PANA SPRAY Plus is a lubricant to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization and is intended for use to clean and lubricate the dental and medical surgical handpieces.

Device Description

PANA SPRAY Plus (PSP) 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. Additional testing has been conducted to support the claim for cleaning.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "PANA SPRAY Plus" device.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results typical of a device seeking de novo authorization or a PMA. As such, the information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of a 510(k) submission, meaning it refers to non-clinical performance testing against established standards and comparisons to predicate devices to demonstrate equivalent performance and safety. There is no mention of a traditional "study" with a test set of patients or human readers.

Acceptance Criteria and Reported Device Performance

The "PANA SPRAY Plus" device is a lubricant for dental and medical surgical handpieces, with an added claim for cleaning. The acceptance criteria are benchmarked against performance of predicate devices and relevant ISO standards.

Acceptance Criteria Category	Reported Device Performance
Cleaning Efficacy	Undergone reprocessing/cleaning validation in accordance with FDA guidance titled, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." (Specific metrics like soil reduction percentage are not provided in this summary but are implicit in meeting the guidance.)
Biocompatibility	Biocompatibility testing conducted in accordance with ANSI/AAMI/ISO 10993-1, covering selection of tests for cytotoxicity, sensitization, and irritation. (Results indicated compliance, suggesting no unacceptable biological response.)
Reliability	Continues to meet all NAKANISHI, INC. internal requirements for reliability (package vibration, unit drop, and temperature testing). (Specific thresholds or results are not detailed in this summary.)
Durability	Continues to meet all NAKANISHI, INC. internal requirements for durability (repeated usage, actual usage, and contra/turbine testing). (Specific thresholds or results are not detailed in this summary.)
Functional Equivalence (ISO 14557)	Comparison testing against predicate K113674 demonstrated performance equivalence for: - Bur extraction force - Eccentricity - Noise level - Stopping torque All results were reported as "in compliance with ISO 14557." (This implies that the measured values for these parameters for PANA SPRAY Plus were within the acceptable ranges defined by ISO 14557 and comparable to the predicate.)
Safety and Efficacy (General)	"The test results indicate that PANA SPRAY Plus is substantially equivalent to the predicate devices and does not raise new questions of safety or efficacy."

Detailed Study Information (Based on provided text)

Given that this is a 510(k) summary for a Class I device (lubricant/cleaner), the "study" described is primarily non-clinical, involving laboratory testing and comparison to predicate devices, rather than clinical trials with human subjects.

Sample size used for the test set and the data provenance:
- Cleaning Efficacy: The document states that "reprocessing/cleaning validation" was done "in accordance with FDA guidance." This typically involves testing a defined number of soiled devices, but the specific sample size for the cleaning test is not mentioned in this summary.
- Biocompatibility: "Biocompatibility testing was conducted in accordance with ANSI/AAMI/ISO 10993-1." Specific sample sizes for cytotoxicity, sensitization, and irritation tests are not mentioned. These are typically in-vitro or animal studies.
- Reliability & Durability: "Continues to meet all NAKANISHI, INC. internal requirements." The sample sizes for package vibration, unit drop, temperature testing, repeated usage, actual usage, and contra/turbine testing are not mentioned.
- Functional Equivalence (ISO 14557): "Comparison testing was conducted using predicate K113674 to demonstrate performance equivalence for bur extraction force, eccentricity, noise level, and stopping torque." The sample size (number of handpieces tested, number of repetitions) for these comparisons is not mentioned.
- Data Provenance: The testing was conducted by NAKANISHI, INC. (the manufacturer) or their contracted labs. The country of origin for the testing would likely be Japan or a region where Nakanishi Inc. operates, but it's not explicitly stated. The data is implicitly prospective as it was generated to support the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- As this is non-clinical testing focused on physical performance, cleaning efficacy, and biocompatibility, the concept of "experts establishing ground truth for a test set" in the human diagnostic context isn't directly applicable. The "ground truth" for these tests is defined by the methods and acceptance criteria of the respective standards (e.g., FDA guidance for reprocessing, ISO 10993-1 for biocompatibility, ISO 14557 for handpiece performance).
- Therefore, the "experts" involved would be those qualified to conduct and interpret these specific types of laboratory and engineering tests (e.g., microbiologists for cleaning validation, toxicologists for biocompatibility, mechanical engineers for functional performance). Their specific number and qualifications are not detailed in the summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. This type of adjudication method is used in studies involving human interpretation or subjective assessments, typically for clinical endpoints or diagnostic accuracy. It is not relevant for the non-clinical performance and safety tests described here, where outcomes are quantitative measurements against defined standards.
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:
- No. An MRMC study is not applicable to this device. This device is a lubricant/cleaner, not an AI-powered diagnostic tool or a device that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The concept of "standalone performance" typically applies to AI algorithms. This device is a physical product (lubricant/aerosol) and does not involve an algorithm. Therefore, this question is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is defined by the established scientific and engineering standards and methods utilized for testing:
  - Cleaning Efficacy: Ground truth is linked to the reduction of simulated soil as measured by validated laboratory methods, as per FDA guidance.
  - Biocompatibility: Ground truth is determined by the presence/absence of toxicological responses as per ISO 10993 methods.
  - Functional Performance (ISO 14557): Ground truth is established by the quantitative measurements (e.g., force, RPM, noise level) compared against the specified limits and ranges within the ISO 14557 standard.
The sample size for the training set:
- This question is not applicable. This device is not an AI/machine learning device that requires a "training set."
How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15,2017

Nakanishi, Inc. % Diane Rutherford Submissions Manger Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson. Texas 75080

Re: K163483

Trade/Device Name: Pana Spray Plus Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: July 31, 2017 Received: August 3, 2017

