(246 days)
No
The device description and performance studies focus on the physical properties and cleaning/lubrication function of a handpiece spray, with no mention of AI or ML.
No.
This device is a lubricant and cleaning agent for dental and medical surgical handpieces, intended for maintenance of the instruments themselves, not for direct therapeutic use on a patient.
No
The device is described as a lubricant and cleaner for dental and medical surgical handpieces, used for maintenance purposes, not for diagnosing medical conditions.
No
The device description clearly states it is an alcohol-based lubricant, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lubricate and clean dental and medical surgical handpieces. This is a maintenance function for a medical device, not a diagnostic test performed on a biological sample.
- Device Description: The device is a lubricant introduced into handpieces. This aligns with its maintenance purpose.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
EFB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
PSP has undergone reprocessing/cleaning validation to support the claim of cleaning in accordance with FDA guidance titled, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". In addition, biocompatibility testing was conducted in accordance with 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name PANA SPRAY Plus
Indications for Use (Describe)
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 surgical handpieces.
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 Shimohinata
Kanuma-shi, Tochigi-ken 322-8666 Japan | | | | New Device | Primary Predicate Devices | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | NAKANISHI, INC.
Mr. Kimihiko Satoh
General Manager, Regulatory Affairs Dept
TEL: +81-0289-64-3380
FAX: +81-0289-62-6665
k-satoh@nsk-nakanishi.co.jp | | | Trade Name | PANA SPRAY Plus | PANA SPRAY Plus | Spray & Clean Handpiece
Cleaner & 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] | HANDPIECE
HEADQUARTERS
[K113674] | |
| Common Name: | Dental handpieces and accessories | | | Product Code(s)
Regulation | EFB
872.4200 | EFB
872.4200 | EFB
872.4200 | |
| Classification
Name: | Handpiece, air-powered, dental | | | Class | 1 | 1 | 1 | |
| Product Code: | EFB Class 1 872.4200 | | | Prescription Only ? | Yes | Yes | Yes | |
| Predicate
Devices: | PRIMARY: K131014 - NAKANISHI, INC. PANA SPRAY Plus
REFERENCE: K113674 - Handpiece Headquarters Inc, - HPR Inc.
Spray & Clean/Maxima/EZcare Handpiece Cleaner & Lubricant | | | Indication for Use | 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. | 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. | The Dental Handpiece
Cleaner and Lubricant is
intended to be used
during routine
maintenance in order to
lubricate and clean air-
powered Dental
Handpieces (including
low speed and high
speed) and Dental air
motors after each patient
use and prior to
sterilization.
The Dental Handpiece
Lubricant is intended to
be used during routine
maintenance in order to
lubricate air-powered
Dental Handpieces
(including low speed and
high speed) and Dental
air motors after each
patient use and prior to
sterilization. | |
| 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. | | | Device Design | | | | |
| Indications
for Use: | 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. | | | Availability: | 480 mL Can
Case of 6 (480 mL) Cans | 480 mL Can
Case of 6 (480 mL) Cans | 6 oz Can
Case of 12 cans | |
| Summary of
Technological
Characteristics: | The reason for this submission is to change the previously cleared Pana Spray
Plus indications (K131014) to include cleaning. The proposed PSP and the
predicate Spray & Clean Handpiece Cleaner & Lubricant (K113674) both are
indicated for cleaning and lubrication of handpieces (including low speed and
high speed) and air motors after each patient use and prior to sterilization.
The proprietary formulation of the proposed PANA SPRAY Plus (PSP) is
unchanged from that of the predicate Pana Spray Plus (K131014). The
proprietary formulation of PSP and both predicates includes lubricant and
alcohol components. All are for prescription use only, are provided in aerosol
cans and share the method of delivery/principle of operation. Slight variations | | | For use with: | High & Low speed
handpieces
and air motors | High & Low speed
handpieces
and air motors | High & Low speed
handpieces
and air motors | |
| Max Temperature | 120°F (49°C) | 120°F (49°C) | 120°F | | | | | |
| Contents | Lubricant plus
propellant | Lubricant plus
propellant | Lubricant plus
propellant | | | | | |
| 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.
5
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.