(407 days)
Not Found
No
The summary describes standard electrosurgical forceps with optional smoke evacuation. There is no mention of AI/ML in the intended use, device description, or performance studies. The device's function is based on delivering electrosurgical current and facilitating smoke removal, not on intelligent data processing or learning.
Yes
The device is used to deliver electrosurgical current for coagulation of tissue, which is a therapeutic intervention.
No
The device is described as an electrosurgical instrument used to deliver current for coagulation and facilitate smoke removal during electrosurgical procedures, not for diagnostic purposes.
No
The device description explicitly states it is made of stainless steel forceps and is connected via a cable to an electrosurgical generator, indicating it is a physical hardware device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that the devices "deliver electrosurgical current to target tissue for coagulation in electrosurgical procedure." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The description reinforces this by stating they are "active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue." Again, this is a description of a surgical tool used on living tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These devices do not perform such tests. They are used during a surgical procedure on the patient.
The devices are electrosurgical forceps used for coagulation during surgery, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
- Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
-
Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
-
Single Use Hand Switch Monopolar Forceps (CD956) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
-
Single Use Hand Switch Bipolar Forceps (CD957)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957.
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
All patients, no specific restriction
Intended User / Care Setting
Hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation and Verification testing was performed on device sterility in accordance with ISO11135:2014/AMD 1:2018 Sterilization of health-care products - Ethylene oxide - Requirement s for the development, validation and routine control of a sterilization process for medical devices.
Performance Testing included comparative device use on porcine tissue: kidney, liver and 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.
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 side of the image 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.
March 17, 2022
Modern Medical Equipment Manufacturing, LTD. Mr. Philip Hung QA Manager / Management Representative Unit A, 10/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street. Kwai Chung, N.T., Hong Kong, China
Re: K210315
Trade/Device Name: Monopolar and Bipolar Forceps (with and without Smoke Evacuation). Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI
Dated: January 04, 2022 Received: January 26, 2022
Dear Mr. Hung:
We have reviewed vour 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210315
Device Name
Monopolar and Bipolar Forceps ( with and without Smoke Evacuation)
Indications for Use (Describe)
- Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
-
Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
-
Single Use Hand Switch Monopolar Forceps (CD956) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
-
Single Use Hand Switch Bipolar Forceps (CD957)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
3
| 1. 510(k) Owner
| Name: | Modern Medical Equipment Manufacturing Limited | |
|---|---|---|
| Address: | Modern Medical Equipment Mfg., Ltd. | |
| Unit A, 10/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. Philip Hung | |
| Position: | Quality Assurance Manager / Management Representative | |
| Email Address: | philip_hung@modernmedical.com.hk | |
| Date of preparation: | Feb14, 2022 | |
| 2. Device | ||
| Device Trade name: | Monopolar and Bipolar Forceps | |
| ( with and without Smoke Evacuation) | ||
| Common or usual name: | Single Use Hand Switch Monopolar and Bipolar Forceps | |
| Single Use Hand Switch Monopolar and Bipolar Forceps | ||
| with Smoke Evacuation. | ||
| Classification name: | Electrosurgical Cutting & Coagulation | |
| Device & Accessories | ||
| Classification number: | 21 CFR 878.4400 | |
| Classification Panel: | General & Plastic Surgery | |
| Product Code: | GEI | |
| Class: | II |
3. Predicate device
3.1 Olsen Medical SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS with 510(k) number K130669, cleared Dec 06,2013.
4
3.2 Modern Medical Smoke Evacuation Fingerswitch, Smoke Evacuation System With Electrosurgical
Pencil with 510(k) number K200372, cleared Nov 30, 2020.
3.3 Modern Medical Bipolar Forceps with 510(k) number K032327
4. Device description
Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957. Please refer it to the item 6, for the detail of these four models.
5. Intended use
The device is intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue.
