(54 days)
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.
The CODMAN VersaTru Disposable Non-Stick Bipolar Forceps (VersaTru Bipolar Forceps) are single use, disposable, sterile electrosurgical devices, for use in electrosurgery for the coagulation of tissue. The forceps are part of an electrosurgical system consisting of an electrosurgical bipolar generator and bipolar cord attached to the proximal end of the forceps, to provide power and deliver electrical current from the generator to the distal tips of the forceps.
This document is a 510(k) Summary for the "CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps" and "CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps". It describes the device, its intended use, a comparison to a predicate device, and performance data used to establish substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a separate table with quantified values. Instead, it presents various test categories and states that the device "Pass"ed each one. The acceptance criteria are implicitly defined by the standards and internal requirements referenced for each test.
| Test Category | Specific Test | Reported Device Performance | Implicit Acceptance Criteria (based on referenced standards/guidance) |
|---|---|---|---|
| Bench Testing | Lesion Size | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements |
| Resistivity | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Weight Test | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Non-Stick Test | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Thermal Effects Lesion Study | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Mechanical Test | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Dimensional Verification | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Physical Characterization | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Functional Testing (after transit) | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Ergonomics Validation | Pass | Alignment with FDA's guidance (August 15, 2016) and internal requirements | |
| Electromagnetic Compatibility/ Electrical Safety Testing | All tests in accordance with: IEC 60601-1-2:2014, IEC 60601-1:2005/A1:2012, IEC 60601-2-2:2009/C1:2014 | Pass | Compliance with referenced IEC standards |
| Sterilization | Sterility Assurance Level (SAL) | 10^-6 | SAL of 10^-6 in accordance with ISO 11137-1:2006/Amd1:2013 and ISO 11137-2:2013 |
| Shelf-Life Testing | Accelerated aging studies | Pass | Device and packaging remain functional and maintain sterility for up to 1 year, in accordance with FDA guidance (August 15, 2016) and internal requirements |
| Biocompatibility Testing | Cytotoxicity Study | PASS (Non-cytotoxic) | Compliance with ISO 10993-5 and FDA guidance |
| Guinea Pig Maximization Sensitization Test | PASS (Non-sensitizing) | Compliance with ISO 10993-10 and FDA guidance | |
| Intracutaneous Study | PASS (Non-irritating) | Compliance with ISO 10993-10 and FDA guidance | |
| Systemic Toxicity Study | PASS (Non-toxic) | Compliance with ISO 10993-11 and FDA guidance | |
| USP Rabbit Pyrogen Study | PASS (Non-pyrogenic) | Compliance with ISO 10993-11, USP <151>, and FDA guidance | |
| ASTM Hemolysis Study | PASS (Non-hemolytic) | Compliance with ISO 10993-4, ASTM F756, and FDA guidance | |
| Chemical Characterization of Extractables | PASS | Compliance with ISO 10993-18 and FDA guidance | |
| Toxicology Risk Assessment | PASS | Compliance with ISO 10993-17 and FDA guidance |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of devices) used for each individual bench test, electrical safety test, sterilization validation, shelf-life test, or biocompatibility test. It generally states that "All testing was performed on final sterile devices" and refers to applicable standards. For example, for sterilization validation, ISO standards typically dictate minimum sample sizes based on the chosen method and desired SAL.
- Data Provenance: The data provenance is described as being generated from "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" guidance, internal requirements, and international standards (IEC, ISO, ASTM). This indicates that the tests were conducted specifically for the purpose of this 510(k) submission, likely in a controlled laboratory environment. The country of origin of the data is not explicitly stated but is implicitly tied to the submitter (Medos International SARL in Switzerland) and the manufacturer testing facilities. The studies are prospective in nature, as they are part of the premarket submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to the presented document. The document describes testing of a physical medical device (bipolar forceps) against engineering and biological performance standards, not an AI or diagnostic device that requires expert ground truth labeling. The "ground truth" for these tests is defined by the physical and chemical properties measured and compared against established engineering, electrical, and biological safety standards.
