(326 days)
Not Found
No
The document describes a simple electrosurgical tool for coagulation, irrigation, and illumination, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is intended for "coagulation of tissue" and "coagulation and irrigation of tissue," which are therapeutic actions.
No
The device is designed for surgical procedures involving coagulation, irrigation, and illumination of tissue, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly states it is a physical, disposable bipolar forceps with components for grasping, manipulating, coagulating, irrigating, and illuminating tissue, requiring connection to an electrosurgical generator. This is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrosurgery for coagulation of tissue," "coagulation and irrigation of tissue," and "coagulation and to supply light for surgical procedures." These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description details a surgical instrument designed to "grasp, manipulate, coagulate, irrigate and illuminate" tissue. It connects to an electrosurgical generator and is used directly in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment and manipulation of tissue during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
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)
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:
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.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| 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."
3
510(k) Summary
| Manufacturer: | Katalyst Surgical, LLC
754 Goddard Avenue
Chesterfield, MO 63005
636-536-5950 (phone)
636-787-0603 (fax) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Liz Morgan
Katalyst Surgical, LLC
636-536-5950 (phone)
636-787-0603(fax)
e.morgan@katalystsurgical.com |
| Date Prepared: | November 4, 2021 |
| 510(k) Number: | K213610 |
| Device Trade Name: | Kogent Disposable Copper Bipolar Forceps
Kogent Disposable Irrigating Copper Bipolar Forceps
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.
4
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 | |
| 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 | |
| IEC 60601-1-6 | ||
| IEC 60601-2-2 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| 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:
5
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Kogent Disposable Copper | |
| Irrigating Bipolar Forceps | Synergetics Disposable | |
| Spetzler Malis Dual | ||
| 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 | |
| sterile and are intended for | ||
| use in electrosurgery for | ||
| coagulation and irrigation of | ||
| tissue | Sterile single use, for use in | |
| electrosurgery for | ||
| coagulation and irrigation 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 | |
| IEC 60601-1-6 | ||
| IEC 60601-2-2 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| 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 |
| Tyvek 1073B Lid | ||
| Biocompatibility | Biocompatible per test | |
| reports | Biocompatible per test | |
| reports | ||
| Method of Sterilization | ETO | ETO |
| Sterility Assurance Level | 10-6 | 10-6 |
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Kogent Disposable Copper | |
| Illuminating Bipolar | ||
| Forceps | Synergetics Spetzler Malis | |
| Dual Illuminating Bipolar | ||
| 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 | |
| sterile and are intended for | ||
| use in electrosurgery for | ||
| coagulation and to provide | ||
| light for surgical procedures | Single use devices sold | |
| sterile and are intended for | ||
| use in electrosurgery for | ||
| coagulation of tissue and to |
6
| | | supply light for surgical
procedures |
|----------------------------------|---------------------------------------------------|-----------------------------------------------------|
| 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
IEC 60601-1-6
IEC 60601-2-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 |
| Size Offerings Overall
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
Tyvek 1073B Lid |
| Biocompatibility | Biocompatible per test
reports | Biocompatible per test
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:
7
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.