6. Indication for use
- 6.1 Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coaqulation in electrosurgical procedure, with the additional function to facilitate the removal of surqical smoke generated by electrosurgery
6.2 Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
6.3 Single Use Hand Switch Monopolar Forceps (CD956)
The device delivers electrosurqical current to target tissue for coaqulation in electrosurgical procedure.
- 6.4 Single Use Hand Switch Bipolar Forceps (CD957)
5
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
7. Technological characteristics
Single Use Hand Switch Forceps has substantially equivalent construction and performance as the predicate devices.
8. Substantial Equivalence
The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent.
1. Table 1: Subject-Predicate Comparison
Proposed device: Single Use Hand Switch Monopolar Forceps with Smoke Evacuation_(CD954)
| Compared
Items | Proposed
Device
(K210315) | Predicate
Device
(K130669) | Predicate
Device
(K200372) | Result | Comments
on difference/
equivalent
evidence |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate device: K130669 and K200372 | | | | | |
| Single Use
Hand Switch
Monopolar
Forceps with
Smoke
Evacuation | Olsen Medical
Bipolar and
Monopolar
Forceps | Single Use
Smoke
Evacuation
Fingerswitch
/ Pencil | | | |
| Classification
Name | Electrosurgic
al, Cutting
and
Coagulation
Accessories | Electrosurgic
al, Cutting
and
Coagulation
Accessories | Electrosurgic
al, Cutting
and
Coagulation
Accessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | 878.4400 | Equivalent | |
| Common
Name | Single Use
Hand Switch
Monopolar
Forceps with
Smoke
Evacuation | Single Use
Bipolar and
Monopolar
Forceps
Multiple-Use
Bipolar and
Monopolar
Forceps | Single Use
Smoke
Evacuation
Fingerswitch /
Pencil | Equivalent | |
| Product Code | GEI | GEI | GEI | Equivalent | |
| | | | | | |
| Intended use | The device is
intended to be
used as
active
electrosurgica
l devices
where
monopolar
electrosurgica
l coagulation
is desired
during
surgery and
are intended
to grasp,
manipulate
coagulate
selected soft
tissue. | The OLSEN
Medical
Electrosurgic
al Monopolar
and Bipolar
Forceps are
intended to be
used as
active
electrosurgica
l devices
where
monopolar or
bipolar
electrosurgica
l cutting and
coagulation is
desired during
surgery and
are intended
to grasp,
manipulate
cut or
coagulate
selected soft
tissue. | Monopolar
cutting and
coagulation in
electrosurgica
l procedure,
with the
additional
function to
facilitate the
removal of
surgical
smoke
generated by
electrosurgery
. | Equivalent | Evidence: IFU |
| Prescription
or OTC | Prescription
Use | Prescription
Use | Prescription
Use | Equivalent | |
| Indication for
use | The device
delivers
electrosurgica
l current to
target tissue
for
coagulation in
electrosurgica
l procedure,
with the
additional
function to
facilitate the
removal of
surgical
smoke
generated by
electrosurgery
. | OLSENMedic
al®
Electrosurgic
al Monopolar
and Bipolar
Forceps have
been
designed as
active
electrosurgica
l instruments
to grasp,
manipulate,
cut or
coagulate
selected soft
tissue. These
stainless steel
forceps are
connected
through a
suitable active
electrosurgica
l cable
(bipolar or
monopolar) to
the specified | Monopolar
electrosurgica
l pencil which
delivers
electrosurgica
l current to
target tissue
for cutting and
coagulation in
electrosurgica
l procedure,
with the
additional
function to
facilitate the
removal of
surgical
smoke
generated by
electrosurgery
. | Equivalent | Evidence: IFU |
| | | output
terminal of an
electrosurgica
I generator.
Irradiation | | | |
| Sterility | ETO | | ETO | Equivalent | ETO
sterilization
validation
have done for
this device.
