(42 days)
Not Found
No
The device description focuses on the physical components and their function (electrical conduction and fluid delivery) and does not mention any computational or algorithmic processing, let alone AI/ML. The performance studies are limited to electrical safety and bench testing, which are typical for this type of device and do not suggest AI/ML involvement.
No
The device is described as an accessory (cord sets and tubing) that connects an electrical generator and saline source to bipolar forceps. It facilitates the function of a therapeutic device (bipolar forceps for coagulation) but is not a therapeutic device itself.
No
The device is described as providing irrigation and energy for coagulation, which are therapeutic functions, not diagnostic ones. Its purpose is to facilitate electrosurgery by connecting to a generator and forceps, and providing fluid for irrigation, rather than detecting or identifying a medical condition.
No
The device description clearly details physical components like electrical cords, copper wires, insulation sheaths, PVC and silicone tubing, and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation and energy simultaneously to bipolar forceps for surgical procedures (coagulation). This is a therapeutic/surgical function performed directly on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description details a device that connects to an electrical generator and bipolar forceps, and a saline source. This is consistent with a surgical tool, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Irrigation Tubing Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
2
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) 2-2268-1726 | |
Fax: (886) 2-2268-3800 | |
Correspondent Contact | |
Information: | Craig Coombs |
Coombs Medical Device Consulting | |
1193 Sherman Street | |
Alameda, CA 94501 | |
Tel: 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 and
Tubing Set |
|----------------------------------------------------|------------------------------------------------------------------|
| Predicate Device Manufacturer: | Codman & Shurtleff, Inc. |
| Predicate Device Common Name: | Electrosurgical accessory
Irrigation 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 Bipolar
Cord Sets | Predicate Device:
Codman Integrated
Bipolar Cord Tubing
and Set (K163106) | Pertinence of Feature
to Consideration of
Substantial
Equivalence. |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Irrigation Tubing
Bipolar Cord Sets are
intended to provide
irrigation and energy
simultaneously to bipolar
forceps specifically
designed for irrigation. | The CODMAN
Integrated Bipolar Cord
and Tubing Sets are
intended to provide
irrigation and energy
simultaneously to
bipolar forceps
specifically designed for
irrigation. | The Indications for Use
of the two devices are
identical, except for
name of the devices |
| Product Code | GEI | GEI | Identical |
| Technology | | | |
| Mechanism of
Operation | The integrated Bipolar
Cord Set and Irrigation
tubing is designed to
connect an RF electrical
generator to bipolar
coagulating forceps via
an electrically conducting
cord. It is also intended
to connect a saline
source, via the irrigation
tubing. The saline flow
through the tubing is
controlled by a surgeon-
controlled fluid | Same | Identical |
| Feature | Application Device:
Irrigation Tubing Bipolar
Cord Sets | Predicate Device:
Codman Integrated
Bipolar Cord Tubing
and Set (K163106) | Pertinence of Feature
to Consideration of
Substantial
Equivalence. |
| | controller. This allows
for simultaneous,
controlled, coagulation
and irrigation
capabilities. | | |
| Compatible w/
Monopolar or Bipolar
RF administration? | Bipolar only | Bipolar only | Identical |
| Integral Electrical
Cable and Fluid
Tubing? | Yes | Yes | Identical |
| Fluid feed
compatibility | Rotary or Gravity | Rotary or Gravity | Identical |
| Design - Electrical
Cable | | | |
| Cable length | 3.6 meters | 3.4 meters | Functionally Identical |
| Wire Gauge | 24 AWG | 24 AWG | Identical |
| Materials for cable
insulation | PVC | PVC | Identical |
| Generator plug
design | Electrodes Consolidated
into a single plug with
banana plug connectors | Two separate plugs with
banana plug connectors | Visually different but
electrically identical. |
| Plug Overmold | PVC | PVC | Identical |
| Design - Saline
Tubing | | | |
| Tubing length | 4.4 meters | 4.8 meters | Functionally identical |
| Materials for
irrigation tubing | PVC and silicone | PVC and silicone | Identical |
| Tubing Inner
Diameter | PVC: 3.0 mm
Silicone (Gravity Feed):
3.0 mm
Silicone (Rotary Pump):
0.8 mm | PVC: 3.0 mm
Silicone (Gravity Feed):
3.0 mm
Silicone (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: 21 cc/min | Min: 21 cc/min | Identical |
| Proximal Spike
adapter for Saline
source | ABS | ABS | Identical |
| Feature | Application Device:
Irrigation Tubing Bipolar
Cord Sets | Predicate Device:
Codman Integrated
Bipolar Cord Tubing
and Set (K163106) | Pertinence of Feature
to Consideration of
Substantial
Equivalence. |
| Tubing Sections
Adaptor | PVC | PVC | Identical |
| Tubing Clamp | Polypropylene | Celanese and Polyacetal | These materials do not
come in contact with the
patient or the saline
stream. Both clamps
have identical
functionality. No new
questions of safety or
efficacy are raised by
the material differences. |
| Other Attributes | | | |
| Single Use or
Reusable? | Single Use | Single Use | Identical |
| Provided Sterilized? | Yes | Yes | Identical |
| Performance/ Safety
Testing in accordance
with: | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | Identical |
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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).