(274 days)
No
The description focuses on the physical components and basic electrical functions (cut/coag) of a standard electrosurgical pencil. There is no mention of AI, ML, or any data processing/analysis that would suggest such technology is incorporated.
Yes
This device is used to cut and coagulate soft tissue during electrosurgical procedures, which directly treats the patient by altering body structure and function.
No
The device is described as being used to "cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure," which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical electrosurgical pencil with hardware components (electrode tip, shaft, handle, cable, plug, switches) and mentions bench testing on porcine tissue, 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 "cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a surgical tool used for cutting and coagulating tissue during surgery. It connects to an electrosurgical generator and is used with a patient grounding pad. This is consistent with a surgical device, not an IVD.
- Performance Studies: The performance studies involve bench testing on animal tissue and evaluating thermal effects during cutting and coagulation. This is relevant to the performance of a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device is a surgical instrument used for electrosurgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
Product codes
GEI
Device Description
The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post.
The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.
The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.
The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014 and packaging.
Performance Testing included bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016, the evaluation of the thermal effects on the tissues and measurement of the thermal zone sizes are proved that the subject device and the predicate device are equivalent in the performance.
The safety performance of the subject device passed all the testing according to internal requirements and international standards shown below to support the substantial equivalence of the subject device
- IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), Medica electrical equipment - Part 1: General requirements for basic safety and essential performance
- -IEC60601-2-2: 2009 (Fifth Ed), 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.
- IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- -ISO10993, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.
Key Metrics
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.
0
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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 16, 2020
Modern Medical Equipment Manufacturing, LTD. Jerry Cheung Assistant Regulatory Manager Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Kwai Chung, N.T., Hong Kong, China
Re: K192542
Trade/Device Name: Single Use Electrosurgical pencil with non-coated and non-stick electrode (Nonsterile and sterile)
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 10, 2019 Received: May 11, 2020
Dear Jerry Cheung:
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
2
Indications for Use
510(k) Number (if known) K192542
Device Name
Single Use Electrosurgical pencil with non-coated and non-stick electrode (Non-sterile and sterile)
Indications for Use (Describe)
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Production Use (Part 21 CFR 301 Subpart D) Own-Time Support Use (21 CFR 301 Subpart C) | Production Use (Part 21 CFR 301 Subpart D) | Own-Time Support Use (21 CFR 301 Subpart C) |
| Production Use (Part 21 CFR 301 Subpart D) | Own-Time Support Use (21 CFR 301 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 1. 510(k) Owner
| Name: | Modern Medical Equipment Manufacturing Limited |
|---|---|
| Address: | Modern Medical Equipment Mfg., Ltd. |
| Flat A, 11/F., Mai Wah Ind. Bldg., | |
| 1-7 Wah Sing Street, | |
| Kwai Chung, N.T., Hong Kong, China. | |
| Telephone: | (852) 2420 9068 |
| Fax: | (852) 2481 1234 |
| Contact person: | Mr. Jerry Cheung |
| Date of preparation: | 30 July, 2019 |
| 2. Device | |
| Name of Device: | Single Use Electrosurgical pencil with non-coated and |
| non-stick electrode (Non-sterile and sterile) | |
| Trade or proprietary name: | Single Use Electrosurgical pencil with non-coated and |
| non-stick electrode; | |
| Common or usual name: | Single Use Electrosurgical pencil with electrode |
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Panel: | General & Plastic Surgery |
| Regulation number: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Class: | II |
3. Predicate and Reference devices
Predicate Device: Megadyne Pencil with 510(k) number K965054. Reference Device: Megadyne E-Z Clean electrosurgical electrode with 510(k) number K081791
4. Device description
The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post.
4
The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.
The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.
The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.
5. Indication for use
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
6 Technological characteristics
The proposed devices have substantially equivalent construction and performance as the predicate devices.
