(246 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on mechanical and electrical functions for root canal procedures and apex location.
Yes
The device is described as a motorized handpiece used for enlargement and preparation of root canals and for measuring canal length, which are therapeutic actions to treat a condition (root canal issue).
Yes
The device "can be used to enlarge canals while monitoring the file tip inside the canal" and "also be used as an apex locator," which are diagnostic functions for determining canal length and file position within the root canal.
No
The device description explicitly states it is a "battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments". This indicates it is a physical hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description of the ZR-Rap Endo Motor clearly states its function is for endodontic treatment and measuring root canal length. This is a procedure performed inside the patient's mouth, directly on the tooth and root canal.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It interacts directly with the anatomical structure (root canal).
Therefore, based on the provided information, the ZR-Rap Endo Motor is a dental device used for treatment and measurement within the body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Product codes (comma separated list FDA assigned to the subject device)
EKX, LOY
Device Description
The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal, softened dentin
Indicated Patient Age Range
Adult
Intended User / Care Setting
qualified dental personnel.
This device must only be used in hospital environments, clinics or dental offices.
Dental clinic, University hospital and the other clinical settings
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and FDA Guidance:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- A IEC 80601-2-60: 2019 Medical Electrical Equipment - Part 2-60: Particular Requirements for Basic Safety and Essential Performance of Dental Equipment.
-
ISO 14457: 2017 Dentistry - Handpieces and motors
-
Moderate level of software documentation per the FDA Guidance for Software Contained in Medical Devices.
- A Reprocessing validation (i.e., cleaning, disinfection, and sterilization) per the FDA Guidance Document for Reprocessing Medical Devices in Healthcare Setting.
- A Comparative Root Canal Measurement Performance Test to evaluate the root canal length
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of the root apex locator function: -0.5mm to +0.5mm for Apex position.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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April 26, 2023
Shenzhen Perfect Medical Instruments Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai, Shanghai 200122 CHINA
Re: K222548
Trade/Device Name: Endo Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX, LOY Dated: January 30, 2023 Received: January 30, 2023
Dear Jarvis Wu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222548
Device Name Endo Motor
Indications for Use (Describe)
The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K222548
Document Date Prepared:2022/8/12
A. Applicant:
Name: Shenzhen Perfect Medical Instruments Co., Ltd.
Address: Room 102, Building A, Ruiji Factory, No. 3 Zaohekeng, Jixia Community, Nanwan Street,
Longgang District.Shenzhen, P.R. China. 518100
Contact Person: Kristy Mo
Tel: +86- 13929326975
Mail: kristy@medtung.com
Submission Correspondent:
Primary contact: Mr. Jarvis Wu
Shanghai SUNGO Management Consulting Co., Ltd.
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: haiyu.wang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: fda.sungo@gmail.com
B. Device:
Proprietary Name: Endo Motor Common Name: Endodontic treatment motorized handpiece with built-in apex locator Model(s): ZR-Rap
Regulatory Information
Classification Name: Dental handpiece and accessories Classification: Class I Primary Product code: EKX Secondary Product Code: LQY Regulation Number: 878. 4200
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C. Predicate device:
Manufacturer: Changzhou Sifary Medical Technology Co., Ltd. Device name: E-Connect S Endo Motor With Built-In Apex Locator 510(K) Number: K201993
(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)
D. Indications use of the device:
The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
E. Device Description:
The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate device | Comparison |
|---|---|---|---|
| Manufacturer | Shenzhen Perfect Medical | ||
