(146 days)
The Prophy-Mate Neo device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powders or calcium carbonate powders, air, and water onto tooth surfaces.
The Prophy-Mate neo can also be used in dental applications to prepare surface prior to bonding and to prepare for pit and fissure sealant.
The Prophy-Mate neo is an air-powered tooth polishing system. The product expels a mixture of powders (sodium bicarbonate or calcium carbonate), water, and air onto the surfaces of the tooth. The Prophy-Mate neo consists of the Powder case, Handpiece, with a 60° and 80° Nozzle attachment.
The provided text describes the 510(k) summary for the Prophy-Mate neo, an air-powered tooth polishing system. It is a submission to the FDA for market clearance, not a study report that details performance against specific acceptance criteria in a comprehensive clinical or analytical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly present in the provided document.
Here's an analysis of what can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the Prophy-Mate neo's performance. For a 510(k) submission, the primary "acceptance criterion" is typically substantial equivalence to predicate devices, meaning it does not raise new issues of safety and effectiveness and performs as intended.
- Reported Device Performance: The document states: "The Prophy-Mate neo was developed and is produced under consideration of all applicable technical standards, and internal specifications. The product's conformance with applicable international and internal standards was verified in the course of bench testing."
- This broadly indicates that the device met relevant technical and internal standards, but specific performance metrics, like efficiency of stain removal, abrasion levels, or durability, are not quantified or reported in this summary.
Without explicit performance metrics and acceptance thresholds, a table like the one requested cannot be constructed from this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "bench testing."
- Data Provenance: Not specified beyond "bench testing." No information on country of origin or whether it was retrospective or prospective data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable/Not specified. The assessment appears to be based on technical standards and internal specifications, not expert evaluation of clinical performance.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. There's no mention of a test set requiring adjudication in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done, or at least not reported in this summary. This type of study is typically for evaluating diagnostic imaging or AI systems where human reader performance is a key metric. This device is a dental tool, not a diagnostic system.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This is a physical dental device, not an algorithm or AI system.
7. Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" implicitly refers to the adherence to "applicable technical standards, and internal specifications" and the established safety and effectiveness of the predicate devices. It is not based on expert consensus, pathology, or outcomes data in the sense typically associated with diagnostic devices.
8. Sample Size for the Training Set
- Not applicable/Not specified. There's no mention of a "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified, as there is no training set.
In summary, the provided document is a regulatory submission focused on substantial equivalence to predicate devices for a physical medical device. It attests to compliance with technical standards through bench testing but does not detail a clinical or analytical study with specific quantifiable acceptance criteria and performance results in the way typically expected for a diagnostic or AI device.
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5. 510(k) SUMMARY
| Submitter: | Nakanishi, Inc.700 ShimohinataKanuma-Shi, Tochigi-Ken Japan 322-8666 |
|---|---|
| Contact Person: | Mr. Toshihiko ShinozakiAssistant Manager, R&D Dept. Pharmaceutical Affairs Gr.TEL: 0289(64)3380FAX: 0289(62)6665t-shinozaki@nsk-nakanishi.co.jp |
| Date Prepared: | January 26, 2012 |
| Trade Name: | Prophy-Mate neo |
| Common Name: | Air Powered Tooth Polishing System |
| Classification Name: | EFB 872.4200 Handpiece, Air-Powered, Dental |
| Predicate Device: | K032395 - Prophy-MateK973876 - Prophyflex2, Model 2012K022119 - EMS AIR-FLOW® handy 2 |
| Device Description: | The Prophy-Mate neo is an air-powered tooth polishing system. The product expelsa mixture of powders (sodium bicarbonate or calcium carbonate), water, and aironto the surfaces of the tooth. The Prophy-Mate neo consists of the Powder case,Handpiece, with a 60° and 80° Nozzle attachment. |
| Statement ofIntended Use: | The Prophy-Mate Neo device is intended for use in dental applications to removestains and plaque deposits from the teeth by shooting a mixture of sodiumbicarbonate powders or calcium carbonate powders, air, and water onto toothsurfaces.Sodium bicarbonate should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.The Prophy-Mate neo can also be used in dental applications to prepare surfaceprior to bonding and to prepare for pit and fissure sealant. |
| Summary ofTechnologicalCharacteristics: | The 360° twist free swivel joint at the handpiece end and the hose end of thepowder case enables smooth operation even under high air pressure. The handpieceswivels so easily that access to hard to reach areas becomes effortless. TheProphy-Mate neo is designed to minimize stain and fatigue even during prolonged operationThe choice of nozzle between 60° and 80° enables easy reach of all tooth surfaces and unobstructed vision. |
月112673
FEB - 7 2012
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Section 5: Page 1 of 2
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Performance Testing: applicable technical
The Prophy-Mate neo was developed and is produced under consideration of all standards, and internal specifications. The product's conformance with applicable international and internal standards was verified in the course of bench testing.
Conclusion:
Nakanishi considers the Prophy-Mate neo to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in intended use, principles of operation, functional design, and established medical use, and does not raise new issues of safety and effectiveness.
Image /page/1/Picture/4 description: The image shows a black and white drawing of a bird. The bird is in flight, with its wings spread and its head turned to the side. The bird's feathers are detailed, and its beak is sharp. The background is plain white, which helps to emphasize the bird.
Section 5: Page 2 of 2
NAKANISHI INC. www.nsk-inc.com
Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which features a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nakanishi. Incorporated Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
Re: K112673
Trade/Device Name: Prophy-Mate neo Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: January 26, 2012 Received: February 1, 2012
Dear Ms. Rutherford:
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.
FEB - 7 2012
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Page 2 – Ms. Rutherford
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/ucm115809.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 vours.
Wh for
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
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INDICATIONS FOR USE
510(k) Number: 1212673
Device Name: Prophy-Mate neo
Indications for Use:
The Prophy-Mate Neo device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powders or calcium carbonate powders, air, and water onto tooth surfaces.
The Prophy-Mate neo can also be used in dental applications to prepare surface prior to bonding and to prepare for pit and fissure sealant.
Prescription Use _ X (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDHR, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General HospitalInfection Control, Dental Devices | |
| 510(k) Number: | K112673 |
Page 1 of 1
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.