(290 days)
Not Found
No
The description focuses on the mechanical and electrical functions of an electrosurgical pencil with smoke evacuation, with no mention of AI or ML capabilities.
Yes
The device is used to conduct electrosurgical current to target tissue for monopolar cutting and coagulation, which directly treats the tissue. The smoke evacuation function is secondary to this primary therapeutic action.
No
The device is described as an electrosurgical tool for cutting and coagulation, with an additional function for smoke evacuation. Its purpose is to perform surgical procedures, not to diagnose conditions.
No
The device description clearly details physical components such as handles, electrodes, tubing, filters, and buttons, indicating it is a hardware device with electrosurgical and smoke evacuation functions. There is no mention of software as the primary or sole component.
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 device is used to "conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke". This describes a surgical tool used directly on a patient's tissue during a procedure.
- Device Description: The description details a physical device with an active handle, electrodes, buttons for cutting and coagulation, and a smoke evacuation system. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis of biological samples.
Therefore, this device is a surgical instrument used for electrosurgery and smoke evacuation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
There are two main series of smoke evacuation pencil.
(1) Smoke Evacuation Fingerswitch (PS947): The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation. The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 4.5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector. In addition to these familiar features and functions, the switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36+/-0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation.
(2) Smoke evacuation system with electrosurgical pencil (CE809): The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36+/-0.2mm, can be put into the handle that functions as smoke evacuation pencil. The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector.
The products, PS947 and CE809 do not have technology difference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
target 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014.
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:
- ANSI/AMMI ES60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC60601-2-2: 2017 (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
- ISO10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- -ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- -ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.
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.
0
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 & 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.
November 30, 2020
Modern Medical Equipment Manufacturing, Ltd. Jerry Cheung Assistant Regulatory Manager Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street Kwai Chung N.T. Hong Kong, China
Re: K200372
Trade/Device Name: Sterile and Non-sterile Single Use Smoke Evacuation Fingerswitch, Nosecone and Smoke Evacuation System with Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2020 Received: February 14, 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) K2000372
Device Name
Sterile and Non-sterile Single Use Smoke Evacuation Fingerswitch, Nosecone and Smoke Evacuation System with Electrosurgical Pencil
Indications for Use (Describe)
The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
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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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: | 26 Nov, 2020 |
| 2. Device | |
| Name of Device: | Sterile and Non-sterile Single Use Smoke Evacuation |
| Fingerswitch, Nosecone and Smoke Evacuation | |
| System with Electrosurgical Pencil | |
| Trade or proprietary name: | Sterile and Non-sterile Single Use Smoke Evacuation |
| Fingerswitch, Nosecone and Smoke Evacuation | |
| System with Electrosurgical Pencil | |
| Common or usual name: | Sterile and Non-sterile Single Use Smoke |
| Evacuation Pencil | |
| Classification name: | Electrosurgical Cutting & Coagulation |
| Device & Accessories | |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Class: | II |
3. Predicate device
MEDTEK PLUMEPEN Integrated Smoke Evacuation Pencil with 510(k) number K103375.
4. Device description
There are two main series of smoke evacuation pencil.
- (1) Smoke Evacuation Fingerswitch (PS947)
4
The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation.
The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 4.5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector.
In addition to these familiar features and functions, the switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation.
(2) Smoke evacuation system with electrosurgical pencil (CE809)
The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil.
The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector.
The products, PS947 and CE809 do not have technology difference.
5. Indication for use
The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
5
6. Technological characteristics
Single Use Smoke Evacuation Fingerswitch and Smoke Evacuation System with Electrosurgical Pencil integrates two technologies of electrosurgery and smoke evacuation. These two 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 devices and the predicate device.
| Compared
Items | Proposed Device | Proposed Device | Predicate Device
(K103375) | Comments on
difference |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Single Use Smoke
Evacuation
Fingerswitch
(PS947)
The device is
intended to be used
as the active
monopolar electrode
in an electrosurgery
generator system for
cutting and
coagulation, with the
additional function to
facilitate the removal
of surgical smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke evacuation
system | Single Use Smoke
evacuation system
with electrosurgical
pencil (CE809)
The device is
intended to be used
as the active
monopolar electrode
in an electrosurgery
generator system for
cutting and
coagulation, with the
additional function to
facilitate the removal
of surgical smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke evacuation
system | MEDTEK
PLUMEPEN
Integrated Smoke
Evacuation Pencil
The PLUMEPEN is
designed for general
electrosurgical
applications,
including cutting and
coagulation, and for
removing smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke evacuation
system. The pencil
enables the operator
to remotely conduct
an electrosurgical
current from the
output connector of
an electrosurgical
unit to the operative
site for the desired
surgical effect. | Same |
| | | | | |
| Indication for
use | The device is used
to conduct
electrosurgical
current from an
electrosurgical
generator to target
tissue in
electrosurgical
procedures for
monopolar cutting
and coagulation,
with the additional
function of
evacuation to
facilitate the removal
of surgical smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke evacuation
system. | The device is used
to conduct
electrosurgical
current from an
electrosurgical
generator to target
tissue in
electrosurgical
procedures for
monopolar cutting
and coagulation,
with the additional
function of
evacuation to
facilitate the removal
of surgical smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke evacuation
system. | To remove smoke
plume form the
surgical site and
remotely conduct an
electrosurgical
current from the
output connector of
an electrosurgical
unit to the target
tissue for the
desired surgical
effect | Same |
| Regulation
number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product code | GEI | GEI | GEI | Same |
| OTC or
prescription | 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 |
| Technology | Monopolar
electrosurgery and
use of vacuum
source to capture
smoke | Monopolar
electrosurgery and
use of vacuum
source to capture
smoke | Monopolar
electrosurgery and
use of vacuum
source to capture
smoke | Same |
| Device mode | Cut and coag. | Cut and coag. | Cut and coag. | Same |
| Design | Smoke evacuation | Smoke evacuation | Electrosurgical | Similar
construction and
provide the same
technology to
achieve target
function.
