(86 days)
Not Found
No
The description focuses on the mechanical and control aspects of an ultrasonic aspirator, with no mention of AI or ML capabilities for data analysis, decision-making, or adaptive control. The performance studies also do not indicate any evaluation of AI/ML algorithms.
No.
The device is used for surgical tissue removal, which is not considered a therapeutic function based on the provided text. Therapeutic devices are typically used for treatment or healing, whereas this device is for fragmenting, emulsifying, and aspirating tissue during surgery, aiding in tissue removal rather than direct therapy or treatment of a disease.
No
The device is an ultrasonically vibrating surgical aspirator used for fragmentation, emulsification, and aspiration of tissue during various surgical procedures, not for diagnosis.
No
The device description explicitly details hardware components including a console, handpiece, tips, cassette, and footswitches, indicating it is a hardware-based system with integrated software for control.
Based on the provided information, the Sonopet iQ Ultrasonic Aspirator System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in surgical procedures for the fragmentation, emulsification, and aspiration of soft and hard tissue within the body. IVD devices are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical device that physically interacts with tissue during a procedure. This is consistent with a surgical tool, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Sonopet iQ Ultrasonic Aspirator System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue and hard tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated Organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
Product codes
LFL
Device Description
The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective resection of target tissue while preserving vessels, ducts and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), fifteen (15) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette. Users may choose from three different styles of footswitches. An optional hand controller that allows adjustment of the console settings is also available.
Control of the system functional outputs (ultrasonic energy, irrigation, and aspiration) is achieved via the console. The console interfaces with the irrigation cassette to control the levels of aspiration and irrigation at the surgical site. It also controls the energy delivered to the connected handpiece to control the motion of the tip. The settings on the console are adjusted directly on the console or via the optional connected hand controller. Activation of the system is controlled by pressing the treadle of a wired or wireless foot pedal.
This system is for professional use only within a professional healthcare environment.
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
professional health care environment
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
A suite of performance testing was executed to demonstrate substantial equivalence with the predicate devices. Testing included, but was not limited to:
- Reprocessing, sterilization, and package integrity testing per FDA Guidance documents and recognized standards
- Biocompatibility testing per FDA Guidance documents and recognized standards
- Software and wireless technology testing per FDA Guidance documents and recognized standards
- EMC and Electrical Safety testing per FDA recognized standards
- Bench testing per various internal protocols
- Simulated Use testing per various internal protocols
- Human Factors and Usability testing per FDA Guidance documents and recognized standards
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of performance testing were determined successful for all protocols and demonstrate that the functionality, integrity, and safety and effectiveness of the Sonopet iQ Ultrasonic Aspirator System are sufficient for their intended use. Verification test results for the Sonopet iQ Ultrasonic Aspirator System confirm differences in technology raise no new issues of safety and effectiveness when compared to the predicate devices.
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
N/A
0
Image /page/0/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and black. The word is centered and takes up most of the frame. The background is white.
510(k) Summary
| 807.92(a)(1) – Submitter Information | |
|---|---|
| 510(k) Owner/Submitter: | Stryker Instruments |
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| (p) 269-323-7700 | |
| Contact Person: | Julia L. Helgeson |
| Principal RA Specialist | |
| Registration Number: | 1811755 |
| Date Summary Prepared: | April 09, 2019 |
| 807.92(a)(1) – Submitter Information | |
|---|---|
| 510(k) Owner/Submitter: | Stryker Instruments |
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| (p) 269-323-7700 | |
| Contact Person: | Julia L. Helgeson |
| Principal RA Specialist | |
| Registration Number: | 1811755 |
| 807.92(a)(2) – Name of Device | |
|---|---|
| Trade Name(s): | Sonopet iQ Ultrasonic Aspirator System |
| Common Name: | Surgical Ultrasonic Aspirator |
| Classification Name: | Aspirator, Surgical Ultrasonic |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Unclassified |
| Product Code(s): | LFL |
Page 1/4
1
807.92(a)(3) – Legally marketed device(s) to which equivalence is claimed Sonopet Model UST-2001 Ultrasonic Surgical Aspirator – K010309
807.92(a)(4) – Device Description
The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective resection of target tissue while preserving vessels, ducts and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), fifteen (15) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette. Users may choose from three different styles of footswitches. An optional hand controller that allows adjustment of the console settings is also available.
Control of the system functional outputs (ultrasonic energy, irrigation, and aspiration) is achieved via the console. The console interfaces with the irrigation cassette to control the levels of aspiration and irrigation at the surgical site. It also controls the energy delivered to the connected handpiece to control the motion of the tip. The settings on the console are adjusted directly on the console or via the optional connected hand controller. Activation of the system is controlled by pressing the treadle of a wired or wireless foot pedal.
This system is for professional use only within a professional healthcare environment.
| 807.92(a)(5) – Intended Use of the Device | ||
|---|---|---|
| Indications for Use: | The Sonopet iQ Ultrasonic Aspirator System is indicated for use in | |
| surgical procedures where fragmentation, emulsification and | ||
| aspiration of soft tissue and hard tissue is desirable, including | ||
| Neurosurgery, Gastrointestinal and affiliated Organ surgery, | ||
| Urological surgery, Plastic and Reconstructive surgery, General | ||
| surgery, Orthopedic surgery, Gynecological surgery, Thoracic | ||
| surgery, Laparoscopic surgery, and Thoracoscopic surgery. | ||
| CONTRAINDICATION: This ultrasonic surgical aspirator device is not | ||
| indicated for and should not be used for the fragmentation, | ||
| emulsification, and aspiration of uterine fibroids. |
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate The subject and predicate devices are ultrasonic surgical instruments which use electrical energy in the ultrasonic frequency range to drive a tip for the fragmentation and emulsification of soft and hard tissue. The systems use irrigation at the surgical site to emulsify the fragmented tissue. The systems also use aspiration to remove the fragmented and emulsified tissue from the surgical site.
