(181 days)
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI/ML terms or data-driven performance metrics.
No
The device is used for delivery and evacuation of irrigation solutions, which is a supportive function during a root canal procedure, not a treatment itself.
No
Explanation: The device is intended for delivering and evacuating irrigation solutions during root canal procedures, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines a physical apparatus ("closed system negative pressure irrigation apparatus," "cannula," "coronal chamber," "lightcurable barrier") and the performance studies focus on physical characteristics and function (suction flow rate, dimensions, corrosion, etc.), indicating it is a hardware device.
Based on the provided information, the PS System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "delivery and evacuation of endodontic irrigation solutions during root canal procedures." This is a therapeutic and procedural use within the oral cavity, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the mechanical function of irrigating and evacuating solutions within the tooth canal. It describes a system for delivering and removing fluids, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely procedural.
Therefore, the PS System falls under the category of a dental device used for a therapeutic procedure, not an IVD.
N/A
Intended Use / Indications for Use
The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
Product codes (comma separated list FDA assigned to the subject device)
NYL
Device Description
The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
The PS System is packaged in procedural kits composed of the following items:
- Stage (molar, premolar or anterior)
- Placement tool (molar, premolar or anterior)
- Cannula set with connection tubing (molar, premolar or anterior)
- Vacuum Line with suction adapter
- Light Curable Barrier
- Sodium hypochlorite with wetting agents (i.e. Chlor-Xtra)
- SmearOFF
- Syringe
- Application Tips
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity / Isolated tooth
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)
The following performance tests were conducted as part of design verification:
- Suction Flow Rate Performance
- Critical Dimensions for Clinical Performance Analysis
- Corrosion Testing
- Simulated Canal Performance Testing
- Shelf Life Verification
- Biocompatibility Analysis
- Transit Testing
- Additive Manufacturing Summary Document
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 2, 2021
Inter-Med, INC. Brett Arand Senior Product Development Engineer 2200 South Street Racine, Wisconsin 53404
Re: K211721-S002
Trade/Device Name: PS System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: NYL Dated: May 21, 2021 Received: June 4, 2021
Dear Brett Arand:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K211721
Device Name
PS System
Indications for Use (Describe)
The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in a bold, sans-serif font, with the "i" in lowercase and the rest of the letters in uppercase. There is a horizontal line underneath the word "intermed". To the right of the word "intermed" is a globe graphic. To the right of the globe graphic is the word "INC.", which is in a smaller, sans-serif font.
Image /page/3/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in large, bold letters, with the letters slightly overlapping. Above the word "VISTA" is a stylized mountain range. Below the word "VISTA" are the words "Dental Products".
510(k) Summary-K211721 PS System
1. Applicant
Inter-Med / Vista Dental Products 2200 South Street Racine, WI, USA 53404
Contact Person: Brett Arand Telephone Number: (262) 633-0755 Fax Number: (262) 636-9760 Email: barand(@vista-dental.com
Date Prepared: November 3rd, 2021 Prepared By: Brett Arand
2. Device Name
| Proprietary Name: | PS System |
|---|---|
| Classification Name: | Handheld controller, air-powered, root canal irrigatio |
| CRF Number: | 872.4200 |
| Product Code: | NYL |
| Device Class: | Class I |
3. Predicate Device
The PS System is substantially equivalent to the legally marketed device Endo Vac Apical Negative Pressure Irrigation System (K140685), submitted by Sybron Endo and cleared on July 2nd, 2014, product code NYL.
4. Device Description
The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
4
Image /page/4/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in a sans-serif font, with a line underneath it. To the right of the word is a globe, and to the right of the globe is the word "INC."
Image /page/4/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below "VISTA" is the phrase "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".
The PS System is packaged in procedural kits composed of the following items:
| PS System Component | Class | Product
Code | FDA Status |
|------------------------------------------------------------------------|-------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Stage (molar, premolar or anterior) | | | |
| 2. Placement tool (molar, premolar or
anterior) | 1 | NYL | Subject of new 510(k) |
| 3. Cannula set with connection tubing
(molar, premolar or anterior) | 1 | NYL | Subject of new 510(k) |
| 4. Vacuum Line with suction adapter | | | |
| 5. Light Curable Barrier | 1 | EIE | Exempt per 21 CFR 872.6300 |
| 6. Sodium hypochlorite with wetting agents
(i.e. Chlor-Xtra) | U | KJJ | Reference to Chlor-Xtra cleared
in K082470 in light of
completed Chlor-Xtra Plus 8%
NaOCl Regulatory Change
Assessment dated 10/27/2021
included in Section 11 - Device
DescriptionCleared via K082470 |
| 7. SmearOFF | U | KJJ | Cleared via K193409 |
| 8. Syringe | 1 | EIC | Premarket notification exempt
per 21 CFR 872.4565 |
| 9. Application Tips | 1 | EIC | Premarket notification exempt
per 21 CFR 872.4565 |
This is the only 510(k) for the PS System medical device, no prior 510(k)s have been submitted.
