Premium Plus Prophy Air Motor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Premium Plus International Limited Jessica Mao QA Engineer Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West Yuen Long, N.T. Hong Kong, China Re: K170261 Trade/Device Name: Premium Plus Prophy Air Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: September 11, 2017 Received: September 15, 2017 Dear Jessica Mao: 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 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov October 19, 2017 {1}------------------------------------------------ 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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 Tina Kiang, Ph.D. 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170261 Device Name Premium Plus Prophy Air Motor Indications for Use (Describe) The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------| | <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com # Section 5 510(k) Summary [As Required by 21 CFR 807.92] Revision date: Oct. 17, 2017 Premium Plus International Limited Submitter: Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, N.T. Hong Kong, China (Establishment registration number: 3006847937) Contact Person: Jessica Mao QA Engineer Tel: 852-27613211 Fax: 852-27613210 Email: jessicamao@premiumplushk.com Trade/Device Name: Premium Plus Prophy Air Motor Common Name: Dental Handpiece Model Type: 1002-4 Device Panel: Dental Basis for Submission: New Device Regulation Name: Handpiece, Air-Powered, Dental Device Classification: Class I Regulation Number: 21 CFR 872.4200 Regulation Description: Dental Handpiece and Accessories Product Code: EFB #### Predicate Device to Premium Plus Prophy Air Motor: Trade Name: Prophy Star 3 Hygiene Handpiece 510(k) Number: K070869 Manufactured by: DentalEz Inc., StarDental Division #### Device Description: Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth. #### Indications for Use: The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis. An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 1 of 4 Section 5 {4}------------------------------------------------ Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com | | Predicate Device | Subject Device | | |----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Device | Prophy Star 3 Hygiene<br>Handpiece (K070869) | Premium Plus Prophy<br>Air Motor | / | | Indications for<br>Use | The prophy handpiece is used<br>by trained dental<br>professionals to perform<br>dental prophylaxis | Premium Plus Prophy<br>Air Motor is intended to<br>be used with a<br>disposable prophy angle<br>and polishing paste by a<br>trained dental clinician<br>to perform dental<br>prophylaxis. | Same | | Target Users | Professional dentists and<br>hygienists | Professional dentists<br>and hygienists | Same | | Location of<br>Use | Dental offices | Dental offices | Same | | Product<br>Design | Metal housing (external<br>casing) with internal drive<br>shaft, gearings and chuck<br>assembled and aligned to<br>each other. | Anodized aluminum<br>housing with internal<br>drive shaft, gearings<br>and chuck assembled<br>and aligned to each<br>other | Same | | Dimensions &<br>Weight: | Length 108.99 mm<br>Diameter at handle 16.76 mm<br>Weight 62 grams | Length 111.00 mm<br>Diameter at handle 16.76 mm<br>Weight 69 grams | The<br>subject<br>device is a bit<br>longer, bigger,<br>and heavier than<br>the predicate<br>device. | | Operating Air<br>Pressure,<br>Operating<br>Speed and<br>Power Output | Air Pressure 35-40 psi<br>Operating Speed 0 to 5,000<br>rpm<br>Power Output 5.8 Watts | Air Pressure 200kPa<br>Operating Speed 0 to<br>2,480 rpm<br>Power Output 6.0 Watts | Operating speed<br>is different | | Drive<br>Mechanism | Chuck driven by pneumatic<br>air rotor | Chuck driven by<br>pneumatic air rotor | Same | | Bio-<br>compatibility | Made of non-toxic anodized<br>aluminum | Biocompatibility tests<br>were conducted in<br>accordance with the<br>requirements of ISO<br>10993-5 and ISO | Same | | Compatibility<br>with other<br>dental devices | Designed to fit securely onto<br>standard Mid-West style air<br>hose connector and standard<br>Doriot style prophy angles | Designed to fit securely<br>onto standard 4-hole<br>(mid-west style)<br>connector and standard<br>Doriot style prophy<br>angles | Same | | Sterility | Non-sterile | Non-sterile | Same | | Mechanical<br>Safety | Robust construction to<br>withstand forces generated<br>during cleaning cycle | Robust construction to<br>withstand forces<br>generated during<br>cleaning cycle. The<br>subject device passed<br>the performance test in<br>accordance with ISO<br>14457. | Same | ### Comparison of Technological Characteristics: {5}------------------------------------------------ Flat 1001 Yven Long Trading Centre, No. 33 Wang Yip Street West, Yven Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com ## Discussion of similarities and differences between the Proposed Device and the Predicate Device In compare to the Prophy Star 3 Hygiene Handpiece, the Premium Plus Prophy Air Motor has the same indications for use, same target users and same location of use. They both have the same drive mechanism. They both have similar dimensions & weight, similar operating air pressure and similar power output. Furthermore, they both are non-sterile, bio-compatible, compatible with the same type of air hose connector and same type of disposable prophy angle, and both are mechanically safe. Their operational speeds are different. The subject device's operational speed is within the extent of the predicate device's speed. The subject device conforms to the requirements of ISO 14457. ## Performance Test: The following tests were conducted to evaluate the functional performance and safety of Premium Plus Prophy Air Motor: - ISO 14457:2012 Dentistry Handpieces and Motors Test ● - ISO 9168:2009 Dentistry Hose Connectors for Air Driven Dental Handpieces Test ● The test results confirm that Premium Plus Prophy Air Motor conforms to the requirements in ISO 14457:2012 and ISO 9168:2009, and is substantially equivalent for use as a dental prophy air motor. An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 3 of 4 Section 5 {6}------------------------------------------------ Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com #### Biocompatibility Test: The following tests were performed to evaluate the biocompatibility of the device: - Cytotoxicity per ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: ● Tests for in vitro cytotoxicity - Oral Irritation per ISO 10993-10: Biological evaluation of medical device - Part 10: Tests for irritation and delayed -type hypersensitivity - Sensitization per ISO 10993-10: Biological evaluation of medical device Part 10: Tests ● for irritation and delayed -type hypersensitivity ### Validation Testings: Recommendations of the FDA Guidance on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed. - Cleaning Validation Protein Analysis ● - Cleaning Validation - Hemoglobin Analysis - Sterilization Validation - Gravity cycle 132 ℃ 15min - Sterilization Validation - Gravity cycle 121 ℃ 30min - Sterilization Validation - Prevacuum cycle 132 ℃ 4min #### Conclusion Based on the above analysis, Premium Plus International Limited believes that the Premium Plus Prophy Air Motor is Substantially Equivalent to the claimed predicate, that is the Prophy Star 3 Hygiene Handpiece.