(240 days)
The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) is desired, 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 Kogent TorUS® consists of a console that provides power and control of the ultrasonic aspiration and irrigation functions, three surgical handpieces that provide the ultrasonic mechanical energy to the surgical site, a foot pedal to allow the user control over the ultrasonics, titanium tips (variety of models), irrigation sleeves, suction/irrigation system (manifold tubing and a vacuum canister) and accessories used for assembly and reprocessing. The Kogent TorUS accommodates most commercially available suction canisters and optional specimen traps.
The provided text describes the Kogent TorUS® Ultrasonic Aspirator System and asserts its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, reported device performance metrics in a quantitative table, or details of a study that directly prove the device meets such criteria.
Instead, the document highlights specific types of testing performed to demonstrate substantial equivalence, focusing on safety standards, biocompatibility, and general performance aspects relative to the predicate devices.
Let's break down what is and is not present based on your request:
1. A table of acceptance criteria and the reported device performance
- Not present. The document lists the types of bench testing performed (Thermal Effects, Suction and Aspiration Level, Surgical Bone Removal and Cutting, Soft and Fibrous Tissue Removal) but does not provide a table with "acceptance criteria" (e.g., "bone removal rate > X mm/sec") or "reported device performance" (e.g., "achieved Y mm/sec bone removal"). It states that the testing "indicates that the Kogent TorUS® Ultrasonic Aspirator System is substantially equivalent," implying the results met some unstated internal criteria for equivalence.
2. Sample size used for the test set and the data provenance
- Not present. The document mentions "bench testing" but does not specify the sample sizes used for any of the individual tests. It also does not explicitly state the "data provenance" (e.g., country of origin, retrospective/prospective). Given that it's bench testing, it would likely be laboratory data rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not present. This type of information is typically relevant for studies involving subjective human assessment (e.g., image interpretation, diagnostic accuracy). For a surgical aspiration device, "ground truth" would likely be established through objective physical measurements and comparisons to predicate device performance, not expert consensus on interpretations.
4. Adjudication method for the test set
- Not present. Similar to point 3, adjudication methods like "2+1" or "3+1" are used in studies where there's a need to resolve discrepancies in human interpretations or diagnoses. This is not applicable to the bench testing described for a surgical device's physical performance characteristics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not present. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems where human readers interact with the AI. This device is a surgical tool, and the documentation does not describe any AI component or human-in-the-loop diagnostic assistance for which an MRMC study would be appropriate. The focus is on the device's physical performance and safety.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. As mentioned above, there is no indication of an algorithm or AI component in this device. Therefore, a "standalone algorithm only" performance study is not applicable.
7. The type of ground truth used
- For the bench testing, the "ground truth" would implicitly be objective physical measurements and established engineering standards for performance characteristics (e.g., measuring actual aspiration rates, temperature changes, or material removal efficiency against specified targets or predicate device performance). The document does not explicitly state "ground truth" but implies comparison to predicate device performance.
8. The sample size for the training set
- Not applicable/Not present. Since there's no mention of an AI model or machine learning component, there would be no "training set" in the context of this device's evaluation.
9. How the ground truth for the training set was established
- Not applicable/Not present. (See point 8).
Summary of available information related to performance evaluation, but not a direct answer to your table request:
The document states that Clinical Testing was not required and that "Bench testing" was performed to demonstrate substantial equivalence. The bench tests evaluated:
- Thermal Effects Testing at the Tip
- Suction and Aspiration Level Testing
- Surgical Bone Removal and Cutting Testing
- Soft and Fibrous Tissue Removal Testing
These tests were done to compare the Kogent TorUS® Ultrasonic Aspirator System to the predicate device (Stryker Sonopet iQ Ultrasonic Surgical Aspirator and Sonopet Model UST-2001 Ultrasonic Surgical Aspirator) with the conclusion that the new device is "substantially equivalent" in performance. No specific quantitative data points, acceptance thresholds, or sample sizes for these tests are provided in this document.