ട. Intended Use / Indication for Use
The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
6. Technological Characteristics and Substantial Equivalence
The technological characteristics of the PS System are very similar to the predicate EndoVac System (K140685). The PS System and the predicate EndoVac System (K140685) perform the same function, which is a method to deliver irrigant, rinse and evacuate during root canal procedures. A comprehensive comparison of technological characteristics and substantial equivalence between the systems is provided below.
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Image /page/5/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in a dark gray sans-serif font, with a line underneath it. To the right of the word is a globe, with the letters "INC." in a smaller font to the right of the globe.
Image /page/5/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized font, with a mountain range graphic above it. Below the word "VISTA" is the text "Dental Products".
| Table 5-2: Predicate and Proposed Device Comparison Table | ||
|---|---|---|
| Predicate Device | Proposed Device | |
| EndoVac System | PS System | |
| 510(k) | K140685 | K211721 |
| Trade name | EndoVac Apical Negative | |
| Pressure Irrigation System | PS System (Molar, | |
| Premolar, Anterior) | ||
| Class | Class 1 | Class 1 |
| FDA Classification | ||
| Name and CFR | ||
| Number | Handheld controller, Air- | |
| Powered, Root Canal | ||
| Irrigation | ||
| 872.4200 | Handheld controller, Air- | |
| Powered, Root Canal | ||
| Irrigation | ||
| 872.4200 | ||
| Product code | NYL | NYL |
| Indication for use / | ||
| intended use | The EndoVac system is | |
| intended for the delivery | ||
| and evacuation of | ||
| endodontic irrigation | ||
| solutions during root canal | ||
| procedures. | The PS System is intended | |
| for the delivery and | ||
| evacuation of endodontic | ||
| irrigation solutions during | ||
| root canal procedures. | ||
| Target Users | Licensed Dental | |
| Professionals | Licensed Dental | |
| Professionals | ||
| Anatomical site | Oral cavity / Isolated tooth | Oral cavity / Isolated tooth |
Inter-Med, Inc. | 2200 South Street, Racine, WI 53404
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Image /page/6/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in a bold, sans-serif font, with a line underneath it. To the right of the word "intermed" is a globe graphic, and to the right of the globe is the word "INC" in a smaller, sans-serif font.
Image /page/6/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized font, with a mountain range graphic above it. Below the word "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".
| Predicate Device | Proposed Device | |
|---|---|---|
| EndoVac System | PS System | |
| Device Components | Syringes, Multi-Port | |
| Adapter, Master Delivery | ||
| Tip, Fingerpiece, Handheld | ||
| controller, MicroCannula | ||
| and MacroCannula, | ||
| Connection tubing | Stage (molar, premolar or anterior), Cannula with | |
| Connection Tubing (molar, | ||
| premolar or anterior), | ||
| Vacuum Line with suction | ||
| adapter, VacuSeal Light | ||
| Curable Barrier, Sodium | ||
| hypochlorite with wetting | ||
| agents (i.e. Chlor-Xtra), | ||
| SmearOFF, Syringes and | ||
| Application Tips | ||
| Vacuum Connection | Multi-Port Adapter | Suction Adapter (fits both |
| HVE and LVE) | ||
| Suction Adapter | ||
| Dimensions | 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) | The Suction Adapter | |
| critical to functionality | ||
| dimension in this | ||
| component is the Outer | ||
| Diameter (OD) due to | ||
| compatibility with dental | ||
| chair evacuation line | ||
| HVE adapter: 0.438 in ± | ||
| 0.01 in | ||
| LVE adapter: 0.25 in ± 0.01 | ||
| in |
7
Image /page/7/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in a bold, sans-serif font, with a horizontal line underneath. To the right of the word is a globe graphic, and the letters "INC" are to the right of the globe.
Image /page/7/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized font, with a mountain range graphic above it. Below the word "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".
| Predicate Device | Proposed Device | |
|---|---|---|
| EndoVac System | PS System | |
| Cannula 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) | The Cannula 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) | ||
| Cannula Working | ||
| Length | MicroCannula working | |
| length is from 14 to 30 mm | ||
| ± 0.5 mm | Cannula working length is | |
| greater than 30mm | ||
| Cannula Material | MicroCannula: AISI 304 | |
| Stainless Steel | AISI 304 Stainless Steel | |
| Mode of Operation | Manually operated | Manually operated |
| Fluid Delivery System | Manual operation of | |
| syringe plunger (i.e. | ||
| positive pressure from user) | Manual operation of the | |
| dental chair vacuum system | ||
| (i.e. negative pressure | ||
| suction from dental chair | ||
| vacuum) | ||
| Liquids & Storage | • 20 ml syringe NaOCl | |
| • 3 ml syringe EDTA | • 100mL (molar), 60mL (pre- | |
| molar), 40mL (anterior) | ||
| solution pouch Chlor-Xtra | ||
| Plus | ||
| • 3ml syringe SmearOFF |
8
Image /page/8/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in a bold, sans-serif font, with a line underneath it. To the right of the word "intermed" is a globe, and to the right of the globe is the word "INC" in a smaller font.