Evidence: EO
validation
report number
R-EO2011
Evidence: IFU |
| Usage | Single Use | Disposable
and reusable | Single Use | Equivalent | Evidence: IFU |
| Tip Material | Stainless
Steel | Stainless
Steel | Stainless
Steel | Equivalent | Evidence:
Material
Technical
Data Sheet |
| Size (distal
tips) | 0.1-1.2mm | 0.5-1.5mm | 0.5mm | Not
Equivalent | Tip Size
doesn't
increase any
risk for the
product.
Evidence:
Simulation
test report
956MVPE1N-
2111123R.
Evidence: IFU |
| Packaging | Tyvek Pouch | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| Electrical
Safety
Testing | IEC
60601-2-2 | IEC
60601-2-2 | IEC
60601-2-2 | Equivalent | Evidence:
DSS_GZES2
00802563702
-IEC
60601-2-2 |
| Energy
delivery | Monopolar
electrosurgica
I Forceps
which delivers
electrosurgica
I current to
target tissue. | Monopolar or
bipolar
electrosurgica
I Forceps
which delivers
electrosurgica
I current to
target tissue. | Monopolar
electrosurgica
I Forceps
which delivers
electrosurgica
I current to
target tissue. | Equivalent | Evidence: test
report number
954MVPE2N-
2012196R |
| Rated
Accessory
Voltage | 2.0kVp | The bipolar
forceps are
intended for
use
with a
maximum
voltage of 500
volts while the
monopolar
forceps have
a | 4.5kVp | Equivalent | Evidence:
Accelerated
aging test
report |
| | maximum
voltage of
2000 volts. | | | | |
| Biocompatibili
ty | Non irritant,
non sensitive
to skin, non
toxic to cells | Non irritant,
non sensitive
to skin, non
toxic to cells | Non irritant,
non sensitive
to skin, non
toxic to cells | Equivalent | Evidence:
Biocompatibili
ty test report |
| Shelf life | 3 years | 3 years | 3 years | Equivalent | Evidence:
Labeling |
| Target
population | All patients,
no specific
restriction | All patients,
no specific
restriction | All patients,
no specific
restriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Hospitals | Equivalent | Evidence: IFU |
Predicate device: K130669 and K200372
6
7
8
Table 2: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Bipolar Forceps with Smoke Evacuation_(CD955)
Predicate device: K032327
| Compared
Items | Proposed
Device
(K210315)
Single Use
Hand Switch
Bipolar Forceps
with Smoke
Evacuation | Predicate Device
(K032327)
Modern Medical
Bipolar Forceps | Result | Comments on
difference/ equivalent
evidence |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Electrosurgical,
Cutting and
Coagulation
Accessories | Electrosurgical,
Cutting and
Coagulation
Accessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | Equivalent | |
| Common
Name | Single Use
Hand Switch
Bipolar Forceps
with Smoke
Evacuation | Modern Medical
Bipolar Forceps | Equivalent | |
| Product Code | GEI | GEI | Equivalent | |
| | | | | |
| Intended use | The device is
intended to be
used as active
electrosurgical
devices where
bipolar
electrosurgical
coagulation is
desired during
surgery and are
intended to
grasp,
manipulate r
coagulate
selected soft
tissue. | The device is
intended to be
used as active
electrosurgical
devices where
bipolar
electrosurgical
coagulation is
desired during
surgery and are
intended to
grasp,
manipulate r
coagulate
selected soft
tissue. | Equivalent | Evidence: IFU |
| Prescription or
OTC | Prescription
Use | Prescription Use | Equivalent | |
| Indication for
use | The device
delivers
electrosurgical
current to target
tissue for
coagulation in
electrosurgical
procedure, with
the additional
function to
facilitate the
removal of
surgical smoke
generated by
electrosurgery. | The device
delivers
electrosurgical
current to target
tissue for
coagulation in
electrosurgical
procedure, with
the additional
function to
facilitate the
removal of
surgical smoke
generated by
electrosurgery. | Equivalent | Evidence: IFU |
| Sterility | ETO | Irradiation | Equivalent | ETO sterilization
validation have done for
this device. Evidence:
EO validation report
number R-EO2011
Evidence: IFU |
| Usage | Single Use | Disposable and
reusable | Equivalent | Evidence: IFU |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence: Material
Technical Data Sheet |
| Size (distal
tips) | 0.1-1.2mm | 0.5-2.0mm | Not equivalent | Tip Size doesn't
increase any risk for the
product.
