(28 days)
Not Found
No
The document describes a standard ultrasonic surgical aspirator system and does not mention any AI or ML components in the intended use, device description, or performance studies.
Yes
The device is used for surgical procedures like fragmentation, emulsification, aspiration, and debridement of tissues, which directly address a health condition or restore normal function.
No
Explanation: The device is described as an "ultrasonic surgical system" and an "ultrasonic powered surgical tool" intended for "fragmentation, emulsification," "breakage, aspiration and debridement of soft tissues," and "cutting and shaping of bone tissue." These are all therapeutic or interventional functions, not diagnostic ones.
No
The device description explicitly states that the system consists of a console, foot switch, and accessories including handpieces and tips, which are hardware components. While it mentions "application software," the device is clearly a physical surgical system with software as one component.
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 system for the fragmentation, emulsification, cutting, and shaping of tissues (soft and hard). This is a direct surgical intervention on the patient's body.
- Device Description: The description details a surgical tool that performs physical actions on tissue (breakage, aspiration, debridement, cutting, shaping).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) to perform surgical procedures.
N/A
Intended Use / 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 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
Product codes
LFL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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,
1
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)
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
4
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
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.
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 -
5
- 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 DEVICE
K202299 |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SMTP Technology Co., Ltd. | SMTP Technology Co., Ltd. |
| Classification | Unclassified | Unclassified |
| Common/Usual
Name | Ultrasonic Surgical Aspirator
Ultrasonic Surgical System | Ultrasonic Surgical Aspirator
Ultrasonic Surgical System |
| Regulation
Panel | General & Plastic Surgery | General & Plastic Surgery |
| Product Code | LFL | LFL |
| 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 | 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 | 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 |
| Vibration
System | Continuous Wave
Frequency:
39kHz & 52kHz | Continuous Wave
Frequency:
39kHz & 52kHz |
| Electrical Power
Supply | 100-240 VAC 50/60 Hz. | 100-240 VAC 50/60 Hz. |
| Footswitch | Foot switch connected to the
device control unit by means of a
cord. | Foot switch connected to the
device control unit by means of a
cord. |
| Console | The functional parameters are
displayed and controlled through a
console with touch screen. | The functional parameters are
displayed and controlled through a
console with touch screen. |
| Irrigation
System | Peristaltic pump. | Peristaltic pump. |
| Irrigation fluid | Adjustable between:
5 to 120 ml/min. | Adjustable between:
5 to 120 ml/min. |
| Aspiration
Vacuum | 600mmHg (80kPa) maximum | 600mmHg (80kPa) maximum |
| Soft Tissue
Protection in
Bone Cutting
Mode | Yes | No |
| Blade with Slot
of 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
7
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.