4. Adjudication method for the test set:
Not applicable, as no expert adjudication was required for the types of tests described. The results are objective measurements against defined acceptance criteria (standards).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document pertains to the 510(k) clearance for bipolar forceps, which is a physical surgical instrument, not an AI-assisted diagnostic tool. No MRMC studies were conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the various tests conducted (bench, electrical, sterilization, biocompatibility, shelf-life) is established by:
- Physical/Chemical Measurements: Direct measurements of device dimensions, electrical properties, material composition, etc.
- Biological Endpoints: Observing cellular responses (cytotoxicity), immunological reactions (sensitization), tissue irritation, systemic toxicity, pyrogenicity, and hemolysis in in vitro or in vivo (animal) models.
- Functional Performance: Testing the device's ability to perform its intended function (e.g., coagulation, non-stick properties) under simulated conditions.
- Compliance with Standards: The ultimate ground truth is compliance with the referenced international standards (IEC, ISO, ASTM) and FDA guidance documents, which set the safety and performance benchmarks.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of physical medical device clearance. This question is relevant to AI/machine learning models.
9. How the ground truth for the training set was established:
Not applicable. As there were no AI algorithms involved, there was no training set or ground truth for such a set.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| ☐ 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: (508) 828-3288 Fax: (508) 977-6979
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(21 CFR 878.4400) | |
| Regulatory Classification | II | |
| Product Code | GEI | |
| III. Predicate Device | The predicate device for this submission is the Synergetics™ DisposableSpetzler™ Malis® Standard Bipolar Forceps (K121426), which was clearedon July 10, 2012. | |
| IV. Device Description | The CODMAN VersaTru Disposable Non-Stick Bipolar Forceps (VersaTruBipolar Forceps) are single use, disposable, sterile electrosurgical devices, foruse in electrosurgery for the coagulation of tissue. The forceps are part of anelectrosurgical system consisting of an electrosurgical bipolar generator andbipolar cord attached to the proximal end of the forceps, to provide power anddeliver 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 foruse 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:Synergetics DisposableSpetzler Malis StandardBipolar Forceps(K121426) | Subject Device:CODMAN VersaTruDisposable Non-Stick BipolarForceps(This Submission) | |
| FDA Product Code | GEI | Same as predicate |
| Classification | Class II - 21 CFR 878.4400 | Same as predicate |
| Classification Name | Electrosurgical, Cutting &Coagulation & Accessories | Same as predicate |
| Indications for Use | Sterile, single use, for use inelectrosurgery for coagulation oftissue | Intended for use inelectrosurgery for coagulation oftissue |
| Single Use | Yes | Same as predicate |
| Forceps Design | Bayonet Style | Same as predicate |
| Product Line | Standard | StandardSlim |
| Forceps Length | 7", 8", 9" | Standard: 7", 8", 9"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 SafetyTesting | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | Same as predicate |
| PackagingMaterials(Sterile Barrier) | PETG trayTyvek lid | Same as predicate |
| Packaging Unit | 5 units per box | 1 unit per box |
| SterilityAssurance Level(SAL) | 10-6 | Same as predicate |
| SterilizationMethod | 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(1X MEM)ISO 10993-5 | PASSNon-cytotoxic | |
| ISO Guinea Pig Maximization Sensitization TestISO 10993-10 | PASSNon-sensitizing | |
| ISO Intracutaneous Study in RabbitsISO 10993-10 | PASSNon-irritating | |
| ISO Systemic Toxicity Study in MiceISO 10993-11 | PASSNon-toxic | |
| USP Rabbit Pyrogen Study, Material MediatedISO 10993-11General Chapter <151> | PASSNon-pyrogenic | |
| ASTM Hemolysis Study (Extract Only)ISO 10993-4ASTM F756 | PASSNon-hemolytic | |
| Chemical Characterization of ExtractablesISO 10993-18 | PASS | |
| Toxicology Risk AssessmentISO 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.
§ 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.