(112 days)
Not Found
No
The description focuses on mechanical and electronic control systems (peristaltic pumps, PCBAs, FPGAs) for fluid delivery and vacuum control, with no mention of AI or ML algorithms for decision-making, data analysis, or adaptive control.
Yes
The device is intended for the delivery and evacuation of irrigation solutions and removing debris during root canal procedures, which are therapeutic interventions.
No
The device is described as an irrigation solution delivery and evacuation system for root canal procedures, designed to remove debris and injured tissue. Its function is procedural (cleaning and debridement) rather than diagnostic (identifying a condition or disease).
No
The device description explicitly mentions hardware components such as peristaltic pumps, Printed Circuit Board Assemblies (PCBA), and Field Programmable Gate Array (FPGA) configuration files, and the performance studies include hardware-related testing like EMC and ESD.
Based on the provided information, the EndoVac™ Pure System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures." This describes a therapeutic and procedural device used directly on a patient's anatomical site (root canal).
- Device Description: The description details a system involving vacuum, fluid delivery, pumps, and electronic components for use during a dental procedure. It does not describe a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
In summary, the EndoVac™ Pure System is a medical device used for a dental procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NYL
Device Description
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.
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
Licensed Dental Professionals
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)
Clinical performance testing has not been performed for EndoVac Pure™
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
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
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
1
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
5
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
EndoVac System | Proposed
EndoVac Pure |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K140685 | K162436 |
| Trade Name | EndoVac Apical Negative
Pressure 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 intended
for the delivery and evacuation
of endodontic irrigation solutions
during root canal procedures. | The EndoVac Pure™ system is
intended for the delivery and
evacuation of endodontic irrigation
solutions during root canal
procedures. |
| Indications For Use | The EndoVac system is intended
for the delivery and evacuation
of endodontic irrigation solutions
during root canal procedures. | 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. |
| Device Components | Syringes, Multi-Port Adapter,
Master Delivery Tip,
Fingerpiece, Handheld | Base Unit, HVE Adapter, Handheld
controller, Apex Cartridge (with
MicroCannula and MacroCannula). |
| Element | Predicate
EndoVac System | Proposed
EndoVac Pure |
| Suction Adapter | controller, MicroCannula and
MacroCannula, Connection
tubing,
The Multi-Port Adapter
critical to functionality dimension
in this component is the Outer
Diameter (OD) due to
compatibility with dental chair
high evacuation line OD = 0.434
in) | AC Supply, Universal Latches,
Connection tubing,
HVE adapter:
Critical to functionality dimension
in this component is the Outer
Diameter (OD) due to compatibility
with dental chair High evacuation
line (OD = 11.0 ±0.1 mm) (0.434
in) |
| Fluid Delivery
Feature | Delivery Needle in Master
Delivery Tip and Luer Lock
Connection | Delivery Needle in Apex Cartridge
and Handheld controller
Connection |
| MacroCannula
Dimensions | The MacroCannula
critical to functionality
dimension in this component is
the OD due to the clinical
application into the root canal
cleaning procedure (OD = 0.020
±0.001 in) | MacroCannula on Apex Cartridge
critical to functionality dimension
in this component is the OD due to
the clinical application into the root
canal cleaning procedure (OD =
0.595 ±0.012 mm) (0.023 inch) |
| MacroCannula
material | Titan Petchem SM598 (Ethylene
Propylene Copolymer) / colorant
(BLMT 2070) | Polyamide (PI) |
| MicroCannula
Dimensions | MicroCannula critical to
functionality dimension in this
component is the OD due to the
clinical application into the root
