CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps

K162469 · Medos International SARL · GEI · Oct 26, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K162469
• Device Name: CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps
• Applicant: Medos International SARL
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps and CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps are intended for use in electrosurgery for coagulation of tissue.

Device Story

Single-use, sterile, disposable electrosurgical bipolar forceps; connects to external electrosurgical bipolar generator via bipolar cord. Device delivers electrical current from generator to distal tips to coagulate tissue. Used in clinical settings by surgeons. Output is thermal energy for tissue coagulation; assists in achieving hemostasis during surgery. Benefits include non-stick tip properties and disposable design to ensure sterility and performance consistency.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including lesion size, resistivity, weight, non-stick performance, thermal effects, mechanical integrity, dimensional verification, and ergonomics validation. Biocompatibility, electrical safety (IEC 60601-1, 60601-2-2), and EMC testing (IEC 60601-1-2) were performed.

Technological Characteristics

Bayonet-style bipolar forceps; plated aluminum tips; polyamide coating. Energy source: external electrosurgical generator. Connectivity: wired connection to generator. Sterilization: gamma irradiation (SAL 10^-6). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993, ISO 11137.

Indications for Use

Indicated for use in electrosurgery for coagulation of tissue in patients requiring surgical intervention.

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 Standard Bipolar Forceps (K121426)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 26, 2016

Medos International SARL Ms. Jennifer Siu Regulatory Affairs Specialist Chemin-Blanc 38 2400 LeLocle, Switzerland

Re: K162469

Trade/Device Name: CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps. CODMAN VersaTru Slim Disposable Non-Stick Bipolar 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 1, 2016 Received: September 2, 2016

Dear Ms. Siu:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K162469

Device Name

CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps

Indications for Use (Describe)

CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps and CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps are intended for use in electrosurgery for coagulation of tissue.

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

| | <span> <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☒</span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K162469 – 510(k) Summary

#### Codman & Shurtleff, Inc. I. Submitter 325 Paramount Drive Raynham, MA 02767

On behalf of: Medos International SARL Chemin-Blanc 38 2400 LeLocle, Switzerland

Contact: Jennifer Siu Phone: [phone] Fax: [phone]

Date of Submission: September 1, 2016

# II. Device

| II. Device | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | Device Proprietary Name | CODMAN VersaTru™ Disposable Non-Stick Bipolar Forceps |
| | Common Name | Disposable Bipolar Forceps |
| | Classification Name | Electrosurgical, Cutting & Coagulation & Accessories<br>(21 CFR 878.4400) |
| | Regulatory Classification | II |
| | Product Code | GEI |
| III. Predicate Device | The predicate device for this submission is the Synergetics™ Disposable<br>Spetzler™ Malis® Standard Bipolar Forceps (K121426), which was cleared<br>on July 10, 2012. | |
| IV. Device Description | The CODMAN VersaTru Disposable Non-Stick Bipolar Forceps (VersaTru<br>Bipolar Forceps) are single use, disposable, sterile electrosurgical devices, for<br>use in electrosurgery for the coagulation of tissue. The forceps are part of an<br>electrosurgical system consisting of an electrosurgical bipolar generator and<br>bipolar cord attached to the proximal end of the forceps, to provide power and<br>deliver electrical current from the generator to the distal tips of the forceps. | |
| V. Indications for Use | CODMAN VersaTru Disposable Non-Stick Bipolar Forceps are intended for<br>use in electrosurgery for coagulation of tissue. | |

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# VI. Comparison to Predicate Device

The VersaTru Bipolar Forceps is substantially equivalent to the predicate device, the Synergetics Disposable Spetzler Malis Standard Bipolar Forceps. The subject device has the same indications for use and clinical utility, and similar design principles, materials, and packaging as the predicate device. The table below provides a comparison between the subject device and the predicate device.