Image /page/8/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized font, with a mountain range graphic above it. Below the word "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line to the left of the word "VISTA".
| Predicate Device | Proposed Device | |
|---|---|---|
| EndoVac System | PS System | |
| 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. | The cannula are connected | |
| to a syringe and positive | ||
| pressure is applied to | ||
| dislodge and unclog any | ||
| debris by rotating stop-cock | ||
| on tubing manifold, | ||
| however since fluid is | ||
| drawn out of the cannula | ||
| and not through the cannula | ||
| clogging is drastically | ||
| reduced. | ||
| Cross contamination | ||
| (cleaning, disinfection, | ||
| sterilization) | Meet Requirements | |
| Patient contacting portion | ||
| is autoclavable | All components are non- | |
| sterile and single use | ||
| Shelf-Life | NA, no solutions included | Shelf life is 24 months |
| Biocompatibility | ||
| Testing / Analysis | ||
| Performed | Meets Requirements | All components that make |
| patient contact have been | ||
| evaluated according to ISO | ||
| 7405 / ISO 10993-1 and | ||
| meet requirements | ||
| Recommended | ||
| Irrigation Time | Per manufacturer's | |
| instruction for use there are | ||
| 3 phases of EndoVac | ||
| irrigation / evacuation: | There are 2 phases of PS | |
| System irrigation / | ||
| evacuation: |
9
Image /page/9/Picture/0 description: The image shows the logo for Intermed INC. The logo features the word "intermed" in a bold, sans-serif font, with a line underneath. To the right of the word is a globe graphic, and to the right of the globe is the word "INC" in a smaller, sans-serif font.
Image /page/9/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. To the right of the word "VISTA" is the trademark symbol. Below the word "VISTA" are the words "Dental Products".
| Predicate Device | Proposed Device | |
|---|---|---|
| EndoVac System | PS System | |
| (1) Gross evacuation during | ||
| orifice expansion and | ||
| between instrument | ||
| changes, as needed | ||
| (2) Macro evacuation after | ||
| complete instrumentation, | ||
| 30 second for each canal | ||
| (3) Micro evacuation at full | ||
| WL, 3 cycles each 70-90 | ||
| seconds for each canal. | ||
| Total irrigation time per | ||
| canal is 250 seconds, | ||
| therefore 4 roots: 1000 | ||
| seconds (16:40 minutes) | (1) Gross evacuation during | |
| orifice expansion and | ||
| between instrument | ||
| changes, as needed | ||
| (2) Multi-cannular | ||
| irrigation once stage has | ||
| been sealed, | ||
| Total irrigation time for any | ||
| number of canals is | ||
| approximately 15-20 | ||
| minutes | ||
| Prescription / OTC | Prescription | Prescription |
Applicable Standards
ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 14971 – Application of Risk Management to Medical Devices ISO 80369-7 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications ISO 10271 - Dentistry - Corrosion test methods for metallic materials
Non-Clinical Performance Testing and Compliance 7.
The technological characteristics of the PS System are very similar to the predicate EndoVac (K140685) negative pressure irrigation system. The PS System and the predicate EndoVac System (K140685) perform the same function, which is a method to
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Image /page/10/Picture/0 description: The image shows the logo for Intermed INC. The logo features the word "intermed" in a bold, sans-serif font, followed by "INC." in a smaller font. To the right of the text is a globe graphic, with lines of latitude and longitude. A horizontal line underlines the text.
Image /page/10/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in large, bold letters, with a mountain range graphic above it. Below the word "VISTA" is the phrase "Dental Products" in smaller letters. There is also a horizontal line below the phrase "Dental Products".
deliver irrigant, rinse and evacuate during root canal procedures. The following performance tests were conducted as part of design verification:
- Suction Flow Rate Performance
- Critical Dimensions for Clinical Performance Analysis ●
- Corrosion Testing ●
- Simulated Canal Performance Testing ●
- Shelf Life Verification ●
- . Biocompatibility Analysis
- Transit Testing ●
- Additive Manufacturing Summary Document
Clinical Performance Data 8.
Clinical performance testing has not been performed for the PS System.
9. Conclusion as to Substantial Equivalence
The proposed PS System and the predicate EndoVac System (K140685) have the same Indications for Use (besides trade name), which is, for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. The PS System 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 PS System and the EndoVac System are both negative pressure irrigation apparatuses that reduce the risk of apical extrusion compared to convention positive pressure syringe irrigation.
The technological characteristics of the PS System are very similar to the predicate EndoVac System (K140685). The proposed PS System is substantially equivalent to the predicate EndoVac System (K140685) based on design, performance, technological characteristics use of biocompatible materials, indications for use and the intended use. Any noted differences in technological characteristics between the proposed and predicate devices do not raise any new questions of safety and effectiveness. Based on extensive comparative analysis and testing the PS System is substantially equivalent to the predicate EndoVac System (K140685).