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

Device Description

The Ultrasonic Surgical Aspirator System (Model: XD880B) is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissues, and can also be used for precise cutting and shaping of bone tissue, using with the liguid-flow sleeve and liquid-flow tube. The product can be applied to a number of departments according to the suitable parameters and accessories, including:

. Department of Neurosurgery, general surgery and other departments for soft tissue 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 Ultrasonic Surgical Aspirator System consists of a console, application software, foot switch, and accessories. The accessories include handpieces, tips, wrenches, liquid-flow sleeves, liquid-flow tubes, sterilization tray, suction canister and mobile cart. The handpiece, tip, liquid-flow sleeve and liquid-flow tube assemble to ultrasonic tool part to complete the cutting and fragment of soft tissue and bone tissue.

AI/ML Overview

This looks like a 510(k) summary for an Ultrasonic Surgical Aspirator System (Model: XD880B) seeking to demonstrate substantial equivalence to a predicate device (K202299).

Here's an analysis based on your request, focusing on acceptance criteria and supporting studies. It's important to note that for a Class II device like this, the focus is often on demonstrating equivalence to an existing device rather than establishing novel clinical efficacy against specific, quantitative acceptance criteria in the same way a new drug or high-risk device might. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs at least as well as the predicate device, especially for any design changes.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the entire device. Instead, it describes changes from the predicate and then cites testing to show these changes do not negatively impact safety or effectiveness.

However, based on the non-clinical performance data section, we can infer some "acceptance criteria" related to the modifications:

Acceptance Criteria (Inferred)	Reported Device Performance
Soft Tissue Protection in Bone Cutting Mode: Demonstrated effective protection of soft tissue.	"Safety and Performance Testing for Soft Tissue Protection in Bone Cutting Mode." (Successful performance implied)
Acoustic Performance for Modified Tips: Acoustic characteristics meet specifications.	"Acoustic Performance Testing for modified tips." (Performance meets specifications implied)
Cutting Efficiency for Modified Tips: Cutting efficiency is maintained or improved.	"Cutting Efficiency and Thermal testing Report for Modified Tips." (Efficiency maintained/improved implied)
Thermal Performance for Modified Tips: Thermal output remains within safe limits.	"Cutting Efficiency and Thermal testing Report for Modified Tips." (Safe thermal performance implied)
Overall Substantial Equivalence for Modified Tips: Modified tips are substantially equivalent.	"Comparison of Substantial Equivalence for Modified Tips." (Substantial equivalence demonstrated implied)

Note: The document states, "the test results confirm that the performance specifications meets the modification inputs." This is the general statement of "acceptance," indicating compliance with internal specifications derived from the predicate's performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical tests" and "bench testing." It does not specify sample sizes for these tests, nor does it provide details on data provenance like country of origin or whether a "retrospective" or "prospective" design applies to bench testing (these terms are more relevant for human data). These are laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is typically not relevant or included for non-clinical, bench testing of an ultrasonic surgical aspirator system. The "ground truth" for such tests would be measurable physical parameters (e.g., thermal output, acoustic frequency, cutting depth/speed) against established engineering specifications or comparisons to the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies, especially those involving subjective interpretations (e.g., image reading, clinical outcomes). Since the testing described is non-clinical bench testing, this concept and information are not applicable or provided.

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

An MRMC study is not mentioned as this device is not an AI-powered diagnostic imaging tool requiring human interpretation. It is a surgical tool.

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

This refers to the performance of an algorithm or AI without human involvement. The Ultrasonic Surgical Aspirator System is a physical surgical device, not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The device's performance is inherently linked to its physical operation properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests mentioned:

Soft Tissue Protection in Bone Cutting Mode: The ground truth would likely be based on objective measurements of tissue damage or protection, adhering to predetermined safety thresholds.
Acoustic Performance Testing for modified tips: The ground truth would be quantitative measurements of acoustic parameters (e.g., frequency spectrum, amplitude) compared to design specifications or predicate measurements.
Cutting Efficiency and Thermal testing Report for Modified Tips: The ground truth would be objective measurements of cutting speed/volume and temperature generated during operation, compared against predicate performance or safety limits.

The "ground truth" is thus based on objective physical measurements and engineering specifications, rather than subjective human interpretation, pathology, or clinical outcomes data for these non-clinical tests.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical surgical tool and not an AI or machine learning system, there is no "training set."

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

As there is no training set for an AI/ML model, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 27, 2021

SMTP Technology Co., Ltd. Songtao Zhan CTO 1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang Free Trade Zone, 215634 Jiangsu Province China

Re: K212750

Trade/Device Name: Ultrasonic Surgical Aspirator System, Model: XD880B Regulatory Class: Unclassified Product Code: LFL Dated: August 26, 2021 Received: August 30, 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 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). 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long H. Chen -S-5
Digitally signed by Long H. Chen
Date: 2021.09.27 15:18:39-04'00'

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) K212750

Device Name

Ultrasonic Surgical Aspirator System

Indications for Use (Describe)

· 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Ultrasonic Surgical Aspirator System

1. Date Prepared

Sep. 27th, 2021

2. Submitter's Information

Company Name:	SMTP Technology Co., Ltd.
Company Address:	1F&4F, Building A, Emerging Industry Incubation Center, Zhangjiagang Free Trade Zone, 215634, Jiangsu Province, CHINA
Fax:	+86 10 88572898 ext. 8005
Contact Person:	Songtao Zhan
	CTO
	Tel: +86 10 88572898
	zhansongtao@smtpmed.com

