(181 days)
The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
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 provided document is a 510(k) summary for the PS System, a dental device used for endodontic irrigation. It describes the device's function, comparison to a predicate device, and non-clinical and clinical performance data.
Based on the document, here's an analysis of the acceptance criteria and study information, addressing your points:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted and then concludes based on the results. The key "acceptance criteria" appear to be:
- Ability to deliver and evacuate endodontic irrigation solutions.
- Performance akin to the predicate device (EndoVac System K140685).
- Reduction of apical extrusion risk compared to conventional positive pressure syringe irrigation.
- Safety and effectiveness equivalent to the predicate.
Reported Device Performance (based on the "Non-Clinical Performance Testing and Compliance" section):
The document states that 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
The conclusion states that based on "extensive comparative analysis and testing," the PS System is substantially equivalent to the predicate, and that differences "do not raise any new questions of safety and effectiveness." This implies the tests successfully demonstrated comparable performance and met the underlying safety and effectiveness expectations for such a device. However, specific quantitative performance metrics or pass/fail thresholds for these tests are NOT provided in this summary document.
2. Sample sizes used for the test set and the data provenance
The document is a 510(k) summary, which typically provides an overview rather than detailed study protocols. As such, the sample sizes for the non-clinical tests are not specified.
Data Provenance: The studies are described as "Non-Clinical Performance Testing." The document is submitted by Inter-Med, Inc. from Racine, WI, USA, suggesting the testing was likely conducted in the US or by a US-affiliated entity. The document doesn't specify if the data is retrospective or prospective, but as it's for design verification, it would inherently be prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and material performance tests (e.g., suction flow rate, corrosion, biocompatibility, dimensions). These types of tests typically rely on established standards and laboratory measurements rather than expert human interpretation for "ground truth." Therefore, experts in establishing "ground truth" would not be relevant in the same way they would be for, say, an AI-based diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in clinical studies or studies involving human readers/interpreters, especially for AI or diagnostic devices where subjective interpretation is involved. Since this document focuses on non-clinical performance testing of a physical medical device, adjudication methods are not applicable and thus not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The PS System is a dental handpiece/irrigation system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm or AI device. It is a physical medical device for irrigation. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests mentioned (Suction Flow Rate, Critical Dimensions, Corrosion, Simulated Canal Performance, Shelf Life, Biocompatibility, Transit), the "ground truth" would be established by:
- Reference standards and measurements: For dimensions, flow rates, and physical properties.
- Standardized testing protocols: For corrosion, shelf life stability, and transit resilience.
- ISO standards and established biological assays: For biocompatibility (e.g., ISO 7405, ISO 10993-1).
There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context, as they are not relevant to the types of tests described.
8. The sample size for the training set
The device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
As there is no "training set" (see point 8), this question is not applicable.
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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
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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
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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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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.
