(54 days)
Not Found
No
The summary describes a standard electrosurgical electrode and its components, intended for cutting and coagulation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on non-clinical testing and equivalence to predicate devices, not on algorithmic performance.
Yes
This device is used for electrosurgical cutting and coagulation in minimally invasive surgical procedures, which are therapeutic interventions.
No
The device is intended for electrosurgical cutting and coagulation during minimally invasive surgical procedures, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical components (electrodes, shafts, tips) and their function in a surgical procedure, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "monopolar electrosurgical cutting and coagulation" during "minimally invasive surgical procedures." This describes a surgical tool used on the patient's tissue, not a device used to test samples from the patient outside the body.
- Device Description: The description details how the device is used in conjunction with other surgical equipment (electrosurgical pencils, trocars, generators, patient return electrode) to deliver electrical current for cutting and coagulation. This is a description of a surgical instrument.
- FDA Classification: The device is classified under "Electrosurgical, Cutting & Coagulation Device and Accessories," Product Code GEI, Regulation number 878.4400. This classification is for surgical devices, not IVDs.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
In summary, the device is a surgical instrument used for electrosurgery during laparoscopic procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The New Deantronics single use, laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
Product codes
GEI
Device Description
The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only. The New Deantronics disposable laparoscopic electrodes are used in conjunction with monopolar electrosurgical pencils that accept 2.36 mm connector, trocars or cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During the operation, the electrode and the insulated shaft are to be inserted through a trocar and the conductive shaft end is inserted into the nose of electrosurgical pencil from which it receives the high frequency current to apply on target tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use. The New Deantronics laparoscopic electrodes consists of four distinct sections, including a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector. There are two groups of laparoscopic electrodes, including non-coated and coated electrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with nonsticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths. There are sixteen models of New Deantronics laparoscopic electrodes available.
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
General patients that require laparoscopic electrosurgery
Intended User / Care Setting
healthcare professional / Hospital
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)
Non-clinical testing demonstrated that the subject devices meet applicable specification, functions as intended and meets nationally recognized standards. Key results include:
- (1) ISO 14971:2007, Medical devices Application of risk management to medical devices
- (2) IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- (3) IEC 60601-1-2:2014, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral requirements for basic salesy and the mances - Requirements and tests.
- (4) IEC 60601-2-2: 2009 + C1:2014, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
- (5) ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.
- (6) ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- (7) ISO 11135:2014, Sterillization of Healthcare Products- Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
- (8) IEC 62366-1:2015, Medical devices Part 1: Application of usability engineering to medical devices
All the test results demonstrate the performance of monopolar laparoscopic accessories meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the monopolar laparoscopic electrodes is as safe and effective as the predicate devices.
A side by side study comparing the ND electrode to the predicate devices demonstrates substantial equivalence. A thermal Effect Study productions the New Deantronics electrode performs equivalent or better than the predicates. The device is safe and effective based on the non-clinical studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. Above the profiles is a design element resembling a wing or feather. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
New Deantronics Taiwan, Ltd. % Mr. Lewis Ward L.W. Ward and Associates Incorporated 4655 Kirkwood Court Boulder, Colorado 80301
January 5, 2016
Re: K153265
Trade/Device Name: New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 13, 2015 Received: November 12, 2015
Dear Mr. Ward:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K153265
Device Name
Device Name
New Deantronics Disposable Laparoscopic Electrodes, non-coated and coated
Indications for Use (Describe)
Indications for Use (Describe)
The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the I he burden time for this collection of information is connulatin the data needed and complete time to review instruction. Send comments regarding this burden estimate or any other aspect and review the collection of internations for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
3
Image /page/3/Picture/1 description: The image contains the logo for Deantronics. The logo features a blue circle with a red dot inside, followed by the word "DEANTRONICS" in blue, block letters. Below the company name, the words "New Deantronics Group" are written in a smaller, blue font.