| Comparison of the Predicate and Subject Device | | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Predicate Device:<br>Synergetics Disposable<br>Spetzler Malis Standard<br>Bipolar Forceps<br>(K121426) | Subject Device:<br>CODMAN VersaTru<br>Disposable Non-Stick Bipolar<br>Forceps<br>(This Submission) |
| FDA Product Code | GEI | Same as predicate |
| Classification | Class II - 21 CFR 878.4400 | Same as predicate |
| Classification Name | Electrosurgical, Cutting &<br>Coagulation & Accessories | Same as predicate |
| Indications for Use | Sterile, single use, for use in<br>electrosurgery for coagulation of<br>tissue | Intended for use in<br>electrosurgery for coagulation of<br>tissue |
| Single Use | Yes | Same as predicate |
| Forceps Design | Bayonet Style | Same as predicate |
| Product Line | Standard | Standard<br>Slim |
| Forceps Length | 7", 8", 9" | Standard: 7", 8", 9"<br>Slim: 8", 9" |
| Forceps Tip Size | 0.5 mm, 1.0 mm, 1.5 mm | Same as predicate |
| Forceps Color | Yellow | Blue |
| Forceps Tips | Plated aluminum | Plated aluminum |
| Coating | Polyvinylidene fluoride | Polyamide |
| Electrical Safety<br>Testing | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 | Same as predicate |
| Packaging<br>Materials<br>(Sterile Barrier) | PETG tray<br>Tyvek lid | Same as predicate |
| Packaging Unit | 5 units per box | 1 unit per box |
| Sterility<br>Assurance Level<br>(SAL) | 10-6 | Same as predicate |
| Sterilization<br>Method | Ethylene oxide | Gamma irradiation |
| Shelf Life | 5 years | 1 year |

#### VII. Performance Data

The following performance data has been provided in support of the substantial equivalence determination. All testing was performed on final sterile devices unless otherwise specified.

# Bench Testing

Performance bench testing was conducted in alignment with FDA's guidance

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Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements.

| Performance Bench Test Results | |
|------------------------------------|------------|
| Test | Conclusion |
| Lesion Size | Pass |
| Resistivity | Pass |
| Weight Test | Pass |
| Non-Stick Test | Pass |
| Thermal Effects Lesion Study | Pass |
| Mechanical Test | Pass |
| Dimensional Verification | Pass |
| Physical Characterization | Pass |
| Functional Testing (after transit) | Pass |
| Ergonomics Validation | Pass |

# Electromagnetic Compatibility/ Electrical Safety Testing

EMC and electrical safety testing were conducted in accordance with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, IEC 60601-1:2005/A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, and IEC 60601-2-2:2009/C1:2014 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. The VersaTru Bipolar Forceps passed all EMC and electrical safety testing.

# Sterilization

The VersaTru Bipolar Forceps is sterilized using a validated gamma irradiation sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-1:2006/Amd1:2013 and ISO 11137-2:2013, Sterilization of health care products – Radiation.

# Shelf-Life Testing

Shelf-life testing was conducted in accordance with FDA's guidance document Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements. VersaTru Bipolar Forceps was subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for up to 1 year.

# Biocompatibility Testing

Biocompatibility testing was conducted in accordance with ISO 10993-1:2009/AC:2010, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, and FDA's guidance documents, Use of International Standard ISO 10993-1, "Biological

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evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016 and Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016.

| Biocompatibility Test Results | | |
|--------------------------------------------------------------------------------------|-------------------------|--|
| Test | Conclusion | |
| Cytotoxicity Study using the ISO Elution Method<br>(1X MEM)<br>ISO 10993-5 | PASS<br>Non-cytotoxic | |
| ISO Guinea Pig Maximization Sensitization Test<br>ISO 10993-10 | PASS<br>Non-sensitizing | |
| ISO Intracutaneous Study in Rabbits<br>ISO 10993-10 | PASS<br>Non-irritating | |
| ISO Systemic Toxicity Study in Mice<br>ISO 10993-11 | PASS<br>Non-toxic | |
| USP Rabbit Pyrogen Study, Material Mediated<br>ISO 10993-11<br>General Chapter <151> | PASS<br>Non-pyrogenic | |
| ASTM Hemolysis Study (Extract Only)<br>ISO 10993-4<br>ASTM F756 | PASS<br>Non-hemolytic | |
| Chemical Characterization of Extractables<br>ISO 10993-18 | PASS | |
| Toxicology Risk Assessment<br>ISO 10993-17 | PASS | |

# Animal Studies

No animal studies were performed as appropriate verification and validation of the new device was achieved based on the comparison to the predicate device and from the results of the bench testing, biocompatibility evaluation, and electrical/safety testing.

# Clinical Studies

No clinical studies were performed as appropriate verification and validation of the new device was achieved based on the comparison to the predicate device and from the results of the bench testing, biocompatibility evaluation, and electrical/safety testing.

VIII. Conclusion

Based upon the intended use, design, function, materials, comparison to the predicate device, and testing conducted, it is concluded that the subject device, VersaTru Bipolar Forceps, is substantially equivalent to the predicate device, Synergetics Disposable Spetzler Malis Standard Bipolar Forceps (K121426), and therefore does not raise different issues of safety and effectiveness.