| Instruments Co., Ltd. | Changzhou Sifary | ||
| Medical Technology Co., Ltd. | - | ||
| 510K number | K222548 | K201993 | - |
| Device name | Endo Motor | E-connect S Endo Motor | - |
| Classification | |||
| Regulation | 21CRF 872.4200 | 21CRF 872.4200 | Same |
| Classification | Class I | Class I | Same |
| Product Code | EKX, LQY | EKX, LQY | Same |
| Common name | Endodontic treatment motorized | ||
| handpiece with built-in apex | |||
| locator | Endodontic treatment motorized | ||
| handpiece with built-in apex | |||
| locator | Same | ||
| Indications for use | The Endo Motor, model: ZR-Rap, | ||
| is a cordless endodontic treatment | |||
| motorized handpiece with root | |||
| canal measuring capability. It can | |||
| be used to enlarge canals while | |||
| monitoring the position of the file | |||
| tip inside the canal. It can be used | |||
| as a low-speed motorized | |||
| handpiece and device for | |||
| measuring canal length. This | |||
| device must only be used in | |||
| hospital environments, clinics or | |||
| dental offices by qualified dental | |||
| personnel. | E-connect S is a cordless | ||
| endodontic treatment motorized | |||
| handpiece with root canal | |||
| measuring capability. It can be | |||
| used to enlarge canals while | |||
| monitoring the position of the file | |||
| tip inside the canal. It can be used | |||
| as a low-speed motorized | |||
| handpiece and device for | |||
| measuring canal length. This | |||
| device must only be used in | |||
| hospital environments, clinics or | |||
| dental offices by qualified dental | |||
| personnel. | Same | ||
| Patient populations | Adult | Adult | Same |
| Anatomical sites | Root canal, softened | ||
| dentin | Root canal, softened | ||
| dentin | Same | ||
| Where used | Dental clinic, University | ||
| hospital and the other | |||
| clinical settings | Dental clinic, University | ||
| hospital and the other | |||
| clinical settings | Same | ||
| Energy used and/or | |||
| delivered | Li-ion battery (DC 3.7V) | Li-ion battery (DC 3.7V) | Same |
| Exterior Design | 28.2cm × 19.0cm × 6.2cm | 21.5cm × 17.5cm × 9cm | Similar |
| Performance 1 - | |||
| canal enlargement | 150rpm-650rpm | ||
| 0.6N.cm-4N.cm | 120-1000 rpm | ||
| 0.5N.cm-4N.cm | Different | ||
| Performance 2 - | |||
| apex locator | Accuracy of the root apex | ||
| locator function: -0.5mm | Accuracy of the root apex | ||
| locator function: -0.5mm | Same | ||
| to +0.5mm for Apex position. | to +0.5mm for Apex position. | ||
| Materials | Used materials conform | Used materials conform | Same |
| Biocompatibility | to ISO10993. | to ISO10993. | Same |
| Spray Nozzle | Spray nozzle (Oil injector) | Spray nozzle | Same |
| Compatibility | |||
| with environment | |||
| and other devices | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same |
| Sterility | Contra Angle, Lip Hook, | ||
| File clip, Protective silicon cove | Contra Angle, Lip Hook, | ||
| File clip, Insulating | |||
| Sleeve autoclavable. | Same | ||
| Electrical safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Mechanical safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Thermal safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Radiation safety | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same |
5
Shenzhen Perfect Medical Instruments Co., Ltd. Room 102, Building A, Ruiji Factory, No. 3 Zaohekeng, Jixia Community, Nanwan Street, Longgang District,Shenzhen, P.R. China. 518100
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Different Analysis:
The rotation speed of Endo Motor is within the speed range of the predicate device, and it has passed performance test, no affect on safety or efficacy.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and FDA Guidance:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- A IEC 80601-2-60: 2019 Medical Electrical Equipment - Part 2-60: Particular Requirements for Basic
7
Safety and Essential Performance of Dental Equipment.
-
ISO 14457: 2017 Dentistry - Handpieces and motors
-
Moderate level of software documentation per the FDA Guidance for Software Contained in Medical Devices.
- A Reprocessing validation (i.e., cleaning, disinfection, and sterilization) per the FDA Guidance Document for Reprocessing Medical Devices in Healthcare Setting.
- A Comparative Root Canal Measurement Performance Test to evaluate the root canal length
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Endo Motor (Model: ZR-Rap) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201993.