(251 days)
Liquid used for root canal rinsing during endodontic treatment. During mechanical canal widening it removes the non-vital pulp debris. it cleans the canal and removes at the same time smear layer in order to expose dentinal tubuli orifices before canal filling.
Liquid for root canals rinsing
This document is a 510(k) summary for the medical device "CHLORAXID 3%" and "CHLORAXID 5,25%", which are liquids used for root canal rinsing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no specific, quantitative acceptance criteria or corresponding reported device performance metrics listed in a table format as would be typical for a new device claiming superiority or specific performance targets.
Instead, this submission is a Substantial Equivalence (SE) claim. The acceptance criterion for this type of submission is that the device is "substantially equivalent in safety and effectiveness" to legally marketed predicate devices.
The reported device performance, in this context, is the demonstration that CHLORAXID 3% and CHLORAXID 5,25% are substantially equivalent to their respective predicate devices based on:
- Similar intended use.
- Similar technological characteristics (main active substance is Sodium Hypochlorite as the standard of care for root canal irrigation).
- Chemical composition.
- Literature evidence for the biological effect of the chemical compounds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The non-clinical performance and biocompatibility data provided in this submission was based on professional literature by comparison with reference device and its chemical composition. Realistic study of biological effect of device CHLORAXID 3 % and CHLORAXID 5,25% has been abandoned because sufficient literature evidence exists for confirmation biological effect of device contained chemical compounds specified in their composition."
Therefore:
- Sample Size for Test Set: Not applicable, as no new clinical or non-clinical studies were conducted for this submission. The "test set" effectively refers to the existing body of scientific literature on Sodium Hypochlorite.
- Data Provenance: The data provenance is "professional literature," implying global scientific publications, not specific to one country or a retrospective/prospective study on this particular device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no new studies were performed, there were no "experts" establishing a ground truth for a specific test set related to this submission. The "ground truth" for the efficacy and safety of Sodium Hypochlorite as a root canal cleanser is established by the long-standing scientific and clinical consensus reflected in "professional literature."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new studies were performed or test sets created.
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
Not applicable. This device is a chemical liquid for root canal rinsing, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a chemical liquid, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is expert consensus and accumulated scientific evidence published in professional literature regarding the efficacy and safety of Sodium Hypochlorite as a root canal cleanser. The document emphasizes that Sodium Hypochlorite "is the standard of care for root canal irrigation," which strongly points to an established expert consensus.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device (a chemical solution) or for a Substantial Equivalence submission purely based on literature review.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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Image /page/0/Picture/0 description: The image shows a circular logo with the text "BERKAMED" at the top and "MEDICAL COMPANY" at the bottom. There is a diamond shape on the left side of the word "BERKAMED" and a hexagon shape on the right side of the word. The logo appears to be a stamp or seal, as the edges are slightly blurred and uneven.
P.P.H. CERKAMED Wo;tiech Powlowski, ul. Kwictkowskiego 1, 37-450 Stalows Woła, Polska
NIP: PL C65-204-B7-70 REGON: 43-11-62-810 tel./fax +48 15 842 35 85, tcl. +48 15 841 64 33
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SUMMARY 510 (k)
| 510 (k) summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R §807.92. |
|---|---|
| Submitter | CERKAMED Wojciech PawlowskiKwiatkowskiego 1 Str.37-450 Stalowa Wola, POLAND |
| Contact person | Kinga WieruckaKwiatkowskiego 1 Str.; 37-450 Stalowa Wola, POLANDPhone: +48 15 842 35 85Fax: +48 15 842 35 85e-mail : kinga.wierucka@cerkamed.pl |
| Date prepared | 05.07.2013 |
| Trade name | CHLORAXID 3%CHLORAXID 5,25% |
| Common name | Liquid used for root canal rinsing |
| Classification name | Cleanser root canal |
| Risk Classification | Unclassified (pre-amendment) |
| Classification Product Code | KJJ |
| Predicate devices | Sodium Hypochlorite 3% & 6%; Inter Med Inc/ Vista Dental, K082470Pulpdent Sodium Hypochlorite Solution, K962743. |
