(219 days)
Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM are solutions used for debridement and the instrumentation of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6% are Sodium Hypochlorite in water.
Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water.
Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in water with alkalizing salt agents to increase the electrical capacity of the solution.
The provided document is a 510(k) summary for a medical device (Sodium Hypochlorite solutions for root canal cleaning) and a letter from the FDA determining substantial equivalence to predicate devices. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC comparative effectiveness studies in the way an AI/ML device submission would.
For devices classified as Endodontic Cleansers (Product Code KJJ), the FDA primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones. The "performance" section mentions "Laboratory analyses are provided in this premarket notification" and "Several published articles supporting this statement have been included in this premarket notification," indicating that the "study" proving the device meets acceptance criteria is likely a combination of these laboratory analyses and existing scientific literature on sodium hypochlorite as a root canal irrigant, rather than a novel clinical trial designed to establish specific performance metrics for this particular device.
Therefore, I cannot extract the specific information requested in the prompt's numbered list because it is not present in the provided 510(k) summary. The summary focuses on demonstrating equivalence to predicate devices based on formula and intended use, and the established standard of care for the active ingredient.
To address the prompt as best as possible with the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, specific quantitative acceptance criteria or device performance metrics for the new device (beyond its chemical composition and intended use) are not explicitly stated. The acceptance criteria for this type of device, as per the 510(k) process, revolve around substantial equivalence to predicate devices in terms of:
- Indications for Use: Identical or similar
- Technological Characteristics: Similar (e.g., Sodium Hypochlorite in water)
- Safety and Effectiveness: Demonstrated by similarity to established predicate devices and the known properties of sodium hypochlorite as a root canal irrigant.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Inferred from 510(k) Summary) |
|---|---|
| Purity and Concentration: Device is 3% or 6% Sodium Hypochlorite solution, with or without wetting agents. | Confirmation of Composition: "Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water. Sodium Hypochlorite 6% with wetting agents... is a Sodium Hypochlorite solution in water with alkalizing salt agents." The primary "performance" is the composition as stated, which aligns with established and effective formulations. |
| Intended Use: Device functions as a root canal cleanser for debridement and instrumentation. | Confirmation of Indication: "Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents... are solutions used for debridement and the instrumentation of root canal." This aligns with the intended use of predicate devices and the widely accepted role of sodium hypochlorite in endodontics. |
| Safety and Effectiveness: Equivalent to legally marketed predicate devices. | Substantial Equivalence: The device is stated to be "similar in function and intended use to" three predicate devices (Pulpdent Sodium Hypochlorite Solution, Aquatine EC Endodontic Cleanser, ChlorCid Sodium Hypochlorite Solution). The summary notes: "Sodium Hypochlorite is the standard of care for root canal irrigation. Several published articles supporting this statement have been included in this premarket notification." This indicates that the safety and effectiveness are established by the well-known properties of the active ingredient and alignment with predicate devices, rather than new, device-specific performance metrics from a dedicated clinical trial for this 510(k). "Laboratory analyses are provided" likely refers to chemical composition verification, stability, etc., rather than efficacy in a clinical setting. |
Regarding the other points (2-9):
These points are directly related to the design and execution of clinical performance studies, which are typically required for novel devices or those with higher risk classifications where substantial equivalence cannot be adequately demonstrated through existing literature and technological characteristics alone.
For this 510(k) submission (K082470) for an Endodontic Cleanser, the FDA determined substantial equivalence based on the product's formulation (sodium hypochlorite) and its intended use being consistent with predicate devices and the established "standard of care." Therefore, the details requested in points 2-9 about specific clinical study parameters (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not provided in this 510(k) summary. These types of studies were not deemed necessary explicitly for this specific device's clearance. The "performance" section mentions "Laboratory analyses" and "published articles," indicating a reliance on existing scientific knowledge and basic quality control, not a dedicated clinical effectiveness trial for this particular submission.
{0}------------------------------------------------
Inter-Med, Inc. / Vista-Dental, Inc. 2200 Northwestern Ave., Ra:ine, WI 53404
Section G
APR - 3 2009
510(k) Sunimary
| 510(k) Summary | This summary of 510(k) safety and effectiveness is being submitted inaccordance with the requirements of 21 CFR 807.92 |
|---|---|
| Applicant | Inter-Med, Inc. / Vista-Dental, Inc.2200 Northwestern Ave,Racine, WI 53404 |
| Contact Person | Name and Title: George Horvat-QA/RA ManagerPh: 262-636-9755Fax: 262-636-9760 |
| Trade Name | Sodium Hypochlorite-3% & 6%6% Sodium Hypochlorite with wetting agents marketed asChlor-XTRATM |
| Classification Name | Cleanser, Root Canal |
| Common Name | Endodontic Cleanser |
| Predicate Devices | Pulpdent Sodium Hypochlorite Solution, Pulpdent Corporation,K09662743, AquatineTM EC Endodontic Cleanser; PuriCore, Inc.,K061689; ChlorCid Sodium Hypochlorite Solution, Product CodeEKS, Class 1 Exempt from Premarket Notification, manufactured byUltradent Products, Inc., Registered Establishment # 1718912 |
| Description | Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% SodiumHypochlorite in water.Sodium Hypochlorite 6% with wetting agents to lower surface tensionmarketed as Chlor-XTRATM is a Sodium Hypochlorite solution inwater with alkalizing salt agents to increase the electrical capacity ofthe solution. |
| Indications for Use | Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6%with wetting agents to lower surface tension marketed as Chlor-XTRATM are solutions used for debridement and the instrumentationof root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6%are Sodium Hypochlorite in water. |
| SubstantialEquivalence | The product is similar in function and intended use to:- Pulpdent Sodium Hypochlorite Solution, manufactured byPulpdent Corporation, K0962743- AquatineTM EC Endodontic Cleanser; manufactured by PuriCore, Inc., K061689- ChlorCid Sodium Hypochlorite Solution, manufactured byUltradent Products, Inc. under Registered Establishment #1718912, Product Code EKS, Class 1 Exempt fromPremarket Notification. |
| Performance | Laboratory analyses are provided in this premarket notification.Sodium Hypochlorite is the standard of care for root canal irrigation.Several published articles supporting this statement have beenincluded in this premarket notification. |
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and the public trust. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Horvat Quality Manager Inter-Med, Incorporated 2200 Northwestern Avenue Racine, Wisconsin 53404
APR - 8 2009
K082470 Re:
Trade/Device Name: Sodium Hypochlorite 3% & 6% Solution Sodium Hypochlorite 6% with Wetting Agents to lower Surface Tension Marketed as Chlor-Xtra Regulation Number: 21 CFR Unclassified Regulation Name: None Regulatory Class: None Product Code: KJJ Dated: March 30, 2009 Received: March 30, 2009
Dear Mr. Horvat:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{2}------------------------------------------------
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Kunan
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
70 510(k) Number (if known): == 0 8 2-4
Device Names:
-
- Sodium Hypochlorite 3% & 6% Solution
-
- Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-Xtra
Indications for Use:
Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with Soulum Pryponionto o % uface tension marketed as Chlor-XTRA™ are welting agems to lower banalos ent and in the instrumentation of root canal. solum Hypochlorite 3% & 6% and Chlor-XTRA™ 6 % are Sodium Hypochlorite solutions in water.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/CR Over-The-Counter Use __
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Roeser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082470
N/A