(56 days)
The Codman Electrosurgical Irrigator is indicated to provide flow of irrigation fluid to the tips of bipolar irrigating forceps during electrosurgery.
The Codman Electrosurgical Irrigator is a reusable, non-sterile electrosurgical device, for use in electrosurgery to deliver irrigation fluid to tissue. The irrigator is part of an electrosurgical system consisting of an electrosurgical generator connected via an interconnecting cable, and a pair of bipolar irrigating forceps connected via a cord and tubing set.
This document describes the premarket notification (510(k)) for the Codman Electrosurgical Irrigator. It covers the device's indications for use, comparison to a predicate device, and performance data. However, it does not contain the detailed information requested regarding the acceptance criteria and study proving a device meets those criteria for software or AI-based devices. The device described in this 510(k) is an electrosurgical irrigator, which is a physical medical device, not an AI or software product that would typically involve acceptance criteria related to accuracy, sensitivity, or specificity.
Therefore, many of the requested categories are Not Applicable in this context.
Here's a breakdown based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Testing | Pass requirements | Pass |
| Design Verification Testing | Pass requirements | Pass |
| Flow Accuracy Testing | Pass requirements | Pass |
| Summative Study | Pass requirements | Pass |
| Nurse Design Validation Study | Pass requirements | Pass |
| Surgeon Design Validation Study | Pass requirements | Pass |
| Software Testing | Pass requirements | Pass |
| Software Unit Verification Testing | Pass requirements | Pass |
| Software Integration and System Verification Testing | Pass requirements | Pass |
| Electrical Safety/EMC Testing | Pass specified standards | Pass |
| IEC 60601-1:2005/A1:2012/C1:2012, Edition 3.1 | Pass the standard | Pass |
| IEC 60601-1-2:2014, Edition 4.0 | Pass the standard | Pass |
| Sterilization | (Not applicable, non-sterile) | (Not applicable) |
| Cleaning Validation | Support cleaning instructions | Performed |
| Shelf-Life Testing | (Not applicable, reusable) | (Not applicable) |
| Biocompatibility Testing | (Not applicable, non-patient contacting) | (Not applicable) |
The document states "All testing was performed on final devices" and provides "Conclusion: Pass" for each listed test, implying that the devices met their respective acceptance criteria. Specific numerical acceptance criteria (e.g., "flow rate within +/- 5%") are not explicitly stated in this summary.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the "Design Verification Testing," "Flow Accuracy Testing," "Summative Study," "Nurse Design Validation Study," or "Surgeon Design Validation Study." Given the nature of a 510(k) summary for a physical electrosurgical irrigator, "test set" does not refer to a dataset like in AI/software. The testing involved physical devices. No data provenance in terms of country of origin or retrospective/prospective is relevant for this type of device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The device is a physical irrigator. Ground truth in the context of expert review for AI/software assessment is not relevant. The "Nurse Design Validation Study" and "Surgeon Design Validation Study" imply involvement of relevant healthcare professionals, but specifics on their number or qualifications for establishing "ground truth" are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device premarket submission. The testing involved performance studies of a physical device.
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 is not an AI/software device and does not involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this physical device, "ground truth" would refer to measured physical properties (e.g., flow rate, electrical safety parameters) rather than clinical interpretations requiring expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
In summary: The provided document is a 510(k) summary for a physical medical device (Codman Electrosurgical Irrigator). The requests for information largely pertain to AI/software performance studies and are therefore not applicable to this submission. The document confirms that the device passed various bench, software (for its control functions), and electrical safety tests, supporting its substantial equivalence to a predicate device.
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November 27, 2018
Integra LifeSciences Corporation Ms. Jennifer Siu Sr. Regulatory Affairs Specialist 11 Cabot Boulevard Mansfield, Massachusetts 02048
Re: K182801
Trade/Device Name: Codman Electrosurgical Irrigator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 28, 2018 Received: October 2, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long H. Chen Chen -S Digitally signed by Long H. Date: 2018.11.27 14:59:06 -5 05'00'
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) K182801
Device Name Codman® Electrosurgical Irrigator
Indications for Use (Describe)
The Codman Electrosurgical Irrigator is indicated to provide flow of irrigation fluid to the tips of bipolar irrigating forceps during electrosurgery.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Integra LifeSciences Corporation I. Submitter 11 Cabot Boulevard Mansfield, MA 02048
Contact Miss Jennifer Siu, Neuroscience, B.S. Sr. Regulatory Affairs Specialist jennifer.siu@integralife.com (781) 971-5692
Date of Submission: September 28, 2018
| II. Device | Device Proprietary Name | Codman® Electrosurgical Irrigator | |
|---|---|---|---|
| Common Name | Irrigator | ||
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories(21 CFR 878.4400) | ||
| Regulatory Classification | II | ||
| Product Code | GEI | ||
| Review Panel | General & Plastic Surgery | ||
| III. PredicateDevice | The predicate device for this submission is the Malis™ IrrigationModule 1000 (K033499), which was cleared on November 28, 2003. | ||
| IV. DeviceDescription | The Codman Electrosurgical Irrigator is a reusable, non-sterile electrosurgicaldevice, for use in electrosurgery to deliver irrigation fluid to tissue. Theirrigator is part of an electrosurgical system consisting of an electrosurgicalgenerator connected via an interconnecting cable, and a pair of bipolarirrigating forceps connected via a cord and tubing set. | ||
| V. Indicationsfor Use | The Codman Electrosurgical Irrigator is indicated to provide flow of irrigationfluid to the tips of bipolar irrigating forceps during electrosurgery. | ||
| VI.Comparison toPredicateDevice | The Codman Electrosurgical Irrigator is substantially equivalent to thepredicate device, the Malis Irrigation Module 1000. The subject device has thesame intended use and clinical utility, and similar design and operatingprinciples, accessories, and patient/user interface as the predicate device. The |
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table below provides a comparison between the subject device and the predicate device.
