(91 days)
Butler NuCare™ Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare™ Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.
Butler NuCare™ Prophylaxis Paste with NovaMin® is a product that is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Butler NuCare™ Prophylaxis Paste with NovaMin® is also designed to physically occlude dentinal tubules for the immediate relief of tooth sensitivity, post-scaling and root planing. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
Here's an analysis of the provided text, focusing on acceptance criteria, study details, and related information, formatted as requested.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it makes a general statement about efficacy.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| None explicitly quantified. | "Butler NuCare™ Prophylaxis Paste with NovaMin® occludes a significant number of tubules when compared with controls." |
| "no evidence of any hazardous effects to the patient if the product is used as directed." | "Many different biocompatibility tests have been performed on the NovaMin® particulate, the active ingredient... The results of these tests indicate there is no evidence of any hazardous effects to the patient if the product is used as directed." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The text only mentions "a bovine table overalian block model" for the tubule occlusion efficacy study.
- Data Provenance: The tubule occlusion study used a bovine (cattle) model, not human data. The location or timeline (retrospective/prospective) of this study is not mentioned. The biocompatibility tests are also not described in terms of sample size or provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described (tubule occlusion in a bovine model) does not appear to involve human expert ground truth for interpretation. Biocompatibility tests rely on laboratory standards and results rather than expert consensus on interpretation of device performance against ground truth in a clinical sense.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the in vitro (bovine block model) tubule occlusion study and biocompatibility tests, an adjudication method for human readings would not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The study described evaluated the device's performance (in vitro tubule occlusion) against controls, not in the context of human readers with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a prophylactic paste, not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable. The device's performance was evaluated for tubule occlusion and biocompatibility.
7. The Type of Ground Truth Used
- For Tubule Occlusion Efficacy: The ground truth was established by comparing the device's ability to occlude tubules against "controls" in a bovine table overalian block model. This implies a quantitative measurement of tubule occlusion compared to a baseline or non-treated sample, rather than expert consensus, pathology, or outcomes data from human subjects.
- For Biocompatibility: The ground truth is based on standard biocompatibility test methodologies and thresholds, which determine whether there is "evidence of any hazardous effects."
8. The Sample Size for the Training Set
This information is not applicable as the device is a dental prophylaxis paste, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8.
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510(k) Premarket Notification NovaMin Technology, Inc. Butler NuCare™ Prophylaxis Paste with NovaMin®
CONFIDENTIAL
AUG 2 3 701
1. SUBMITTER INFORMATION:
| Name: | NovaMin Technology, Inc. |
|---|---|
| Address: | 13709 Progress Blvd., #23 |
| Alachua, Florida 32615 USA | |
| Phone: | (386) 418-1551 |
| Facsimile: | (386) 418-1465 |
| Contact: | David C. Greenspan, Ph.D. |
May 19, 2004 Preparation Date:
2. DEVICE NOMENCLATURE:
| Trade Name: | Butler NuCare™ Prophylaxis Paste with NovaMin® |
|---|---|
| Common Name: | Dental Prophylaxis Paste |
| Classification Name: | Prophylaxis Paste |
3. LEGALLY MARKETED PREDICATE DEVICE:
| Device Name: | Butler GUM® Prophylaxis Paste with NovaMin® |
|---|---|
| 510(k) Number: | K024343 |
| Applicant: | NovaMin Technology, Inc. |
4. DEVICE DESCRIPTION:
Butler NuCare™ Prophylaxis Paste with NovaMin® is a product that is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Butler NuCare™ Prophylaxis Paste with NovaMin® is also designed to physically occlude dentinal tubules for the immediate relief of tooth sensitivity, post-scaling and root planing. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O . When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
5. INTENDED USE:
Butler NuCare® Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare™ Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.
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6. TECHNOLOGICAL CHARACTERISTICS:
The technological characteristics of Butler NuCare™ Prophylaxis Paste with NovaMin® and Butler The technological characteries of Dain® are the same. Both devices are designed to polish and Clean the tooth surface as part of a professionally administered dental prophylaxis treatment. Both cican the tooth surface as part of a pross hypersensitivity associated with exposed dentin by the devices are also tesigned to renove resources poth surface. Both devices use NovaMin" to deposition of a calcium phosphate layer that occludes and blocks hydrodynamic flow. produce a calcially phosphate in the ingredients used to make the base of the products, and .in the material used as the abrasive agent.
7. SAFETY AND PERFORMANCE DATA:
Many different biocompatibility tests have been performed on the NovaMin® particulate, the active ingredient in Butler NuCare™ Prophylaxis Paste with NovaMin®. The results of these tests indicate there is no evidence of any hazardous effects to the patient if the product is used as directed.
The tubule occlusion efficacy of Butler NuCare™ Prophylaxis Paste with NovaMin® was evaluated rice table overalian block model. The results indicate Butler NuCare™ Prophylaxis Paste with NovaMin® occludes a significant number of tubules when compared with controls.
8. CONCLUSIONS:
Butler NuCare™ Prophylaxis Paste with NovaMin® is considered to be substantially couvvalent to the Dutter Nacked predicate device, Butler GUM® Prophylaxis Paste with NovaMin® (K024343). The legariy marketed prodicate and biocompatibility data demonstrate the safety and efficacy of Butler NuCarc™ Prophylaxis Paste with NovaMin® for the intended uses.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2004
Dr. David C. Greenspan Vice President & Chief Technology Officer NovaMin Technology, Incorporated 13709 Progress Boulevard #23 Alachua, Florida 32615
Re: K041371
Ko+1371
Trade/Device Name: Butler NuCare™ Prophylaxis Paste with NovaMin** Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: 1 Product Code: EJR Dated: May 21, 2004 Received: May 25, 2004
Dear Dr. Greenspan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your sectetermined 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 interstate conninetee prior to may 20, 1970, consided in accordance with the provisions of Amendinents, or to do roob and Cosmetic Act (Act) that do not require approval of a premarket the rederal Pood, Drag, and Ooou may, therefore, market the device, subject to the general approvin upprovisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (FMA). it may be subject to meet adam federal Regulations, Title 21, Parts 800 to 898. In your device can be found in ther announcements concerning your device in the Eederal Register.
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Page 2 - Dr. Greenspan
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. or the Act of any vith 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 and instillents as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as between as 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 premaired predicated. - > > 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), n you donto the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilitics under the Act from the may obtain 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,
Qels
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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OF INDICATIONS FOR U
, 413711 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
Butler NuCare™ Prophylaxis Paste with NovaMin® is intended for cleaning and polishing.
Secondation of the comment of the red dental monbulaxis treatment. Secondary Butler NuCare™ Prophylaxis Pasce with Novahin Tismatores was is treatment. Secondarily:
procedures as part of a professionally administered dental for a immediate relief of procedures as part of a professionally administered demails teamers. In the inimediate relief of Buttor into post-scaling and root planing.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)
(Division Sign-On)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number k(1137)
Prescription Use __X __
OR (Per 21 CFR 801.109) Over-The-Counter Use ___
SECTION D – STATEMENT OF INDICATIONS FOR USE
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.