3. Trade Name, Common Name, Classification

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:	Class II
Classification Panel:	General & Plastic Surgery

4. Identification of Predicate Devices(s)

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

Manufacturer:	SMTP Technology Co., Ltd.
Trade Name:	Ultrasonic Surgical Aspirator System

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Classification Name: Regulation Number: Product Code: Class: Classification Panel: FDA 510 (k) #:

instrument, ultrasonic surgical N/A, Pre-Amendment LFL Class II General & Plastic Surgery K202299

5. Description of the Device

. Department of Neurosurgery, general surgery and other departments for soft tissue 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 Ultrasonic Surgical Aspirator System consists of a console, application software, foot switch, and accessories. The accessories include handpieces, tips, wrenches, liquid-flow sleeves, liquid-flow tubes, sterilization tray, suction canister and mobile cart. The handpiece, tip, liquid-flow sleeve and liquid-flow tube assemble to ultrasonic tool part to complete the cutting and fragment of soft tissue and bone tissue.

6. Indications for 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 -

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Laparoscopic Surgery -
Thoracoscopic Surgery -

7. Substantial Equivalence

Most the features and characteristics of the subject device Ultrasonic Surgical Aspirator System are identical to those of the predicate device under K202299, and where there are differences, such differences do not have an impact on the safety or effectiveness of the subject device.

The following Table 7A compares the subject device Ultrasonic Surgical Aspirator System to the predicate device.

State	SUBJECT DEVICE	PREDICATE DEVICEK202299
Manufacturer	SMTP Technology Co., Ltd.	SMTP Technology Co., Ltd.
Classification	Unclassified	Unclassified
Common/UsualName	Ultrasonic Surgical AspiratorUltrasonic Surgical System	Ultrasonic Surgical AspiratorUltrasonic Surgical System
RegulationPanel	General & Plastic Surgery	General & Plastic Surgery
Product Code	LFL	LFL
Indications forUse	The XD880B Ultrasonic SurgicalAspirator System is an ultrasonicsurgical system consisting ofhandpieces and associated tips.The product is intended for thefragmentation, emulsification andaspiration of both soft and hard(i.e. bone and boneapproximations) tissue, theintended use is as follows withdifferent configurations:NeurosurgeryGastrointestinal and AffiliatedOrgan SurgeryUrological surgeryPlastic and Reconstructive surgery	The XD880B Ultrasonic SurgicalAspirator System is an ultrasonicsurgical system consisting ofhandpieces and associated tips.The product is intended for thefragmentation, emulsification andaspiration of both soft and hard(i.e. bone and boneapproximations) tissue, theintended use is as follows withdifferent configurations:NeurosurgeryGastrointestinal and AffiliatedOrgan SurgeryUrological surgeryPlastic and Reconstructive surgery
	General Surgery	General Surgery
	Orthopedic Surgery	Orthopedic Surgery
	Gynecological Surgery	Gynecological Surgery
	Thoracic Surgery	Thoracic Surgery
	Wound Care	Wound Care
	Laparoscopic Surgery	Laparoscopic Surgery
	Thoracoscopic Surgery	Thoracoscopic Surgery
VibrationSystem	Continuous WaveFrequency:39kHz & 52kHz	Continuous WaveFrequency:39kHz & 52kHz
Electrical PowerSupply	100-240 VAC 50/60 Hz.	100-240 VAC 50/60 Hz.
Footswitch	Foot switch connected to thedevice control unit by means of acord.	Foot switch connected to thedevice control unit by means of acord.
Console	The functional parameters aredisplayed and controlled through aconsole with touch screen.	The functional parameters aredisplayed and controlled through aconsole with touch screen.
IrrigationSystem	Peristaltic pump.	Peristaltic pump.
Irrigation fluid	Adjustable between:5 to 120 ml/min.	Adjustable between:5 to 120 ml/min.
AspirationVacuum	600mmHg (80kPa) maximum	600mmHg (80kPa) maximum
Soft TissueProtection inBone CuttingMode	Yes	No
Blade with Slotof Cutting Tips	With slot	Without slot.
Dimensions	18.0cm H ×31.0cm W × 53.5cm D	18.0cm H ×31.0cm W × 53.5cm D
Weight	9.3kg	9.3kg

Table 7A – 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 is identified minor differences; the differences were supported with safety and performance testing, as appropriate, and do not affect device safety and performance. The subject device has same indications for use with predicate device. The technological characteristics differences listed

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in the above table between the subject device and the predicate device do not raise any new harms of safety and effectiveness.

Non-Clinical Performance Data:

SMTP completed the following non-clinical tests to demonstrate safety and effectiveness of Ultrasonic Surgical Aspirator System to show substantial equivalence to the predicate device, the test results confirm that the performance specifications meets the modification inputs. Bench Testing

. Safety and Performance Testing for Soft Tissue Protection in Bone Cutting Mode.
Acoustic Performance Testing for modified tips. ●
Cutting Efficiency and Thermal testing Report for Modified Tips.
. Comparison of Substantial Equivalence for Modified Tips.

Clinical Performance Data:

Clinical evaluation is not applicable for the proposed device.

8. Conclusion

The Ultrasonic Surgical Aspirator 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 harms of safety and effectiveness. Safety and performance testing have demonstrated the Ultrasonic Surgical Aspirator System is as safe and effective as the predicate device. Therefore, the subject device Ultrasonic Surgical Aspirator System is substantially equivalent to the predicate device.

Regulation Number and Section

N/A