(253 days)
Not Found
No
The device description mentions a "micro-processor electronic board that controls and supervises the functional parameters of the device," which is standard for medical devices and does not indicate AI/ML. There is no mention of AI, ML, deep learning, neural networks, or any related terms in the document. The performance studies focus on traditional metrics like safety, efficiency, and biocompatibility, not AI/ML performance metrics.
Yes.
The device is an ultrasonic surgical system used for cutting bone, osteotomy, osteoplasty, and drilling in various surgical procedures, which are therapeutic interventions.
No.
Explanation: The XD880A Ultrasonic Osteotomy Surgical System is described as an ultrasonic surgical device used for cutting bone, osteotomy, osteoplasty, and drilling. Its function is to perform surgical procedures, not to diagnose a condition or disease.
No
The device description clearly outlines multiple hardware components including a console, handpiece, tips, torque wrench, footswitch, irrigation set, peristaltic pump, ultrasonic generator, electrical power supply module, and a micro-processor electronic board. While software is mentioned for control and supervision, it is integrated within and controls these physical components, making it a hardware-based system with embedded software, not a software-only medical device.
Based on the provided information, the XD880A Ultrasonic Osteotomy Surgical System is not an In Vitro Diagnostic (IVD) device.
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 a patient's body for therapeutic or procedural purposes.
- Device Description: The description details a surgical system with a handpiece, tips, console, and irrigation system designed to perform physical actions on bone tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
- Anatomical Site: The anatomical sites listed (Bone, tissue/bone/indirect blood path, spinal cord, spinal canal, vertebral plate, flat joints, spinous process, back legs) are all parts of the patient's body where the surgical procedure is performed.
- Performance Studies: The performance studies focus on the device's safety and efficiency in performing surgical procedures on bone, not on the analysis of biological samples.
In summary, the XD880A Ultrasonic Osteotomy Surgical System is a surgical device used for performing procedures on a patient's body, not for analyzing biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
XD880A 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 (comma separated list FDA assigned to the subject device)
JDX, DZI, ERL, HBE, HWE
Device Description
XD880A Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch and an 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. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device.
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.
XD880A Ultrasonic Osteotomy Surgery System uses ultrasonic technology to generate mechanical micro-vibrations 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 tip insert.
The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude (less than 0.12mm), while keeping the soft tissues with elastic properties and free of damage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone (including spine and vertebral plate), soft tissues
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical Safety and Electromagnetic Compatibility (EMC): The system complies with the IEC 60601-1:2006 standards for safety and the IEC 60601-1-2:2007/2010 standard for EMC.
Biocompatibility: XD880A Ultrasonic Osteotomy Surgical System components that come into direct contact with patients during surgical procedures are the handpiece and tips inserts. These components are classified as 'external communicating devices', as they get in contact with 'tissue/bone/indirect blood path' for a duration less than 24 hours. The cutting tips are made of Titanium Alloy TC4. The liquid-flow sleeve and liquid-flow tube are made of Medical Silicone Rubber. Both materials showed to be biocompatible.
Software Verification and Validation: Software verification and validation testing were conducted in line with the requirements of FDA Guidance 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', 11 May 2005. The software for this device was considered as a "moderate level of concern".
Mechanical and Acoustic Testing: Bench testing and acoustic testing were conducted on the subject device. Testing results demonstrated that the subject device performs within its specifications.
Animal Study: A GLP animal study has been conducted with the 15 types of tips on 10 beagles. The objective of the study was to evaluate the efficiency, convenience and safety of the 15 tips during spine surgery. Animals were split into two groups of 5 animals each. The 15 types of tips were split between the two groups of animals. All animals were anesthetized and surgery was performed to cut the vertebral plate with XD880A Ultrasonic Osteotomy Surgical Tips.
The tips' efficiency was evaluated by analyzing the cutting time of the bone and bleeding volume when using each tip on the animals. The tips' safety was evaluated by monitoring and recording neurophysiological parameters of each animal prior, during and after the surgery, including Sensory Evoked Potential (SEP) latent period and fluctuation, and Motor Evoked Potential (MEP). A clinical observation of animals' mental state and behavior was performed on all animals on day 1, day 3 and day 7 after operation. CT scan was performed on day 7 and histopathology was performed on day 8 after operation.
