is the OD due to the<br>clinical application into the root<br>canal cleaning procedure (OD =<br>0.0125 to 0.0118 in) | MicroCannula on Apex Cartridge<br>critical to functionality dimension<br>in this component is the OD due to<br>the clinical application into the root<br>canal cleaning procedure (OD =<br>0.0125 to 0.0118 in) |
| MicroCannula<br>Material | 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 syringe<br>plunger | Base Unit contains two peristaltic<br>pumps that are manually operated<br>by fluid delivery buttons in the<br>handheld controller |
| AC Supply<br>Connection | None | 100-240V AC, 1.0-0.5A, 50-60Hz |
| Element | Predicate<br>EndoVac System | Proposed<br>EndoVac Pure |
| Flow Uptake | MicroCannula uptake flow<br>5ml/min ± 15%<br>MacroCannula uptake flow<br>40ml/min ± 20% | MicroCannula uptake flow<br>5ml/min ± 15%<br>MacroCannula uptake flow<br>40ml/min ± 20% |
| MicroCannula,<br>Working Length | MicroCannula working length is<br>from 14 to 30 mm ±0.5 mm | MicroCannula working length is<br>from 14 to 30 mm ±0.5mm |
| System Purge | Remove syringe plunger and<br>empty each syringe, manually<br>push the plunger to empty each<br>syringe | Double press purge button to empty<br>each reservoir |
| Hood Design | 1 Configurations<br>Master Delivery Tip Hood | 2 Configurations<br>MacroCannula Hood<br>Apex Irrigation Hood |
| Vacuum Evacuation<br>System | MicroCannula and<br>MacroCannula are two<br>independent single use<br>components | Single Use, sterile Apex Cartridge<br>includes coaxial MicroCannula and<br>MacroCannula |
| Vacuum Connection | Multi-Port Adapter | HVE Adapter |
| Liquid Storage | Syringes<br>20 ml syringe NaOCl<br>3 ml syringe EDTA | Liquid Reservoirs<br>100 ml NaOCl<br>25 ml EDTA |
| Unclogging<br>Mechanism | Requires MacroCannula and<br>MicroCannula to be disconnected<br>from the vacuum line. The<br>MacroCannula and<br>MicroCannula are independently<br>connected to another syringe and<br>positive pressure is applied to<br>dislodge and unclog any debris. | Built-in unclogging mechanism<br>allows MacroCannula and<br>MicroCannula without<br>disconnecting from the vacuum<br>line. The MicroCannula can be<br>used to drive out any clogged<br>debris in the MacroCannula by<br>sliding in and out of it. The<br>MicroCannula can be pulled back<br>into the MacroCannula removing<br>any debris on the external sides of<br>the MicroCannula. The<br>MicroCannula can also be pulled<br>back into the head of the Apex<br>Cartridge system allowing<br>maximum vacuum pressure to<br>dislodge any clogged debris on the<br>inside of the MicroCannula. |
| MicroCannula and<br>MacroCannula | Negative pressure used to clean<br>root canal on both MicroCannula<br>and MacroCannula.<br>MacroCannula doesn't require | Negative pressure used to clean<br>root canal on both MicroCannula<br>and MacroCannula.<br>MacroCannula doesn't require any |
| Element | Predicate<br>EndoVac System | Proposed<br>EndoVac Pure |
| | any working length measurement<br>but can be adjusted by clinician<br>if needed.<br>MicroCannula working length<br>utilizes a sliding rubber stop as a<br>datum and can be used to set the<br>working length. The rubber stop<br>may move accidentally if<br>pressure is applied to it. | working length measurement but<br>can be adjusted by clinician if<br>needed.<br>MicroCannula working length<br>utilizes a rigid hood as a datum and<br>a ratcheting slider to set the<br>working length. The ratchet on the<br>slider prevents the working length<br>from being adjusted inadvertently. |
| Cross contamination<br>(cleaning,<br>disinfection,<br>sterilization) | Meets Requirements<br>Patient contacting portion is<br>Autoclaveable | Meets Requirements<br>Patient contacting portion is single<br>use and sterile.<br>Handheld controller is cleaned<br>and disinfected between uses,<br>then covered with an FDA<br>cleared dental barrier sleeve<br>which is non-sterile and intended<br>for single patient use only. |
| Alarm System | None | Alarm at Device Malfunction.<br>Multiple alarms have been<br>incorporated in the EndoVac<br>PureTM system to alert the user in<br>case of issues that may affect the<br>clinical outcome.<br>- Issue #1 - Low fluid with an<br>audible alarm and yellow flashing<br>light<br>- Issue #2 - System malfunction<br>with a red flashing light |
| Adverse Tissue<br>Reaction and<br>Biocompatibility | Meets requirements | Meets requirements |
| Electromagnetic<br>Compatibility | None | Meets requirements |
| Sterilization<br>Validation | 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).