(164 days)
No
The device description focuses on the mechanical and electrical functions of a surgical drive system, with no mention of AI, ML, or related concepts. The performance studies are standard electrical safety, EMC, reprocessing, and software validation tests, not related to AI/ML performance.
No.
The device performs mechanical actions like drilling, milling, and sawing during surgical procedures, which are not therapeutic in nature. It is a surgical tool, not a treatment device.
No
Explanation: The device is described as a surgical drive system used for drilling, milling, sawing, and screwing in soft and hard tissue. Its function is to convert electrical energy into mechanical rotary motion for surgical procedures, not to diagnose conditions.
No
The device description explicitly states it is an electrical drive unit including a motor, power console, foot control, connection cables, and other accessories, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for mechanical actions (drilling, milling, sawing, screwing) on soft and hard tissue and bone. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details an electrical drive unit that converts electrical energy into mechanical motion for surgical procedures. This aligns with a surgical tool, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, reprocessing, sterility, and software validation – all relevant to a surgical device, but not typical for IVD performance evaluation (which would involve metrics like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a direct surgical function on the patient's body.
N/A
Intended Use / Indications for Use
The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery
Product codes
DZI, ERL
Device Description
The Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone.
The basic function of the Surgical Drive System is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and hard tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- Electrical safety test according to IEC 60601-1 and IEC 8060-2-60 standard;
- Electromagnetic compatibility test according to IEC 60601-1-2 and IEC/TR 60061-4-2 standard;
- -Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling;
- -Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile;
- -Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices;
- -Software verification and validation test according to the requirements of IEC 62304 and the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- -Validation of the effectiveness of reprocessing and validation of the maximum number of reprocessing according to ISO 17665-1:
The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device K213221.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 18, 2024
Guangdong Jinme Medical Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District, Guangzhou Guangdong. CHINA
Re: K240340
Trade/Device Name: Surgical Drive System (Model: ES70, ES90, E8) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZI, ERL Dated: February 5, 2024 Received: February 5, 2024
Dear Cassie Lee:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
Submission Number (if known)
Device Name
Surgical Drive System (Model: ES70, ES90, E8)
Indications for Use (Describe)
The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue.
Including: ENT surgery and Maxillofacial surgery
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."
4
510(k) Summary of K240340
1. Date of the summary prepared: July 17, 2024
2. Submitter's Information
Company Name: GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. Address: Room 301, 401, 501, Block No.3, Wanyang Science Park, 84 Taoyuan East Rd. Shishan Town, Nanhai District, Foshan, Guangdong, CHINA Contact name: Ying Yang Title: Manager Tel: +86-13929914992 Fax: / E-mail: 1109607962@qq.com
Application Correspondent
Contact Person: Ms. Cassie Lee Company: Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Title: Manager Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
3. Subject Device Information
Company Name: GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. Trade/Device Name: Surgical Drive System (Model: ES70, ES90, E8) Common Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Classification Name: Ear, nose, and throat electric or pneumatic surgical drill. Product Code: ERL, DZI Regulation Number: 21 CFR 874.4250, 21 CFR 874.4360 Review Panel: Ear Nose & Throat Regulatory Class: II
4. Predicate Device Information
510(k) Number: K213221 Company Name: W&H Dentalwerk Bürmoos GmbH Trade/Device Name: AMADEO, M-UK1015 (incl. attachments and accessories) Common Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Classification Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Product Code: ERL, DZI Regulation Number: 21 CFR 874.4250 Regulatory Class: II
5
5. Device Description
The Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone.
The basic function of the Surgical Drive System is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.
6. Intended Use / Indications for Use
The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery
7. Comparison to predicate devices
Compare with the predicate devices, the subject device is very similar in technical design, intended use/indications for use, functions, etc. And the differences between the subject device and predicate devices do not affect substantial equivalence. Please refer to the detailed Substantial Equivalence Comparison of the subject device and predicate devices in the following table.
| Elements of Comparison | Subject Device | Predicate Device 1
(Primary Predicate device) | Remark |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Company | GUANGDONG JINME
MEDICAL TECHNOLOGY
CO., LTD. | W&H Dentalwerk Bürmoos
GmbH | -- |
| Device Name | Surgical Drive System
(Model: ES70, ES90, E8) | AMADEO, M-UK1015 (incl.