Evidence: |
| | | | | 955MVPE1N-2111122R |
| Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| Electrical
Safety
Testing | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence:
DSS_GZES200802563
702-IEC 60601-2-2 |
| Energy delivery | Bipolar
electrosurgical
Forceps which
delivers
electrosurgical
current to target
tissue. | Monopolar or
bipolar
electrosurgical
Forceps which
delivers
electrosurgical
current to target
tissue. | Equivalent | Evidence: test report
number
954MVPE2N-2012196R |
| Rated
Accessory
Voltage | 2.0kVp | The bipolar
forceps are
intended for use
with a maximum
voltage of 500
volts while the
monopolar
forceps have a
maximum
voltage of 2000
volts. | Equivalent | Evidence: Accelerated
aging test report |
| Biocompatibility | Non irritant, non
sensitive to
skin, non toxic
to cells | Non irritant, non
sensitive to skin,
non toxic to cells | Equivalent | Evidence:
Biocompatibility test
report |
| Shelf life | 3 years | 3 years | Equivalent | Evidence: Labeling |
| Target
population | All patients, no
specific
restriction | All patients, no
specific
restriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Equivalent | Evidence: IFU |
| Functionality | With smoke
evacuation | Without smoke
evacuation | Not equivalent | The smoke evacuation
is a features that be
added to the forceps to
increase convenience
of functionality,
without altering the
intended use or risk
profile (relative to a
predicate) of the
proposed device.
Instead, smoke
evacuation
functionality. |
| | | | | Evidence: Simulation
test report.
955MVPE1N-2111121F |
9
10
11
Table 3: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Monopolar Forceps_(CD956) Predicate device: K130669
| Compared Items | Proposed Device
(K210315)
Single Use Hand Switch
Monopolar Forceps | Predicate Device
(K130669)
Olsen Medical
Bipolar and
Monopolar Forceps | Result | Comments on
difference/
equivalent
evidence |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Electrosurgical,
Cutting and
Coagulation
Accessories | Electrosurgical,
Cutting and
Coagulation
Accessories | Equivalent | |
| Regulation
Common
Name | 878.4400
Single Use Hand Switch
Monopolar
Forceps | 878.4400
Single Use
Bipolar and
Monopolar
Forceps
Multiple-Use
Bipolar and
Monopolar
Forceps | Equivalent | |
| Product Code
Intended use | GEI
The device is
intended to be
used as active
electrosurgical
devices where
monopolar
electrosurgical
coagulation is
desired during
surgery and are
intended to
grasp,
manipulate
coagulate
selected soft
tissue. | GEI
The OLSEN
Medical
Electrosurgical
Monopolar and
Bipolar Forceps
are intended to
be used as active
electrosurgical
devices where
monopolar or
bipolar
electrosurgical
cutting and
coagulation is
desired during
surgery and are
intended to
grasp,
manipulate cut or
coagulate
selected soft
tissue. | Equivalent | Evidence: IFU |
| Prescription or
OTC | Prescription Use | Prescription Use | Equivalent | |
| Indication for use | | OLSENMedical® | Equivalent | Evidence: IFU |
| | The device
delivers
electrosurgical
current to target
tissue for and
coagulation in
electrosurgical
procedure. | Electrosurgical
Monopolar and
Bipolar Forceps
have been
designed as
active
electrosurgical
instruments to
grasp,
manipulate, cut
or coagulate
selected soft
tissue. These
stainless steel
forceps are
connected
through a
suitable active
electrosurgical
cable (bipolar or
monopolar) to the
specified output
terminal of an
electrosurgical
generator. | Equivalent | |
| Sterility | ETO | Irradiation | Equivalent | ETO sterilization
validation have
done for this
device. Evidence:
EO validation
report number
R-EO2011
Evidence: IFU |
| Usage | Single Use | Disposable and
reusable | Equivalent | Evidence: IFU |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence:
Material
Technical Data
Sheet |
| Size (distal
tips) | 0.1-1.2mm | 0.5-1.5mm | Not Equivalent | Tip Size doesn't
increase any risk
for the product.
