(94 days)
Not Found
No
The document describes software modifications for inter-device communication and integrated OR control, but does not mention AI or ML capabilities.
No.
The device is used for the fragmentation, emulsification, and aspiration of soft tissue during surgical procedures, not for treating existing conditions or diseases.
No
The device is an ultrasonic surgical aspirator for fragmenting, emulsifying, and aspirating soft tissue during surgery; its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is an "ultrasonically vibrating surgical device" and includes hardware components like a console, handpiece, tips, and cassette. While it has software modifications and optional software functionality (RISE), it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable." This describes a surgical tool used during a procedure on a patient's body.
- Device Description: The description details a surgical device that uses ultrasonic energy, irrigation, and aspiration to remove tissue. This is consistent with a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVD devices are designed to perform tests on these types of samples to aid in diagnosis or monitoring.
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 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 (comma separated list FDA assigned to the subject device)
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 energy (25kHz), sixteen (16) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette.
Modifications to the device console software allow for inter-device communications with compatible Stryker devices, and the implementation of Stryker's proprietary communications protocol 'DCM' (Device Communication Module) to support these communications.
RISE (Reimagining Integrated Surgical Experience) is an optional software functionality that allows for ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System (SDC4K), and CORE 2 consoles) and utilizes the DCM communications protocol.
The RISE functionality is built into the Sonopet iQ console software but can only be accessed via a Stryker-provided activation license.
RISE provides for an integrated OR (Operating Room) solution to healthcare facilities that simplifies workflows and reduces OR clutter. In a RISE configuration, adjustment of the Sonopet iQ power, suction, irrigation, and pulse control settings can now be made directly on the Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console.
RISE functionality also features optional foot pedal assignment, which provides users the opportunity to use a single foot pedal to control multiple handpieces.
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
General
Intended User / Care Setting
Professional use only in a professional healthcare 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 testing per FDA guidance documents and recognized standards
Results of testing demonstrate the subject device to be substantially equivalent to the predicate device in terms of safety and effectiveness.
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 console confirm differences in technology raise no new issues of safety and effectiveness when compared to the predicate device.
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
N/A
0
March 24, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. The logo is simple and professional, and it is easily recognizable.
Stryker Instruments Louise Keane Regulatory Affairs Manager 1941 Stryker Way Portage, Michigan 49002
Re: K243930
Trade/Device Name: Sonopet iQ Ultrasonic Aspirator System (5500-050-000) Regulatory Class: Unclassified Product Code: LFL Dated: December 20, 2024 Received: March 20, 2025
Dear Louise Keane:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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).
Page
2
2
Image /page/2/Figure/2 description: The image shows a digital signature. The signature is for James H. Jang -S. The date of the signature is 2025.03.24, and the time is 23:28:37 -04'00'.
For
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
3
K243930
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
Indications for Use (Describe)
The Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft 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.
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
Submitter Information
Stryker Instruments 1941 Stryker Way, Portage, MI 49002, USA
Contact Information
Leandra Burke Staff Regulatory Affairs Specialist Tel: (269)823-4639 Email: leandra.burke@stryker.com
Date: 20 December 2024
| Subject Device Details | |
|---|---|
| Trade / Proprietary Name | Sonopet iQ Ultrasonic Aspirator System |
| Regulation Name | Aspirator, Surgical Ultrasonic |
| Review Panel | General and Plastic Surgery |
| Product Code | LFL |
| Regulatory Class | Unclassified |
| Predicate Device Details | |
|---|---|
| Trade / Proprietary Name | Sonopet iQ Ultrasonic Aspirator System |
| 510(k) | K213824 |
| Product Code | LFL |
| Manufacturer | Stryker Corporation |
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 energy (25kHz), sixteen (16) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette.
Modifications to the device console software allow for inter-device communications with compatible Stryker devices, and the implementation of Stryker's proprietary communications protocol 'DCM' (Device Communication Module) to support these communications.
RISE (Reimagining Integrated Surgical Experience) is an optional software functionality that allows for ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System (SDC4K), and CORE 2 consoles) and utilizes the DCM communications protocol.