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June 19, 2020
Katalyst Surgical, LLC Meryl K. Wilhelm Director of Quality Assurance and Regulatory Affairs 754 Goddard Avenue Chesterfield, Missouri 63005
Re: K192963
Trade/Device Name: Kogent TorUS Ultrasonic Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: October 17, 2019 Received: October 23, 2019
Dear Meryl K. Wilhelm:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (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 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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Indications for Use
510(k) Number (if known) K192963
Device Name Kogent TorUS® Ultrasonic Aspirator System
Indications for Use (Describe)
The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) is desired, 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.
| 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
| Manufacturer: | Katalyst Surgical, LLC754 Goddard AvenueChesterfield, MO 63005636-536-5950 (phone)636-787-0603 (fax) |
|---|---|
| Contact: | Meryl Koch WilhelmKatalyst Surgical, LLC636-536-5950 (phone)636-787-0603(fax)m.koch@katalystsurgical.com |
| Date Prepared: | June 18th, 2020 |
| 510(k) Number: | K192963 |
| Device Trade Name: | Kogent TorUS® Ultrasonic Aspirator System |
| Common Name: | Ultrasonic Surgical Aspirator |
| Classification Name: | Aspirator, Surgical Ultrasonic |
| Device Class: | Unclassified |
| Product Code: | LEI |
Indications for Use:
The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue (e.g. bone) is desired, 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.
Contraindications for Use:
The Kogent TorUS® Ultrasonic Aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
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Device Description:
The Kogent TorUS® consists of a console that provides power and control of the ultrasonic aspiration and irrigation functions, three surgical handpieces that provide the ultrasonic mechanical energy to the surgical site, a foot pedal to allow the user control over the ultrasonics, titanium tips (variety of models), irrigation sleeves, suction/irrigation system (manifold tubing and a vacuum canister) and accessories used for assembly and reprocessing. The Kogent TorUS accommodates most commercially available suction canisters and optional specimen traps.
Predicate Devices:
| 510(k) | Company Name | Device Name |
|---|---|---|
| K190070 | Stryker Instruments | Sonopet iQ Ultrasonic Surgical Aspirator |
| K010309 | MUTOH America Co. | Sonopet Model UST-2001 Ultrasonic Surgical Aspirator |
Comparison of Technical Characteristics:
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Device Name | Kogent TorUS®Ultrasonic AspiratorSystem | Sonopet iQ UltrasonicAspirator System | Sonopet Model UST-2001 UltrasonicSurgical Aspirator |
| Company | Katalyst Surgical, LLC | Stryker Instruments | Mutoh America Co. |
| K Number | Subject Device | K190070 | K010309 |
| Classification | Unclassified | Unclassified | Unclassified |
| Product Code | LFL | LFL | LFL |
| Indications foruse | The Kogent TorUS®Ultrasonic Aspiratorsystem is indicated foruse in surgicalprocedures wherefragmentation,emulsification, andaspiration of soft tissueand hard tissue (e.g.bone) is desired,including Neurosurgery,Gastrointestinal andAffiliated Organ | The Stryker Sonopet iQUltrasonic SurgicalSystem is indicated foruse in surgicalprocedures wherefragmentation,emulsification, andaspiration of soft andhard tissue is desirable,including neurosurgery,gastrointestinal andaffiliated organ surgery,urological surgery, | The Stryker SonopetUltrasonic SurgicalSystem is indicated foruse in surgicalprocedures wherefragmentation,emulsification, andaspiration of soft tissueis desirable, includingneurosurgery,gastrointestinal andaffiliated organ surgery,urological surgery, |
| Surgery, UrologicalSurgery, Plastic andReconstructive Surgery,General Surgery,Orthopedic Surgery,Gynecological Surgery,Thoracic Surgery,Laparoscopic Surgery,and ThoracoscopicSurgery. | plastic and reconstructivesurgery, general surgery,orthopedic surgery,gynecological surgery,thoracic surgery,laparoscopic surgery,and thoracoscopicsurgery. | plastic andreconstructive surgery,general surgery,orthopedic surgery,gynecological surgery,thoracic surgery,laparoscopic surgery,and thoracoscopicsurgery. | |
