Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

K213610 · Katalyst Surgical, LLC · GEI · Oct 7, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213610
• Device Name: Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
• Applicant: Katalyst Surgical, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.

Device Story

Disposable bipolar forceps for general surgical procedures; used to grasp, manipulate, coagulate, irrigate, and illuminate tissue. Device connects to electrosurgical generator via bipolar cable; coagulation activated by footswitch. Irrigating models deliver sterile fluid to tips; illuminating models use fibers to deliver light to surgical site. Used in clinical/surgical settings by physicians. Provides coagulation, irrigation, and illumination to assist surgical visualization and hemostasis; benefits patient through precise tissue management and reduced cross-contamination risk due to single-use design.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, 60601-2-2), biocompatibility (ISO 10993-5, -10, -11), sterilization validation (ISO 11135), and performance testing (thermal conductivity, non-stick ability, flow rate, illumination output, and thermal effects on tissue).

Technological Characteristics

Bayonet-style bipolar forceps; silver-plated copper base with PVDF insulation. Energy source: electrosurgical generator. Features: irrigation channels, illumination fibers. Sterilization: Ethylene Oxide (ETO) to 10^-6 SAL. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-6, ISO 10993, ISO 11135, ASTM F1980.

Indications for Use

Indicated for use in electrosurgery for coagulation of tissue, irrigation of tissue, and/or illumination of the surgical site during surgical procedures. Single-use, sterile, prescription-only devices.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Kogent Bipolar Forceps (K123172)
• Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps (K110924)
• Synergetics Spetzler Malis Dual Illuminating Bipolar Forceps (K160103)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 7, 2022

Katalyst Surgical, LLC Liz Morgan Ouality and Regulatory Specialist 754 Goddard Ave Chesterfield, Missouri 63005

Re: K213610

Trade/Device Name: Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 6, 2022 Received: September 6, 2022

Dear Liz Morgan:

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

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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 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 medical devices and radiation-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,

for

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 Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K213610

Device Name Kogent Disposable Copper Bipolar Forceps Kogent Disposable Irrigating Copper Bipolar Forceps Kogent Disposable Illuminating Copper Bipolar Forceps

Indications for Use (Describe)

The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> 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: | Liz Morgan<br>Katalyst Surgical, LLC<br>636-536-5950 (phone)<br>636-787-0603(fax)<br>[e-mail] |
| Date Prepared: | November 4, 2021 |
| 510(k) Number: | K213610 |
| Device Trade Name: | Kogent Disposable Copper Bipolar Forceps<br>Kogent Disposable Irrigating Copper Bipolar Forceps<br>Kogent Disposable Illuminating Copper Bipolar Forceps |
| Common Name: | Bipolar Forceps |
| Classification: | 21 CFR 878.4400 |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Class: | II |
| Product Code: | GEI |

Indications for Use:

The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.

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## Device Description:

These devices are disposable bipolar forceps, designed for single use in general surgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, irrigate and illuminate, when applicable, selected tissues. The irrigation tube is designed to carry sterile fluid to the tips of the instrument. The illumination style forceps contain illumination fibers on each tine to deliver light to the surgical site. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The forceps are provided sterile by ethylene oxide and in sterile pouches.

### Predicate Device:

The Kogent Disposable Copper Bipolar Forceps was shown to be substantially equivalent to the previously cleared devices: Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps K110924, Synergetics Spetzler Malis Dual Illuminating Bipolar Forceps K160103, and Kogent Bipolar Forceps K123172.

| | Subject Device | Predicate Device |
|-------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Device Name | Kogent Disposable Copper<br>Bipolar Forceps | Kogent Bipolar Forceps |
| Company | Katalyst Surgical, LLC | Katalyst Surgical, LLC |
| K Number | K213610 | K123172 |
| Classification | Class II | Class II |
| Product Code | GEI | GEI |
| Indications for Use | Single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue | Single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue |
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Silver Plated copper base with PVDF insulation | Silver Plated aluminum base with PVDF insulation |
| Electrical Safety Testing | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-2-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 |
| Size Offerings Overall Length | 6.25, 7, 8, and 9 inches | 7, 8, and 9 inches |
| Size Offerings Distal Tip | 0.5mm, 1.0mm, 1.5mm | 0.5mm, 1.0mm, 1.5mm |
| Packaging Configuration | Double Tyvek/Poly pouches | Double Tyvek/Poly pouches |
| Biocompatibility | Biocompatible per test reports | Biocompatible per test reports |
| Method of Sterilization | ETO | ETO |
| Sterility Assurance Level | 10-6 | 10-6 |

