VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS

K111751 · ETHICON, Inc. · HIN · Dec 2, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K111751
• Device Name: VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
• Applicant: ETHICON, Inc.
• Product Code: HIN · Obstetrics/Gynecology
• Decision Date: Dec 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. Procedures include: Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa Endometrial ablation

Device Story

Electrosurgical system for gynecologic hysteroscopic procedures; utilizes bipolar technology for tissue vaporization, ablation, excision, and thermal coagulation/hemostasis. System components: generator, 4mm angled loop electrode, footswitch, and connector cable. Operated by physicians in clinical settings. Generator provides five output modes: Ablation (VC), Enhanced Ablation (VP), Blended Ablation (BL), Enhanced Blended Ablation (VBL), and Coagulation (DES). Footswitch allows clinician control of power and mode settings. Output enables precise tissue management, reducing surgical time and improving patient outcomes for intrauterine pathologies.

Clinical Evidence

Two bench studies and one animal study (conducted per 21 CFR Part 58) compared the subject device to the predicate. Endpoints included maximum thermal margin, depth of tissue necrosis, mean volume of gas generated, mean tissue removal rate, and hemostasis performance. Results demonstrated substantial equivalence.

Technological Characteristics

Bipolar electrosurgical system. Components: generator, 4mm angled loop electrode, footswitch, connector cable. Five output modes: VC, VP, BL, VBL, DES. Hardware and software updates accommodate the 4mm electrode. Bipolar technology maintains identical principle of operation to predicate.

Indications for Use

Indicated for gynecologic hysteroscopic electrosurgical procedures including excision of intrauterine myomas, polyps, lysis of adhesions, incision of septa, and endometrial ablation. Contraindicated in patients with acute cervicitis, pregnancy, cervical or uterine malignancy, active pelvic inflammatory disease, unaddressed adnexal pathology, or for tubal sterilization.

Regulatory Classification

Identification

A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and (iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),” (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,” (4) Labeling: (i) Indication: For female tubal sterilization, and (ii) Instructions for use: (A) Destroy at least 2 centimeters of the fallopian tubes, (B) Use a cut or undampened sinusoidal waveform, (C) Use a minimum power of 25 watts, and (D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.

Predicate Devices

• GYNECARE VERSAPOINT Bipolar Electrocautery System (K962482)
• VERSAPOINT VRS 2.5mm Angled Loop Electrode (K994418)

Submission Summary (Full Text)

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# 510(k) Summary

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| Submitter<br>Information | Company: | Ethicon, Inc.<br>Route 22 West<br>Somerville, NJ 08876 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Brian A. Kanerviko<br>Director, WW Regulatory Affairs |
| | Email: | [e-mail] |
| | Telephone: | 908-218-3392 |
| | FAX: | 908-218-2595 |
| | Date Prepared: | June 6, 2011 |
| Identification<br>of the Device | Common Name: | Electrosurgery System |
| | Device Name: | GYNECARE VERSAPOINT™ II Bipolar<br>Electrosurgery System |
| | Classification Name: | Bipolar endoscopic coagulator cutter and accessories<br>Hysteroscope and accessories |
| | Device<br>Classification: | Regulation Number: 21 CFR 884.4150<br>Regulatory Class: Class II<br>Product Code: HIN |
| | | Regulation Number: 21 CFR 884.1690<br>Regulatory Class: Class II<br>Product Code: HIH |
| Predicate<br>Devices | | GYNECARE VERSAPOINT Bipolar Electrocautery System (K962482)<br>VERSAPOINT VRS 2.5mm Angled Loop Electrode (K994418) |
| Description of<br>the Device | | The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System<br>(VERSAPOINT II System) is the next generation of the currently-marketed<br>GYNECARE VERSAPOINT™ Bipolar Electrosurgery System<br>(VERSAPOINT System). This electrosurgical system utilizes bipolar<br>technology specifically designed to provide a range of gynecological surgical<br>treatments, including vaporization to ablate and excise tissue, thermal<br>coagulation of tissue and hemostasis of blood vessels. The VERSAPOINT II<br>System is comprised of four main elements:<br>• the VERSAPOINT II Generator, |
| | | Continued on next page |
| Description of the Device, continued | the VERSAPOINT II 4mm Angled Loop Electrode, the VERSAPOINT II Footswitch, and the VERSAPOINT II Connector Cable. The VERSAPOINT II System offers five bipolar output modes: Ablation (VC [VaporCut]) – for tissue removal and cutting Enhanced Ablation (VP [VersaPulse]) - an enhanced version of the Ablation (VC) output mode attained by use of short-duration high power pulses Blended Ablation (BL) – simultaneous ablation and coagulation (the generator rapidly switches between ablation and coagulation output modes) Enhanced Blended Ablation (VBL) – a variant of the VP output mode that rapidly switches the output ON and OFF to deliver blended ablation/coagulation Coagulation (DES [Desiccate]) - for thermal coagulation and hemostasis | |
| Indications for Use | The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. Procedures include: Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa Endometrial ablation | |
| Contraindications for Use | The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is NOT intended for use in tubal sterilization procedures. The use of this device is contraindicated in patients with the following conditions: Acute cervicitis Pregnancy Cervical or uterine malignancy Active pelvic inflammatory disease Unaddressed adnexal pathology | |

