(60 days)
No
The summary describes a standard electrosurgical electrode and does not mention any AI/ML components or capabilities.
Yes
The device is described as performing electrosurgical cutting and coagulation, which are therapeutic actions to alter tissue.
No
Explanation: The device is described as being used for "monopolar electrosurgical cutting and coagulation" and "delivers the current onto a target tissue for cutting and coagulation." These are therapeutic, not diagnostic, actions.
No
The device description clearly states it is a physical device ("Laparoscopic Hollow Electrodes") intended for surgical procedures, requiring insertion through a trocar and connection to an electrosurgical pencil. It also mentions physical components like an insulated shaft and conductive shaft end. The performance studies focus on bench testing of the physical device, electrical safety, shelf-life, and biocompatibility, all related to hardware. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for "minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired." This describes a surgical tool used directly on a patient's tissue in vivo.
- Device Description: The description details how the electrodes are used in conjunction with other surgical equipment (handset, trocar, generator, return electrode) to deliver electrical current for cutting and coagulation during a laparoscopic procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve the analysis of any such specimens.
The device is a surgical instrument used for therapeutic purposes (cutting and coagulation) directly on the patient during a procedure, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.
Product codes
GEI
Device Description
The New Deantronics Laparoscopic Hollow Electrodes, sold as sterile packaged, and ready for use devices, are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The laparoscopic electrodes are used in conjunction with a Valleylab™ E2750 Laparoscopic Handset and 5 mm (internal diameter) or larger trocar, electrosurgical generator, and patient return electrode. During the operation, the electrode tip and the insulated shaft are to be inserted through a trocar, then conductive shaft end is inserted into the nose of an electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a laparoscopic procedure. These devices can be used in hospitals and are used by trained professionally only.
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
trained professionally only / hospitals
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:
All the test results demonstrate the performance of New Deantronics Laparoscopic Hollow Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Laparoscopic Hollow Electrodes are as safe and effective as the predicate devices. Performance bench testing was conducted in accordance with FDA's guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements. Suction & Aspiration testing and Thermal Effects on Tissue testing were conducted to demonstrate adequate performance within a system.
Electrical Safety and Electromagnetic Compatibility Testing:
Electrical safety testing was conducted in accordance with: IEC 60601-1:2005+AM1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-2-2:2017 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. Electromagnetic Compatibility Testing (EMC) was 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 disturbances - Requirements and tests. The New Deantronics Laparoscopic Hollow Electrodes passed all electrical safety and EMC testing.
Shelf-Life Testing:
Shelf-life testing was conducted in accordance with FDA's guidance document Premarket Notification (510(k)) Submissions for Electrosurqical Devices for General Surgery issued August 15, 2016 and internal requirements. The New Deantronics Laparoscopic Hollow Electrodes were subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for 2 years.
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 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. This testing demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended.
Animal Studies:
No animal studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing.
Clinical Studies:
No clinical studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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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.
February 19, 2019
New Deantronics Taiwan Ltd. % Craig Coombs President Coombs Medical Device Consulting, Inc 1193 Sherman St Alameda, California 94501
Re: K183594
Trade/Device Name: Laparoscopic Hollow Electrodes:
Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm : Laparoscopic Wire L-Hook Electrode. Retractable. Aspiration Hole. 28cm: Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J-Hook Electrode, Hollow, 28cm ; Laparoscopic Wire L-Hook Electrode, Hollow, 28cm ; Laparoscopic Cylindrical Tip Electrode, Hollow, 28cm Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 20, 2018
Received: December 21, 2018
Dear Craig 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. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Image /page/1/Picture/6 description: The image shows a digitally signed document. The document indicates that it was signed by Long H. Chen -S on February 19, 2019, at 15:19:41 -05'00'. The document is for Binita S. Ashar, M.D., M.B.A., F.A.C.S., who is the Director of the Division of Surgical Devices, Office of Device Evaluation.
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183594
Device Name Laparoscopic Hollow Electrodes
Indications for Use (Describe)
These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| \u2611 Prescription Use (Part 21 CFR 801 Subpart D) | \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | New Deantronics Taiwan Ltd. |
| 12F., No.51, Sec. 4, Chong Yang Rd., | |
| Tu Cheng District, | |
| 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: | Laparoscopic Hollow Electrodes |
Predicate Device Information:
| Predicate Device: | Disposable Laparoscopic Electrodes,
Coated and Non-coated |
|-------------------------------------------|-------------------------------------------------------------------------------------|
| Predicate Device Manufacturer: | New Deantronics |
| Predicate Device Common Name: | Electrosurgical accessory |
| Predicate Device Premarket Notification # | K153265 |
| Predicate Device Classification: | 21 CFR 878.4400
Electrosurgical, Cutting & Coagulation
Device and Accessories |
| Predicate Device Class & Product Code: | Class 2, GEI |
Reference Device Information:
| Reference Device: | Valleylab Laparoscopic Electrodes |
|---|---|
| Reference Device Manufacturer: | Valleylab, Inc. |
| Reference Device Common Name: | Electrosurgical accessory |
| Reference Device Premarket Notification # | K964175 |
| Reference Device Classification: | 21 CFR 878.4400 |
| Electrosurgical, Cutting & Coagulation | |
| Device and Accessories | |
| Reference Device Class & Product Code: | Class 2, GEI |
4
B. Date Summary Prepared
15 Feb 2019
C. Description of Device
The New Deantronics Laparoscopic Hollow Electrodes, sold as sterile packaged, and ready for use devices, are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The laparoscopic electrodes are used in conjunction with a Valleylab™ E2750 Laparoscopic Handset and 5 mm (internal diameter) or larger trocar, electrosurgical generator, and patient return electrode. During the operation, the electrode tip and the insulated shaft are to be inserted through a trocar, then conductive shaft end is inserted into the nose of an electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a laparoscopic procedure. These devices can be used in hospitals and are used by trained professionally only.
