(163 days)
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
The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System (VERSAPOINT II System) is the next generation of the currently-marketed GYNECARE VERSAPOINT™ Bipolar Electrosurgery System (VERSAPOINT System). This electrosurgical system utilizes bipolar technology specifically designed to provide a range of gynecological surgical treatments, including vaporization to ablate and excise tissue, thermal coagulation of tissue and hemostasis of blood vessels. The VERSAPOINT II System is comprised of four main elements: the VERSAPOINT II Generator, 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
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that performance was evaluated against the predicate device to demonstrate "substantial equivalence." The acceptance criteria were based on similar performance to the legally marketed predicate. Specific numerical targets or ranges for the acceptance criteria are not explicitly detailed in the provided text, but the study aimed to show that the new device's performance was comparable.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Maximum thermal margin and depth of tissue necrosis | Comparable to predicate device | Demonstrated substantial equivalence |
| Mean volume of gas generated | Comparable to predicate device | Demonstrated substantial equivalence |
| Mean tissue removal rate | Comparable to predicate device | Demonstrated substantial equivalence |
| Hemostasis performance | Comparable to predicate device | Demonstrated substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each study. The text mentions "Two bench studies and one animal study." While these studies form the "test set" for demonstrating substantial equivalence, the specific number of samples or animals used in each is not provided.
- Data Provenance: The animal study was conducted "in compliance with the Good Laboratory Practices regulation, 21 CFR Part 58," indicating a prospective, controlled study design typically involving animal subjects. The location (country of origin) of these studies is not specified. Bench studies are inherently controlled laboratory evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The studies described are performance-based evaluations of the electrosurgical system's physical effects (tissue necrosis, gas generation, tissue removal, hemostasis) rather than diagnostic or interpretative tasks requiring human expert ground truth.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication is not relevant for this type of performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for diagnostic devices where human readers interpret images or data, and the AI's assistance to these readers is being evaluated. The GYNECARE VERSAPOINT™ II is an electrosurgical system, not a diagnostic imaging or interpretive aid.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies conducted can be considered "standalone" in the sense that they evaluated the device's inherent performance characteristics (like thermal effects, gas generation, tissue removal) independently of human cognitive interpretation or decision-making. The device is a surgical tool, and its performance is assessed by its direct effects on tissue.
7. Type of Ground Truth Used
The "ground truth" for these studies was based on direct measurement and observation of the physical effects of the electrosurgical system.
- Bench Studies: Involved direct measurements of thermal margin, depth of tissue necrosis, volume of gas generated, and tissue removal rate in controlled laboratory settings.
- Animal Study: Involved direct observation and measurement of tissue effects and hemostasis performance in a living model. This would likely include histological analysis and quantitative measurements of tissue damage or desired surgical outcomes.
8. Sample Size for the Training Set
Not applicable. The GYNECARE VERSAPOINT™ II is an electrosurgical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "hardware and software updates" mentioned likely refer to engineering and control system logic modifications, not a data-driven learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm in this context. The "updates" were likely developed based on engineering principles, predicate device performance data, and design specifications, rather than a data-driven training process.
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510(k) Summary
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| SubmitterInformation | Company: | Ethicon, Inc.Route 22 WestSomerville, NJ 08876 |
|---|---|---|
| Contact Person: | Brian A. KanervikoDirector, WW Regulatory Affairs | |
| Email: | bkanervi@its.jnj.com | |
| Telephone: | 908-218-3392 | |
| FAX: | 908-218-2595 | |
| Date Prepared: | June 6, 2011 | |
| Identificationof the Device | Common Name: | Electrosurgery System |
| Device Name: | GYNECARE VERSAPOINT™ II BipolarElectrosurgery System | |
| Classification Name: | Bipolar endoscopic coagulator cutter and accessoriesHysteroscope and accessories | |
| DeviceClassification: | Regulation Number: 21 CFR 884.4150Regulatory Class: Class IIProduct Code: HIN | |
| Regulation Number: 21 CFR 884.1690Regulatory Class: Class IIProduct Code: HIH | ||
| PredicateDevices | GYNECARE VERSAPOINT Bipolar Electrocautery System (K962482)VERSAPOINT VRS 2.5mm Angled Loop Electrode (K994418) | |
| Description ofthe Device | The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System(VERSAPOINT II System) is the next generation of the currently-marketedGYNECARE VERSAPOINT™ Bipolar Electrosurgery System(VERSAPOINT System). This electrosurgical system utilizes bipolartechnology specifically designed to provide a range of gynecological surgicaltreatments, including vaporization to ablate and excise tissue, thermalcoagulation of tissue and hemostasis of blood vessels. The VERSAPOINT IISystem is comprised of four main elements:• 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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| TechnologicalCharacteristics | This electrosurgical system utilizes bipolar technology specifically designedto provide a range of gynecological surgical treatments, identical to thepredicate device.This premarket notification is for modifications to the currently-marketedGYNECARE VERSAPOINT™ Bipolar Electrosurgery System (generator,connector cable, foot switch and loop electrode). Modifications to thegenerator include hardware and software updates to accommodate a new 4mmloop electrode. A new connector cable is provided to enable connection ofthe new 4mm loop electrode and existing electrodes to the generator. Inaddition, a new heavier weight footswitch has been added to the system whichallows the clinician to change power and mode settings. |
|---|---|
| PerformanceTesting | Two bench studies and one animal study (conducted in compliance with theGood Laboratory Practices regulation, 21 CFR Part 58) demonstrate thesubstantial equivalence of the performance of the GYNECAREVERSAPOINT™ II Bipolar Electrosurgery System to the predicateGYNECARE VERSAPOINT™ Bipolar Electrosurgery System with regardsto:maximum thermal margin and depth of tissue necrosis, mean volume of gas generated, mean tissue removal rate, and hemostasis performance. |
| ConclusionsDrawn fromStudies | Validity of Scientific Data:The bench studies followed scientific protocols with pre-determinedacceptance criteria. The animal study was conducted in compliance withGood Laboratory Practices (GLPs). The data were scientifically valid inaccordance with 21 CFR 860.7.Substantial Equivalence:Information presented in this premarket notification establishes that theGYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is as safeand effective as the predicate device when used in accordance with thelabeled directions for use for the stated indication.Risk and Benefits:The risks of the subject device are the same as those of the predicate device.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
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 (800) 638-2041 or (301) 796-7100 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
ork) N
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)
§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a)
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.(b)
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.