KOGENT BIPOLAR FORCEPS

K123172 · Katalyst Surgical, LLC · GEI · Dec 21, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K123172
• Device Name: KOGENT BIPOLAR FORCEPS
• Applicant: Katalyst Surgical, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Story

Disposable bipolar forceps for electrosurgical coagulation and irrigation; single-use; sterile. Connects to bipolar output of electrosurgical generator via cable; activated by footswitch. Irrigation tube delivers fluid to instrument tips. Used by surgeons in clinical settings to grasp, manipulate, and coagulate tissue. Output is electrosurgical energy; clinical benefit is controlled tissue coagulation and irrigation during surgery.

Clinical Evidence

Bench testing only. Testing included HF leakage current, HF dielectric strength, mains frequency dielectric strength, dielectric withstand, anchorage, and resistance/continuity. All tests passed according to IEC 60601-2-2 Ed5 2009 standards.

Technological Characteristics

Disposable bipolar forceps; electrosurgical energy source; ethylene oxide sterilization. Features irrigation tube for fluid delivery. Electrical safety compliant with IEC 60601-2-2 Ed5 2009. Connectivity via bipolar cable to electrosurgical generator.

Indications for Use

Indicated for use in electrosurgery for coagulation and/or irrigation of tissue in patients undergoing surgical procedures requiring bipolar electrosurgical instruments.

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

• Synergetics Disposable Spetzler-Malis Bipolar forceps (K121426)
• Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps (K110924)

Submission Summary (Full Text)

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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. [e-mail] 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.

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#### 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<br>Reference | Result |
|----------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------|---------------------------------------------|--------|
| HF Leakage<br>Current | Leakage current | - | $Ileakage=1.8x10^-5 x d x L x ftestxUpeak [mA]$ | mA | 201.8.8.3.102<br>IEC_60601-2-<br>2_Ed5_2009 | PASS |
| HF Dielectric<br>Strength | Active accessory<br>HF dielectric<br>strength | 120 % of the<br>rated accessory<br>voltage. | | KV | 201.8.8.3.103<br>IEC_60601-2-<br>2_Ed5_2009 | PASS |
| Mains<br>Frequency<br>Dielectric<br>Strength | The test duration<br>shall be 30<br>seconds for active<br>connectors | | Pass/ Fail - 3.0KV at 60HZ<br>Frequency | KV | 201.8.8.3.104<br>IEC_60601-2-<br>2_Ed5_2009 | PASS |
| Dielectric<br>Withstand | Scan the cord of<br>active accessory<br>for 5 minutes. | | Pass/ Fail - 3.0KV at 60HZ<br>Frequency | KV | | |
| Anchorage | Workmanship | Pass/ Fail - Cable fails the test if it<br>separates from the connectors, or<br>termination during any phase of<br>the test | | | 201.8.10.4.2<br>IEC_60601-2-<br>2_Ed5_2009 | PASS |
| | Resistance/<br>Continuity | | 0.2 | Ohms | | |

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#### 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<br>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<br>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.

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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

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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 [phone] or [phone] 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

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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