Study results demonstrated that all tips were efficient and safe when used at the recommended conditions. The average cutting time was 12min 2s and 10min 24s in the first and second group of animals respectively. The average bleeding volume was 31.4mL and 28.6mL in the first and second group of animals respectively. No accidental damage was caused to nerves, vessels or soft tissues during surgeries. SEP and MEP values were normal for all animals. Clinical evaluation using the Tarlov rating standard process on day 1, day 3 and day 7 after surgery recorded a score of 4 for all animals, with minor exceptions returning to normal states. CT scan showed the spine was in order and curvature was normal, with expected postoperative edema. Histopathology examination showed no histopathological damage of the spinal cord tissue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 24, 2018
Morley Research Consortium Dr. Suzan Davis, Pharm. D. RAC, EMBA, CQA Head of Regulatory Affairs and Compliance Four Concourse Parkway Suite 215 Atlanta, Georgia 30328
Re: K172464
Trade/Device Name: XD880A 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, DZI, ERL, HBE, HWE Dated: March 15, 2018 Received: March 22, 2018
Dear Dr. Davis:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172464
Device Name
XD880A Ultrasonic Osteotomy Surgical System
Indications for Use (Describe)
XD880A 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)
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510(k) Summary in accordance with 21 CFR 807.92
1. Administrative Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Submission Date: | July 31st, 2017 |
| 510(k) Submitter: | SMTP Technology Co., Ltd. |
| 1F, 4F Building A, Emerging Industry Incubation Center | |
| Zhangjiagang FTZ, Jiangsu, 215600, P.R. China | |
| Phone: +86-512-82508100 | |
| Fax: +86-512-82508100 | |
| 510(k) Contact Person: | Dr. Suzan Davis Pharm.D, RAC, EMBA, CQA |
| Head of Regulatory Affairs and Compliance | |
| Morley Research Consortium | |
| Four Concourse Parkway Suite 215 | |
| Georgia, Atlanta, 30328, USA | |
| Phone: 781-672-4200 | |
| Fax:781-672-4201 | |
| sdavis@morleyrc.com | |
| Manufacturer: | SMTP Technology Co., Ltd. |
| 1F, 4F Building A, Emerging Industry Incubation Center | |
| Zhangjiagang FTZ, Jiangsu, 215600, P.R. China | |
| SMTP Technology Co., Ltd. | |
| 2. Device | |
| Proprietary Name: | XD880A Ultrasonic Osteotomy Surgical System |
| Regulation Number: | 21 CFR 888.4580 |
| Device Classification Name: | Sonic Surgical instrument and accessories/attachments |
| Regulation Identification: | A sonic surgical instrument is a hand-held device |
| with various accessories or attachments, such as a | |
| cutting tip, that vibrate at high frequencies, and it is | |
| intended for medical purposes to cut bone or other | |
| materials, such as acrylic. | |
| Regulation Medical Specialty: | Orthopedic |
| Classification product codes: | JDX |
| DZI, ERL, HBE, HWE |
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Device Class:
Class II
3. Predicate Devices
The substantial equivalence of the subject device is based on the following legally marketed predicate devices
| Trade Name | Manufacturer | Product Code | 510(k) Number | Decision Date |
|---|---|---|---|---|
| Piezosurgery Flex | MECTRON | |||
| Spa | JDX, DZI, | |||
| ERL, HBE, | ||||
| HWE | K132848 | 29 November | ||
| 2013 | ||||
| Piezoelectric System | SATELECT- | |||
| Acteon Group | JDX, DZI, | |||
| ERL, HBE, | ||||
| HWE | K100410 | 28 April 2010 |
4. Device Description
XD880A Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch and an 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. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device.
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.
XD880A Ultrasonic Osteotomy Surgery System uses ultrasonic technology to generate mechanical micro-vibrations 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 tip insert.
The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude (less than 0.12mm), while keeping the soft tissues with elastic properties and free of damage.
5
5. Intended Use
XD880A Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system that includes a handpiece and associated cutting tips intended for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:
- Otolaryngology -
- Oral/maxillofacial -
- -Hand and foot
- Neurosurgery (bone only) -
- Spine -
- Plastic/reconstructive. -
6. Performance Testing
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the XD880A Ultrasonic Osteotomy Surgical System. The system complies with the IEC 60601-1:2006 standards for safety and the IEC 60601-1-2:2007/2010 standard for EMC.
Biocompatibility
XD880A Ultrasonic Osteotomy Surgical System components that come into direct contact with patients during surgical procedures are the handpiece and tips inserts. According to ISO 10993-1. these components are classified as 'external communicating devices'. as they get in contact with 'tissue/bone/indirect blood path' for a duration less than 24 hours (