Kogent Torus Ultrasonic Aspirator

K192963 · Katalyst Surgical, LLC · LFL · Jun 19, 2020 · SU

Device Facts

• Record ID: K192963
• Device Name: Kogent Torus Ultrasonic Aspirator
• Applicant: Katalyst Surgical, LLC
• Product Code: LFL · SU
• Decision Date: Jun 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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.

Device Story

Kogent TorUS is an ultrasonic surgical aspirator system used in clinical surgical settings. It consists of a console, foot pedal, and ultrasonic handpieces with titanium tips. The system uses piezo-electric ultrasonic energy to fragment and emulsify tissue, while a vacuum pump and peristaltic irrigation pump aspirate the debris. Operated by surgeons, the device provides mechanical energy to the surgical site to facilitate tissue removal. The system accommodates standard suction canisters and specimen traps. By enabling precise tissue fragmentation and aspiration, it assists in various surgical procedures. The device is AC-powered and controlled via a foot pedal.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, including thermal effects, suction/aspiration levels, surgical bone removal/cutting, and soft/fibrous tissue removal testing. Biocompatibility was verified per ISO 10993 standards.

Technological Characteristics

System includes console, handpiece, titanium tips, irrigation sleeves, and suction tubing. Energy source: AC-powered, 25kHz piezo-electric ultrasonic transducer. Aspiration: vacuum pump (max 78kPa). Irrigation: peristaltic pump. Sterilization: Ethylene Oxide (disposable) and Steam (reusable). Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 10993, ISO 11135, ASTM F1980.

Indications for Use

Indicated for patients undergoing surgical procedures requiring soft and hard tissue (e.g., bone) fragmentation, emulsification, and aspiration across various surgical specialties including neuro, GI, urological, plastic, general, orthopedic, gynecological, thoracic, laparoscopic, and thoracoscopic surgery. Contraindicated for uterine fibroid removal.

Predicate Devices

• Sonopet iQ Ultrasonic Surgical Aspirator (K190070)
• Sonopet Model UST-2001 Ultrasonic Surgical Aspirator (K010309)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".

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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;">X</span> 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, LLC<br>754 Goddard Avenue<br>Chesterfield, MO 63005<br>636-536-5950 (phone)<br>636-787-0603 (fax) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact: | Meryl Koch Wilhelm<br>Katalyst Surgical, LLC<br>636-536-5950 (phone)<br>636-787-0603(fax)<br>[e-mail] |
| 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®<br>Ultrasonic Aspirator<br>System | Sonopet iQ Ultrasonic<br>Aspirator System | Sonopet Model UST-<br>2001 Ultrasonic<br>Surgical 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 for<br>use | The Kogent TorUS®<br>Ultrasonic Aspirator<br>system is indicated for<br>use in surgical<br>procedures where<br>fragmentation,<br>emulsification, and<br>aspiration of soft tissue<br>and hard tissue (e.g.<br>bone) is desired,<br>including Neurosurgery,<br>Gastrointestinal and<br>Affiliated Organ | The Stryker Sonopet iQ<br>Ultrasonic Surgical<br>System is indicated for<br>use in surgical<br>procedures where<br>fragmentation,<br>emulsification, and<br>aspiration of soft and<br>hard tissue is desirable,<br>including neurosurgery,<br>gastrointestinal and<br>affiliated organ surgery,<br>urological surgery, | The Stryker Sonopet<br>Ultrasonic Surgical<br>System is indicated for<br>use in surgical<br>procedures where<br>fragmentation,<br>emulsification, and<br>aspiration of soft tissue<br>is desirable, including<br>neurosurgery,<br>gastrointestinal and<br>affiliated organ surgery,<br>urological surgery, |
| | Surgery, Urological<br>Surgery, Plastic and<br>Reconstructive Surgery,<br>General Surgery,<br>Orthopedic Surgery,<br>Gynecological Surgery,<br>Thoracic Surgery,<br>Laparoscopic Surgery,<br>and Thoracoscopic<br>Surgery. | plastic and reconstructive<br>surgery, general surgery,<br>orthopedic surgery,<br>gynecological surgery,<br>thoracic surgery,<br>laparoscopic surgery,<br>and thoracoscopic<br>surgery. | plastic and<br>reconstructive surgery,<br>general surgery,<br>orthopedic surgery,<br>gynecological surgery,<br>thoracic surgery,<br>laparoscopic surgery,<br>and thoracoscopic<br>surgery. |
| Contraindications | This ultrasonic surgical<br>aspirator device is not<br>indicated for and should<br>not be used for the<br>fragmentation,<br>emulsification, and<br>aspiration of uterine<br>fibroids. | This ultrasonic surgical<br>aspirator device is not<br>indicated for and should<br>not be used for the<br>fragmentation,<br>emulsification, and<br>aspiration of uterine<br>fibroids. | This ultrasonic surgical<br>aspirator device is not<br>indicated for and should<br>not be used for the<br>fragmentation,<br>emulsification, and<br>aspiration of uterine<br>fibroids. |
| Design<br>Specification | Mechanical Ultrasonic<br>Energy<br>Irrigation<br>Aspiration | Mechanical Ultrasonic<br>Energy<br>Irrigation<br>Aspiration | Mechanical Ultrasonic<br>Energy<br>Irrigation<br>Aspiration |
| Energy source | AC powered from<br>electrical mains through<br>detachable cord | AC powered from<br>electrical mains through<br>detachable cord | AC powered from<br>electrical mains through<br>detachable cord |
| Electrical<br>Classification | Class II | Class II | Class II |
| MR Safety | MR unsafe | MR unsafe | MR unsafe |
| System<br>Activation<br>Control Method | Foot pedal | Foot pedal | Foot pedal |
| Ultrasonic Energy<br>Control | Piezo-electric,<br>sinusoidal, non-<br>continuous | Piezo-electric,<br>sinusoidal, non-<br>continuous | Piezo-electric,<br>sinusoidal, non-<br>continuous |
| Irrigation Control | Forced, via peristaltic<br>pump | Forced, via peristaltic<br>pump | Forced, via peristaltic<br>pump |
| 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,<br>emulsification, aspiration | Fragmentation,<br>emulsification, aspiration | Fragmentation,<br>emulsification,<br>aspiration |
| Components | Console, handpiece,<br>tubing, tips, irrigation<br>sleeve, torque wrench,<br>suction canister | Console, handpiece,<br>tubing, tips, irrigation<br>sleeve, torque wrench,<br>suction canister | Console, handpiece,<br>tubing, tips, irrigation<br>sleeve, torque wrench,<br>suction canister |
| Energy<br>Mechanism | Ultrasonic Energy | Ultrasonic Energy | Ultrasonic Energy |
| Sterilization | Ethylene Oxide<br>(disposable) and Steam<br>(reusable) | Ethylene Oxide<br>(disposable) and Steam<br>(reusable) | Ethylene Oxide<br>(disposable) and Steam<br>(reusable) |
| Biocompatibility | Biocompatible per test<br>reports | Biocompatible per test<br>reports | Biocompatible per test<br>reports |
| Handpiece<br>Frequencies | 25kHz | 25kHz | 25kHz and 34kHz |
| Aspiration<br>Potential (vacuum<br>pressure) | 78kPa maximum | 75.5kPa maximum | 85kPa maximum |
| Volumetric Flow<br>Rate | 533mL/min (maximum) | Unknown | 522mL/min (maximum) |
| Maximum Output<br>Power | 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.