(42 days)
The Irrigation Tubing Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
The Irrigation Tubing Bipolar Cord Se is designed to connect to both an electrical generator and bipolar forceps via an electrically conducting cord and to a saline source for irrigation via a catheter to provide simultaneous coagulation capabilities and irrigation capabilities. A co-extrusion manufacturing process is applied to integrate a bipolar cord with irrigation tubing into one unit. This integrated Irrigation Tubing Bipolar Cord set are helpful to keep the bipolar electrosurgery organized. The electrically conducting cord is formed with a pair of copper wires each coaxially surrounded by an outer insulation sheath. The insulated bipolar cord (24 AWG) provides safety protection to patients and surgical staff. The fluid catheter is formed of PVC and silicone tubing connected by connectors and is defined as fluid passage pathway.
This is a 510(k) premarket notification for a medical device called "Irrigation Tubing Bipolar Cord Sets." As per the provided document, the device's acceptance criteria are demonstrated through non-clinical testing, specifically electrical safety testing and bench testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Irrigation Tubing Bipolar Cord Sets meet the requirements of its pre-defined acceptance criteria and intended uses."
The specific acceptance criteria and detailed performance metrics are not explicitly laid out in a table format in the provided text. However, the document lists the standards the testing was performed in accordance with:
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Electrical safety) | Met requirements |
| IEC 60601-1-2 (EMC) | Met requirements |
| IEC 60601-2-2 (HF surgical equipment performance) | Met requirements |
| Pre-defined acceptance criteria for intended uses (Bench Testing) | Met requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the electrical safety testing and bench testing, nor does it explicitly state the data provenance (e.g., country of origin or retrospective/prospective nature). The testing appears to be non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Electrical safety and bench testing typically rely on established engineering standards and test protocols rather than expert consensus on a "ground truth" derived from human interpretation.
4. Adjudication method for the test set
This information is not applicable and is not provided in the document. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which is not the nature of the electrical safety and bench testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical electrical safety and bench testing, not a clinical study involving human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is hardware (irrigation tubing bipolar cord sets) and does not involve an algorithm or AI. The testing described is for the physical and electrical performance of the hardware.
7. The type of ground truth used
For electrical safety and bench testing, the "ground truth" is typically defined by established engineering standards and specifications (e.g., IEC standards for electrical safety and performance parameters for fluid flow, cable length, etc.). The device's performance is measured against these objective, predefined criteria.
8. The sample size for the training set
This information is not applicable and is not provided in the document. The device is hardware, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this hardware device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 18, 2018
New Deantronics Taiwan Ltd. % Mr. Craig Coombs Coombs Medical Device Consulting, Inc 1193 Sherman St Alameda, California 94501
Re: K180908
Trade/Device Name: Irrigation Tubing Bipolar Cord Sets Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 4, 2018 Received: April 6, 2018
Dear Mr. Coombs:
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 adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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Page 2 - Mr. Craig Coombs
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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, Jennif Steven 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) K180908
Device Name Irrigation Tubing Bipolar Cord Sets
Indications for Use (Describe)
The Irrigation Tubing Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and the word "DEANTRONICS" is in blue as well. There is a blue circle with a red dot in the middle between the two words.
Section 5: 510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | New Deantronics Taiwan Ltd.12F., No.51, Sec. 4, Chong Yang Rd.,Tu Cheng Dist,New Taipei City 23675, Taiwan R.O.C.Tel: (886) 2-2268-1726Fax: (886) 2-2268-3800 |
| Correspondent ContactInformation: | Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140 |
| Device Common Name: | Electrosurgical accessory |
| Device Classification Number: | 21 CFR 878.4400 |
| Device Classification &Product Code: | Class 2,GEI |
| Device Proprietary Name: | Irrigation Tubing Bipolar Cord Sets |
Predicate Device Information:
| Predicate Device: | Codman Integrated Bipolar Cord andTubing Set |
|---|---|
| Predicate Device Manufacturer: | Codman & Shurtleff, Inc. |
| Predicate Device Common Name: | Electrosurgical accessoryIrrigation Tubing Bipolar Cord Sets |
| Predicate Device Premarket Notification # | K163106 |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification &Product Code: | Class 2,GEI |
B. Date Summary Prepared
4 April 2018
C. Description of Device
The Irrigation Tubing Bipolar Cord Se is designed to connect to both an electrical generator and bipolar forceps via an electrically conducting cord and to a saline source for irrigation via a catheter to provide simultaneous coagulation capabilities and irrigation capabilities.
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Image /page/4/Picture/1 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, outlined in white, and is located on the left side of the logo. To the right of the word "NEW" is a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue and is located to the right of the circle.
A co-extrusion manufacturing process is applied to integrate a bipolar cord with irrigation tubing into one unit. This integrated Irrigation Tubing Bipolar Cord set are helpful to keep the bipolar electrosurgery organized.
