(145 days)
Not Found
No
The summary describes a standard electrosurgical generator with different power modes and safety features, with no mention of AI or ML capabilities.
Yes
A therapeutic device is used to treat a disease, injury, or other medical condition. This device is an electrosurgical generator intended for use during surgical procedures for cutting and coagulating, which are therapeutic actions.
No
The device is an electrosurgical generator designed for cutting and coagulating tissue during surgical procedures, not for diagnosing conditions.
No
The device description clearly states physical dimensions and weight, indicating it is a physical hardware device, not software only. It also mentions being mains powered and having physical components like a Return Electrode Contact Quality Monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating." This describes a device used directly on a patient during surgery, not a device used to examine specimens (like blood, tissue, or urine) outside of the body.
- Device Description: The description details a generator that supplies electrical energy for surgical purposes. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This electrosurgical generator is a therapeutic device used to perform surgical procedures.
N/A
Intended Use / Indications for Use
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight.
The Electrosurgical Generator supplies high frequency electrosurgical power from low power (100W, Coag>70W).
The Electrosurgical Generator outputs high frequency energy in the following modes:
-
- Monopolar CUT: Pure Blend 1 Blend 2
-
- Monopolar COAG: Pin Point Spray
-
- Bipolar: Standard
The Electrosurgical Generator can be activated via a hand switch or a foot switch.
The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode.
The Electrosurgical Generator is mains powered.
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
Surgeon
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)
The application Electrosurgical Generator was tested and found to be in compliance with the following standards:
IEC 60601-1: 2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
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.
IEC 60601-2-2:2017 Medical electrical equipment –Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
IEC 62304:2006+AMD 1:2015 Medical device software — Software life cycle processes
ISTA 3A:2008 International Safe Transit Association Procedure 3A.
In addition, the Electrosurgical Generator was fully tested and in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020).
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). On the left is the Department of Health and 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.
September 28, 2020
New Deantronics Taiwan Ltd. % Craig Coombs President Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda. California 94501
Re: K201221
Trade/Device Name: Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 8, 2020 Received: September 9, 2020
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.
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.
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201221
Device Name Electrosurgical Generator
Indications for Use (Describe)
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
| 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) |
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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 there is a blue circle with a red dot in the middle. The word "DEANTRONICS" is in blue and is to the right of the circle.
Section 5: 510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | New Deantronics Taiwan Ltd. |
| 12F., No.51, Sec. 4, Zhongyang Rd., | |
| Tucheng District | |
| New Taipei City 236, | |
| Taiwan. | |
| Tel: (886) 2-2268-1726 | |
| Fax: (886) 2-2268-3800 | |
| Sponsor Contact: Ms. Jane Liu, President | |
| Email: jane@newdean.com.tw | |
| Correspondent Contact | |
| Information: | Mr. Craig Coombs |
| President | |
| Coombs Medical Device Consulting | |
| 1100 Pacific Marina, Suite 806 | |
| Alameda, CA 94501 | |
| Tel: 510-995-8499 | |
| Email: CraigJCoombs@gmail.com | |
| Device Common Name: | Electrosurgical Generator |
| Device Classification Number: | 21 CFR 878.4400 |
| Device Classification & | |
| Product Code: | Class II, |
| GEI | |
| Device Proprietary Name: | Electrosurgical Generator |
Predicate Device Information:
| Predicate Device: | Force FX™ electrosurgical generators |
|---|---|
| Predicate Device Manufacturer: | Covidien (formerly Valleylab, Inc.) |
| Predicate Device Common Name: | Electrosurgical Generator |
| Predicate Device Premarket Notification #: | K143161 |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Electrosurgical, Cutting & Coagulation | |
| Device and Accessories | |
| Predicate Device Classification & | |
| Product Code: | Class 2, |
| GEI |
B. Date Summary Prepared
4 May 2020
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Image /page/4/Picture/0 description: The image shows the logo for New Deantronics. The logo has the word "NEW" stacked on top of a blue circle with a red dot in the middle. To the right of the circle is the word "DEANTRONICS" in blue. The logo is simple and professional.
C. Description of Device
The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight.
The Electrosurgical Generator supplies high frequency electrosurgical power from low power (100W, Coag>70W).
