ENDOCYN ROOT CANAL IRRIGATION SOLUTION

K141352 · Oculus Innovative Sciences · KJJ · Aug 18, 2014 · DE

Device Facts

• Record ID: K141352
• Device Name: ENDOCYN ROOT CANAL IRRIGATION SOLUTION
• Applicant: Oculus Innovative Sciences
• Product Code: KJJ · DE
• Decision Date: Aug 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.

Device Story

Endocyn Root Canal Irrigation Solution is a clear, aqueous, slightly chlorinated-odor solution used by dentists during root canal therapy. It functions as an endodontic cleanser to irrigate, debride, and lubricate root canal systems, facilitating the removal of foreign material and debris during instrumentation. The solution is supplied in PET bottles with PP screw-top closures. It is applied directly into the root canal system by the clinician. The device benefits the patient by ensuring a clean, lubricated canal environment, which is essential for successful endodontic procedures.

Clinical Evidence

Bench testing only. Performance testing included package integrity, visual inspection, pH, osmolality, free available chlorine, and bioburden. Biocompatibility testing confirmed compliance with ISO-10993 standards.

Technological Characteristics

Aqueous solution; supplied in PET bottles with PP screw-top closures. Non-sterile. Chemical properties include specific pH, osmolality, and free available chlorine levels. No electronic or software components.

Indications for Use

Indicated for use in patients undergoing root canal therapy requiring irrigation, cleansing, and debridement of root canal systems, and lubrication during instrumentation.

Predicate Devices

• Aquatine EC Endodontic Cleanser (K061689)
• Sodium Hypochlorite 3% and 6% and Sodium Hypochlorite with wetting agents (Chlor-XTRA) (K082470)

Submission Summary (Full Text)

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

August 18, 2014

Oculus Innovative Sciences. Inc. Mr. Brian W. Martin Director of Regulatory Affairs and Ouality Control 1129 North McDowell Blvd. Petaluma, CA 94954

Re: K141352

Trade/Device Name: Endocyn Root Canal Irrigation Solution Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Codes: KJJ Dated: June 11, 2014 Received: June 12, 2014

Dear Mr. Martin:

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 - Mr. Martin

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/ResourcesforYou/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/ResourcesforYou/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

Enclosure

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# Indications for Use

510(k) Number (if known) K141352

Device Name Endocyn Root Canal Irrigation Solution

#### Indications for Use (Describe)

Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.

Type of Use (Select one or both, as applicable)

2 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 contains the logo for Oculus Innovative Sciences. The logo features a series of overlapping golden rings above the word "OCULUS" in a bold, dark font. Below "OCULUS" are the words "Innovative Sciences" in a smaller font.

# 510(k) SUMMARY

The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

| 510(k) Owner<br>Oculus Innovative Sciences, Inc.<br>1129 North McDowell Blvd.<br>Petaluma, CA 94954<br>Phone: [phone]<br>Fax: [phone] | Official Contact<br>Brian W. Martin<br>Director of Regulatory Affairs and Quality<br>Control |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Information<br>Trade or Proprietary<br>Name: | Endocyn Root Canal Irrigation Solution |
| Common Name: | Endodontic Cleanser |
| Classification Name: | Cleanser, Root Canal |
| Regulation: | 21 CFR Unclassified, Pre-amendment status |
| Product Code(s) | KJJ |
| Device Panel | Dental |
| Legally marketed<br>device(s) to which<br>equivalence is claimed: | Aquatine EC Endodontic Cleanser manufactured by PuriCore<br>(K061689) and Sodium Hypochlorite 3% and 6% and 6%<br>Sodium Hypochlorite with wetting agents marketed as Chlor-<br>XTRA manufactured by Inter-Med, Inc./Vista-Dental, Inc.<br>(K082470) |
| Reason for 510(k)<br>submission | New Device |
| Device Description | The Endocyn Root Canal Irrigation Solution is a colorless,<br>slightly chlorinated odor, clear aqueous solution intended to<br>irrigate, cleanse, and debride root canal systems. The solution<br>will be supplied in polyethylene terephthalate (PET) round-<br>bottles with polypropylene (PP) screw-top closure. |
| Intended Use | Endocyn Root Canal Irrigation Solution is intended to irrigate,<br>cleanse, and debride root canal systems including the removal<br>of foreign material and debris during root canal therapy. It is |
| | also intended to provide for lubrication and irrigation during<br>root canal instrumentation. |
| Performance Testing | The following tests were reviewed to support the performance<br>of the Endocyn Root Canal Irrigation Solution: package<br>integrity, visual inspection, pH, osmolality, free available<br>chlorine, and bioburden. The Endocyn Root Canal Irrigation<br>Solution meets specification and performance characteristics<br>and is substantially equivalent to the predicate devices. |
| Biocompatibility Testing | Biocompatibility Testing of the Oculus Endocyn Root Canal<br>Irrigation Solution confirmed that the device meets the<br>applicable requirements of the Blue Book Memorandum G95-<br>1 entitled Use of International Standards ISO-10993<br>Biological Evaluation of Medical Devices and is<br>biocompatible. |
| Safety and Effectiveness | The Endocyn Root Canal Irrigation Solution does not raise<br>any new safety and efficacy concerns when compared to a<br>similar device already legally marketed. |

Oculus Innovative Sciences, Inc. Endocyn Root Canal Irrigation Solution 510(k) K141352

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Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized golden swirl above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Sciences" in a smaller font.

| Substantial Equivalence (SE) Rationale | | | | |
|----------------------------------------|--|--|--|--|
|----------------------------------------|--|--|--|--|

| | Endocyn Root Canal<br>Irrigation Solution | Aquatine EC<br>Endodontic<br>Cleanser | Sodium Hypochlorite 3% and<br>6% |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Status | Present application | Predicate | Predicate |
| 510(k)<br>Number | K141352 | K061689 | K082470 |
| Product<br>Code | KJJ | KJJ | KJJ |
| Indications<br>for Use | Endocyn Root Canal Irrigation<br>Solution is intended to irrigate,<br>cleanse, and debride root canal<br>systems including the removal<br>of foreign material and debris<br>during root canal therapy. It is<br>also intended to provide for<br>lubrication and irrigation during<br>root canal instrumentation. | Intended to<br>irrigate,<br>cleanse, and<br>debride root<br>canal systems. | Sodium Hypochlorite 3% and<br>6% and Sodium Hypochlorite<br>6% with wetting agents to lower<br>surface tension marketed as<br>Chlor-XTRA are solutions used<br>for debridement and the<br>instrumentation of root canal.<br>Sodium Hypochlorite-3% and<br>6% and Chlor-XTRA 6% are<br>Sodium Hypochlorite in water. |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Delivery<br>System | Aqueous solution | Aqueous<br>solution | Aqueous solution |

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The Endocyn Root Canal Irrigation Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Aquatine EC Endodontic Cleanser manufactured by PuriCore (K061689) and Sodium Hypochlorite 3% and 6% manufactured by Inter-Med, Inc./Vista-Dental, Inc. (K082470). Therefore, the Oculus Endocyn Root Canal Irrigation Solution is substantially equivalent to the predicate devices.

Submitted by:

Brian W. Martin Director of Regulatory Affairs and Quality Control

Bin Wint 06/11/2014

Date Submitted:

June 11, 2014