(57 days)
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, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
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.
The modification described here within is a software enhancement to the Console of the Sonopet iQ Ultrasonic Aspirator System, cleared under K190070. Specifically, the purpose of this software enhancement is to add an optional feature called Pulse Control.
Pulse Control provides an additional means of controlling the dose of ultrasonic energy by modulating the tip displacement amplitude and reduces tip temperature across the various aspirator tips while minimizing the associated reduction in hard tissue resection rate.
In conjunction with the addition of the Pulse Control feature, the memory control parameters on the Sonopet iQ Tips have been updated to enable amplitude modulated pulsing of the ultrasonic control output wave form.
This document is a 510(k) Premarket Notification from the FDA regarding the Stryker Sonopet iQ Ultrasonic Aspirator System. Based on the provided text, the device is an ultrasonic surgical aspirator, and the submission is for a software enhancement (Pulse Control) to an already cleared device (K190070).
The document explicitly states:
"Clinical testing was not required for this Special 510(k)."
This means that the information requested regarding acceptance criteria and a study proving the device meets those criteria (i.e., a clinical study or performance human-in-the-loop study) is not available within this document. The submission focuses on non-clinical testing to demonstrate that the software modification does not raise new safety or effectiveness concerns.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance (for a clinical study).
- Sample sizes for a test set or data provenance (as no clinical test set was used).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement.
- Information about standalone (algorithm only) performance.
- Type of ground truth used (as no clinical data was required).
- Sample size for the training set (as no AI/machine learning training was described for a clinical application that would require a ground-truthed training set).
- How ground truth for the training set was established.
The document states that the testing conducted was:
- Software Verification Testing
- Validation Testing
- Performance Testing
- IEC 60601-1 Electrical Safety
- IEC 60601-1-2 EMC Testing
These are non-clinical tests designed to assess the safety and functionality of the device itself and the impact of the software change, not its performance in a clinical setting against a specific diagnostic or therapeutic outcome.
In summary, the provided document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria through clinical performance or AI/ML-based evaluation, because clinical testing was not required for this submission.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
February 3, 2022
Stryker Corporation Thomas Flannelly Staff Regulatory Affairs Engineer 4100 East Milham Ave. Kalamazoo, Michigan 49001
Re: K213824
Trade/Device Name: Sonopet iQ Ultrasonic Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: January 14, 2022 Received: January 18, 2022
Dear Thomas Flannelly:
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 ffor 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/cfpm/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
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requirements, including, but not limited to: registration and listing (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (0S) 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-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).
Sincerely,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213824
Device Name Sonopet iQ Ultrasonic Aspirator System
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 and hard tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated Organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device 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 201 Subpart D) |
|---|
| Over-The-Counter Use |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/2 description: The image shows the text "Page 1 of 6" at the top left corner. Below that, the word "stryker" is written in a bold, sans-serif font. The word is in all lowercase letters and is the main focus of the image.
Submitter Information
This Premarket Notification is submitted by:
Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Contact Information
Thomas Flannelly Staff Regulatory Affairs Engineer Ph: 011-353-87-6487949 Email: Thomas.Flannelly@stryker.com Date Prepared: 7 December 2021
Device Name
| Subject Device Information | ||
|---|---|---|
| Trade/ Proprietary Name | Sonopet iQ Ultrasonic Aspirator System | |
| Primary | Regulation Name | Aspirator, Surgical Ultrasonic |
| Review Panel | General and Plastic Surgery | |
| Product Code | LFL | |
| Regulatory Class | Unclassified |
Subject Device Information
Predicate Device
The legally marketed predicate for the subject device is detailed in the table below.
Predicate Device Information
| Predicate Device Trade Name | 510(k) | Product Code | Manufacturer |
|---|---|---|---|
| Sonopet iQ Ultrasonic AspiratorSystem | K190070 | LFL | Stryker Instruments |
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.
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Image /page/4/Picture/2 description: The image shows the text "Page 2 of 6" at the top, indicating it is a page number within a larger document. Below this, the word "stryker" is displayed in a bold, sans-serif font. The word is all lowercase and appears to be a logo or brand name.
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
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.
The modification described here within is a software enhancement to the Console of the Sonopet iQ Ultrasonic Aspirator System, cleared under K190070. Specifically, the purpose of this software enhancement is to add an optional feature called Pulse Control.
Pulse Control provides an additional means of controlling the dose of ultrasonic energy by modulating the tip displacement amplitude and reduces tip temperature across the various aspirator tips while minimizing the associated reduction in hard tissue resection rate.
In conjunction with the addition of the Pulse Control feature, the memory control parameters on the Sonopet iQ Tips have been updated to enable amplitude modulated pulsing of the ultrasonic control output wave form.
