ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM

K140685 · Sybron Endo · NYL · Jul 2, 2014 · Dental

Device Facts

• Record ID: K140685
• Device Name: ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
• Applicant: Sybron Endo
• Product Code: NYL · Dental
• Decision Date: Jul 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

Device Story

EndoVac system provides negative pressure irrigation for root canal therapy. Components include Multi-Port Adapter (connects to dental office Hi-Vac system), Master Delivery Tip (simultaneous irrigation/evacuation), MacroCannula (removes coarse debris), and MicroCannula (removes apical debris via 12 laser-drilled 100 um holes). Device operates by drawing fluid apically via vacuum suction, moving irrigants from pulp chamber to apical termination and into Hi-Vac system. Used in dental clinics by practitioners. Benefits include effective apical irrigation and reduced risk of irrigant overflow compared to positive pressure systems.

Clinical Evidence

No clinical data. Safety and efficacy supported by bench testing and review of published literature.

Technological Characteristics

Negative pressure irrigation system. Components: Multi-Port Adapter, Master Delivery Tip, MacroCannula, MicroCannula (12 laser-drilled 100 um holes). Materials comply with ISO 10993. Sterilization via moist heat (ISO 17665-1, ANSI/AAMI ST79). Reprocessing per AAMI TIR 12/39. Non-powered, vacuum-driven.

Indications for Use

Indicated for patients undergoing root canal procedures requiring delivery and evacuation of endodontic irrigation solutions.

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

• RinsEndo (K052271)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 2, 2014

SybronEndo C/O Ms. Courtney Clark, CBA, RAC Regulatory Affairs Manager, Submissions Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange. California 92867

Re: K140685

Trade/Device Name: Endo Vac® Apical Negative Pressure Irrigation System Regulation Number: 21 CFR 872.4200 Regulation Name: Handpiece, Air-Powered, Root Canal Irrigation Regulatory Class: I Product Code: NYL Dated: May 30, 2014 Received: June 2, 2014

Dear Ms. Clark:

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.

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Page 2 - Ms. Clark

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 801); medical device reporting (reporting of medical device-related 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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K140685

Device Name: EndoVac® Apical Negative Pressure Irrigation System

Indications for Use:

The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2014.07.02 08:42:50 -04'00'

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### SECTION 5. 510(k) SUMMARY

Image /page/3/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, sans-serif font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The color of the text and the curved line is a dark blue.

#### EndoVac® Apical Negative Pressure Irrigation System

- Submitter Information: 1.
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

| Contact Person: | Courtney Clark |
|-------------------|----------------|
| Telephone Number: | 714-516-7426 |
| Fax Number: | 714-516-7472 |
| Date Prepared: | 17 March 2014 |

#### 2. Device Name:

.

- EndoVac® Negative Pressure Irrigation System Proprietary Name: ●
- Classification Name: Handpiece, air-powered, root canal irrigation
- Regulation Description: Dental handpiece and accessories ●
- CFR Number: 872.4200
- Device Class: Class I reserved ●
- . Product Code: NYL
- 3. Predicate Device:

EndoVac® Apical Negative Pressure Irrigation System is substantially equivalent to the legally marketed device RinsEndo, manufactured by Air Techniques, K052271 cleared on May 26, 2006, product code NYL.

- 4. Description of Device:
The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. EndoVac® Apical Negative Pressure Irrigation System is used in root canal therapy and is comprised of four main components. The Multi-Port Adapter is used to connect the Master Delivery Tip to the dental office Hi-Vac system. The Master Delivery Tip provides a constant flow of irrigant that lowers the risk of overflow due to continuous suction. Additional tips include the MacroCannula which is used to remove coarse debris after instrumentation, and the MicroCannula which features microscopic evacuation holes allowing the irrigant to flow to the apical termination.