| Contraindications | This ultrasonic surgicalaspirator device is notindicated for and shouldnot be used for thefragmentation,emulsification, andaspiration of uterinefibroids. | This ultrasonic surgicalaspirator device is notindicated for and shouldnot be used for thefragmentation,emulsification, andaspiration of uterinefibroids. | This ultrasonic surgicalaspirator device is notindicated for and shouldnot be used for thefragmentation,emulsification, andaspiration of uterinefibroids. |
| DesignSpecification | Mechanical UltrasonicEnergyIrrigationAspiration | Mechanical UltrasonicEnergyIrrigationAspiration | Mechanical UltrasonicEnergyIrrigationAspiration |
| Energy source | AC powered fromelectrical mains throughdetachable cord | AC powered fromelectrical mains throughdetachable cord | AC powered fromelectrical mains throughdetachable cord |
| ElectricalClassification | Class II | Class II | Class II |
| MR Safety | MR unsafe | MR unsafe | MR unsafe |
| SystemActivationControl Method | Foot pedal | Foot pedal | Foot pedal |
| Ultrasonic EnergyControl | Piezo-electric,sinusoidal, non-continuous | Piezo-electric,sinusoidal, non-continuous | Piezo-electric,sinusoidal, non-continuous |
| Irrigation Control | Forced, via peristalticpump | Forced, via peristalticpump | Forced, via peristalticpump |
| Aspiration | Vacuum Pump | Vacuum Pump | Vacuum Pump |
| Control | |||
| Tip Lengths | 10-20cm | 11-20cm | 9.7-20cm |
| Tip Application | Torque wrench | Torque wrench | Torque wrench |
| Functionalities | Fragmentation,emulsification, aspiration | Fragmentation,emulsification, aspiration | Fragmentation,emulsification,aspiration |
| Components | Console, handpiece,tubing, tips, irrigationsleeve, torque wrench,suction canister | Console, handpiece,tubing, tips, irrigationsleeve, torque wrench,suction canister | Console, handpiece,tubing, tips, irrigationsleeve, torque wrench,suction canister |
| EnergyMechanism | Ultrasonic Energy | Ultrasonic Energy | Ultrasonic Energy |
| Sterilization | Ethylene Oxide(disposable) and Steam(reusable) | Ethylene Oxide(disposable) and Steam(reusable) | Ethylene Oxide(disposable) and Steam(reusable) |
| Biocompatibility | Biocompatible per testreports | Biocompatible per testreports | Biocompatible per testreports |
| HandpieceFrequencies | 25kHz | 25kHz | 25kHz and 34kHz |
| AspirationPotential (vacuumpressure) | 78kPa maximum | 75.5kPa maximum | 85kPa maximum |
| Volumetric FlowRate | 533mL/min (maximum) | Unknown | 522mL/min (maximum) |
| Maximum OutputPower | 100W | Unknown | 100W |
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The impact of the differences was evaluated through bench testing comparative studies as well as usability studies. These differences do not impact the intended use, indications for use, operating principle or energy source.
Performance Data:
Clinical Testing was not required to prove substantial equivalence. Bench testing performed between the candidate device and the predicate device indicates that the Kogent TorUS® Ultrasonic Aspirator System is substantially equivalent to the reference device. Testing included, but was not limited to:
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Medical Electrical Equipment:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for ● Basic Safety and Essential Performance
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for ● Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements for ● Basic Safety and Essential Performance - Collateral Standard: Usability
Software:
- IEC 62304 Medical Device Software Software Life Cycle Processes .
Biocompatibility:
- ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and ● Testing Within a Risk Management Process
- . ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for ● Irritation and Skin Sensitization
- . ISO 10993-11 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity and Material-Mediated Pyrogenicity
Sterilization:
- ISO 11135 Sterilization of health-care products-Ethylene oxide-Requirements for ● the development, validation and routine control of a sterilization process for medical devices
- . Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff
Shelf Life:
- ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Bench Testing:
- Thermal Effects Testing at the Tip ●
- Suction and Aspiration Level Testing ●
- Surgical Bone Removal and Cutting Testing ●
- Soft and Fibrous Tissue Removal Testing ●
Conclusion
The Kogent TorUS® Ultrasonic Aspirator System was shown to be substantially equivalent to the previously cleared predicate device with respect to intended use and substantially equivalent to the reference device with respect to technological characteristics, performance characteristics, and biocompatibility.
N/A