The electrically conducting cord is formed with a pair of copper wires each coaxially surrounded by an outer insulation sheath. The insulated bipolar cord (24 AWG) provides safety protection to patients and surgical staff. The fluid catheter is formed of PVC and silicone tubing connected by connectors and is defined as fluid passage pathway.
D. Indications for Use
The Irrigation Tubing Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
E. Comparison to Predicate Device
As described below, the application New Deantronics Bipolar Cord Tubing Set is substantially equivalent in intended use, technology, design and physician use to the predicate Codman Integrated Bipolar Cord Tubing and Set (K163106).
| Feature | Application Device:Irrigation Tubing BipolarCord Sets | Predicate Device:Codman IntegratedBipolar Cord Tubingand Set (K163106) | Pertinence of Featureto Consideration ofSubstantialEquivalence. |
|---|---|---|---|
| Indications for Use | The Irrigation TubingBipolar Cord Sets areintended to provideirrigation and energysimultaneously to bipolarforceps specificallydesigned for irrigation. | The CODMANIntegrated Bipolar Cordand Tubing Sets areintended to provideirrigation and energysimultaneously tobipolar forcepsspecifically designed forirrigation. | The Indications for Useof the two devices areidentical, except forname of the devices |
| Product Code | GEI | GEI | Identical |
| Technology | |||
| Mechanism ofOperation | The integrated BipolarCord Set and Irrigationtubing is designed toconnect an RF electricalgenerator to bipolarcoagulating forceps viaan electrically conductingcord. It is also intendedto connect a salinesource, via the irrigationtubing. The saline flowthrough the tubing iscontrolled by a surgeon-controlled fluid | Same | Identical |
| Feature | Application Device:Irrigation Tubing BipolarCord Sets | Predicate Device:Codman IntegratedBipolar Cord Tubingand Set (K163106) | Pertinence of Featureto Consideration ofSubstantialEquivalence. |
| controller. This allowsfor simultaneous,controlled, coagulationand irrigationcapabilities. | |||
| Compatible w/Monopolar or BipolarRF administration? | Bipolar only | Bipolar only | Identical |
| Integral ElectricalCable and FluidTubing? | Yes | Yes | Identical |
| Fluid feedcompatibility | Rotary or Gravity | Rotary or Gravity | Identical |
| Design - ElectricalCable | |||
| Cable length | 3.6 meters | 3.4 meters | Functionally Identical |
| Wire Gauge | 24 AWG | 24 AWG | Identical |
| Materials for cableinsulation | PVC | PVC | Identical |
| Generator plugdesign | Electrodes Consolidatedinto a single plug withbanana plug connectors | Two separate plugs withbanana plug connectors | Visually different butelectrically identical. |
| Plug Overmold | PVC | PVC | Identical |
| Design - SalineTubing | |||
| Tubing length | 4.4 meters | 4.8 meters | Functionally identical |
| Materials forirrigation tubing | PVC and silicone | PVC and silicone | Identical |
| Tubing InnerDiameter | PVC: 3.0 mmSilicone (Gravity Feed):3.0 mmSilicone (Rotary Pump):0.8 mm | PVC: 3.0 mmSilicone (Gravity Feed):3.0 mmSilicone (Rotary Pump):0.8mm | Identical |
| Tubing Flow rate(Rotary type) | Min: 1.15cc/min (+/-30%)Max: 16 cc/min (+/-30%) | Min: 1.15cc/min (+/-30%)Max: 16 cc/min (+/-30%) | Identical |
| Tubing Flow rate(Gravity type) | Min: < 6 cc/minMax: > 21 cc/min | Min: < 6 cc/minMax: > 21 cc/min | Identical |
| Proximal Spikeadapter for Salinesource | ABS | ABS | Identical |
| Feature | Application Device:Irrigation Tubing BipolarCord Sets | Predicate Device:Codman IntegratedBipolar Cord Tubingand Set (K163106) | Pertinence of Featureto Consideration ofSubstantialEquivalence. |
| Tubing SectionsAdaptor | PVC | PVC | Identical |
| Tubing Clamp | Polypropylene | Celanese and Polyacetal | These materials do notcome in contact with thepatient or the salinestream. Both clampshave identicalfunctionality. No newquestions of safety orefficacy are raised bythe material differences. |
| Other Attributes | |||
| Single Use orReusable? | Single Use | Single Use | Identical |
| Provided Sterilized? | Yes | Yes | Identical |
| Performance/ SafetyTesting in accordancewith: | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | Identical |
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Image /page/5/Picture/0 description: The image shows the logo for "NEW DEANTRONICS". The word "NEW" is in blue, and the word "DEANTRONICS" is in blue as well. There is a blue circle with a red dot in the middle between the two words.
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New Deantronics concludes that the devices are substantially equivalent.
F. Summary of Supporting Data
Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Irrigation Tubing Bipolar Cord Sets meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the irrigation tubing bipolar cord sets are as safe and effective as the predicate devices.
New Deantronics concludes that the New Deantronics Irrigation Tubing Bipolar Cord Sets are substantially equivalent to the predicate Codman Integrated Bipolar Cord Tubing and Set (K163106).
§ 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.