Ultrasonic Surgical Aspirator System

K202299 · Smtp Technology Co., Ltd. · LFL · May 21, 2021 · SU

Device Facts

• Record ID: K202299
• Device Name: Ultrasonic Surgical Aspirator System
• Applicant: Smtp Technology Co., Ltd.
• Product Code: LFL · SU
• Decision Date: May 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Wound Care Laparoscopic Surgery Thoracoscopic Surgery

Device Story

Ultrasonic surgical aspirator system; consists of console, foot switch, handpieces, and tips. Inputs: electrical power; user-selected parameters via touchscreen. Operation: console drives ultrasonic handpiece to generate continuous wave vibrations (39kHz/52kHz) for tissue fragmentation/emulsification; integrated peristaltic pump provides irrigation; vacuum system provides aspiration. Output: fragmented/emulsified tissue removed via suction. Used in OR/clinical settings by surgeons for soft tissue debridement and bone cutting/shaping. Healthcare providers monitor parameters on console; output facilitates precise tissue removal, reducing collateral damage. Benefits: precise tissue management across multiple surgical specialties.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software V&V (IEC 62304), sterilization validation (ISO 17665-1, ISO 11135), shelf-life, handpiece lifetime, and acoustic performance (IEC 61847).

Technological Characteristics

Ultrasonic surgical aspirator; continuous wave vibration at 39kHz and 52kHz. Peristaltic irrigation pump (5-120 ml/min); vacuum aspiration (max 600mmHg). Console with touchscreen interface. Power: 100-240 VAC, 50/60 Hz. Sterilization: moist heat (ISO 17665-1) and EO (ISO 11135).

Indications for Use

Indicated for fragmentation, emulsification, and aspiration of soft and hard (bone) tissue in neurosurgery, GI, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, and wound care surgeries, including laparoscopic and thoracoscopic procedures.

Predicate Devices

• Alliger Ultrasonic Surgical System Model AUSS-7 (K070313)
• FS 1000 RF Ultrasonic Surgical Aspirator System and Accessories (K062471)

Reference Devices

• XD880A Ultrasonic Osteotomy Surgical System (K172464)

Submission Summary (Full Text)

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May 21, 2021

SMTP Technology Co., Ltd % Randy Jiang Sr. consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K202299

Trade/Device Name: Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: April 13, 2021 Received: April 19, 2021

Dear Randy Jiang:

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/cdth/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.

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,

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including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical 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-devices/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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe 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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K202299

#### Device Name

Ultrasonic Surgical Aspirator System

#### Indications for Use (Describe)

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological surgery
- · Plastic and Reconstructive surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery
- · Thoracic Surgery
- · Wound Care
- · Laparoscopic Surgery
- · Thoracoscopic Surgery

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">Prescription Use (Part 21 CFR 201 Subpart D)</span> | <span style="text-decoration: overline;">Over-The-Counter Use (21 CFR 201 Subpart C)</span> |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

## Ultrasonic Surgical Aspirator System

#### 1. Submission Sponsor

SMTP Technology Co., Ltd. 1F&4F, Building A, Emerging Incubation Center, Zhangjiagang Free Trade Zone, Jiangsu Province, China. Contact: Songtao Zhan Title: CTO Phone number: [phone]

#### 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: [e-mail] Contact: Randy Jiang Title: Senior Consultant

#### 3. Date Prepared

May, 19th, 2021

#### 4. Device Identification

| Trade/Proprietary Name: | Ultrasonic Surgical Aspirator System |
|-------------------------|--------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical Aspirator |
| Classification Name: | instrument, ultrasonic surgical |
| Regulation Number: | N/A, Pre-Amendment |
| Product Code: | LFL |
| Class: | Unclassified |
| Classification Panel: | General & Plastic Surgery |

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| | K# | Name | Manufacturer |
|-------------------------------|---------|--------------------------------------------------------------------|--------------------------|
| Primary Predicate<br>Device | K070313 | Alliger Ultrasonic Surgical System<br>Model AUSS-7 | Misonix Inc. |
| Secondary Predicate<br>Device | K062471 | FS 1000 RF Ultrasonic Surgical<br>Aspirator System and Accessories | Misonix Inc. |
| Reference Device | K172464 | XD880A Ultrasonic Osteotomy<br>Surgical System | SMTP Technology Co., Ltd |

#### 5. Legally Marketed Predicate Device(s)

#### 6. Indication for Use Statement

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- . Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- . Gynecological Surgery
- Thoracic Surgery
- Wound Care
- . Laparoscopic Surgery
- Thoracoscopic Surgery

#### 7. Device Description

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:

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- . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
- . Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
- . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.

The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.

#### 8. Substantial Equivalence Discussion

The following Table 1 compares the Ultrasonic Surgical Aspirator System to the predicate devices with respect to intended use, power supply, product classification, irrigation system, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate devices.