Extending the
suction tip and |
| | fingerswitch is | system with pencil | pencil is integrated | |
| | produced from that | includes pencil is | with smoke | |
| | electrosurgical | combined with the | evacuation with | |
| | pencil is integrated | specified suction | extendable suction | |
| | with smoke | handle that performs | tip A variety of | |
| | evacuation with | as those of suction | length of electrode | |
| | switching control | evacuation pencil. | be used with | |
| | moving on the shaft
of device in order to
perform as
extending or
retracting suction
tip. Nosecone can
be added to further
extend the suction
tip. | | extendable suction
tip. | electrode is only
for facilitating
operation in
deeper surgical
site |
| Structure of
Pencil
- Housing
- Cable | | | | |
| - Housing - Cable | - ABS
- PVC | - ABS
- PVC | - ABS
- PVC | The material
used and
structure among |
| -Nosecone /
Suction tip | - K-resin | - K-resin | - K-resin | the purposed
and predicate
devices are very |
| -Suction
tubing | - EVA | - EVA | - EVA and PVC | similar and do
not raise safety
and
effectiveness
issues because
those were
tested according
to IEC test and
biocompatibility
requirements |
| -Switching | - Push button, rocker | - Push button, rocker | - Push button | Same function |
| -Electrode tip
style | -Blade | -Blade | -Blade | Same |
| -Electrode
Material | -Stainless steel | -Stainless steel | - Stainless steel | Same |
| - Length | - 50mm, 63.5mm, 69
mm, and 120mm. | - 69 mm | -69mm or longer | Similar, longer
lengths do not
affect cut and
coag.
performance but
only facilitates
the electrode tip
go to deeper
surgical site. |
| | | | | |
| - Diameter | -2,36 mm | -2,36 mm | ~2.36mm | Same |
| - Conductive
end | -15.5mm | -15.5mm | -15.5mm | Same |
| - Tip width | - 2.3mm | - 2.3mm | - 2.3mm | Same |
| - Tip depth | ~0.5mm | ~0.5mm | ~0.5mm | Same |
| - Insulation
material | - PTFE Shrink Wrap | - HIPS | - HIPS | The proposed
electrode passes
the required tests
according to
ISO10993,
IEC60601-1 and
IEC60601-2-2 so
there will not any
issue for safety. |
| - Electrode
coating | -Teflon one coat | -Teflon one coat | - Teflon one coat | Same |
| -Rated
accessory
voltage | - 4.5kVp | - 5kVp | - 5kVp | Similar, does not
affect
performance |
| Max.
operation
power | -300W | -300W | -300W | Same |
| Sterile | EO sterile SAL 10-6 | EO sterile SAL 10-6 | EO sterile SAL 10-6 | 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
ES60601-1,
IEC60601-1-2 &
IEC60601-2-2 | Comply with
dielectric strength in
with accordance
ES60601-1,
IEC60601-1-2 &
IEC60601-2-2 | Comply with
dielectric strength in
with accordance
AAMI HF-18 | Same kinds of
safety
requirements |
| Biocompatibil
ity | Comply with
ISO10993 | Comply with
ISO10993 | Comply with
ISO10993 | Meet to
biocompatibility
requirements so
it does not raise |
| | | | | any safety issue for biocompatibility |
6
7
8
9
8. The technology different raising safety or effectiveness of the devices.
Basically, the technologies used for the proposed device and predicate device are the same including electrosurgical monopolar cutting and coagulation, and smoke evacuation, only a little difference on suction tip mechanism that will not raise any additional safety issue.
9. Non-clinical Performance Testing Data
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014.
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
- ANSI/AMMI ES60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC60601-2-2: 2017 (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
- ISO10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- -ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
10
- -ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.
10. Conclusion
Based on comparing technological characteristic and performance testing data, the subject device, Single Use Smoke Evacuation Fingerswitch and Single Use Smoke Evacuation System with Electrosurgical Pencil are substantially equivalent to predicate device (K103375).