The following primary characteristics are identical for the subject and predicate devices:
2
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Energy Source | AC Powered from Electrical | |
| Mains through detachable | ||
| cord | AC Powered from Electrical | |
| Mains through detachable | ||
| cord | ||
| Operating Principle/ | ||
| Functional Outputs | Mechanical Ultrasonic Energy | |
| Irrigation | ||
| Aspiration | Mechanical Ultrasonic Energy | |
| Irrigation | ||
| Aspiration | ||
| Tissue Fragmentation Method | Ultrasonic Energy | Ultrasonic Energy |
| Ultrasonic Energy Control | Piezo-electric, sinusoidal, non- | |
| continuous | Piezo-electric, sinusoidal, non- | |
| continuous | ||
| Irrigation Control | Forced, via peristaltic pump | Forced, via peristaltic pump |
| Aspiration Control | Vacuum | Vacuum |
| System Activation Control | ||
| Method | Foot Pedal | Foot Pedal |
| Terminal Sterilization Methods | Ethylene oxide | Ethylene oxide |
| Reprocessing Methods (Sterile | ||
| Reusable) | Manual or automated | |
| (mechanical) cleaning with | ||
| Moist Heat Sterilization | Manual or automated | |
| (mechanical) cleaning with | ||
| Moist Heat Sterilization | ||
| Reprocessing Methods (Non- | ||
| sterile Reusable) | Clean and Disinfect | Clean and Disinfect |
| Electrical Classification | Class II | Class II |
| MR Safety | MR Unsafe | MR Unsafe |
The following technological characteristics of the subject and predicate device systems differ. These differences and changes offer new or altered features over those of the predicate device, but do not impact the intended use, indications for use, operating principle, or energy source.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Power Delivery Options | Constant, Variable | Constant |
| Aspiration Flow Control | Vacuum pump, combination | |
| of solenoid and pinch valves | Vacuum pump, combination | |
| of needle and pinch valves | ||
| Aspiration Potential (vacuum | ||
| pressure) | 75.5kPa maximum | 85kPa maximum |
| Frequency | 25kHz | 25kHz and 34kHz |
| Accessory Connections/ | ||
| Device Recognition | Keyed connectors, illuminated | |
| ports for status, RFID | ||
| recognition, communication | ||
| bus recognition | Keyed connectors, recognition | |
| by discrete component | ||
| Handpiece to Tip Assembly | In sterile field, direct torque | |
| with wrench (no need to rest | ||
| in sterilization tray) | In sterile field, torque with | |
| wrench, requires sterilization | ||
| tray to stabilize handpiece | ||
| Primary User Interface | Graphic User Interface (GUI), | |
| illuminated ports | Push button, LED indicators | |
| Foot Pedal Options | Wired or wireless | |
| Basic or advanced features | Wired | |
| Basic | ||
| Tip Lengths | 11 – 20cm | 9.7 – 20cm |
3
| Tip Distal Geometries | Straight, Knife, Claw, Barracuda | Straight, Knife, Claw, Barracuda, Curette |
|---|---|---|
| Operating Conditions | 10 – 27°C | |
| 10% - 85% RH | ||
| 70kPa – 106kPa | 10 – 40°C | |
| 10% - 85% RH | ||
| 70kPa – 106kPa |
807.92(b)(1) - Nonclinical Testing to Support Submission
A suite of performance testing was executed to demonstrate substantial equivalence with the predicate devices. Testing included, but was not limited to:
- Reprocessing, sterilization, and package integrity testing per FDA Guidance documents and recognized standards
- Biocompatibility testing per FDA Guidance documents and recognized standards
- Software and wireless technology testing per FDA Guidance documents and recognized ● standards
- EMC and Electrical Safety testing per FDA recognized standards
- Bench testing per various internal protocols ●
- Simulated Use testing per various internal protocols
- Human Factors and Usability testing per FDA Guidance documents and recognized standards
807.92(b)(2) - Clinical Testing
No clinical testing was required to support this submission.
807.92(b)(3) - Conclusions Drawn from Testing Performed
Results of performance testing were determined successful for all protocols and demonstrate that the functionality, integrity, and safety and effectiveness of the Sonopet iQ Ultrasonic Aspirator System are sufficient for their intended use. Verification test results for the Sonopet iQ Ultrasonic Aspirator System confirm differences in technology raise no new issues of safety and effectiveness when compared to the predicate devices.
Conclusion/ Substantial Equivalence (SE) Rationale:
The subject device, in comparison with the legally marketed predicate, has the same intended use, indications for use, operating principles, energy source, and functional outputs. Performance testing and risk analysis demonstrate that the device is as safe and effective as the predicate device and does not raise different significant questions of safety and effectiveness.
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April 11, 2019
Stryker Corporation Julia Helgeson Principal RA Specialist 4100 E. Milham Ave. Kalamazoo, Michigan 49001
Re: K190070
Trade/Device Name: Sonopet iQ Ultrasonic Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: January 11, 2019 Received: January 15, 2019
Dear Julia Helgeson:
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, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
6
801); medical device 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
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