(283 days)
NOT FOUND
No
The description focuses on the mechanical and ultrasonic aspects of the device, with no mention of AI or ML for data processing, decision making, or parameter adjustment.
No.
The device is used for cutting, fragmenting, and reshaping bone tissue in surgical procedures. It performs a surgical function but does not directly provide therapy or treatment for a disease or condition.
No
The device is described as an ultrasonic surgical system for cutting, osteotomy, osteoplasty, and drilling bone tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a console, handpiece, tips, wrenches, foot switch, and irrigation set. While the console has a software interface, the device's primary function relies on the interaction of these physical components to perform surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a system that uses ultrasonic vibrations to physically interact with and modify bone tissue. This is a mechanical/surgical function, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used for treatment.
N/A
Intended Use / 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.
Product codes
JDX
Device Description
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.
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
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains 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.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
| 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 Name: | Ultrasonic Osteotomy Surgical System |
|---|---|
| Classification Name: | Sonic Surgical instrument and |
| 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 |
| System | |
| Product Code: | JDX |
4
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 -
5
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, | ||
| foot switch and accessories. The | |||
| accessories include handpiece, | |||
| liquid-flow tube, | |||
| liquid-flow | |||
| sleeve, wrench | |||
| and | |||
| an | |||
| assortment of cutting tips. | The device consists of a console, | ||
| foot switch and accessories. The | |||
| accessories include handpiece, | |||
| liquid-flow tube, | |||
| liquid-flow | |||
| sleeve, wrench | |||
| and | |||
| an | |||
| assortment of cutting tips. | Same | ||
| 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: | 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 | - Otolaryngology
- Oral/maxillofacial
- Hand and foot
- Neurosurgery
- Spine
- Plastic/reconstructive | Same |
| User Interface | The functional parameters are
displayed
and
controlled
through a console with touch | The functional parameters are
displayed
and
controlled
through a console with touch | Same |
| | screen. | screen. | |
| Ultrasonic
vibration
activation | 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. | Same |
| | | | Similar |
| Irrigation
System | Peristaltic pump
The placement of pump is
vertical | Peristaltic pump
The placement pump is
horizontal | The subject device has
the same type peristaltic
pump with the predicate
device. The difference is
placement direction of
the pump. The direction
change does not impact
the flow rate parameter. |
| Wrench type | Torque wrench; Normal wrench | Normal wrench | Similar
The new torque wrench
has the same material
and function with the
normal wrench. The
torque wrench does not
contact patients. |
| Tip material | Titanium alloy | Titanium alloy | Same |
| Sterilization
Method | EO for disposable components
Moist heat for reusable
components | Moist heat | Similar
The subject device
provides sterilized
packaging by EO
sterilization for
disposable components.
The sterilization
methods and
parameters of all
components have been
verified and confirmed. |
| Performance Description | | | |
| Frequency | 39 kHz±4kHz | 39 kHz±4kHz | Same |
| Maximum
flow | 120ml/min±20% | 120ml/min±20% | Same |
| Ultrasound
output mode | Continuous or pulsed mode | Continuous or pulsed mode | Same |
| Electrical Description | | | |
| Electrical
Safety
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
length | About 3m | About 3m | Same |
| Conditions Description | | | |
| Operating
environment
conditions | Environment Temperature:10 °C
30°C1060hPa | Environment Temperature:
Relative Humidity: 30%75%,1060hPa | Environment Temperature:10 °C
no condensation
Atmospheric pressure:
700hPa
30°C50°C
Relative Humidity: 30%75%,1060hPa | Same |
no condensation
Atmospheric pressure:
700hPa
| Shipping and
storage
conditions | Environment Temperature:
30°C
Relative Humidity: ≤ 90%, no
condensation
Atmospheric pressure:
700hPa
30°C50°C1060hPa | Same |
Relative Humidity: ≤ 90%, no
condensation
Atmospheric pressure:
700hPa
Table 1 – Comparison of Characteristics
6
7
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.
8
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.