#### Comparison of Technical Characteristics:

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| | Subject Device | Predicate Device |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Device Name | Kogent Disposable Copper<br>Irrigating Bipolar Forceps | Synergetics Disposable<br>Spetzler Malis Dual<br>Irrigating Bipolar Forceps |
| Company | Katalyst Surgical, LLC | Synergetics, Inc |
| K Number | K213610 | K110924 |
| Classification | Class II | Class II |
| Product Code | GEI | GEI |
| Indications for Use | Single use product sold<br>sterile and are intended for<br>use in electrosurgery for<br>coagulation and irrigation of<br>tissue | Sterile single use, for use in<br>electrosurgery for<br>coagulation and irrigation of<br>tissue |
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Silver Plated copper base<br>with PVDF insulation | Silver Plated aluminum base<br>with PVDF insulation |
| Electrical Safety Testing | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-2-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 |
| Size Offerings Overall Length | 7,8 and 9 inch handles | 7,8 and 9 inch handles |
| Size Offerings Distal Tip | 0.5mm, 1.0mm, 1.5mm | 0.5mm, 1.0mm, 1.5mm |
| Packaging Configuration | Double Tyvek/Poly pouches | Rigid PETG Tray with<br>Tyvek 1073B Lid |
| Biocompatibility | Biocompatible per test<br>reports | Biocompatible per test<br>reports |
| Method of Sterilization | ETO | ETO |
| Sterility Assurance Level | 10-6 | 10-6 |

| | Subject Device | Predicate Device |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Name | Kogent Disposable Copper<br>Illuminating Bipolar<br>Forceps | Synergetics Spetzler Malis<br>Dual Illuminating Bipolar<br>Forceps |
| Company | Katalyst Surgical, LLC | Synergetics, Inc |
| K Number | K213610 | K160103 |
| Classification | Class II | Class II |
| Product Code | GEI | GEI |
| Indications for Use | Single use product sold<br>sterile and are intended for<br>use in electrosurgery for<br>coagulation and to provide<br>light for surgical procedures | Single use devices sold<br>sterile and are intended for<br>use in electrosurgery for<br>coagulation of tissue and to |

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| | | supply light for surgical<br>procedures |
|----------------------------------|---------------------------------------------------|-----------------------------------------------------|
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Silver Plated copper base<br>with PVDF insulation | Silver Plated aluminum base<br>with PVDF insulation |
| Electrical Safety Testing | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-2-2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 |
| Size Offerings Overall<br>Length | 7,8 and 9 inch handles | 8 and 9 inch handles |
| Size Offerings Distal Tip | 0.5mm, 1.0mm, 1.5mm | 0.5mm, 1.0mm, 1.5mm |
| Packaging Configuration | Double Tyvek/Poly pouches | Rigid PETG Tray with<br>Tyvek 1073B Lid |
| Biocompatibility | Biocompatible per test<br>reports | Biocompatible per test<br>reports |
| Method of Sterilization | ETO | ETO |
| Sterility Assurance Level | 10-6 | 10-6 |

### Performance Data:

Clinical Testing was not required to prove substantial equivalence. Bench testing performed between the candidate device and the predicate devices that the Kogent Copper Bipolar Forceps are substantially equivalent to predicate devices.

The product required the following other tests which were completed successfully:

#### Medical Electrical Equipment:

IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 IEC 60601-2-2: 2017 for use in conjunction with IEC 60601-1:2005, COR1:2006, COR 2:2007, AMD1:2012 or IEC 60601-1:2012 IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012

#### Biocompatibility:

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity

#### Sterilization:

ISO 11135:2014 Sterilization of health-care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices

#### Shelf Life:

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# K213610

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Bench Testing Thermal Conductivity Non-Stick Ability Average Flow Rate Average Illumination Output Average Temperature Rise due to Illumination Output Thermal Effects on Tissue

## Conclusion

The Kogent Disposable Copper Bipolar Forceps were shown to be substantially equivalent to previously cleared devices with respect to intended use, indications for use, technological characteristics, performance characteristics, and biocompatibility.