K Number
K131014
Device Name
PANA SPRAY PLUS
Manufacturer
Date Cleared
2013-08-12

(123 days)

Product Code
Regulation Number
872.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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 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.
More Information

No
The device is a lubricant for dental and medical surgical handpieces and the description focuses on its physical properties and performance as a lubricant, with no mention of AI or ML.

No
The device is a lubricant for dental and medical surgical handpieces, intended for maintenance and not for treating or diagnosing medical conditions.

No
The device is a lubricant for dental and medical surgical handpieces, used for routine maintenance prior to sterilization. It is not designed to diagnose any condition or disease.

No

The device description clearly states it is a lubricant, which is a physical substance, not software. The performance studies also focus on physical properties and testing of the lubricant and its packaging.

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 dental and medical surgical handpieces for maintenance and prior to sterilization. This is a mechanical function related to the operation and care of a medical device, not a diagnostic test performed on a biological sample.
  • Device Description: The description confirms it's a lubricant introduced into the handpiece. This aligns with its mechanical maintenance purpose.
  • Lack of IVD Characteristics: There is no mention of:
    • Analyzing biological samples (blood, urine, tissue, etc.).
    • Detecting or measuring substances in biological samples.
    • Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. PANA SPRAY Plus does not fit this description.

N/A

Intended Use / 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.

Product codes

FMC, EFB

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 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.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

PANA SPRAY Plus was evaluated to confirm that the device met NSK America 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 SPANA SPRAY Plus met all NSK America internal requirements and is therefore substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052700 NSK America Pana-Spray

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K 131014

NSK America Corporation

5. 510(k) SUMMARY

| Submitter: | NSK America
1800 Global Parkway
Hoffman Estates, IL 60192 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner /
Contact Person: | Hirohiko Murase
Executive Vice President and General Manager
TEL: 847-843-7664
FAX: 847-843-7622
murase@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 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. |
| Statement of
Intended Use: | PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of
dental and surgical handpieces after each patient use and prior to sterilization. |
| Summary of
Technological
Characteristics: | Both the proposed PANA SPRAY Plus and the predicate Pana Spray are lubricants
provided in aerosol cans for the maintenance of dental handpieces and air motors.
The method of delivery, function, and performance of the proposed and predicate
devices are the same. |
| Summary of
Non-Clinical Data:
Test Data: | PANA SPRAY Plus was evaluated to confirm that the device met NSK America
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 met all NSK America internal
requirements and is therefore substantially equivalent to the predicate device. |
| Conclusion: | NSK America considers PANA SPRAY Plus to be substantially equivalent to the
predicate device(s) listed above. This conclusion is based on the similarities in
primary intended use, principles of operation, functional design, and established
medical use. |

AUG 1 2 2013イ

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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.

2

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

3

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