The Electrosurgical Generator outputs high frequency energy in the following modes:
-
- Monopolar CUT: Pure Blend 1 Blend 2
-
- Monopolar COAG: Pin Point Spray
-
- Bipolar: Standard
The Electrosurgical Generator can be activated via a hand switch or a foot switch.
The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode.
The Electrosurgical Generator is mains powered.
D. Indications for Use
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
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E. Comparison to Predicate Device
| Feature | Application Device:
Electrosurgical Generator
(Model: ES300, K201221) | Predicate:
Covidien Force FXTM
Electrosurgical Generator
(K143161) | Pertinence of Feature to
Consideration of
Substantial Equivalence |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Electrosurgical
Generator is an
electrosurgical generator
containing monopolar and
bipolar technology. It is
intended for use with
accessories during surgical
procedures where the
surgeon requires
electrosurgical cutting and
coagulating. | The Force FX™ Electrosurgical
Generator is an
electrosurgical generator
containing monopolar and
bipolar technology. It is
intended for use with
accessories during surgical
procedures where the surgeon
requires electrosurgical cutting
(resecting, dividing, or
separating) and coagulating
(hemostasis). | Identical, except specific
examples of clinical
techniques were dropped
as unnecessary. |
| FDA Product
Code | GEI | GEI | Identical |
| Operating
Principle | The Electrosurgical
Generator is a radio-
frequency (RF)
electrosurgical generator
that delivers energy to
compatible surgical
instruments. The
concentration of energy at
the tip of the instrument in
conjunction with tissue
characteristics produces
heat. The heating of tissue
provides the desired surgical
effect (cutting, coagulation).
Variations in the waveform
result in the different
surgical effects achieved by
different modes. | The Force FXTM is a radio-
frequency (RF) electrosurgical
generator that delivers energy
to compatible surgical
instruments. The concentration
of energy at the tip of the
instrument in conjunction with
tissue characteristics produces
heat. The heating of tissue
provides the desired surgical
effect (cutting, coagulation).
Variations in the waveform
result in the different surgical
effects achieved by different
modes. | Identical |
| Input Power | 100 - 240 V | 100 - 240 V | Identical |
| Output
configuration | Isolated | Isolated | Identical |
| Type | CF | CF | Identical |
| Working theories | | | |
| Monopolar | ESU generator connects its
electrosurgical electrode
accessories and a neutral
pad to form a cyclic circuit,
the HF current generated
from the generator and
through the accessory to
achieve CUT or COAG, and
then return to generator by
the neutral pad. | ESU generator connects its
electrosurgical accessories and
a neutral ESU pad to form a
cyclic circuit, the HF current
generated from the generator
and through the accessory to
achieve CUT or COAG, and then
return to generator by the
neutral pad. | Identical |
| Monopolar | ESU generator connects its
electrosurgical electrode
accessories and a neutral
pad to form a cyclic circuit,
the HF current generated
from the generator and
through the accessory to
achieve CUT or COAG, and
then return to generator by
the neutral pad. | ESU generator connects its
electrosurgical accessories and
a neutral ESU pad to form a
cyclic circuit, the HF current
generated from the generator
and through the accessory to
achieve CUT or COAG, and then
return to generator by the
neutral pad. | Identical |
| | | | |
| Feature | Application Device:
Electrosurgical Generator
(Model: ES300,K201221) | Predicate:
Covidien Force FX™
Electrosurgical Generator
(K143161) | Pertinence of Feature to
Consideration of
Substantial Equivalence |
| Bipolar | HF current generated from
the generator and the cyclic
circuit formed between the
two tips of the bipolar
forceps, the HF power
through the two tips to
work on patient obtaining
COAG, no need extra ESU
pad. | HF current generated from the
generator and the cyclic circuit
formed between the two tips of
the bipolar forceps, the HF
power through the two tips to
work on patient obtaining
COAG, no need extra ESU pad. | Identical |
| Physical Specification | | | |
| Appearance | Image: Electrosurgical Generator (Model: ES300,K201221) | Image: Covidien Force FX Electrosurgical Generator (K143161) | Different, but they do not
raise new issues of safety
or effectiveness. |
| Dimensions | 29.5 cm x 37.6 cm x 17.8 cm | 35.6 cm x 35.6 cm x 11.1 cm | |
| and weight | Weight: