(87 days)
No
The device is a root canal irrigation solution, and the description focuses on its chemical properties and intended use for irrigation and debridement. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an irrigation solution used during root canal therapy to cleanse and debride root canal systems, which is a supportive function rather than a direct therapeutic one.
No
The device is an irrigation solution used during root canal therapy to cleanse and debride root canal systems, not to diagnose a condition. Its function is therapeutic/procedural, not diagnostic.
No
The device is a liquid solution supplied in bottles, clearly indicating it is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "irrigate, cleanse, and debride root canal systems... during root canal therapy." This is a therapeutic and procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a solution for direct application within the root canal system.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
KJJ
Device Description
The Endocyn Root Canal Irrigation Solution is a colorless, slightly chlorinated odor, clear aqueous solution intended to irrigate, cleanse, and debride root canal systems. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following tests were reviewed to support the performance of the Endocyn Root Canal Irrigation Solution: package integrity, visual inspection, pH, osmolality, free available chlorine, and bioburden. The Endocyn Root Canal Irrigation Solution meets specification and performance characteristics and is substantially equivalent to the predicate devices.
Biocompatibility Testing of the Oculus Endocyn Root Canal Irrigation Solution confirmed that the device meets the applicable requirements of the Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices and is biocompatible.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures resembling human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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.
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
Oculus Innovative Sciences, Inc.
1129 North McDowell Blvd.
Petaluma, CA 94954
Phone: (707) 283-0550
Fax: (707) 283-0551 | Official Contact
Brian W. Martin
Director of Regulatory Affairs and Quality
Control |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Information
Trade or Proprietary
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
device(s) to which
equivalence is claimed: | Aquatine EC Endodontic Cleanser manufactured by PuriCore
(K061689) and Sodium Hypochlorite 3% and 6% and 6%
Sodium Hypochlorite with wetting agents marketed as Chlor-
XTRA manufactured by Inter-Med, Inc./Vista-Dental, Inc.
(K082470) |
| Reason for 510(k)
submission | New Device |
| Device Description | The Endocyn Root Canal Irrigation Solution is a colorless,
slightly chlorinated odor, clear aqueous solution intended to
irrigate, cleanse, and debride root canal systems. The solution
will be supplied in polyethylene terephthalate (PET) round-
bottles with polypropylene (PP) screw-top closure. |
| 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. |
| Performance Testing | The following tests were reviewed to support the performance
of the Endocyn Root Canal Irrigation Solution: package
integrity, visual inspection, pH, osmolality, free available
chlorine, and bioburden. The Endocyn Root Canal Irrigation
Solution meets specification and performance characteristics
and is substantially equivalent to the predicate devices. |
| Biocompatibility Testing | Biocompatibility Testing of the Oculus Endocyn Root Canal
Irrigation Solution confirmed that the device meets the
applicable requirements of the Blue Book Memorandum G95-
1 entitled Use of International Standards ISO-10993
Biological Evaluation of Medical Devices and is
biocompatible. |
| Safety and Effectiveness | The Endocyn Root Canal Irrigation Solution does not raise
any new safety and efficacy concerns when compared to a
similar device already legally marketed. |
Oculus Innovative Sciences, Inc. Endocyn Root Canal Irrigation Solution 510(k) K141352
4
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
Irrigation Solution | Aquatine EC
Endodontic
Cleanser | Sodium Hypochlorite 3% and
6% |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Status | Present application | Predicate | Predicate |
| 510(k)
Number | K141352 | K061689 | K082470 |
| Product
Code | KJJ | KJJ | KJJ |
| Indications
for 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. | Intended to
irrigate,
cleanse, and
debride root
canal systems. | Sodium Hypochlorite 3% and
6% and Sodium Hypochlorite
6% with wetting agents to lower
surface tension marketed as
Chlor-XTRA are solutions used
for debridement and the
instrumentation of root canal.
Sodium Hypochlorite-3% and
6% and Chlor-XTRA 6% are
Sodium Hypochlorite in water. |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Delivery
System | Aqueous solution | Aqueous
solution | Aqueous solution |
5
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