canal cleaning procedure (OD =
0.0125 to 0.0118 in) | MicroCannula on Apex Cartridge
critical to functionality dimension
in this component is the OD due to
the clinical application into the root
canal cleaning procedure (OD =
0.0125 to 0.0118 in) |
| MicroCannula
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
plunger | Base Unit contains two peristaltic
pumps that are manually operated
by fluid delivery buttons in the
handheld controller |
| AC Supply
Connection | None | 100-240V AC, 1.0-0.5A, 50-60Hz |
| Element | Predicate
EndoVac System | Proposed
EndoVac Pure |
| Flow Uptake | MicroCannula uptake flow
5ml/min ± 15%
MacroCannula uptake flow
40ml/min ± 20% | MicroCannula uptake flow
5ml/min ± 15%
MacroCannula uptake flow
40ml/min ± 20% |
| MicroCannula,
Working Length | MicroCannula working length is
from 14 to 30 mm ±0.5 mm | MicroCannula working length is
from 14 to 30 mm ±0.5mm |
| System Purge | Remove syringe plunger and
empty each syringe, manually
push the plunger to empty each
syringe | Double press purge button to empty
each reservoir |
| Hood Design | 1 Configurations
Master Delivery Tip Hood | 2 Configurations
MacroCannula Hood
Apex Irrigation Hood |
| Vacuum Evacuation
System | MicroCannula and
MacroCannula are two
independent single use
components | Single Use, sterile Apex Cartridge
includes coaxial MicroCannula and
MacroCannula |
| Vacuum Connection | Multi-Port Adapter | HVE Adapter |
| Liquid Storage | Syringes
20 ml syringe NaOCl
3 ml syringe EDTA | Liquid Reservoirs
100 ml NaOCl
25 ml EDTA |
| Unclogging
Mechanism | Requires MacroCannula and
MicroCannula to be disconnected
from the vacuum line. The
MacroCannula and
MicroCannula are independently
connected to another syringe and
positive pressure is applied to
dislodge and unclog any debris. | Built-in unclogging mechanism
allows MacroCannula and
MicroCannula without
disconnecting from the vacuum
line. The MicroCannula can be
used to drive out any clogged
debris in the MacroCannula by
sliding in and out of it. The
MicroCannula can be pulled back
into the MacroCannula removing
any debris on the external sides of
the MicroCannula. The
MicroCannula can also be pulled
back into the head of the Apex
Cartridge system allowing
maximum vacuum pressure to
dislodge any clogged debris on the
inside of the MicroCannula. |
| MicroCannula and
MacroCannula | Negative pressure used to clean
root canal on both MicroCannula
and MacroCannula.
MacroCannula doesn't require | Negative pressure used to clean
root canal on both MicroCannula
and MacroCannula.
MacroCannula doesn't require any |
| Element | Predicate
EndoVac System | Proposed
EndoVac Pure |
| | any working length measurement
but can be adjusted by clinician
if needed.
MicroCannula working length
utilizes a sliding rubber stop as a
datum and can be used to set the
working length. The rubber stop
may move accidentally if
pressure is applied to it. | working length measurement but
can be adjusted by clinician if
needed.
MicroCannula working length
utilizes a rigid hood as a datum and
a ratcheting slider to set the
working length. The ratchet on the
slider prevents the working length
from being adjusted inadvertently. |
| Cross contamination
(cleaning,
disinfection,
sterilization) | Meets Requirements
Patient contacting portion is
Autoclaveable | Meets Requirements
Patient contacting portion is single
use and sterile.
Handheld controller is cleaned
and disinfected between uses,
then covered with an FDA
cleared dental barrier sleeve
which is non-sterile and intended
for single patient use only. |
| Alarm System | None | Alarm at Device Malfunction.
Multiple alarms have been
incorporated in the EndoVac
PureTM system to alert the user in
case of issues that may affect the
clinical outcome.
- Issue #1 - Low fluid with an
audible alarm and yellow flashing
light - Issue #2 - System malfunction
with a red flashing light |
| Adverse Tissue
Reaction and
Biocompatibility | Meets requirements | Meets requirements |
| Electromagnetic
Compatibility | None | Meets requirements |
| Sterilization
Validation | Meets requirements | Meets requirements |
| Software Validation | Not Applicable | Meets requirements |
Table 7.1: Predicate and Proposed Device Comparison Table
6
7
8
8. Clinical Performance Data
Clinical performance testing has not been performed for EndoVac Pure™
9
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).