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

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.

AI/ML Overview

This FDA 510(k) summary (K240340) for the Surgical Drive System (Model: ES70, ES90, E8) describes a device that is not an AI/ML-driven medical device. The document focuses on establishing substantial equivalence to a predicate device based on technical design, intended use, and conventional performance and safety testing.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, cannot be extracted from this document because it does not involve AI/ML.

However, I can provide a summary of the non-clinical performance testing that was conducted to support the substantial equivalence claim for this medical device, which addresses the "study that proves the device meets the acceptance criteria" in a general sense, but not for AI/ML specific criteria.

Non-AI/ML Related Acceptance Criteria and Study Summary (Based on Provided Document):

The acceptance criteria for this non-AI/ML device are primarily related to safety, electromagnetic compatibility, and reprocessing effectiveness, demonstrated through adherence to recognized international standards.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML):

Acceptance Criteria (Standard Compliance)	Reported Device Performance
Electrical Safety: IEC 60601-1 and IEC 8060-2-60	Test results in compliance with safety standards
Electromagnetic Compatibility: IEC 60601-1-2 and IEC/TR 60061-4-2	Test results in compliance with safety standards
Reprocessing (Effectiveness & Max Number): ISO 17665-1; FDA Guidance (Reprocessing Medical Devices)	Validation performed, effectiveness confirmed
Software Verification & Validation: IEC 62304 and FDA Guidance (Software in Medical Devices)	Verification and validation performed, requirements met
Motor Coupling Systems Classification (ISO 3964): Type 3 (proper specifications as per ISO 3964 or equivalent)	Test results show performance meets standards, no accidental disconnection

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in terms of number of devices / units. Testing would typically involve a statistically relevant sample of devices or components to demonstrate compliance with standards.
Data Provenance: Not explicitly stated, but testing is implied to be conducted by the manufacturer (Guangdong Jinme Medical Technology Co., Ltd.) or a contracted testing facility. The nature of these tests (safety, EMC, reprocessing validation) implies prospective testing on manufactured devices to meet specific engineering and regulatory requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable as this is a non-AI/ML device. "Ground truth" established by expert consensus is typically relevant for evaluating the diagnostic or classification performance of AI/ML algorithms. For this device, compliance is measured against engineering specifications, industry standards, and regulatory requirements, which do not rely on expert "ground truth" in the same way.

4. Adjudication method for the test set:

Not applicable for a non-AI/ML device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or performance evaluations for diagnostic devices to resolve discrepancies in expert interpretations, particularly for establishing ground truth for AI model training or testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable as this is a surgical drive system, not an AI-driven diagnostic or assistive imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable as this is a hardware-based surgical drive system, not an AI algorithm.

7. The type of ground truth used:

For this device, "ground truth" is established by:
- Engineering Specifications: The device is designed to meet specific performance parameters (e.g., motor speed, power output, operating mode).
- International Standards: Compliance with established safety (e.g., IEC 60601-1), EMC (e.g., IEC 60601-1-2), and reprocessing (e.g., ISO 17665-1) standards, where the standard itself defines the acceptable criteria and test methods.
- Software Design Requirements: For the device's control software, compliance is against its own validated design requirements and IEC 62304.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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.

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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).

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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

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Indications for Use

Submission Number (if known)

K240340

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)

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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

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5. Device Description

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

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 JINMEMEDICAL TECHNOLOGYCO., LTD.	W&H Dentalwerk BürmoosGmbH	--
Device Name	Surgical Drive System(Model: ES70, ES90, E8)	AMADEO, M-UK1015 (incl.attachments andaccessories)	--
510(k) Number	K240340	K213221	--
Regulation Number	21 CFR 874.4360, 21 CFR874.4250	21 CFR 874.4360, 21 CFR874.4250	Same
Product Code	ERL, DZI	ERL, DZI	Same
Class	II	II	Same
Intended Use / Indicationsfor Use	The Surgical Drive System(Model: ES70, ES90, E8)is indicated for: drilling,milling, cutting, sawing,screwing (for positioning)	The drive unit for surgicaltransmission instruments isindicated for: drilling, milling,cutting, sawing, screwing(for positioning) of	Same

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	of osteosynthesis screws,implants and platesystems in soft and hardtissue.Including: ENT surgeryand Maxillofacial surgery	osteosynthesis screws,implants and plate systemsin soft and hard tissue.Including: ENT surgery andMaxillofacial 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	SimilarNote 1
Frequency
Operating Mode	Intermittent duty S3 (loadtime max. 3min / rest timemin. 10min)	Intermittent duty S3 (loadtime max. 3min / rest timemin. 5min)	SimilarNote 2
Foot control	Wired	WirelessWired	SimilarNote 3
Components	Control UnitMotor (with the cable)Foot controlPower cordPipeline headPower fuseInstruction for use	Control UnitMotorHandpiece (in differentversions)Foot control (in differentversions)Power cordInstruction for use	SimilarNote 4
Motor coupling systemsclassification (ISO 3964)	Type 3	No publicly available	SimilarNote 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.

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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.

Regulation Number and Section

§ 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.