Submitter New Deantronics Taiwan Ltd. 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist, New Taipei City 23675, Taiwan R.O.C. (886) (0) 2-2268-1726 Phone (886) (0) 2-2268-3800 Fax
Taiwan
大瑞企業股份有限公司
Contact Person: Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 USA 303-530-3279 lwward@gwest.net
Date Prepared: November 13, 2015
- Trade Name: New Deantronics Disposable, laparoscopic electrodes, non-coated I. and coated
- Common Name: Electrosurgical accessory, laparoscopic electrode II.
- Classification: 21 CFR 878.4400, Electrosurgical cutting and coagulation III. device and accessories.
- IV. Product Code: GEI
- V. Indications For Use: The New Deantronics single use, laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
- VI. Predicate Device Non-coated laparoscopic electrode Valleylab, Inc. 510(k) K904560 Cleared for marketing on December 31, 1990.
Coated laparoscopic electrode Megadyne Medical Products, Inc. E-Z Clean Laparoscopic Electrode 510(k) K913281 Cleared for marketing on Aug. 16, 1991.
- Device Description and Technological Characteristics VII. The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only.
USA
New Deantronics Ltd.
1990 North Califomia Blvd.
Suite 1040
Walnut Creek, CA. 94596
Tel: +1 (925) 280-8388
4
Image /page/4/Picture/0 description: The image shows the logo for Deantronics. The logo consists of a blue circle with a red dot in the center, followed by the word "DEANTRONICS" in blue, bold letters. Below the word "DEANTRONICS" is the phrase "New Deantronics Group" in a smaller, lighter blue font.
The New Deantronics disposable laparoscopic electrodes are used in The New Dealitronics disposure rejurgical pencils that accept 2.36 mm conjuriction with monopolar elocal Jour er cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During adapters, electrosulgiour general the insulated shaft are to be inserted the operation, the clootrode the conductive shaft end is inserted into the nose of through a trocal and the ownich it receives the high frequency current electrosurgical pericin on whiletarget tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use.
The New Deantronics laparoscopic electrodes consists of four distinct The New Deamlionio luparoose electrode tip with part of the tip covered sections, incruding a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector.
There are two groups of laparoscopic electrodes, including non-coated There are two groups of lapartrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with nonsticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths.
There are sixteen models of New Deantronics laparoscopic electrodes available.
Table 1. Non-coated laparoscopic electrodes
| Catalog No. | Length (cm) | Coating | Electrode Tip Type |
|---|---|---|---|
| AP300-36 | 36 | No | Straight Spatula |
| AP301-36 | 36 | No | Curved Spatula |
| AP301-45 | 45 | No | Curved Spatula |
| AP302-36 | 36 | No | Wire J |
| AP303-36 | 36 | No | Wire L |
| AP304-36 | 36 | No | Flat L |
| AP303-45 | 45 | No | Wire L |
| AP304-45 | 45 | No | Flat L |
Table 2. Coated laparoscopic electrodes
| Catalog No. | Length (cm) | Coating | Electrode Tip Type |
|---|---|---|---|
| AP300-36C | 36 | Coated | Straight Spatula, Coated |
| AP301-36C | 36 | Coated | Curved Spatula, Coated |
| AP301-45C | 45 | Coated | Curved Spatula, Coated |
| AP302-36C | 36 | Coated | Wire J, Coated |
| AP303-36C | 36 | Coated | Wire L, Coated |
| AP304-36C | 36 | Coated | Flat L, Coated |
| AP303-45C | 45 | Coated | Wire L, Coated |
| AP304-45C | 45 | Coated | Flat L, Coated |
Taiwan
大瑞企業股份有限公司 Deantmonics Taiwan. Ltd 域區中央路 1段 51 號 12 1 12F No 51 Sec Chong Yang Rd., Tu Chen Tel: +8862 2268-172
USA
New Deantronics Ltd 1990 North California Blvd
5
Image /page/5/Picture/0 description: The image shows the logo for Deantronics. The logo features a blue circle with a red dot inside, followed by the word "DEANTRONICS" in blue, bold letters. Below the word, it says "New Deantronics Group" in a smaller, lighter blue font.
Non-clinical testing VIII.