| Descritpion | Liquid for root canals rinsing |
| Active ingredient | Sodium Hypochlorite |
| Indication for use | Liquid used for root canal rinsing during endodontic treatment. |
| The mode of action | During mechanical canal widening it removes the non-vital pulp debris.It cleans the canal and removes at the same time smear layer in order to expose dentinal tubuli orifices before canal filling. |
| Contraindications | Do not use products CHLORAXID 3% and CHLORAXID 5,25% for patients with hypersensitivity to the product's components. |
| Recipient | This device to be sale by or on the order of a dentists.Device qualifies for exemption per 21 CFR 801 D. |
| Substantial equivalence | The product is similar in function and intended use as well as in technological characterization to:- Sodium Hypochlorite 3%& 6% ; manufactured by Inter Med Inc/ Vista Dental- Pulpdent Sodium Hypochlorite Solution, manufactured by Pulpdent Corp. |
| Technologicalcharacteristic | The main active substance in this device is Sodium Hypochlorite. Sodium Hypochlorite is the standard of care for root canal irrigation.Both products: CHLORAXID 3% and CHLORAXID 5,25% are composed of the same substances, have the same intended use and are substantially equivalent in safety and effectiveness for the indications described as the predicate devices. |
| Non-clinical performance | The non-clinical performance and biocompatibility data provided in this submission was based on professional literature by comparison with reference device and its chemical composition.Realistic study of biological effect of device CHLORAXID 3 % and CHLORAXID 5,25% has been abandoned because sufficient literature evidence exists for confirmation biological effect of device contained chemical compounds specified |
| in their composition.These data support determination of substantial equivalence: CHLORAXID 3% andCHLORAXID 5,25% are substantially equivalent in safety and effectiveness to the predicatedevices.All components found in CHLORAXID 3% & CHLORAXID 5,25% have been used in legallymarketed devices. | |
| Conclusion | CHLORAXID 3% is substantially equivalent in safety and effectiveness to SodiumHypochlorite 3% produced by Vista Dental.CHLORAXID 5,25% is substantially equivalent in safety and effectiveness tothe currently cleared and marketed Pulpdent Sodium Hypochlorite Solution. |
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Image /page/1/Picture/0 description: The image shows a circular logo with the text "BERKAMED MEDICAL COMPANY" around the perimeter. Inside the circle, there is a smaller circle. The logo appears to be a stamp or seal, with some smudging and incomplete areas around the edges. The text is in a bold, sans-serif font.
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ
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P.P.H. CERKAMED Wojclech Pawłowski, ul. Kwiatkowskicgo 1, 37-450 Stalowa Woła, Polska
NIP: PL 865-204-87-70 REGON: 43-1 1-62-810 e-mail: buroescerkamed.pl, www.cerkamed.pl
tel./fax: +48 15 842 35 85, tel. +48 15 841 64 33
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Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2013
P.P.H. Cerkamed Wojciech Pawlowski C/O Ms. Kinga Wierucka Project Manager Kwiatkowskiego 1 Street 37-450 Stalowa Wola POLAND
Re: K130180
Trade/Device Name: Chloraxid 3% and Chloraxid 5.25% Regulation Number: None Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: July 5, 2013 Received: July 17, 2013
Dear Ms. Wierucka:
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 docs 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 cither 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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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 of medical devicerelated 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division 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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Image /page/4/Picture/0 description: The image shows a circular logo with the text "BERKAMED" at the top and "MEDICAL COMPANY" at the bottom. The text is arranged around a circle. There is a circular arrow surrounding the logo. The logo appears to be a company logo.
AMED Wojciech Pawłowski, ul. Kwłatkowskiego 1, 37-450 Stalowa Woła, Polska REGON: 43-11-62-810 med.bl. www.corkamod
INDICATION FOR USE CHLORAXID 3% & CHLORAXID 5,25%
510(k) Number (if known): K130180
Device Name: CHLORAXID 3% & CHLORAXID 5,25% - Liquid for root canals rinsing
Intended use:
Liquid used for root canal rinsing during endodontic treatment.
During mechanical canal widening it removes the non-vital pulp debris.
it cleans the canal and removes at the same time smear layer in order to expose dentinal tubuli orifices before canal filling.
AND/OR Over-The-Counter Use -Prescription Use: X (Part 21 CFR 801 Subpart D) (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)
Andrew I. Steen -S 2013.10.03 13:11:03 -04'00'
N/A