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# 510(k) Summary, Continued

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K111751

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| Technological<br>Characteristics | This electrosurgical system utilizes bipolar technology specifically designed<br>to provide a range of gynecological surgical treatments, identical to the<br>predicate device.<br><br>This premarket notification is for modifications to the currently-marketed<br>GYNECARE VERSAPOINT™ Bipolar Electrosurgery System (generator,<br>connector cable, foot switch and loop electrode). Modifications to the<br>generator include hardware and software updates to accommodate a new 4mm<br>loop electrode. A new connector cable is provided to enable connection of<br>the new 4mm loop electrode and existing electrodes to the generator. In<br>addition, a new heavier weight footswitch has been added to the system which<br>allows the clinician to change power and mode settings. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Testing | Two bench studies and one animal study (conducted in compliance with the<br>Good Laboratory Practices regulation, 21 CFR Part 58) demonstrate the<br>substantial equivalence of the performance of the GYNECARE<br>VERSAPOINT™ II Bipolar Electrosurgery System to the predicate<br>GYNECARE VERSAPOINT™ Bipolar Electrosurgery System with regards<br>to:<br>maximum thermal margin and depth of tissue necrosis, mean volume of gas generated, mean tissue removal rate, and hemostasis performance. |
| Conclusions<br>Drawn from<br>Studies | Validity of Scientific Data:<br>The bench studies followed scientific protocols with pre-determined<br>acceptance criteria. The animal study was conducted in compliance with<br>Good Laboratory Practices (GLPs). The data were scientifically valid in<br>accordance with 21 CFR 860.7.<br><br>Substantial Equivalence:<br>Information presented in this premarket notification establishes that the<br>GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is as safe<br>and effective as the predicate device when used in accordance with the<br>labeled directions for use for the stated indication.<br><br>Risk and Benefits:<br>The risks of the subject device are the same as those of the predicate device.<br>The benefits to the patient are the same as those for the predicate device. |

KIII 15

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

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

DEC - 2 2011

Mr. Brian A. Kanerviko Director, WW Regulatory Affairs Ethicon, Inc. Route 22 West SOMERVILLE NJ 08876

K111751

Re:

Trade/Device Name: GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System

Regulation Number: 21 CFR§ 884.4150

Regulation Name: Bipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HIN, HIH Dated: November 11, 2011 Received: November 17, 2011

· Dear Mr. Kanerviko:

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 device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,

Hubert Lenoir 19

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and · Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K | | 75 |

Device Name: GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System

Indications for Use:

The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. Procedures include:

- . Excision of intrauterine myomas
- ◆ Excision of intrauterine polyps
- . Lysis of intrauterine adhesions
- Incision of uterine septa
- . Endometrial ablation

Hebert Penn

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Prescription Use V (21 CFR Part 801 Subpart D)

and/or

Over-the-Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)