(54 days)
Not Found
No
The summary describes a standard electrosurgical bipolar forceps and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is intended for "coagulation of tissue," which is a therapeutic intervention in electrosurgery.
No
The device is described as an electrosurgical device for the coagulation of tissue, indicating a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "single use, disposable, sterile electrosurgical device" and describes physical components like "distal tips" and a connection to a "bipolar cord," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in electrosurgery for coagulation of tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument used to deliver electrical current for tissue coagulation. This is consistent with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / 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."
Product codes
GEI
Device Description
"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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"Prescription Use (Part 21 CFR 801 Subpart D)"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted, including Lesion Size, Resistivity, Weight Test, Non-Stick Test, Thermal Effects Lesion Study, Mechanical Test, Dimensional Verification, Physical Characterization, Functional Testing (after transit), and Ergonomics Validation, all of which passed. Electromagnetic Compatibility/Electrical Safety Testing was performed in accordance with IEC 60601-1-2:2014, IEC 60601-1:2005/A1:2012, and IEC 60601-2-2:2009/C1:2014, and the device passed all tests. Sterilization by gamma irradiation was validated to a SAL of 10^-6 in accordance with ISO 11137-1:2006/Amd1:2013 and ISO 11137-2:2013. Shelf-life testing via accelerated aging established a 1-year shelf life. Biocompatibility testing, including Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Study, Systemic Toxicity, USP Rabbit Pyrogen, ASTM Hemolysis, Chemical Characterization of Extractables, and Toxicology Risk Assessment, all passed in accordance with ISO 10993-1:2009/AC:2010 and related FDA guidance. No animal or clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
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
1
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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3
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™ Disposable | |
| Spetzler™ Malis® Standard Bipolar Forceps (K121426), which was cleared | ||
| on July 10, 2012. | ||
| IV. Device Description | 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. | ||
| V. Indications for Use | CODMAN VersaTru Disposable Non-Stick Bipolar Forceps are intended for | |
| 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: | ||
| Synergetics Disposable | ||
| Spetzler Malis Standard | ||
| Bipolar Forceps | ||
| (K121426) | Subject Device: | |
| CODMAN VersaTru | ||
| Disposable Non-Stick Bipolar | ||
| Forceps | ||
| (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 in | |
| electrosurgery for coagulation of | ||
| tissue | Intended for use in | |
| electrosurgery for coagulation of | ||
| tissue | ||
| Single Use | Yes | Same as predicate |
| Forceps Design | Bayonet Style | Same as predicate |
| Product Line | Standard | Standard |
| Slim | ||
| 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 Safety | ||
| Testing | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-2 | Same as predicate | |
| Packaging | ||
| Materials | ||
| (Sterile Barrier) | PETG tray | |
| Tyvek lid | Same as predicate | |
| Packaging Unit | 5 units per box | 1 unit per box |
| Sterility | ||
| Assurance Level | ||
| (SAL) | 10-6 | Same as predicate |
| Sterilization | ||
| 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
6
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 | PASS | |
| Non-cytotoxic | ||
| ISO Guinea Pig Maximization Sensitization Test | ||
| ISO 10993-10 | PASS | |
| Non-sensitizing | ||
| ISO Intracutaneous Study in Rabbits | ||
| ISO 10993-10 | PASS | |
| Non-irritating | ||
| ISO Systemic Toxicity Study in Mice | ||
| ISO 10993-11 | PASS | |
| Non-toxic | ||
| USP Rabbit Pyrogen Study, Material Mediated | ||
| ISO 10993-11 | ||
| General Chapter | PASS | |
| Non-pyrogenic | ||
| ASTM Hemolysis Study (Extract Only) | ||
| ISO 10993-4 | ||
| ASTM F756 | PASS | |
| Non-hemolytic | ||
| Chemical Characterization of Extractables | ||
| ISO 10993-18 | PASS | |
| Toxicology Risk Assessment | ||
| 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.