Dear Diane 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.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Mary S. Runner -S

for

Lori A. Wiggins, MPT, CLT Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163483

Device Name PANA SPRAY Plus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

Submitter:	NAKANISHI, INC.700 ShimohinataKanuma-shi, Tochigi-ken 322-8666 Japan				New Device	Primary Predicate Devices
Contact Person:	NAKANISHI, INC.Mr. Kimihiko SatohGeneral Manager, Regulatory Affairs DeptTEL: +81-0289-64-3380FAX: +81-0289-62-6665k-satoh@nsk-nakanishi.co.jp			Trade Name	PANA SPRAY Plus	PANA SPRAY Plus	Spray & Clean HandpieceCleaner & Lubricant
Date Prepared:	August 11, 2017			Description
Trade Name:	PANA SPRAY Plus			510(k) Submitter[Number]	NAKANISHI, INC.[K163483]	NSK America(A subsidiary of NAKANISHI, INC.)[K131014]	HANDPIECEHEADQUARTERS[K113674]
Common Name:	Dental handpieces and accessories			Product Code(s)Regulation	EFB872.4200	EFB872.4200	EFB872.4200
ClassificationName:	Handpiece, air-powered, dental			Class	1	1	1
Product Code:	EFB Class 1 872.4200			Prescription Only ?	Yes	Yes	Yes
PredicateDevices:	PRIMARY: K131014 - NAKANISHI, INC. PANA SPRAY PlusREFERENCE: K113674 - Handpiece Headquarters Inc, - HPR Inc.Spray & Clean/Maxima/EZcare Handpiece Cleaner & Lubricant			Indication for Use	PANA SPRAY Plus is alubricant to be used duringroutine maintenance ofdental and medicalsurgical handpieces aftereach patient use and priorto sterilization and isintended for use to cleanand lubricate the dentaland medical surgicalhandpieces.	PANA SPRAY Plus is alubricant intended to beused during routinemaintenance of dental andmedical surgicalhandpieces after eachpatient use and prior tosterilization.	The Dental HandpieceCleaner and Lubricant isintended to be usedduring routinemaintenance in order tolubricate and clean air-powered DentalHandpieces (includinglow speed and highspeed) and Dental airmotors after each patientuse and prior tosterilization.The Dental HandpieceLubricant is intended tobe used during routinemaintenance in order tolubricate air-poweredDental Handpieces(including low speed andhigh speed) and Dentalair motors after eachpatient use and prior tosterilization.
DeviceDescription:	PANA SPRAY Plus (PSP) is an alcohol-based general handpiece and air-motorlubricant. The lubricant is introduced into the handpiece through the air-drivepipe or the back end. PANA SPRAY Plus can be used for the maintenance ofhigh speed handpieces, low speed handpieces, and air motors and should beused after each patient and prior to sterilization of handpiece and air motors.Additional testing has been conducted to support the claim for cleaning.			Device Design
Indicationsfor Use:	PANA SPRAY Plus is a lubricant to be used during routine maintenance ofdental and medical surgical handpieces after each patient use and prior tosterilization and is intended for use to clean and lubricate the dental andmedical surgical handpieces.			Availability:	480 mL CanCase of 6 (480 mL) Cans	480 mL CanCase of 6 (480 mL) Cans	6 oz CanCase of 12 cans
Summary ofTechnologicalCharacteristics:	The reason for this submission is to change the previously cleared Pana SprayPlus indications (K131014) to include cleaning. The proposed PSP and thepredicate Spray & Clean Handpiece Cleaner & Lubricant (K113674) both areindicated for cleaning and lubrication of handpieces (including low speed andhigh speed) and air motors after each patient use and prior to sterilization.The proprietary formulation of the proposed PANA SPRAY Plus (PSP) isunchanged from that of the predicate Pana Spray Plus (K131014). Theproprietary formulation of PSP and both predicates includes lubricant andalcohol components. All are for prescription use only, are provided in aerosolcans and share the method of delivery/principle of operation. Slight variations			For use with:	High & Low speedhandpiecesand air motors	High & Low speedhandpiecesand air motors	High & Low speedhandpiecesand air motors
Max Temperature	120°F (49°C)	120°F (49°C)	120°F
Contents	Lubricant pluspropellant	Lubricant pluspropellant	Lubricant pluspropellant
Physical State	Aerosol Product	Aerosol Product	Aerosol Product

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K163483

in the proprietary chemical formulation between PSP and the predicate Spray & Clean Handpiece Cleaner & Lubricant (K113674) result in slight differences in physical properties. Such slight differences due to proprietary formulations are to be expected and do not impact safety or effectiveness. PSP does not include any accessories.

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Summary of PSP has undergone reprocessing/cleaning validation to support the claim of Non-clinical cleaning in accordance with FDA guidance titled, "Reprocessing Medical Performance Devices in Health Care Settings: Validation Methods and Labeling". In addition, biocompatibility testing was conducted in accordance with Testing: ANSI/AAMI/ISO 10993-1 selection of tests for cytotoxicity, sensitization, and irritation. PANA SPRAY Plus continues to meet all NAKANISHI, INC. internal requirements for reliability (package vibration, unit drop, and temperature testing) and durability (repeated usage, actual usage, and contra/turbine testing). The test results indicate that PANA SPRAY Plus is substantially equivalent to the predicate devices and does not raise new questions of safety or efficacy.

Comparison testing was conducted using predicate K113674 to demonstrate performance equivalence for bur extraction force, eccentricity, noise level, and stopping torque with all results being in compliance with ISO 14557.

NAKANISHI, INC. considers PANA SPRAY Plus to be substantially Conclusion: equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.

Regulation Number and Section

§ 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.