(251 days)
Not Found
No
The device is a liquid for root canal rinsing and the summary does not mention any AI or ML technology.
Yes
The device is a liquid used for root canal rinsing to remove non-vital pulp debris, clean the canal, and remove the smear layer, which directly treats a condition (non-vital pulp) and prepares the site for a medical procedure (canal filling).
No
The device is a liquid for root canal rinsing used during endodontic treatment to clean the canal and remove debris and smear layer. Its intended use does not involve diagnosing conditions or diseases.
No
The device description clearly states it is a "Liquid for root canals rinsing," which is a physical substance, 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 for rinsing root canals during endodontic treatment to remove debris and clean the canal. This is a direct treatment application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: It's described as a "Liquid for root canals rinsing," which aligns with a therapeutic or procedural device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
- Anatomical Site: The anatomical site is the "root canal," which is a part of the patient's body being treated.
- Performance Studies: The performance studies focus on biocompatibility and comparison to predicate devices based on chemical composition and literature, which is typical for therapeutic devices, not IVDs that would focus on analytical and clinical performance metrics like sensitivity and specificity.
IVDs are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is to facilitate a dental procedure, not to diagnose a condition based on a sample.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
Liquid for root canals rinsing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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% and CHLORAXID 5,25% are substantially equivalent in safety and effectiveness to the predicate devices.
All components found in CHLORAXID 3% & CHLORAXID 5,25% have been used in legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sodium Hypochlorite 3% & 6%; Inter Med Inc/ Vista Dental, K082470, Pulpdent Sodium Hypochlorite Solution, K962743.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
くしていない
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 Pawlowski |
| Kwiatkowskiego 1 Str. | |
| 37-450 Stalowa Wola, POLAND | |
| Contact person | Kinga Wierucka |
| Kwiatkowskiego 1 Str.; 37-450 Stalowa Wola, POLAND | |
| Phone: +48 15 842 35 85 | |
| Fax: +48 15 842 35 85 | |
| e-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, K082470 |
| Pulpdent 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. |
| Technological
characteristic | 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% and
CHLORAXID 5,25% are substantially equivalent in safety and effectiveness to the predicate
devices.
All components found in CHLORAXID 3% & CHLORAXID 5,25% have been used in legally
marketed devices. |
| Conclusion | CHLORAXID 3% is substantially equivalent in safety and effectiveness to Sodium
Hypochlorite 3% produced by Vista Dental.
CHLORAXID 5,25% is substantially equivalent in safety and effectiveness to
the 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'