attachments and
accessories) | -- |
| 510(k) Number | K240340 | K213221 | -- |
| Regulation Number | 21 CFR 874.4360, 21 CFR
874.4250 | 21 CFR 874.4360, 21 CFR
874.4250 | Same |
| Product Code | ERL, DZI | ERL, DZI | Same |
| Class | II | II | Same |
| Intended Use / Indications
for Use | The Surgical Drive System
(Model: ES70, ES90, E8)
is indicated for: drilling,
milling, cutting, sawing,
screwing (for positioning) | The drive unit for surgical
transmission instruments is
indicated for: drilling, milling,
cutting, sawing, screwing
(for positioning) of | Same |
6
| | of osteosynthesis screws,
implants and plate
systems in soft and hard
tissue.
Including: ENT surgery
and Maxillofacial surgery | osteosynthesis screws,
implants and plate systems
in soft and hard tissue.
Including: ENT surgery and
Maxillofacial surgery | |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Sterility | Provided non-sterile | Provided non-sterile | Same |
| Use | Rx only | Rx only | Same |
| Mains voltage | 110~220Va.c., 50Hz/60Hz | 120 V, 50-60 Hz | Similar
Note 1 |
| Frequency | | | |
| Operating Mode | Intermittent duty S3 (load
time max. 3min / rest time
min. 10min) | Intermittent duty S3 (load
time max. 3min / rest time
min. 5min) | Similar
Note 2 |
| Foot control | Wired | Wireless
Wired | Similar
Note 3 |
| Components | Control Unit
Motor (with the cable)
Foot control
Power cord
Pipeline head
Power fuse
Instruction for use | Control Unit
Motor
Handpiece (in different
versions)
Foot control (in different
versions)
Power cord
Instruction for use | Similar
Note 4 |
| Motor coupling systems
classification (ISO 3964) | Type 3 | No publicly available | Similar
Note 5 |
Comparison in Detail(s):
Note 1: Although the " Mains voltage Frequency" of the subject device is slightly different from the predicate devices, both the subject device and the predicate devices conducted the safety test according to the IEC 60601 series standards, and it meets the power supply requirements of the US, and the test results are in compliance with safety standards' requirements. So, the difference between the subject and predicate devices will not affect substantial equivalence.
Note 2: Although the "Operating Mode" of the subject device is slightly different from the predicate devices, both the subject device and predicate device K213221 are designed in the operating mode as Intermittent duty S3 and the max. Ioad time is the same and the min rest time is similar. The Rest time will not affect the treatment. The Rest time only affect the temperature raise and both the subject device and predicate devices conducted the IEC safety test, and the test results are in compliance with safety standards' requirements. So, the difference between the subject and predicate devices will not affect substantial equivalence.
7
Note 3: Although the "Foot control" designed with wire of the subject device is slightly different from the predicate devices, the predicate device K213221 has both wireless Foot control. So, the difference between the subject and predicate devices will not affect substantial equivalence.
Note 4: Although the "Components" of the subject device are slightly different from the predicate devices because they will provide different accessories or attachments. But all of them will provide the main components such as Control Unit, Motor, Foot control, Power cord, and Instruction for use. So, the difference between the subject and predicate devices will not affect substantial equivalence.
Note 5: Although the "Motor coupling systems classification (ISO 3964)" of the predicate device is not published our subject device designed the coupling systems classification (ISO 3964) as Type 3. Exactly, both the subject device and predicate device should be designed with proper specifications per ISO 3964 or an equivalent method. Furthermore, we also conducted the IEC series standards with a connected handpiece, the test results show that the subject device's performance can meet the standards' requirements without any accidentally disconnected. So, we can believe this difference between the subject and predicate devices will not affect substantial equivalence.
8. Test Summary
8.1 Summary of Non-clinical tests
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- Electrical safety test according to IEC 60601-1 and IEC 8060-2-60 standard; ।
- Electromagnetic compatibility test according to IEC 60601-1-2 and IEC/TR 60061-4-2 standard; -
- -Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling;
- -Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile;
- -Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices;
- -Software verification and validation test according to the requirements of IEC 62304 and the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- -Validation of the effectiveness of reprocessing and validation of the maximum number of reprocessing according to ISO 17665-1:
8.2 Summary of Clinical Testing
Clinical testing is not required for this submission. The non-clinical performance testing described above is sufficient to support substantial equivalence of the subject device to the predicate.
9. Final conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device K213221.