Non-cillical testing New Deantionies mac ochauspecification, functions as intended and subject devices mot acong rolly recognized standards, including the following items:
- (1) ISO 14971:2007, Medical devices Application of risk management to medical devices
- (2) IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- (3) IEC 60601-1-2:2014, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral requirements for basio salesy and the mances - Requirements and tests.
- (4) IEC 60601-2-2: 2009 + C1:2014, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
- (5) ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.
- (6) ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- (7) ISO 11135:2014, Sterillization of Healthcare Products- Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
- (8) IEC 62366-1:2015, Medical devices Part 1: Application of usability engineering to medical devices
Non-clinical testing conclusion:
All the test results demonstrate the performance of monopolar laparoscopic accessories meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the monopolar laparoscopic electrodes is as safe and effective as the predicate devices.
IX. Substantial equivalence
The proposed devices share the same technological characteristics, technology & operating principles, performance characteristics, and configuration found in the predicate devices. There are no new technologies incorporated into the device.
The laparoscopic electrodes meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are equivalent to the predicate devices identified. The claim for substantial equivalence is supported by the information provided in this submission.
Therefore, the device of this submission is substantially equivalent to the predicate devices of Valleylab, Inc. non-coated laparoscopic electrodes (K904560) and Magadyne Medical Products, Inc. coated laparoscopic electrodes (K913281).
Taiwan
大蕴企業股份有限公司
New Deantronics Ltd.
1990 North California Blvd.
Suite 1040
Walnut Creek, CA 94596
Tel: +1 (925) 280-8388
Fax: +1 (925) 280-1788
6
Image /page/6/Picture/0 description: The image shows the logo for Deantronics. The logo consists of a blue circle with a red dot inside, followed by the word "DEANTRONICS" in blue, and the words "New Deantronics Group" in a smaller font below. The logo is simple and modern, and the colors are eye-catching.
| Table 3. Key Features Comparison to Predicates | ||||
|---|---|---|---|---|
| ------------------------------------------------ | -- | -- | -- | -- |
| This Submission | Predicate Device | Predicate Device | ||
|---|---|---|---|---|
| Product name | New Deantronics Non-coated and Coated Laparoscopic Electrodes | Covidien Non-coated Laparoscopic Electrodes | Megadyne Coated Laparoscopic Electrodes | |
| Manufacturer | New Deantronics | Covidien (formerly Valleylab) | ||
| K#904560 | Megadyne | |||
| K#913281 | ||||
| Taiwan | 510(k) # | |||
| Product Code | Subject of this submission | |||
| GEI | GEI | GEI | ||
| The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. | ||||
| Intended use | These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. | The intended use of the laparoscopic electrodes are for use in laparoscopic and thoracoscopic surgical procedures where monopolar electrosurgical cutting and coagulation are desired. | ||
| Target Population | General patients that require laparoscopic electrosurgery | General patients that require laparoscopic electrosurgery | General patients that require laparoscopic electrosurgery | |
| Where used | Hospital | Hospital | Hospital | |
| Energy Used | High Radiofrequency | High Radiofrequency | High Radiofrequency | |
| Physical Dimensions and Design | Size: | |||
| OD of shaft: 2.36 mm | ||||
| Length: 36 cm or 45 cm | Size: | |||
| OD of shaft: 2.36 mm | ||||
| Length: 36 cm or 45 cm | Size: | |||
| OD of shaft: 2.59 mm | ||||
| Length: 33 cm or 45 cm | ||||
