(63 days)
Not Found
No
The summary describes a mechanical ultrasonic aspirator system and its components. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on non-clinical testing of the device's physical and functional characteristics.
No
The device is used for fragmenting, emulsifying, and aspirating tissue in surgical procedures, which are interventional actions rather than therapeutic. Its function is to remove unwanted tissue, not to treat a condition directly.
No
Explanation: The device is described as an "ultrasonically vibrating surgical device" that "emulsifies fragments and removes unwanted tissue." Its intended use is in "surgical procedures where fragmentation, emulsification, and aspiration of tissue is desirable." This is a therapeutic function, not a diagnostic one.
No
The device description clearly states the system consists of a console, handpiece, tips, sleeves, cassette, and foot pedals, all of which are hardware components. The submission is for a specific tip and sleeve set, which is also a physical component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the fragmentation, emulsification, and aspiration of tissue during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details an ultrasonic surgical aspirator system that physically removes tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to test samples like blood, urine, or tissue to provide diagnostic information. This device is a surgical tool used directly on the patient.
N/A
Intended Use / Indications for Use
The 37cm iQ Large tip and sleeve sets, when used with the appropriate Sonopet iQ handpiece, are intended for use in surgical procedures where fragmentation, emulsification, and aspiration of tissue is desirable.
The 37cm iQ Large tip and sleeve sets intended for soft tissue may be used in surgical procedures including gastrointestinal and affiliated organ surgery, urological surgery, general 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, emulsifies fragments and removes unwanted tissue. The system consists of a console to provide control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), sixteen (16) tips with irrigation sleeves and a cassette for irrigation and suction. Users may choose from three different styles of foot pedals. The sixteen tips and sleeves consist of a soft tissue family and a hard tissue family.
The Sonopet iQ 37cm iQ Large (5500-25S-601) is the subject device of this submission and is an extension to the family of Sonopet iQ soft tissue tips and sleeves which are commercially available in the United States. The Sonopet iQ 37cm iQ Large is a single use device that forms part of the Sonopet iQ Ultrasonic Aspirator System.
The following primary modifications are made to Sonopet iQ 37cm iQ Large with respect to the predicate device:
- The dimensional specifications are longer than the predicate device. The subject ● device is 37cm in length and will be 17cm longer than the predicate device (20cm).
- The design dimensions and materials have undergone modifications to allow it to fit into a 5mm trocar.
- The subject device will not be indicated for neurosurgery, unlike the predicate device. ●
- In its packaging configuration, the subject device will have a single barrier while the predicate device has a double barrier.
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
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)
A suite of non-clinical testing was executed to demonstrate substantial equivalence with the predicate device. Testing included:
- Sterilization and Package Integrity
- Biocompatibility ●
- EMC and Electrical Safety ●
- Design Verification ●
- Human Factors and Usability ●
- . Simulated Use Validations
All pre-defined acceptance criteria for the above tests have been met. Results from this testing confirm that the subject device performs as intended and supports a determination of substantial equivalence 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
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.
March 3, 2023
Stryker Corporation Thomas Flannelly Staff Regulatory Affairs Specialist 1941 Stryker Way Kalamazoo, Michigan 49002
Re: K223770 Trade/Device Name: Sonopet 1Q 3 7cm 1Q Large Regulatory Class: Unclassified Product Code: LFL
Dear Thomas Flannelly:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 16, 2023. Specifically, FDA is updating this SE Letter to include the proper electronic signature as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, OHT4: Office of Surgical and Infection Control Devices, (301)796-5436, mark.trumbore@fda.hhs.gov.
