Ultrasonic Osteotomy Surgical System

K201274 · Smtp Technology Co., Ltd. · JDX · Feb 19, 2021 · Orthopedic

Device Facts

• Record ID: K201274
• Device Name: Ultrasonic Osteotomy Surgical System
• Applicant: Smtp Technology Co., Ltd.
• Product Code: JDX · Orthopedic
• Decision Date: Feb 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive.

Device Story

Ultrasonic surgical system for bone cutting/shaping; utilizes piezoelectric transducer to convert electrical energy into mechanical microvibrations (39 kHz) at tip insert. System comprises console with integrated peristaltic irrigation pump, handpiece, cutting tips, and footswitch. Operated by surgeon in clinical settings; console touch screen allows parameter selection/visualization. Footswitch activates ultrasonic vibration and irrigation flow simultaneously. Mechanical energy fragments/reshapes bone tissue via high-frequency, small-amplitude longitudinal vibration. Irrigation provides sterile fluid to surgical site. Output allows precise bone surgery; benefits include controlled cutting with reduced thermal damage compared to traditional mechanical drills.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including ultrasound performance, irrigation flow, cutting efficiency, thermal testing, mechanical torque wrench testing, and sterilization/shelf-life validation.

Technological Characteristics

Piezoelectric ultrasonic transducer; 39 kHz ± 4 kHz operating frequency; titanium alloy tips; peristaltic irrigation pump; Class I, Type BF applied part; 100-240 VAC power; touch screen interface; EO sterilization for disposables, moist heat for reusable components.

Indications for Use

Indicated for bone cutting, osteotomy, osteoplasty, and drilling in otolaryngology, oral/maxillofacial, hand/foot, neurosurgery, spine, and plastic/reconstructive surgical procedures.

Regulatory Classification

Identification

A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Predicate Devices

• XD880A Ultrasonic Osteotomy Surgical System (K172464)

Submission Summary (Full Text)

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SMTP Technology Co., Ltd Songtao Zhan Contact Address1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang, Jiangsu 215634 China

Re: K201274

Trade/Device Name: Ultrasonic Osteotomy Surgical System Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: Class II Product Code: JDX Dated: January 9, 2021 Received: January 21, 2021

Dear Songtao Zhan:

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 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.

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

February 19, 2021

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device reporting (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic 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) K201274

#### Device Name

Ultrasonic Osteotomy Surgical System

Indications for Use (Describe)

Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:

- Otolaryngology
- Oral/maxillofacial
- Hand and foot
- Neurosurgery
- Spine
- Plastic/reconstructive.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------|
| <div> <input type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# Ultrasonic Osteotomy Surgical System 510 (k) Summary

# 1. Date Prepared

February 19th, 2021

# 2. Submitter's Information

| Company Name: | SMTP Technology Co., Ltd. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 1F&4F, Building A, Emerging Industry<br>Incubation Center, Zhangjiagang Free Trade<br>Zone, 215634, Jiangsu Province, CHINA |
| Fax: | [phone] ext. 8005 |
| Contact Person: | Songtao Zhan<br>CTO<br>Tel: [phone]<br>[e-mail] |

#### 3. Trade Name, Common Name, Classification

| Trade Name: | Ultrasonic Osteotomy Surgical System |
|----------------------|----------------------------------------------------------|
| Classification Name: | Sonic Surgical instrument and<br>accessories/attachments |
| Product Code: | JDX |
| Regulation Number: | 21 CFR 888.4580 |
| Device Class: | Class II |

#### 4. Identification of Predicate Devices(s)

The identification of predicate device within this submission is as follow:

| Manufacturer: | SMTP Technology Co., Ltd. |
|---------------|------------------------------------------------|
| Trade Name: | XD880A Ultrasonic Osteotomy Surgical<br>System |
| Product Code: | JDX |

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Classification Name:

Regulation Number: FDA 510 (k) #:

Sonic Surgical instrument and accessories/attachments 21 CFR 888.4580 K172464

#### 5. Description of the Device

Ultrasonic Osteotomy Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the cutting tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude.

Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of cutting tips, wrench and torque wrench, a foot switch and irrigation set (liquid-flow tube and liquid-flow sleeve).

The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition.

The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.

# 6. Indications for Use

Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:

- -Otolaryngology
- -Oral/maxillofacial
- -Hand and foot
- -Neurosurgery
- -Spine
- Plastic/reconstructive -

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# 7. Substantial Equivalence

Most the features and characteristics of proposed Ultrasonic Osteotomy Surgical System (subject device) are identical to those of the predicate device (K172464), and where there are differences, such differences do not have impact on the safety or effectiveness of the subject device.

The following table compares the subject device Ultrasonic Osteotomy Surgical System to the predicate device.

