(56 days)
Not Found
No
The summary describes a device for delivering irrigation fluid during electrosurgery and does not mention any AI or ML capabilities. The performance studies focus on standard device functionality and safety.
No
The device delivers irrigation fluid during electrosurgery, which is a supportive function to a medical procedure, not a direct therapeutic action on a patient's condition or disease itself.
No
The device description clearly states its purpose is to "provide flow of irrigation fluid to the tips of bipolar irrigating forceps during electrosurgery" and "deliver irrigation fluid to tissue." This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "reusable, non-sterile electrosurgical device" and part of a system including a generator, cables, and forceps, indicating it is a hardware device with potential software components, not a software-only device.
Based on the provided information, the Codman Electrosurgical Irrigator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide flow of irrigation fluid to the tips of bipolar irrigating forceps during electrosurgery." This describes a device used during a surgical procedure on a patient's body.
- Device Description: The description confirms it's a "reusable, non-sterile electrosurgical device, for use in electrosurgery to deliver irrigation fluid to tissue." Again, this points to a device used directly on a patient.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The Codman Electrosurgical Irrigator does not perform this function.
The device is clearly intended for use in vivo (within a living organism) during a surgical procedure, not in vitro (in glass, or outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Codman Electrosurgical Irrigator is indicated to provide flow of irrigation fluid to the tips of bipolar irrigating forceps during electrosurgery.
Product codes
GEI
Device Description
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.
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
Not Found
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
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. Tests included Design Verification Testing, Flow Accuracy Testing, Summative Study, Nurse Design Validation Study, and Surgeon Design Validation Study, all of which Passed.
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. Tests included Software Unit Verification Testing, and Software Integration and System Verification Testing, all of which Passed.
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. Tests included IEC 60601-1:2005/A1:2012/C1:2012, Edition 3.1 and IEC 60601-1-2:2014, Edition 4.0, all of which Passed.
Sterilization: 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. The device is non-sterile and not intended to be sterilized.
Biocompatibility Testing: Not applicable as it is a non-patient contacting 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.
Key Metrics
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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. Predicate | |||
| Device | The predicate device for this submission is the Malis™ Irrigation | ||
| Module 1000 (K033499), which was cleared on November 28, 2003. | |||
| IV. Device | |||
| Description | 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. | |||
| V. Indications | |||
| for Use | The Codman Electrosurgical Irrigator is indicated to provide flow of irrigation | ||
| fluid to the tips of bipolar irrigating forceps during electrosurgery. | |||
| VI. | |||
| Comparison to | |||
| Predicate | |||
| Device | The Codman Electrosurgical Irrigator is substantially equivalent to the | ||
| predicate device, the Malis Irrigation Module 1000. The subject device has the | |||
| same intended use and clinical utility, and similar design and operating | |||
| principles, accessories, and patient/user interface as the predicate device. The |
4
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 Electrosurgical | ||
| Irrigator | ||
| (This Submission) | ||
| FDA Product | ||
| Code | GEI | Same as predicate |
| Classification | ||
| Classification | ||
| Name | Class II - 21 CFR 878.4400 | Same as predicate |
| Classification | ||
| Name | Electrosurgical, Cutting & | |
| Coagulation & Accessories | Same as predicate | |
| Intended Use | To deliver irrigation fluid to the | |
| tips of bipolar irrigating forceps | Same as predicate | |
| Reusable | Yes | Same as predicate |
| Flow Settings | 0 - 20 | Same as predicate |
| Flow | ||
| Performance | Slow drip to constant stream | Same as predicate |
| Method of | ||
| Operation | Peristaltic pump | Same as predicate |
| Irrigator | ||
| Features | LED display | |
| Single irrigation knob | ||
| Peristaltic pump | ||
| Cut/Coag irrigation toggle | LED display | |
| Single irrigation knob | ||
| Peristaltic pump | ||
| Pause button | ||
| Material | Non-patient contacting | Same as predicate |
| Supply Voltage | 100-230 VAC | 100-240 VAC |
| Supply | ||
| Frequency | 50/60 Hz | Same as predicate |
| Supply Current | 0.60 A | 1.0 A |
| AC Powered | Yes | Same as predicate |
| Electrical Safety | ||
| Testing | IEC 60601-1 | |
| IEC 60601-1-2 | Same as predicate | |
| Software Level of | ||
| Concern | ||
| Classification | Minor | Moderate |
| Non-Sterile | Yes | Same as predicate |
| Packaging | Polybags | |
| Foam inserts | ||
| Mailer | ||
| Carton | Same as predicate | |
| Accessories | Power cords | |
| Interconnecting 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.
5
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.
6
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.