| Comparison of the Predicate and Subject Device | ||
|---|---|---|
| Predicate Device:Malis Irrigation Module 1000(K033499) | Subject Device:Codman ElectrosurgicalIrrigator(This Submission) | |
| FDA ProductCode | GEI | Same as predicate |
| ClassificationClassificationName | Class II - 21 CFR 878.4400 | Same as predicate |
| ClassificationName | Electrosurgical, Cutting &Coagulation & Accessories | Same as predicate |
| Intended Use | To deliver irrigation fluid to thetips of bipolar irrigating forceps | Same as predicate |
| Reusable | Yes | Same as predicate |
| Flow Settings | 0 - 20 | Same as predicate |
| FlowPerformance | Slow drip to constant stream | Same as predicate |
| Method ofOperation | Peristaltic pump | Same as predicate |
| IrrigatorFeatures | LED displaySingle irrigation knobPeristaltic pumpCut/Coag irrigation toggle | LED displaySingle irrigation knobPeristaltic pumpPause button |
| Material | Non-patient contacting | Same as predicate |
| Supply Voltage | 100-230 VAC | 100-240 VAC |
| SupplyFrequency | 50/60 Hz | Same as predicate |
| Supply Current | 0.60 A | 1.0 A |
| AC Powered | Yes | Same as predicate |
| Electrical SafetyTesting | IEC 60601-1IEC 60601-1-2 | Same as predicate |
| Software Level ofConcernClassification | Minor | Moderate |
| Non-Sterile | Yes | Same as predicate |
| Packaging | PolybagsFoam insertsMailerCarton | Same as predicate |
| Accessories | Power cordsInterconnecting cable | Same as predicate |
The following performance data has been provided in support of the VII. Performance substantial equivalence determination. All testing was performed on final Data devices unless otherwise specified.
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Bench Testing
Performance bench testing was conducted in alignment with FDA's guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements.
| Performance Bench Test Results | |
|---|---|
| Test | Conclusion |
| Design Verification Testing | Pass |
| Flow Accuracy Testing | Pass |
| Summative Study | Pass |
| Nurse Design Validation Study | Pass |
| Surgeon Design Validation Study | Pass |
Software Testing
Software testing was conducted in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
| Software Verification Test Results | |
|---|---|
| Test | Conclusion |
| Software Unit Verification Testing | Pass |
| Software Integration and System Verification Testing | Pass |
Electrical Safety/Electromagnetic Compatibility Testing
Electrical safety and EMC testing were conducted in accordance with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
| Electrical Test Results | |
|---|---|
| Test | Conclusion |
| IEC 60601-1:2005/A1:2012/C1:2012, Edition 3.1 | Pass |
| IEC 60601-1-2:2014, Edition 4.0 | Pass |
Sterilization
The Codman Electrosurgical Irrigator is a non-sterile capital equipment and is not intended to be sterilized. Therefore, sterilization is not applicable for this device. A validation was performed to support cleaning instructions in the device labeling (Instructions for Use) in accordance with FDA's Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued March 17, 2015.
Shelf-Life Testing
The Codman Electrosurgical Irrigator is a reusable, non-sterile device. Therefore, there is no expiry date and shelf-life is not applicable for this device.
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Biocompatibility Testing
The Codman Electrosurgical Irrigator is a non-patient contacting device. Therefore, biocompatibility is not applicable for this device.
Animal Studies
No animal studies were performed as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, and electrical/safety testing.
Clinical Studies
No clinical studies were performed as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, and electrical/safety testing.
VIII. Conclusion
Based upon the intended use, design, operating principles, patient/user interface, comparison to the predicate device, and testing conducted, it is concluded that the subject device, Codman Electrosurgical Irrigator, is substantially equivalent to the predicate device, Malis Irrigation Module 1000 (K033499), and therefore does not raise different questions 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.