(123 days)
PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization.
PANA SPRAY Plus is an alcohol-based general handpiece and air-motor lubricant. The lubricant is introduced into the handpiece through the air-drive pipe or the back end. PANA SPRAY Plus can be used for the maintenance of high speed handpieces, low speed handpieces, and air motors and should be used after each patient and prior to sterilization of handpiece and air motors.
This document, K131014, is a 510(k) Premarket Notification for a dental handpiece lubricant, PANA SPRAY Plus. It is not a document about an AI/ML medical device, and therefore, most of the requested information regarding AI/ML device testing criteria (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth) is not applicable to this submission.
The acceptance criteria and study proving device performance for the PANA SPRAY Plus are based on demonstrating substantial equivalence to a predicate device through non-clinical testing for reliability and durability.
Here's the information that can be extracted from the provided text, adapted to the context of this non-AI/ML device:
Acceptance Criteria and Device Performance:
- Acceptance Criteria: The device was evaluated to confirm it met "NSK America internal requirements for reliability (package vibration, unit drop, and temperature testing) and durability (repeated usage, actual usage, and contra/turbine testing)."
- Reported Device Performance: "The test results indicate that PANA SPRAY Plus met all NSK America internal requirements and is therefore substantially equivalent to the predicate device."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests | Reported Performance |
|---|---|---|
| Reliability | Package vibration testing | Met NSK America internal requirements |
| Unit drop testing | Met NSK America internal requirements | |
| Temperature testing | Met NSK America internal requirements | |
| Durability | Repeated usage testing | Met NSK America internal requirements |
| Actual usage testing | Met NSK America internal requirements | |
| Contra/turbine testing | Met NSK America internal requirements |
Information Not Applicable or Not Provided for This Device (Common to AI/ML Device Submissions):
- Sample size used for the test set and the data provenance: Not specified for this type of non-clinical testing (e.g., for mechanical/chemical lubricant).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for lubricants is physical/chemical performance, not expert interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI/ML device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is not an AI/ML device).
- The type of ground truth used: For this device, the "ground truth" would be the fulfillment of pre-defined engineering and performance specifications for a lubricant (e.g., lubricating properties maintained after various stress tests, no adverse effects on handpiece function, package integrity). The document refers to "NSK America internal requirements."
- The sample size for the training set: Not applicable (this is not an AI/ML device; there is no training set).
- How the ground truth for the training set was established: Not applicable.
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K 131014
NSK America Corporation
5. 510(k) SUMMARY
| Submitter: | NSK America1800 Global ParkwayHoffman Estates, IL 60192 |
|---|---|
| 510(k) Owner /Contact Person: | Hirohiko MuraseExecutive Vice President and General ManagerTEL: 847-843-7664FAX: 847-843-7622murase@nskamericacorp.com |
| Date Prepared: | April 5, 2013 |
| Trade Name: | PANA SPRAY Plus |
| Common Name: | Handpiece Lubricant |
| Classification Name: | Handpiece, Air-Powered, Dental (21 CFR 872.4200, Product Code FMC) |
| Classification: | Class 1 |
| Predicate Device: | K052700 NSK America Pana-Spray |
| Device Description: | PANA SPRAY Plus is an alcohol-based general handpiece and air-motor lubricant.The lubricant is introduced into the handpiece through the air-drive pipe or the backend. PANA SPRAY Plus can be used for the maintenance of high speed handpieces,low speed handpieces, and air motors and should be used after each patient andprior to sterilization of handpiece and air motors. |
| Statement ofIntended Use: | PANA SPRAY Plus is a lubricant intended to be used during routine maintenance ofdental and surgical handpieces after each patient use and prior to sterilization. |
| Summary ofTechnologicalCharacteristics: | Both the proposed PANA SPRAY Plus and the predicate Pana Spray are lubricantsprovided in aerosol cans for the maintenance of dental handpieces and air motors.The method of delivery, function, and performance of the proposed and predicatedevices are the same. |
| Summary ofNon-Clinical Data:Test Data: | PANA SPRAY Plus was evaluated to confirm that the device met NSK Americainternal requirements for reliability (package vibration, unit drop, and temperaturetesting) and durability (repeated usage, actual usage, and contra/turbine testing).The test results indicate that PANA SPRAY Plus met all NSK America internalrequirements and is therefore substantially equivalent to the predicate device. |
| Conclusion: | NSK America considers PANA SPRAY Plus to be substantially equivalent to thepredicate device(s) listed above. This conclusion is based on the similarities inprimary intended use, principles of operation, functional design, and establishedmedical use. |
AUG 1 2 2013イ
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2013
NSK America Corporation C/O Ms. Diane Rutherford Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
Re: K131014
Trade/Device Name: PANA SPRAY Plus Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: 1 Product Code: EFB Dated: July 17, 2013 Received: July 18, 2013
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.
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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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/2/Picture/6 description: The image shows the text "Mary S. Runner - S" in a simple, sans-serif font. The words are arranged horizontally, with "Mary" on the left, followed by "S. Runner" in the center, and "- S" on the right. The letters "FDA" are embedded in the text.
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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INDICATIONS FOR USE
510(k) Number: K13/014
Device Name: PANA SPRAY Plus
Indications for Use:
PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization.
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)
Sheena A. Green -S Sheena A. Green -5
2013.08.07 15:52:49 -04'00" 15-12:49 -04'00" 1
for M. Susan Runner, DDS, MA
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:_ K131014
Page 1 of 1
Section 4: 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.