(85 days)
Not Found
No
The device description and summary of performance studies indicate a chemical solution for root canal cleansing, with no mention of AI or ML technology.
No
The device is described as a "root canal cleanser" used to "irrigate and cleanse the root canal system." While it plays a role in a medical procedure, its primary function is cleaning rather than directly treating or curing a disease or condition. The term "therapeutic device" usually implies direct treatment, prevention, or diagnosis of a medical condition.
No
The device is described as a root canal cleanser used after instrumentation to irrigate and cleanse the root canal system. It functions as a therapeutic agent for cleaning, not for diagnosing a condition or disease.
No
The device is a chemical solution (Chlorhexidine Gluconate) intended for irrigation and cleansing, not a software program.
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 and cleanse the root canal system" during endodontic procedures. This is a therapeutic/procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a solution delivered into the root canal. This aligns with a procedural aid, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's condition. The purpose is to clean the root canal.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
CHX and CHX-PlusTM are 2% Chlorhexidine Gluconate Solutions in water. CHX – PlusTM also contains wetting agents to lower surface tension. CHX and CHX-PlusTM are root canal cleansers for use in endodontic procedures. After endodontic instrumentation, these products should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating needle
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance and biocompatibility data provided support the safety and effectiveness of CHX and CHX-Plus™ for the indicated uses. All components found in CHX and CHX-Plus™ have been used in legally marketed devices. The efficacy and biocompatibility was demonstrated via non-clinical studies.
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.
K070401, K103244, K924982, K053167, K061689
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/2 description: The image shows the logo for Intermed Inc. The logo features the word "intermed" in bold, black letters, with a line underneath. To the right of the word is a black and white globe. The letters "INC." are in smaller, black letters to the right of the globe.
Inter-Med, Inc. 2200 Northwestern Avenue Racine, WI 53404 (262) 636-9755 (voice) (262) 636-9760 (fax)
SECTION G
510(k) Summary
| 510(k) Summary | This summary of 510(k) safety and effectiveness is
being submitted in accordance with the requirements
of 21 CFRF 807.92 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Inter-Med, Inc / Vista-Dental, Inc.
2200 Northwestern Ave.
Racine, WI 53404 |
| Contact Person | Name and Title: John Baeten, Engineering Manager
Ph: 262-636-9755
Fax: 262-636-9760 |
| Date Prepared | July 27, 2011 |
| Proprietary Name | • CHX
• CHX-PlusTM |
| Classification Name | Cleanser, Root Canal |
| Common Name | Endodontic Cleanser |
| CFR Number | N/A |
| Device Class | Unclassified |
| Product Code | KJJ |
| Predicate Device(s) | K070401, Endo-CHXTM Root Canal Cleanser,
Essential Dental Systems, Inc.
K103244, QMixTM 2inl Endodontic Irrigating Solution,
DENTSPLY International
K924982, ConsepsisTM, Ultradent Products, Inc.
K053167, BioureTM MTADTM Root Canal Cleanser,
DENTSPLY International
K061689, AquatineTM EC Endodontic Cleanser,
PuriCore, Inc. |
| Description | CHX and CHX-PlusTM are 2% Chlorhexidine
Gluconate Solutions in water. CHX – PlusTM also
contains wetting agents to lower surface tension. CHX
and CHX-PlusTM are root canal cleansers for use in
endodontic procedures. After endodontic
instrumentation, these products should be used to
cleanse the canal space before placement of the
endodontic filling. The material should be delivered
into the canal using an irrigating needle |
| Indications for Use | CHX and CHX-Plus™ are used as a final endodontic
rinse after instrumentation to irrigate and cleanse the
root canal system for long lasting cleansing |
| Substantial
Equivalence | CHX and CHX-Plus™ are identical to the predicates
since they irrigate and cleanse via the mechanical
action of the solution moving through the root canal
system. |
| | Both CHX-Plus™ and Endo-CHX™ are combination
products containing 2% chlorhexidine digluconate with
surfactant(s). These items are identical in active
ingredient (i.e. 2% chlorhexidine digluconate) and
indications for use. |
| | Both CHX-Plus™ and Consepsis™ are combination
products containing 2% chlorhexidine digluconate and
surface active agents to lower surface tension. CHX-
Plus™ contains surfactants and Consepsis™ contains
ethyl alcohol. |
| | CHX / CHX-Plus™, Endo-CHX™, Consepsis™, and
QMix™ 2inl Endodontic Irrigating Solution are all root
canal cleansers containing chlorhexidine digluconate. |
| | CHX-Plus™, Endo-CHX™, QMix™ 2inl Endodontic
Irrigating Solution, and BioPure™MTAD™ are all root
canal cleansers containing a surfactant to lower
surface tension. |
| Non-clinical
Performance | The performance and biocompatibility data provided
support the safety and effectiveness of CHX and CHX-
Plus™ for the indicated uses. All components found in
CHX and CHX-Plus™ have been used in legally
marketed devices. The efficacy and biocompatibility
was demonstrated via non-clinical studies. |
| Conclusion | CHX and CHX-Plus™, to be manufactured by Inter-
Med Inc., are substantially equivalent to the currently
cleared and marketed predicates and raise no issues
of safety and effectiveness. |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 8 2011
Mr. John Baeten Engineering Manager Inter-Med, Inc. 2200 Northwestern Avenue Racine, WI 53404
Re: K112250
Trade/Device Name: CHX and CHX-Plus™ Regulation Number: None Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Codes: KJJ Dated: July 27, 2011 Received: August 4, 2011
Dear Mr. Baeten:
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.
3
Page 2 - Mr. Baeten:
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh to!
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Inter-Med, Inc., 2200 Northwestern Ave, Racine, W! 53404
Indications for Use
11/2250 510(k) Number (if known):
Device Names:
-
CHX
-
CHX-Plus™
Indications for Use:
CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing
Prescription Use _ Over-The-Counter Use X Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (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)
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
F-2