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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 | ProductCode | FDA Status |
|---|---|---|---|
| 1. Stage (molar, premolar or anterior) | |||
| 2. Placement tool (molar, premolar oranterior) | 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 clearedin K082470 in light ofcompleted Chlor-Xtra Plus 8%NaOCl Regulatory ChangeAssessment dated 10/27/2021included in Section 11 - DeviceDescriptionCleared via K082470 |
| 7. SmearOFF | U | KJJ | Cleared via K193409 |
| 8. Syringe | 1 | EIC | Premarket notification exemptper 21 CFR 872.4565 |
| 9. Application Tips | 1 | EIC | Premarket notification exemptper 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 NegativePressure Irrigation System | PS System (Molar,Premolar, Anterior) |
| Class | Class 1 | Class 1 |
| FDA ClassificationName and CFRNumber | Handheld controller, Air-Powered, Root CanalIrrigation872.4200 | Handheld controller, Air-Powered, Root CanalIrrigation872.4200 |
| Product code | NYL | NYL |
| Indication for use /intended use | The EndoVac system isintended for the deliveryand evacuation ofendodontic irrigationsolutions during root canalprocedures. | The PS System is intendedfor the delivery andevacuation of endodonticirrigation solutions duringroot canal procedures. |
| Target Users | Licensed DentalProfessionals | Licensed DentalProfessionals |
| 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-PortAdapter, Master DeliveryTip, Fingerpiece, Handheldcontroller, MicroCannulaand MacroCannula,Connection tubing | Stage (molar, premolar or anterior), Cannula withConnection Tubing (molar,premolar or anterior),Vacuum Line with suctionadapter, VacuSeal LightCurable Barrier, Sodiumhypochlorite with wettingagents (i.e. Chlor-Xtra),SmearOFF, Syringes andApplication Tips |
| Vacuum Connection | Multi-Port Adapter | Suction Adapter (fits bothHVE and LVE) |
| Suction AdapterDimensions | The Multi-Port Adaptercritical to functionalitydimension in thiscomponent is the OuterDiameter (OD) due tocompatibility with dentalchair high evacuation line(OD = 0.434 in) | The Suction Adaptercritical to functionalitydimension in thiscomponent is the OuterDiameter (OD) due tocompatibility with dentalchair evacuation lineHVE adapter: 0.438 in ±0.01 inLVE adapter: 0.25 in ± 0.01in |
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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 tofunctionality dimension inthis component is the ODdue to the clinicalapplication into the rootcanal cleaning procedure(OD = 0.0125 to 0.0118 in) | The Cannula critical tofunctionality dimension inthis component is the ODdue to the clinicalapplication into the rootcanal cleaning procedure(OD = 0.0125 to 0.0118 in) |
| Cannula WorkingLength | MicroCannula workinglength is from 14 to 30 mm± 0.5 mm | Cannula working length isgreater than 30mm |
| Cannula Material | MicroCannula: AISI 304Stainless Steel | AISI 304 Stainless Steel |
| Mode of Operation | Manually operated | Manually operated |
| Fluid Delivery System | Manual operation ofsyringe plunger (i.e.positive pressure from user) | Manual operation of thedental chair vacuum system(i.e. negative pressuresuction from dental chairvacuum) |
| Liquids & Storage | • 20 ml syringe NaOCl• 3 ml syringe EDTA | • 100mL (molar), 60mL (pre-molar), 40mL (anterior)solution pouch Chlor-XtraPlus• 3ml syringe SmearOFF |
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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 | |
| UncloggingMechanism | Requires MacroCannulaand MicroCannula to bedisconnected from thevacuum line. TheMacroCannula andMicroCannula areindependently connected toanother syringe andpositive pressure is appliedto dislodge and unclog anydebris. | The cannula are connectedto a syringe and positivepressure is applied todislodge and unclog anydebris by rotating stop-cockon tubing manifold,however since fluid isdrawn out of the cannulaand not through the cannulaclogging is drasticallyreduced. |
| Cross contamination(cleaning, disinfection,sterilization) | Meet RequirementsPatient contacting portionis autoclavable | All components are non-sterile and single use |
| Shelf-Life | NA, no solutions included | Shelf life is 24 months |
| BiocompatibilityTesting / AnalysisPerformed | Meets Requirements | All components that makepatient contact have beenevaluated according to ISO7405 / ISO 10993-1 andmeet requirements |
| RecommendedIrrigation Time | Per manufacturer'sinstruction for use there are3 phases of EndoVacirrigation / evacuation: | There are 2 phases of PSSystem irrigation /evacuation: |
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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 duringorifice expansion andbetween instrumentchanges, as needed(2) Macro evacuation aftercomplete instrumentation,30 second for each canal(3) Micro evacuation at fullWL, 3 cycles each 70-90seconds for each canal.Total irrigation time percanal is 250 seconds,therefore 4 roots: 1000seconds (16:40 minutes) | (1) Gross evacuation duringorifice expansion andbetween instrumentchanges, as needed(2) Multi-cannularirrigation once stage hasbeen sealed,Total irrigation time for anynumber of canals isapproximately 15-20minutes | |
| 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).
§ 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.