D. Indications for Use
These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.
5
E. Comparison to Predicate Device
As described below, the application New Deantronic Hollow Electrodes is substantially equivalent in intended use, technology, design and physician use to the predicate New Deantronics Disposable Laparoscopic Electrodes, coated and non-coated (K153265).
| Feature | Application Device:
New Deantronics
Laparoscopic Hollow
Electrodes | Predicate Device:
New Deantronics
Disposable Laparoscopic
Electrodes, coated and
non-coated
(K153265) | Reference Device:
Valleylab Laparoscopic
Handsets and Laparoscopic
Electrodes
(K964175) | Pertinence of Feature to
Consideration of Substantial
Equivalence. |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | These electrodes are
intended for use in
minimally invasive
surgical procedures
where monopolar
electrosurgical cutting
and coagulation are
desired. Irrigation and
suction capabilities via
the same handset are
available as well. | The disposable
laparoscopic electrodes
are intended for use in
minimally invasive
surgical procedures
where monopolar
electrosurgical cutting
and coagulation are
desired. | The Valleylab Laparoscopic
Handsets (models E2750,
E2751, E2750T and E2751T)
and the Electrodes (model
E2770 series, E2780 series,
E2780R series and E2780R-
ASP) are intended for use in
those laparoscopic or
thoracoscopic surgical
procedures where the
delivery of electrosurgical
current, irrigation and
suction via a single handset
is desirable.
The device is not intended
to be used in endoscopic
surgical procedures. | The Indications for Use of the
application and predicate devices
are nearly the identical; all of
these devices are for RF cutting
or coagulation in minimally
invasive surgical procedures.
The application device has
irrigation and suction capabilities,
but as evidenced by the
reference device, these
capabilities have long been
applied to such devices and raise
no new questions of safety or
efficacy for these types of
devices. |
| Product Code | GEI | GEI | GEI | Identical to both predicate and
reference devices |
| Feature | Application Device:
Laparoscopic Hollow
Electrodes | Predicate Device:
New Deantronics
Disposable Laparoscopic
Electrodes
(K153265) | Reference Device:
Valleylab Laparoscopic
Handsets and Laparoscopic
Electrodes (K964175) | Pertinence of Feature to
Consideration of Substantial
Equivalence. |
| | | | Technology | |
| Mechanism of
Operation | The New Deantronics
Laparoscopic Hollow
Electrodes combine RF
technology with suction
and irrigation of fluids
during electrosurgical
procedures. | Same RF cutting and
coagulation capability | Same RF cutting and
coagulation capability and
same suction & irrigation
capabilities as application
device | Identical to predicate for RF
cutting and coagulation and
identical to reference for RF
capabilities and suction and
irrigation of fluids. |
| Compatible w/ RF
Monopolar or Bipolar
administration? | Monopolar only | Same | Same | Identical to both predicate
and reference devices |
| Compatible Device | Valleylab™ E2750
Laparoscopic handset | Monopolar
electrosurgical pencils w
0.093" (2.36mm) nozzle &
w 5mm cannula or larger | Valleylab™ E2750
Laparoscopic handset | Identical to reference device;
clinically equivalent to
predicate device for insertion
into 3rd party hand pieces |
| | Design | | | |
| Electrode length | Retractable: 28cm
and 36 cm
Non-Retractable:
28cm | 36cm and 45 cm | Same as application | Identical to reference device;
Clinically equivalent to
predicate. All sizes of all
devices intended for
laparoscopic applications |
| Electrode Outer
Diameter | Retractable: 5.00mm
Non-Retractable:
4.75mm | 2.36mm shaft OD | Same as application | Identical to reference device;
Clinically equivalent to
predicate. All sizes of all
devices intended for
laparoscopic applications |
| Feature | Application Device:
Laparoscopic Hollow
Electrodes | Predicate Device:
New Deantronics
Disposable Laparoscopic
Electrodes
(K153265) | Reference Device:
Valleylab Laparoscopic
Handsets and Laparoscopic
Electrodes (K964175) | Pertinence of Feature to
Consideration of Substantial
Equivalence. |
| Electrode Inner
Diameter | Retractable: 4.10mm
Non-Retractable:
3.18mm | Not Applicable | Same as application | ldentical to reference device;
Clinically equivalent to
predicate. |
| Materials for
Electrode Tip | SUS 304 Stainless
without coating | SUS 304 Stainless with
PTFE coating or
without coating | SUS 304 Stainless without
coating | Functional tip identical to
predicate and reference
devices |
| Materials for
Electrode Sheath | Retractable: PTFE, PC
and POF (black)
Non-Retractable: POF