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.03.03
11:16:00-05'00'
Mark Trumbore 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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 16, 2023
Stryker Corporation Thomas Flannelly Staff Regulatory Affairs Specialist 1941 Stryker Way Kalamazoo, Michigan 49002
Re: K223770
Trade/Device Name: Sonopet iQ 37cm iQ Large Regulatory Class: Unclassified Product Code: LFL Dated: December 13, 2022 Received: December 15, 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 (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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
2
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-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,
On behalf of 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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: 06/30/2023 |
| See PRA Statement below. | |
| 510(k) Number (if known) | |
| Device Name | Sonopot iQ 37cm iQ Large |
| Indications for Use (Describe) | The 37cm iQ Large tip and sleeve sets, when used with the appropriate Sonopet iQ handpiece, are intended for use in surgical procedures where fragmentation, emulsification, and aspiration of tissue is desirable. |
| The 37cm iQ Large tip and sleeve sets intended for soft tissue may be used in surgical procedures including gastrointestinal and affiliated organ surgery, urological surgery, general 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) |
| 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." |
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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6.0 Submitter Information
This Premarket Notification is submitted by:
Stryker Instruments 1941 Stryker Way Portage MI 49002-9711 USA
Contact Information
Thomas Flannelly Staff Regulatory Affairs Engineer Ph: 011-353-87-6487949 Email: Thomas.Flannelly@stryker.com Date Prepared: 13 December 2022
6.1 Device Name
| Subject Device Information | |
|---|---|
| Trade/ Proprietary Name | Sonopet iQ 37cm iQ Large |
| Common Name | Sonopet iQ Laparoscopic Tip |
| Regulation Name | Aspirator, Surgical Ultrasonic |
| Review Panel | General and Plastic Surgery |
| Product Code | LFL |
| Regulatory Class | Unclassified |
Table 6-1: Subject Device Information
6.2 Predicate Device
The legally marketed predicate for the subject device is detailed in Table 6-2.
Table 6-2: Predicate Device Information
| Predicate Device Name | Part Numbers | 510(k) | Product
Code | Manufacturer |
|--------------------------------|--------------|---------|-----------------|------------------------|
| Sonopet iQ 20cm iQ
Standard | 5500-25S-301 | K213824 | LFL | Stryker
Instruments |
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6.3 Indications for Use
The 37cm iQ Large tip and sleeve sets, when used with the appropriate Sonopet iQ handpiece, are intended for use in surgical procedures where fragmentation, and aspiration of tissue is desirable.
The 37cm iQ Large tip and sleeve sets intended for soft tissue may be used in surgical procedures including gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
Contraindications: This ultrasonic surgical aspirator device is not indicated for and should not be used for the removal of uterine fibroids.
6.4 Device Description
The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, emulsifies fragments and removes unwanted tissue. The system consists of a console to provide control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), sixteen (16) tips with irrigation sleeves and a cassette for irrigation and suction. Users may choose from three different styles of foot pedals. The sixteen tips and sleeves consist of a soft tissue family and a hard tissue family.
The Sonopet iQ 37cm iQ Large (5500-25S-601) is the subject device of this submission and is an extension to the family of Sonopet iQ soft tissue tips and sleeves which are commercially available in the United States. The Sonopet iQ 37cm iQ Large is a single use device that forms part of the Sonopet iQ Ultrasonic Aspirator System.
The following primary modifications are made to Sonopet iQ 37cm iQ Large with respect to the predicate device:
- The dimensional specifications are longer than the predicate device. The subject ● device is 37cm in length and will be 17cm longer than the predicate device (20cm).
- The design dimensions and materials have undergone modifications to allow it to fit into a 5mm trocar.
- The subject device will not be indicated for neurosurgery, unlike the predicate device. ●
- In its packaging configuration, the subject device will have a single barrier while the predicate device has a double barrier.
6.5 Comparison of Technological Characteristics
The subject device has the same intended use as the predicate device. The Sonopet iQ 37cm iQ Large also shares the same indications as the predicate apart from the neurosurgery indication. They both have the same operating principals, control mechanisms, performance specifications and system interactions. They also share the same energy source and have a similar design. No new materials are introduced for the subject device in comparison to the predicate device, except for the Iron Oxide colorant used on the tips Silicone O-ring.
Risk evaluation and performance testing have shown that the differences between the predicate and subject devices do not introduce new issues of safety and effectiveness. The evaluation and testing have demonstrated that the subject device is substantially equivalent to the predicate device.
Traditional 510(k)
6
6.6 Summary of Non-Clinical Testing
A suite of non-clinical testing was executed to demonstrate substantial equivalence with the predicate device. Testing included:
- Sterilization and Package Integrity
- Biocompatibility ●
- EMC and Electrical Safety ●
- Design Verification ●
- Human Factors and Usability ●
- . Simulated Use Validations
All pre-defined acceptance criteria for the above tests have been met. Results from this testing confirm that the subject device performs as intended and supports a determination of substantial equivalence to the predicate device.
6.7 Summary of Clinical Testing
Clinical testing was not required for this traditional 510(k).
6.8 Conclusion
The Sonopet iQ 37cm iQ Large is substantially equivalent to the predicate device currently cleared under K213824 as it has the same intended use, operating principles, and technological The modifications introduced do not raise new questions of safety or characteristics. effectiveness. Performance testing has demonstrated that the Sonopet iQ 37cm iQ Large is substantially equivalent to the predicate device.