| Operation Principle | Monopolar electrosurgery | Monopolar electrosurgery | Monopolar electrosurgery | |
| Shaft and shaft insulation Materials | Stainless steel shaft, polyolefin shaft insulation, | Stainless steel shaft, polyolefin shaft insulation | Stainless steel shaft, polyolefin shaft insulation | |
| Total electrode Resistance | Less than 100 mΩ | Less than 100 mΩ | Less than 100 mΩ | |
| Electrode tip insulation | PTFE electrode tip insulation, non-coated electrode and PTFE coated electrode | PTFE electrode tip insulation, non-coated electrode | Polyolefin electrode tip insulation, coated electrode | |
| Tip design | Options: | |||
| Straight spatula, curved spatula, J-wire, L-wire, L-flat | Options: | |||
| Straight spatula, curved spatula, J-wire, L-wire, L-flat | Options: Standard blade, spatula, curved spatula, curved, L-hook, J-hook, needle, ball, O-wire, | |||
| Electrode tip coating | Non-coated and PTFE coated | Non-coated | PTFE Coated | |
| Performance | Performs cut and coagulation, in electrosurgical procedure | Performs cut and coagulation in electrosurgical procedure | Performs cut and coagulation in electrosurgical procedure | |
| Sterile | EO sterilization | EO sterilization | EO sterilization | |
| Single use | Single use | Single use | Single use | |
| Compatibility with other devices | Compatible with electrosurgical with 0.093" nozzle and with 5 mm cannula or larger | Compatible with electrosurgical with 0.093" nozzle and with 5 mm cannula or larger | Compatible with electrosurgical pencil with 0.093" nozzle and with 5 mm cannula or larger | |
| Electrical | ||||
| safety | Passes test of 6.3 kV, | |||
| according to IEC 60601-2- | ||||
| 2, 201.8.8.3.104 | ||||
| Capacitive coupled HF | ||||
| current not exceed 50 mA | Passes test of 6.3 kV, | |||
| according to IEC 60601-2- | ||||
| 2, 201.8.8.3.104 | ||||
| Capacitive coupled HF | ||||
| current not exceed 50 mA | Passes test of 6.3 kV, | |||
| according to IEC 60601-2- | ||||
| 2, 201.8.8.3.104 | ||||
| Capacitive coupled HF | ||||
| current not exceed 50 mA | ||||
| Taiwan | Mechanical | |||
| safety | Wire electrode can | |||
| survive 4 bends with no | ||||
| crack or failure. | J-Hook electrode can | |||
| survive 4 bends with no | ||||
| crack or failure. | J-Hook electrode can | |||
| survive 4 bends with no | ||||
| crack or failure. | ||||
| Deantronics Taiwan, Ltd. 12F., No.51, Sec. 4, Rd., Tu Cheng Dist., New Taipei City 23675, Taiwan R.O.C. tel: +886 2 2268-1726 fax: +886 2 2268-3800 | Standards | |||
| met | ISO 10993-1:2009 | |||
| IEC 60601-2-2:2009 | ||||
| ISO 11135:2014 | ||||
| IEC 60601-1:2005 | ||||
| +Amendment 1: 2012 | ||||
| IEC 60601-1-2:2014 | ||||
| ISO 14971 | ||||
| IEC 62366-1:2015 | ||||
| IEC 60601-2-18:2009 | ||||
| ISO 11607-1:2006 | ||||
| +Amendment 1:2014 | ISO 10993-1 | |||
| IEC 60601-2-2 | ||||
| ISO 11135 | ISO 10993-1 | |||
| IEC 60601-2-2 | ||||
| ISO 11135 |
7
Image /page/7/Picture/0 description: The image shows the logo for Deantronics. The logo consists of a blue circle with a red dot in the center, followed by the word "DEANTRONICS" in blue, block letters. Below the company name is the phrase "New Deantronics Group" in a smaller font.
Page 5 of 5 K153265
USA
New Deantronics Ltd 1990 North California Bivd lainut Creek, CA 94598
Tel
X. Conclusion:
The New Deantronics Disposable Laparoscopic Electrode, non-coated and coated i ne few Dealitromes Diperforms as well as or better than the legally marketed is sale and effective and p demonstrated safe and effective and meets the predicates. The dovice to act Electrical Safety, IEC 60601-1-2 EMC and IAO 10993 Biocompatibility. A side by side study comparing the ND electrode to the predicate devices demonstrates substantial equivalence. A thermal Effect Study productions the New Deantronics electrode performs equivalent or better than the predicates. The device is safe and effective based on the non-clinical studies.