5
The RISE functionality is built into the Sonopet iQ console software but can only be accessed via a Stryker-provided activation license.
RISE provides for an integrated OR (Operating Room) solution to healthcare facilities that simplifies workflows and reduces OR clutter. In a RISE configuration, adjustment of the Sonopet iQ power, suction, irrigation, and pulse control settings can now be made directly on the Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console.
RISE functionality also features optional foot pedal assignment, which provides users the opportunity to use a single foot pedal to control multiple handpieces.
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.
Comparison of Technological Characteristics
A comparison of the technological characteristics of the subject device included in the scope of the 510(k) submission with the predicate device is included in the table below.
6
| Feature | Subject device | Predicate device (K213824) | Assessment |
|---|---|---|---|
| Model/brand name | Sonopet iQ Ultrasonic Aspirator System | Sonopet iQ Ultrasonic Aspirator System | Identical |
| Classification | Unclassified | Unclassified | Identical |
| FDA Product code | LFL | LFL | Identical |
| Review Panel | General and Plastic Surgery | General and Plastic Surgery | Identical |
| 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. | 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. | Identical | ||
| Contraindications | This ultrasonic surgical aspirator device is not | ||
| indicated for and should not be used for the | |||
| fragmentation, emulsification, and aspiration | |||
| of uterine fibroids. | This ultrasonic surgical aspirator device is not | ||
| indicated for and should not be used for the | |||
| fragmentation, emulsification, and aspiration | |||
| of uterine fibroids. | Identical | ||
| Conditions of Use | Professional use only in a professional | ||
| healthcare environment | Professional use only in a professional | ||
| healthcare environment | Identical | ||
| Primary User | |||
| Population | Trained Surgeon | Trained Surgeon | Identical |
| Patient Population | General | General | Identical |
| Control Mechanism Comparison | |||
| Ultrasonic Energy | Piezo-electric, sinusoidal, non-continuous | Piezo-electric, sinusoidal, non-continuous | Identical |
| Irrigation | Forced, via peristaltic pump | Forced, via peristaltic pump | Identical |
| Aspiration (Suction) | Vacuum Pump | Vacuum Pump | Identical |
510(k) Summary
stryker
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| ਰੇਤੇ |
| K243 |
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atryker
510(k) Summary
| Feature | Performance Specification Comparison
Subject device | Predicate device (K213824) | Assessment |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------|
| Energy Source | AC powered from mains supply through detachable cord | AC powered from mains supply through detachable cord | Identical |
| Electrical classification | Class II | Class II | Identical |
| MR Safety | MR Unsafe | MR Unsafe | Identical |
| Technological Characteristics / Features Comparison | | | |
| Ultrasonic power delivery modes | Constant, variable | Constant, variable | Identical |
| Primary interface | Graphical User Interface (GUI). | Graphical User Interface (GUI). | Identical |
| Energy activation method | Foot pedal | Foot pedal | Identical |
| System setting adjustment | Console GUI
Hand Controller (optional)
Compatible Stryker devices (via optional RISE functionality) | Console GUI
Hand Controller (optional) | Equivalent confirmed safe and effective. |
| LAN Communications | Ethernet Port – service, ethernet connection for RISE communications | Ethernet Port – service only | Equivalent confirmed safe and effective. |
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Summary of Nonclinical Testing
The following testing was conducted to demonstrate that the modifications to the subject device are as safe and effective as the predicate:
- Software and wireless technology testing per FDA guidance documents and ● recognized standards
- o EMC and Electrical Safety testing per FDA recognized standards
- Bench testing per various internal protocols
- Simulated use testing per various internal protocols .
- Human factors testing per FDA guidance documents and recognized ● standards
Results of testing demonstrate the subject device to be substantially equivalent to the predicate device in terms of safety and effectiveness.
Clinical Testing
No clinical testing was required to support this submission.
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 console confirm differences in technology raise no new issues of safety and effectiveness when compared to the predicate device.
Conclusion
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 new or different questions of safety and effectiveness.