(black) | POF (blue) | Retractable: PTFE, PC and
POF (black)
Non-Retractable: POF
(black) | Nearly identical to predicate
and reference devices |
| Materials for
Electrode Hub
(Retractable Only) | PC (Polycarbonate) | Not Applicable;
No hub | PC (Polycarbonate) | ldentical to reference device |
| Materials for Tip
Protector | Distal: LDPE
Proximal: LDPE | Distal: LDPE
Proximal: LDPE | Retractable
Distal: PVC,
Proximal: LDPE
Non-Retractable
Distal: LDPE, Proximal:
LDPE | Nearly identical to predicate
and reference devices |
| Feature | Application Device:
Laparoscopic Hollow
Electrodes | Predicate Device:
New Deantronics
Disposable Laparoscopic
Electrodes
(K153265) | Reference Device:
Valleylab Laparoscopic
Handsets and Laparoscopic
Electrodes (K964175) | Pertinence of Feature to
Consideration of Substantial
Equivalence. |
| Electrode Tip | Retractable:
Curved Spatula,
Wire J-Hook,
Wire L-Hook,
Flat L-Hook
Non-Retractable:
Straight Spatula,
Curved Spatula,
Wire J-Hook,
Wire L-Hook,
Cylindrical Tip | Straight Spatula,
Curved Spatula,
Wire J-Hook,
Wire L-Hook,
Flat L-Hook | Retractable:
Curved Spatula,
Wire J-Hook,
Wire L-Hook,
Flat L-Hook
Non-Retractable:
Straight Spatula,
Curved Spatula,
Wire J-Hook,
Wire L-Hook,
Cylindrical Tip,
Flat L-Hook | Almost Identical, except for
Non-Retractable Flat L-Hook
existing in reference but not in
application. All styles in
application device are found in
predicate device, except for
cylindrical tip. Differences
raise no new questions of
safety or efficacy |
| Maximum Peak
Voltage | High Frequency:
13.5 $kV_{p-p}$
Main Frequency: 5400V
for 60 seconds | 6300V (60Hz) for 60
seconds | 5200V (60Hz) for 60 seconds | High withstand voltage is as
safe as the predicate and
reference devices. |
| Other Attributes | | | | |
| Single Use or
Reusable? | Single Use | Single Use | Single Use | Identical to predicate and
reference devices |
| Provided Sterilized? | Yes | Yes | Yes | Identical to predicate and
reference devices |
| Sterilization | Retractable: EtO
| EtO | Retractable: EtO | Identical to predicate and |
| Method | Non-Retractable: Gamma | | Non-Retractable: Gamma | reference devices |
| Performance/
Safety Testing in | IEC 60601-1 | IEC 60601-1 | AAMI HF18-1986 | Fundamentally Identical to |
| accordance with | IEC 60601-1-2 | IEC 60601-1-2 | IEC 601-2-2 | predicate and reference devices, |
| | IEC 60601-2-2
IEC 60601-2-18 | IEC 60601-2-2
IEC 60601-2-18 | | application device in
conformance with latest version
of the listed standards |
6
7
8
9
F. Summary of Supporting Data.
New Deantronics has conducted extensive testing to ensure that the subject devices met design specification, function as intended and conform to the internationally recognized standards.
Bench Testing
All the test results demonstrate the performance of New Deantronics Laparoscopic Hollow Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Laparoscopic Hollow Electrodes are as safe and effective as the predicate devices.
Performance bench testing was conducted in accordance with FDA's guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements. Suction & Aspiration testing and Thermal Effects on Tissue testing were conducted to demonstrate adequate performance within a system.
Electrical Safety and Electromagnetic Compatibility Testing
Electrical safety testing was conducted in accordance with: IEC 60601-1:2005+AM1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-2:2017 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.
Electromagnetic Compatibility Testing (EMC) was 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 disturbances - Requirements and tests.
The New Deantronics Laparoscopic Hollow Electrodes passed all electrical safety and EMC testing.
Shelf-Life Testing
Shelf-life testing was conducted in accordance with FDA's guidance document Premarket Notification (510(k)) Submissions for Electrosurqical Devices for General Surgery issued August 15, 2016 and internal requirements. The New Deantronics Laparoscopic Hollow Electrodes were subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for 2 years.
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
10
10993-1, "Biological 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. This testing demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended.
Animal Studies
No animal studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing.
Clinical Studies
No clinical studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing.
Conclusion
It is concluded that the New Deantronics Laparoscopic Hollow Electrodes are substantially equivalent to the predicate New Deantronics Disposable Laparoscopic Electrodes, coated and non-coated (K153265).