| Attribute | Subject device | Primary Predicate Device<br>(K070313) | Secondary Predicate<br>Device (K062471) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SMTP Technology Co.,<br>Ltd. | Misonix Inc. | Misonix Inc. |
| Classification | Unclassified | Unclassified | Unclassified |
| Common/Usual<br>Name | Ultrasonic Surgical<br>Aspirator<br>Ultrasonic Surgical<br>System | Ultrasonic Surgical<br>Aspirator<br>Ultrasonic Surgical System | Ultrasonic Surgical<br>Aspirator<br>Ultrasonic Surgical<br>System |
| Regulation Panel | General & Plastic<br>Surgery | General & Plastic Surgery | General & Plastic Surgery |
| Product Code | LFL | LFL | LFL |
| Indications for<br>Use | The XD880B Ultrasonic<br>Surgical Aspirator<br>System is an ultrasonic<br>surgical system<br>consisting of | The Misonix Inc. AUSS-7<br>Ultrasonic Surgical System<br>is indicated for use in the<br>fragmentation and<br>aspiration of both soft and | The Misonix Inc. FS 1000<br>RE Ultrasonic Aspirator<br>System is indicated for<br>use in the fragmentation,<br>emulsification and |
| | handpieces and<br>associated tips. The<br>product is intended for<br>the fragmentation,<br>emulsification and<br>aspiration of both soft<br>and hard (i.e. bone and<br>bone approximations)<br>tissue, the intended<br>use is as follows with<br>different<br>configurations:<br>Neurosurgery Gastrointestinal<br>and Affiliated<br>Organ Surgery Urological Surgery Plastic and<br>Reconstructive<br>Surgery General Surgery Orthopedic<br>Surgery Gynecological<br>Surgery Thoracic Surgery Wound Care Laparoscopic<br>Surgery Thoracoscopic<br>Surgery | hard (e.g.: bone) tissue in<br>the following surgical<br>specialties:<br>Neurosurgery Gastrointestinal and<br>Affiliated Organ<br>Surgery Urological Surgery Plastic and<br>Reconstructive<br>Surgery General Surgery Orthopedic Surgery Gynecology Thoracic Surgery Wound Care | aspiration of both soft<br>and hard (i.e. bone)<br>tissue in the following<br>surgical specialties:<br>Neurosurgery Gastrointestinal and<br>Affiliated Organ<br>Surgery Urological Surgery Plastic and<br>Reconstructive<br>Surgery General Surgery Orthopedic Surgery Gynecological<br>Surgery Thoracic Surgery Laparoscopic<br>Surgery Thoracoscopic<br>Surgery The system may also be<br>combined with<br>electrosurgery using<br>optional RF Surgery<br>interface components. |
| Vibration System | Continuous Wave<br>Frequency:<br>39kHz & 52kHz | Continuous Wave<br>Frequency:<br>22.0-24.5 kHz | Continuous Wave<br>Frequency: 23+/-1 kHz or<br>22-24 kHz |
| Electrical Power<br>Supply | 100-240 VAC 50/60 Hz. | 100-130 VAC 6.5 Amps,<br>50/60 Hz<br>200/250 VAC 2.25 Amps,<br>50/60 Hz | 115 VAC and 230 VAC<br>50/60Hz |
| Power Input<br>Current | 3.6A max | 6.5A at 100-130 VAC,<br>3.25A at 200/250 VAC | 4A max |
| Footswitch | Foot switch connected<br>to the device control<br>unit by means of a<br>cord. | Wired (connected to rear<br>panel of console), Single<br>pedal footswitch to<br>activate delivery of<br>ultrasound and irrigation | Wired<br>- On/Off Pedal for<br>amplitude, irrigation and<br>aspiration - Flush Button<br>- COAG with CUT lockout<br>feature<br>- COAG simultaneous<br>with ultrasound<br>- COAG only |
| Console | The functional<br>parameters are<br>displayed and<br>controlled through a<br>console with touch<br>screen. | Console with membrane<br>control panel and graphical<br>user interface | Console with membrane<br>control panel and LED<br>indicators. |
| Device contains<br>Software | Yes | Yes | Yes |
| Irrigation System | Peristaltic pump. | Peristaltic pump | Peristaltic pump |
| Irrigation fluid | Adjustable between:<br>5 to 120 ml/min. | Adjustable:<br>0 - 100 ml/min | Up to 10cc/min |
| Aspiration<br>Vacuum | 600mmHg (80kPa)<br>maximum | Max: 28" Hg Max | Min: less than 0.5" Hg<br>Max: 25" Hg |
| Dimensions | 18.0cm H × 31.0cm W ×<br>53.5cm D | 18.0cm H x 41.0cm W x<br>68.5cm D | 102cm H x 63.5cm W x<br>48cm D |
| Weight | 9.3kg | 11.6 kg | 54.5 kg |

#### Table 1 – Comparison of Characteristics

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#### 9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of XD880B Ultrasonic Surgical Aspirator System and to show substantial equivalence to the predicate devices, SMTP Technology Co., Ltd. completed the following nonclinical tests. Results confirm that the design inputs and performance specifications for the device are met. The XD880B Ultrasonic Surgical Aspirator System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate devices:

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- Electrical safety testing per IEC 60601-1 - Passed
- . EMC testing per IEC 60601-1-2 - Passed
- . Software verification and validation per IEC 62304/FDA Guidance - Passed
- . Moist heat sterilization validation per ISO 17665-1- Passed
- EO sterilization validation per ISO 11135 - Passed, demonstrates SAL of 106
- Shelf-life Testing - Passed
- Lifetime validation test for handpieces - Passed
- . Acoustic Performance Test per IEC61847 - Passed
- . Efficiency and Temperature Characteristics Test - Passed

#### 10. Clinical Performance Data

Not applicable.

#### 11. Statement of Substantial Equivalence

The XD880B Ultrasonic Surgical Aspirator System has the same intended use as the predicate devices, and the same or similar indications and technological characteristics. The differences do not raise new or different questions of safety and effectiveness. Electrical safety and performance testing have demonstrated the XD880B Ultrasonic Surgical Aspirator System is as safe and effective as the predicate devices. Therefore, the XD880B Ultrasonic Surgical Aspirator System is substantially equivalent to the predicate devices.