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- న్. Statement of Intended Use:
The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

- 6. Description of Safety and Substantial Equivalence:
### Technological Characteristics

The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. EndoVac® Apical Negative Pressure Irrigation System presents a method to effectively irrigate during root canal treatments. Unlike positive pressure systems which use a cannula or side-port needles to deliver irrigants to the canal, the EndoVac® is a negative pressure system that draws fluid apically by way of vacuum suction. Because the system utilizes negative pressure irrigation, irrigants are suctioned from the pulp chamber, apically, to the apical termination and then away into the office Hi-Vac system. The EndoVac® Apical Negative Pressure Irrigation System is comprised of a Multi-Port Adapter which attaches to the dental Hi-Vac system, the Master Delivery Tip which allows for simultaneous irrigation and evacuation, the MacroCannula which removes coarse debris left in the canal from instrumentation, and the MicroCannula which removes microscopic debris at the apical 1 mm via 12 microscopic, laser-drilled holes, each 100 um in diameter. Other accessories include handpiece and finger-piece attachments, evacuation tubing and syringes.

EndoVac® Apical Negative Pressure Irrigation System is substantially equivalent to the legally marketed RinsEndo dental handpiece manufactured by Airtechniques, Inc. (K052271). The RinsEndo uses a turbine driven dental handpiece to provide hydrodynamic rinsing and flushing of root canals, but has the same intended use as the proposed EndoVac® Apical Negative Pressure Irrigation System. A comparison of the proposed and predicate devices is provided in Table 1.

| Device Name | Proposed EndoVac® System | Predicate RinsEndo (K052271) |
|---------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| FDA Product<br>Code | NYL; Handpiece, air-powered,<br>root canal irrigation | NYL; Handpiece, air-powered,<br>root canal irrigation |
| Classification | Class I reserved | Class I reserved |
| Manufacturer | SybronEndo<br>1332 South Lone Hill Avenue<br>Glendora CA, 91740 | Air Techniques, Incorporated<br>70 Cantiague Rock Road<br>Hicksville, New York 11801 |
| Method of<br>aspiration | Suction through tubing attached<br>to dental office Hi-Vac | Air-driven piston that creates<br>flushing action for rinsing root<br>canals; attached to dental office<br>Hi-Vac |
| Attached to dental<br>handpiece | No | Yes |

#### Table 1: Comparison of Proposed and Predicate Devices

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| Indications for use | The EndoVac® system is | The RinsEndo is used for root |
|---------------------|----------------------------------|--------------------------------|
| | intended for the delivery and | canal irrigation/disinfection. |
| | evacuation of endodontic | |
| | irrigation solutions during root | |
| | canal procedures. | |
| Single use | Yes | Yes |
| disposable cannula | | |
| (tips) | | |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 |
| | standards | standards |
| Sterilization | Autoclavable Master Delivery | Autoclavable handpiece |
| | Tip, Multi-Port Adapter, | |
| | Handpiece and Finger-Piece | |

# Non-Clinical Performance Data.

The performance of EndoVac® Apical Negative Pressure Irrigation System has been verified utilizing the following standards:

- ISO 10993-1 Biological Evaluation of Medical Devices Evaluation and Testing ●
- ISO 10993-5:2009 Biological evaluation of medical devices -- Tests for in vitro ● cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices -- Tests for irritation and ● skin sensitization
- AAMI TIR 12: 2010 Designing, Testing and Labeling Reusable Medical Devices ● for Reprocessing in Health Care Facilities: A Guide for Manufacturers
- . ANSI/AAMI ST:79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- AAMI TIR 39:2009 Guidance on selecting microbial challenge and inoculation . sites for sterilization validation of medical devices
- ISO 17665-1:2006 Sterilization of health care products Moist Heat Part 1: . Requirements for the development, validation and routine control of a sterilization process for medical devices
- Internal method for autoclave life testing of reusable products

# Clinical Performance Data.

SybronEndo has not performed human clinical evaluations for EndoVac® Apical Negative Pressure Irrigation System. A summary of published literature has been included in order to support the safety and efficacy of the device.

#### Conclusion as to Substantial Equivalence

The similarities in design, function, safety and intended use of EndoVac® Apical Negative Pressure Irrigation System with the legally marketed device RinsEndo dental handpiece (K052271) provide evidence that these devices are substantially equivalent. The data provided in this submission support the substantial equivalence of the Endo Vac® Apical Negative Pressure Irrigation System to the predicate, RinsEndo dental handpiece (K052271).