| State | Subject Device | Predicate Device | Comparison |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Description | | | |
| Manufacturer | SMTP Technology Co., Ltd. | SMTP Technology Co., Ltd. | Same |
| Composition | The device consists of a console,<br>foot switch and accessories. The<br>accessories include handpiece,<br>liquid-flow tube,<br>liquid-flow<br>sleeve, wrench<br>and<br>an<br>assortment of cutting tips. | The device consists of a console,<br>foot switch and accessories. The<br>accessories include handpiece,<br>liquid-flow tube,<br>liquid-flow<br>sleeve, wrench<br>and<br>an<br>assortment of cutting tips. | Same |
| Indications for<br>Use | Ultrasonic Osteotomy Surgical<br>System is an ultrasonic surgical<br>system consisting of a handpiece<br>and associated tips for cutting<br>bone, osteotomy, osteoplasty<br>and drilling in a variety of<br>surgical procedures, including<br>but not limited to: | Ultrasonic Osteotomy Surgical<br>System is an ultrasonic surgical<br>system consisting of a handpiece<br>and associated tips for cutting<br>bone, osteotomy, osteoplasty<br>and drilling in a variety of<br>surgical procedures, including<br>but not limited to: | |
| | - Otolaryngology<br>- Oral/maxillofacial<br>- Hand and foot<br>- Neurosurgery<br>- Spine<br>- Plastic/reconstructive | - Otolaryngology<br>- Oral/maxillofacial<br>- Hand and foot<br>- Neurosurgery<br>- Spine<br>- Plastic/reconstructive | Same |
| User Interface | The functional parameters are<br>displayed<br>and<br>controlled<br>through a console with touch | The functional parameters are<br>displayed<br>and<br>controlled<br>through a console with touch | Same |
| | screen. | screen. | |
| Ultrasonic<br>vibration<br>activation | Foot switch connected to the<br>device control unit by means of<br>a cord. | Foot switch connected to the<br>device control unit by means of<br>a cord. | Same |
| | | | Similar |
| Irrigation<br>System | Peristaltic pump<br>The placement of pump is<br>vertical | Peristaltic pump<br>The placement pump is<br>horizontal | The subject device has<br>the same type peristaltic<br>pump with the predicate<br>device. The difference is<br>placement direction of<br>the pump. The direction<br>change does not impact<br>the flow rate parameter. |
| Wrench type | Torque wrench; Normal wrench | Normal wrench | Similar<br>The new torque wrench<br>has the same material<br>and function with the<br>normal wrench. The<br>torque wrench does not<br>contact patients. |
| Tip material | Titanium alloy | Titanium alloy | Same |
| Sterilization<br>Method | EO for disposable components<br>Moist heat for reusable<br>components | Moist heat | Similar<br>The subject device<br>provides sterilized<br>packaging by EO<br>sterilization for<br>disposable components.<br>The sterilization<br>methods and<br>parameters of all<br>components have been<br>verified and confirmed. |
| Performance Description | | | |
| Frequency | 39 kHz±4kHz | 39 kHz±4kHz | Same |
| Maximum<br>flow | 120ml/min±20% | 120ml/min±20% | Same |
| Ultrasound<br>output mode | Continuous or pulsed mode | Continuous or pulsed mode | Same |
| Electrical Description | | | |
| Electrical<br>Safety<br>Classification | Class I, Type BF Applied Part | Class I, Type BF Applied Part | Same |
| Power supply | 100-240 VAC, 50/60 Hz. | 100-240 VAC, 50/60 Hz. | Same |
| Power cord<br>length | About 3m | About 3m | Same |
| Conditions Description | | | |
| Operating<br>environment<br>conditions | Environment Temperature:10 °C<br>~30°C<br>Relative Humidity: 30%~75%,<br>no condensation<br>Atmospheric pressure:<br>700hPa~1060hPa | Environment Temperature:10 °C<br>~30°C<br>Relative Humidity: 30%~75%,<br>no condensation<br>Atmospheric pressure:<br>700hPa~1060hPa | Same |
| Shipping and<br>storage<br>conditions | Environment Temperature:<br>30°C~50°C<br>Relative Humidity: ≤ 90%, no<br>condensation<br>Atmospheric pressure:<br>700hPa~1060hPa | Environment Temperature:<br>30°C~50°C<br>Relative Humidity: ≤ 90%, no<br>condensation<br>Atmospheric pressure:<br>700hPa~1060hPa | Same |

# Table 1 – Comparison of Characteristics

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#### Discussion of Substantial Equivalence:

Comparison of General information, Product performance, Electrical characteristics, and Conditions between the predicate device and the subject device Ultrasonic Osteotomy Surgical System, minor differences with the Predicate device was identified. The differences were supported with safety and performance testing, as appropriate, and are not likely to affect device safety and performance. The subject device has same indications for use. The technological characteristics differences listed in the above table between the subject device and the predicate device do not raise any new questions of safety and effectiveness.

#### Non-Clinical Performance Data:

SMTP completed the following non-clinical tests to demonstrate safety and effectiveness of Ultrasonic Osteotomy Surgical System and to show substantial equivalence to the predicate device, the test results confirm that the design inputs and performance specifications for the Ultrasonic Osteotomy Surgical System are met.

#### Sterilization and Shelf Life

#### Single Use Disposable Components – Sterile packaging provided

Cutting tip, liquid-flow tube and liquid-flow sleeves are provided sterile and are for single use. The submission includes EO sterilization validation tests for sterile package.

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The submission also includes sterile barrier testing, device performance testing on sterilized, simulated shipment testing, accelerated and natural aged testing to support the claimed shelf life.

#### Reusable Components – End user cleaned and sterilized

The reusable handpiece and wrenches are cleaned and sterilized by end user before each use. The cleaning and sterilization testing for each reusable component are performed.

#### Bench Testing

- . Ultrasound Performance Testing
- Irrigation Performance Testing
- Cutting Efficiency and Thermal Testing
- Mechanical Testing for Torque Wrench

# Clinical Performance Data:

Clinical evaluation is not applicable for the proposed device.

# 8. Conclusion

The Ultrasonic Osteotomy Surgical System has the same intended use as the predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Safety and performance testing have demonstrated the Ultrasonic Osteotomy Surgical System is as safe and effective as the predicate device. Based on the information contained within this submission, it is concluded that the Ultrasonic Osteotomy Surgical System is substantially equivalent to the predicate device which is already in commercial distribution in the United States.