(68 days)
Aptus Blue is used in the cleansing of the root canal preparation during endodontic therapy.
Aptus Blue is a 3cc endodontic syringe containing EDTA solution. Aptus Blue allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic tissue from the root canal. It is designed to be used with endodontic irrigation solutions and sodium hypochlorite solutions.
This is a 510(k) premarket notification for a medical device (Aptus Blue) rather than a study with acceptance criteria and performance data in the typical sense of a clinical trial for software or diagnostic devices.
The "acceptance criteria" here refer to the regulatory pathway for demonstrating substantial equivalence to a predicate device. The "study" proving it meets these criteria is the comparison to the predicate device and the assessment of its technological characteristics.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For this type of submission, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, rather than specific performance metrics like sensitivity/specificity.
| Acceptance Criterion (Regulatory) | Reported Device Performance/Characteristics |
|---|---|
| Intended Use Equivalence: Does the device share the same intended use as a legally marketed predicate device? | Aptus Blue: Used in the cleansing of the root canal preparation during endodontic therapy. Predicate Device (RCT Gel K972234 / RC Prep Pro-1976): Implied equivalent use (root canal cleansing). |
| Technological Characteristics Equivalence: Are the technological characteristics substantially equivalent to the predicate device, or do any differences not raise new questions of safety and effectiveness? | Aptus Blue: 3cc endodontic syringe containing EDTA solution. Designed to be used with endodontic irrigation solutions and sodium hypochlorite solutions. All components used in predicate medical devices or found safe for dental use. Predicate Device (RCT Gel K972234 / RC Prep Pro-1976): Implied similar composition (EDTA solution for root canal cleansing). The document states "identical concentrations of active ingredients" with the predicate. |
| Safety and Effectiveness: Does the device demonstrate safety and effectiveness for its intended use? (Often inferred from equivalence to a safe and effective predicate). | Aptus Blue: "We believe that, due to the long established safe and effective use of the predicate device and the identical concentrations of active ingredients, limited contact time within the oral cavity, decomposition, and thorough removal of the product from the canal space, the use of Aptus Blue does not require additional biocompatibility testing and that the device is safe and effective for the intended uses." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on a comparison of device characteristics and intended use to a predicate, not a test set of data.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There was no "test set" in the context of clinical data for which experts establish ground truth.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical device (EDTA solution in a syringe), not an algorithm or software.
7. The Type of Ground Truth Used
- In the context of this 510(k), the "ground truth" for demonstrating safety and effectiveness relies on the established safe and effective use of the predicate device (RC Prep Pro-1976) and the identical active ingredient concentrations and similar technological characteristics of the new device (Aptus Blue).
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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KO30884
Abbreviated 510 (k) Summary
Acadental
Name & Address Acadental
5830 Woodson St. Suite 5 Mission, KS. 66202 (913) 384-7390 Fax (913) 322-6629
CONTACT: Christopher Craig
DATE PREPARED: March 7, 2003
TRADE OR PROPRIETARY NAME: Aptus Blue
CLASSIFICATION NAME: Dental Instrument 872.4565 Class I device
RCT Gel K972234 PREDICATE DEVICE: RC Prep Pro-1976 device
DEVICE DESCRIPTIQN: Aptus Blue is a 3cc endodontic syringe containing EDTA solution. Aptus Blue allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic tissue from the root canal. It is designed to be used with endodontic irrigation solutions and sodium hypochlorite solutions.
INTENDED USE: Aptus Blue is used in the cleansing of the root canal preparation during endodontic therapy.
TECHNOLOGICAL CHARACTERISTICS: All components in Aptus Blue have been used in predicate medical devices or have been found safe for dental use.
We believe that, due to the long established safe and effective use of the predicate device and the identical concentrations of active ingredients, limited contact time within the oral cavity, decomposition, and thorough removal of the product from the canal space, the use of Aptus Blue does not require additional biocompatibility testing and that the device is safe and effective for the intended uses.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 2003
Mr. Christopher Craig Sales Manager Acadental 5830 Woodson, Suite 5 Mission, Kansas 66202
Re: K030884
Trade/Device Name: Aptus Blue® Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: March 07. 2003 Received: March 20, 2003
Dear Mr. Craig:
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.
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Page 2 - Mr. Christopher Craig
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Burns
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION OF USE STATEMENT
510(K) Number (IF KNOWN): K030884
DEVICE NAME: Aptus Blue
INDICATION FOR USE:
Aptus Blue is used in the cleansing of the root canal preparation during endodontic therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
| Or | |
|---|---|
| ---- | -- |
| Over-The-Counter-Use | |
|---|---|
| (Optional Format 1-2-96) |
Kevin Mulvey for MSR
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices |
| 510(k) Number: | K030884 |
|---|---|
| Page 4 of 4 |
Acadental 5830 Wooden Suite 5, Mission, KS. 66202 (913) 384-7390
N/A