Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a traditional ultrasonic aspirator system and does not mention any AI or ML components or functionalities.

Therapeutic

No

The device is used for surgical procedures to fragment, emulsify, and aspirate tissue, which are actions performed during surgery rather than for therapeutic treatment.

Diagnostic

No

Explanation: The device is described as an ultrasonic aspirator system used for fragmentation, emulsification, and aspiration of tissue in surgical procedures. Its intended use focuses on therapeutic surgical interventions rather than diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a console, handpieces, foot pedal, tips, sleeves, and a suction/irrigation system.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is used for "fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) in surgical procedures." This describes a surgical tool used on the patient's body during a procedure.
Device Description: The description details a system with a console, handpieces, tips, irrigation, and suction. These are components of a surgical device, not a device used to test samples outside of 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. IVDs are designed to perform tests on these types of samples to diagnose or monitor medical conditions.

The device is a surgical aspirator, which is a type of medical device used during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LFL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue and hard tissue (e.g. bone)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgical procedures

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)

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:

Thermal Effects Testing at the Tip
Suction and Aspiration Level Testing
Surgical Bone Removal and Cutting Testing
Soft and Fibrous Tissue Removal Testing

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K190070, K010309

Reference Device(s)

K010309

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

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