(73 days)
K121426, K 10924
K121426, K 10924
No
The device description and performance studies focus on the electrosurgical function and physical characteristics of the forceps, with no mention of AI or ML.
Yes
The device is used for electrosurgery for coagulation and irrigation of tissue, which are actions intended to treat or alleviate a disease or injury.
No
The device is described as electrosurgical forceps intended for coagulation and irrigation of tissue, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a disposable bipolar forceps, a physical instrument used in electrosurgery, and requires connection to an electrosurgical generator. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrosurgery for coagulation of tissue" and "coagulation and irrigation of tissue." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical instrument used to grasp, manipulate, coagulate, and irrigate tissue during surgery. It connects to an electrosurgical generator.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of these samples.
The device is clearly a surgical instrument used for therapeutic purposes (coagulation and irrigation) during a surgical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
Product codes
GEI
Device Description
This device is a disposable bipolar forceps, designed for single use in electrosurgical 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, and irrigate, when applicable, selected tissues. The irrigation tube is designed to carry fluid to the tips of the instrument. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The devices are provided sterile by ethylene oxide and in sterile packs.
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)
The Kogent Bipolar Forceps performance testing is summarized below.
| Test Criteria | Description | Lower Spec | Upper Spec | Units | Standard
Reference | Result |
|----------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------|---------------------------------------------|--------|
| HF Leakage
Current | Leakage current | - | Ileakage=1.8x10^-5 x d x L x ftestxUpeak [mA] | mA | 201.8.8.3.102
IEC_60601-2-
2_Ed5_2009 | PASS |
| HF Dielectric
Strength | Active accessory
HF dielectric
strength | 120 % of the
rated accessory
voltage. | | KV | 201.8.8.3.103
IEC_60601-2-
2_Ed5_2009 | PASS |
| Mains
Frequency
Dielectric
Strength | The test duration
shall be 30
seconds for active
connectors | | Pass/ Fail - 3.0KV at 60HZ
Frequency | KV | 201.8.8.3.104
IEC_60601-2-
2_Ed5_2009 | PASS |
| Dielectric
Withstand | Scan the cord of
active accessory
for 5 minutes. | | Pass/ Fail - 3.0KV at 60HZ
Frequency | KV | | |
| Anchorage | Workmanship | Pass/ Fail - Cable fails the test if it
separates from the connectors, or
termination during any phase of
the test | | | 201.8.10.4.2
IEC_60601-2-
2_Ed5_2009 | PASS |
| | Resistance/
Continuity | | 0.2 | Ohms | | |
Bench testing demonstrates that the Kogent Bipolar Forceps are substantially equivalent to the Synergetics Disposable Spetzler-Malis Bipolar forceps K121426 and Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps K 10924.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121426, K 10924
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Katalyst Surgical. LLC Kogent Bipolar Forceps Traditional 510(k)
510(k) Summary
DEC 2 1 2012 Manufacturer: Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 636-536-5950 (phone) 636-787-0603 (fax) Mona Dean Contact: Katalyst Surgical, LLC 636-536-5950 (phone) 636-787-0603(fax) Mona. Dean@katalystsurgical.com Date Prepared: October 5, 2012 Kogent Bipolar Forceps Device Trade Name: Bipolar Forceps Common Name: 21 CFR 878.4400; Electrosurgical cutting and coagulation device Classification: and accessories II Class: Product Code: GEI
Indications for Use:
The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
Device Description:
This device is a disposable bipolar forceps, designed for single use in electrosurgical 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, and irrigate, when applicable, selected tissues. The irrigation tube is designed to carry fluid to the tips of the instrument. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The devices are provided sterile by ethylene oxide and in sterile packs.
p. 1/3
1
Predicate Device:
The Kogent Bipolar Forceps was shown to be substantially equivalent to the previously cleared devices: Synergetics Disposable Spetzler-Malis Bipolar forceps K121426 and Synergetics 11: Disposable Spetzler Malis Dual Irrigating Bipolar Forceps K 10924.
Performance Testing Summary:
The Kogent Bipolar Forceps performance testing is summarized below.
| Test Criteria | Description | Lower Spec | Upper Spec | Units | Standard
Reference | Result |
|----------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------|---------------------------------------------|--------|
| HF Leakage
Current | Leakage current | - | $Ileakage=1.8x10^-5 x d x L x ftestxUpeak [mA]$ | mA | 201.8.8.3.102
IEC_60601-2-
2_Ed5_2009 | PASS |
| HF Dielectric
Strength | Active accessory
HF dielectric
strength | 120 % of the
rated accessory
voltage. | | KV | 201.8.8.3.103
IEC_60601-2-
2_Ed5_2009 | PASS |
| Mains
Frequency
Dielectric
Strength | The test duration
shall be 30
seconds for active
connectors | | Pass/ Fail - 3.0KV at 60HZ
Frequency | KV | 201.8.8.3.104
IEC_60601-2-
2_Ed5_2009 | PASS |
| Dielectric
Withstand | Scan the cord of
active accessory
for 5 minutes. | | Pass/ Fail - 3.0KV at 60HZ
Frequency | KV | | |
| Anchorage | Workmanship | Pass/ Fail - Cable fails the test if it
separates from the connectors, or
termination during any phase of
the test | | | 201.8.10.4.2
IEC_60601-2-
2_Ed5_2009 | PASS |
| | Resistance/
Continuity | | 0.2 | Ohms | | |
P. 2/3
2
Substantial Equivalence:
Bench testing demonstrates that the Kogent Bipolar Forceps are substantially equivalent to the Synergetics Disposable Spetzler-Malis Bipolar forceps K121426 and Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps K ! 10924.
| FDA File Reference No. | 510(k) No. K110924 | 510(k) No. 121426 |
|---|---|---|
| TECHNOLOGICAL | ||
| CHARACTERISTICS | Comparison Result | Comparison Result |
| Indications for Use | Identical | Identical |
| Target Population | Identical | Identical |
| Design | Similar | Similar |
| Materials | Similar | Similar |
| Performance | Identical | Identical |
| Sterility | Identical | Identical |
| Biocompatibility | Identical | Identical |
| Anatomical Sites | Identical | Identical |
| Human Factors | Identical | Identical |
| Energy Used and/or Delivered | Identical | Identical |
| Compatibility with Environment | ||
| and Other Devices | Similar | Similar |
| Where Used | Identical | Identical |
| Electrical Safety | Identical | Identical |
| Thermal Safety | Identical | Identical |
| Radiation Safety | Identical | Identical |
SUMMARY OF EQUIVALENCE
Conclusion
The Kogent 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.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Katalyst Surgical, LLC % Ms. Mona Dean Ouality and Regulatory Manager 754 Goddard Avenue Chesterfield, Missouri 63005
December 21, 2012
Re: K123172
Trade/Device Name: Kogent Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 05, 2012 Received: December 06, 2012
Dear Ms. Dean:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Mona Dean
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Katalyst Surgical, LLC Kogent Bipolar Forceps Traditional 510(k)
Indications for Use
510(k) Number (if known): Pre-enact
Device Name: Kogent Bipolar Forceps
The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Intended for ass in occeps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
Prescription Use ど · AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE . IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dwight Yen 2012.12.20 12:33:10 -05'00'
(Division Sign-off) Division of Surgical Devices 510(k) Number K123172