Comparison of Technological Characteristics
A comparison of the technological characteristics of the subject device included in the scope of this Special 510(k) with the predicate is included in the table below.
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| DESCRIPTION | Subject Device | Technological Comparison | Comparison Assessment |
|---|---|---|---|
| Sonopet iQ Ultrasonic Aspirator System (Pulse Control) | Predicate DeviceSonopet iQ Ultrasonic Aspirator System (K190070) | ||
| Indications for Use | The Sonopet iQ Ultrasonic Aspirator 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, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery. | The Sonopet iQ Ultrasonic Aspirator 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, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery. | Identical |
| Classification of Device | Unclassified | Unclassified | Identical |
| Primary Product Code | LFLSurgical Ultrasonic Aspirator | LFLSurgical Ultrasonic Aspirator | Identical |
| Condition of Use | ReusableSingle Use (In Case of the Tip and Sleeves) | ReusableSingle Use (In Case of the Tip and Sleeves) | Identical |
| Type of Use | Prescription Use Only | Prescription Use Only | Identical |
| Patient Population | General | General | 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 |
| Principle of Operation | The Sonopet iQ Ultrasonic Aspirator System has three major functional capabilities: ultrasonic energy, irrigation, and aspiration. | The Sonopet iQ Ultrasonic Aspirator System has three major functional capabilities: ultrasonic energy, irrigation, and aspiration. | Identical |
| Subject Device | Predicate Device | ||
| DESCRIPTION | Sonopet iQ Ultrasonic Aspirator System (Pulse Control) | Sonopet iQ Ultrasonic Aspirator System (K190070) | Comparison Assessment |
| Energy Source | AC Powered from Electrical Mains through detachable cord | AC Powered from Electrical Mains through detachable cord | Identical |
| Tissue Fragmentation Method | Ultrasonic Energy | Ultrasonic Energy | Identical |
| Ultrasonic Energy Method | Piezo-electric, sinusoidal, non-continuous and Pulse Control | Piezo-electric, sinusoidal, non-continuous | Similar |
| Irrigation Control | Forced, via peristaltic pump | Forced, via peristaltic pump | Identical |
| Aspiration Control | Vacuum | Vacuum | Identical |
| System Activation Control Method | Foot Pedal | Foot Pedal | Identical |
| Reprocessing Methods | Clean and Disinfect | Clean and Disinfect | Identical |
| Electrical Classification | Class II | Class II | Identical |
| MR Safety | MR Unsafe | MR Unsafe | Identical |
| Power Delivery Options | Constant, Variable, Pulsing (Pulse Control) | Constant, Variable | Similar |
| Aspiration Flow Technology | Vacuum pump, combination of pinch and solenoid valves | Vacuum pump, combination of pinch and solenoid valves | Identical |
| Subject Device | Predicate Device | ||
| DESCRIPTION | Sonopet iQ Ultrasonic Aspirator System (Pulse Control) | Sonopet iQ Ultrasonic Aspirator System (K190070) | Comparison Assessment |
| Aspiration Potential | 75.5kPa Maximum | 75.5kPa Maximum | Identical |
| Frequency | 25kHz | 25kHz | Identical |
| Primary User Interface | Power, Irrigation, Aspiration, and Pulse Control | Power, Irrigation, and Aspiration | Similar |
510(k) Summary: K21382
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510(k) Summary: K21382-
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510(k) Summary: K213824
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Image /page/8/Picture/3 description: The image shows the word "Stryker" in a bold, sans-serif font. The word is black and is positioned above a thick, horizontal black line. The font is modern and the overall design is simple and clean. The logo is likely for the Stryker Corporation, a medical technology company.
Summary of Non-Clinical Testing
The intended use of the subject device and predicate are identical, and their technological characteristics are similar. The subject device is a modification of the predicate and utilizes the same design and operating principles. The device modifications do not raise any new or different questions of safety and effectiveness.
Risk management was conducted in accordance with ISO 14971.
The following testing was conducted to demonstrate that the modifications to the subject device are as safe and effective as the predicate.
- Software Verification Testing
- Validation Testing
- Performance Testing ●
- IEC 60601-1 Electrical Safety
- . IEC 60601-1-2 EMC Testing
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject device are sufficient for their intended use, indications for use and support a determination of substantial equivalence.
Summary of Clinical Testing
Clinical testing was not required for this Special 510(k).
Conclusion
The proposed modifications to the subject device do not alter the indications for use, intended use, or its fundamental scientific technology. There are no differences in the indications for use and intended use between the subject and predicate devices.
The only technological difference is the addition of Pulse Control, which provides a means of controlling the dose of ultrasonic energy by modulating the tip displacement amplitude.
The modifications introduced raise no new or different issues of safety and effectiveness and testing has demonstrated substantial equivalence to the predicate device.
N/A