7. Substantial Equivalence
The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. The following table shows the comparisons in more detail information among the subject device and the predicate devices.
| Compared
Items | Proposed Device | Predicate Device
(K965054) | Reference Device
(K081791) | Comments on difference |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Single use
electrosurgical
pencil and
non-coated and
non-stick electrode | Megadyne Pencil | E-Z Clean
electrosurgical
electrode | |
| Intended
use | The monopolar
electrosurgical
pencil with
electrode is used to
deliver high
frequency current
to target issue for
cutting and
coagulation | The monopolar
electrosurgical
pencil with
electrode is used
to conduct
electrosurgical
energy from
electrosurgical
generator to the
target tissue | The monopolar
electrosurgical
electrode is used
with pencil to
conduct radio
frequency current
for cutting and
coagulation from
the electrosurgical
generator to the
target tissue | Same |
| Indication
for use | To cut and
coagulate soft
tissue by means of
high frequency
electrical current
during an
electrosurgical
procedure. | To conduct radio
frequency current
for cutting and
coagulation from
the electrosurgical
generator to the
target tissue | To conduct radio
frequency current
for cutting and
coagulation from
the electrosurgical
generator to the
target tissue | Same |
| Regulation
number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product
code | GEI | GEI | GEI | Same |
| OTC or
prescriptio
n | For prescription
use | For prescription
use | For prescription
use | Same |
| Energy
delivery | High frequency
electrical
current/energy | High frequency
electrical
current/energy | High frequency
electrical
current/energy | Same |
| Monopolar
or bipolar | Monopolar | Monopolar | Monopolar | Same |
| Design | Monopolar
electrosurgical
pencil for cutting
and coagulation
and with different
electrode tips as
blade, needle and
ball | Monopolar
electrosurgical
pencil for cutting
and coagulation
and with different
electrode tips as
blade, needle and
ball | Monopolar
electrosurgical
electrodes of
different electrode
tips as blade, needle
and ball for cutting
and coagulation | Same target purpose |
| Structure
Pencil
- Housing
- Cable | ABS
PVC | ABS
PVC | NA
NA | The material used and
structure among the
purposed and predicate |
| -Switching | Push button, rocker
switch &
footcontrol | Push button, rocker
switch | NA | devices are very similar
and do not raise safety
and effectiveness issues
because those were
tested according to IEC
test and biocompatibility
requirements |
| Electrode
-Material | -Stainless steel | -Stainless steel | -Stainless steel | Similar, those do not raise |
| - Length | - 69 mm, 102mm,
152mm (blade &
needle) - 69-71mm,
105-107mm,
135-137mm (ball) | -2.5", 2.75", 4", 5",
6.5" | -2.5", 2.75", 4", 5",
6.5" | any safety issue |
| | | | | |
| - Diameter - Insulation
material | ~2.36mm
-Polyolefin Shrink,
Wrap and/or
PTFE Shrink Wrap
Or
ABS/HIPS overmold | ~2.36mm
-Polyolefin Shrink,
Wrap and/or
PTFE Shrink Wrap | ~2.36mm
-Polyolefin Shrink,
Wrap and/or
PTFE Shrink
Wrap | The proposed
electrode passes the
required tests
according to IEC60601-1
and IEC60601-2-2 so there
will not any issue for safety
Same |
| - Electrode
Tip
Configurati
on | -Blade,
Needle, Ball | -Blade,
Needle, Ball | -Blade,
Needle, Ball | Similar, provide the similar
function |
| - Electrode
coating | -Teflon one coat | Teflon coat | Teflon coat | Similar, does not affect
performance |
| -Rated
accessory
voltage | - 4kVp, 5kVp | 5kVp | 5kVp | |
| Sterile | EO sterile | Gamma | Gamma | Same purpose, EO
sterilization is validated
according to ISO 11135 |
| Shelf life | 3 years | 3 years | 3 years | Same |
| Electrical
safety | Comply with
dielectric strength
in with accordance
IEC60601-1,
IEC60601-1-2 &
IEC60601-2-2 | Comply with
dielectric strength
in with accordance
AAMI HF-18 | Comply with
dielectric strength
in with accordance
AAMI HF-18 and
IEC60601-2-2 & | Same kinds of safety
requirements |
| Biocompati
bility | Comply with
ISO10993 | Should comply
with ISO10993 | Should comply with
ISO10993 | Meet to biocompatibility
requirements so it does not
raise any safety
issue for
biocomnatibility |
5
6
8. Non-clinical Performance Testing Data
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014 and packaging.
Performance Testing included bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016, the evaluation of the thermal effects on the tissues and measurement of the thermal zone sizes are proved that the subject device and the predicate device are equivalent in the performance.
The safety performance of the subject device passed all the testing according to
7
internal requirements and international standards shown below to support the substantial equivalence of the subject device
- IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), Medica electrical equipment - Part 1: General requirements for basic safety and essential performance
- -IEC60601-2-2: 2009 (Fifth Ed), 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.
- IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- -ISO10993, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.
9. Conclusion
Based on comparing technological characteristic and performance testing data, the subject devices are substantially equivalent to predicate devices