Evidence:
Simulation test
report
956MVPE1N-211
1123R. |
| Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| Electrical
Safety
Testing | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence:
DSS_GZES2008
02563702-IEC
60601-2-2 |
| Energy delivery | Monopolar
electrosurgical
Forceps which
delivers
electrosurgical
current to target
tissue. | Monopolar or
bipolar
electrosurgical
Forceps which
delivers
electrosurgical
current to target
tissue. | Equivalent | Evidence: test
report number
954MVPE2N-201
2196R |
| Rated Accessory
Voltage | 2.0kVp | The bipolar
forceps are
intended for use
with a maximum
voltage of 500
volts while the
monopolar
forceps have a
maximum voltage
of 2000 volts. | Equivalent | Evidence:
Accelerated
aging test report |
| Biocompatibility | Non irritant, non
sensitive to skin,
non toxic to cells | Non irritant, non
sensitive to skin,
non toxic to cells | Equivalent | Evidence:
Biocompatibility
test report |
| Shelf life | 3 years | 3 years | Equivalent | Evidence:
Labeling |
| Target population | All patients, no
specific
restriction | All patients, no
specific
restriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Equivalent | Evidence: IFU |
12
13
Table 4: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Bipolar Forceps_(CD957) Predicate device K130669
| Compared Items | Proposed
Device
(K210315)
Single Use Hand
Switch
Monopolar
Forceps with
Smoke
Evacuation | Predicate Device
(K130669)
Olsen Medical
Bipolar and
Monopolar
Forceps | Result | Comments on
difference/
equivalent
evidence |
|------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------|------------------------------------------------------|
| Classification
Name | Electrosurgical,
Cutting and
Coagulation
Accessories | Electrosurgical,
Cutting and
Coagulation
Accessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | Equivalent | |
| Common
Name | Single Use Hand
Switch Bipolar
Forceps | Single Use
Bipolar and
Monopolar
Forceps
Multiple-Use
Bipolar and | Equivalent | |
14
| Product Code | | Monopolar
Forceps | | |
|------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Intended use | | GEI | Equivalent | Evidence: IFU |
| | GEI | The OLSEN
Medical
Electrosurgical
Monopolar and
Bipolar Forceps
are intended to
be used as active
electrosurgical
devices where
monopolar or
bipolar
electrosurgical
cutting and
coagulation is
desired during
surgery and are
intended to
grasp,
manipulate cut or
coagulate
selected soft
tissue. | Equivalent | |
| Prescription or
OTC | | Prescription Use | Equivalent | |
| Indication for use | | The device
delivers
electrosurgical
current to target
tissue for
coagulation in
electrosurgical
procedure. | OLSENMedical®
Electrosurgical
Monopolar and
Bipolar Forceps
have been
designed as
active
electrosurgical
instruments to
grasp,
manipulate, cut
or coagulate
selected soft
tissue. These
stainless steel
forceps are
connected
through a
suitable active
electrosurgical
cable (bipolar or
monopolar) to the
specified output
terminal of an | Evidence: IFU |
15
| Sterility | ETO | Irradiation | Equivalent | ETO sterilization
validation have
done for this
device. Evidence:
EO validation
report number
R-EO2011 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------|
| Usage | Single Use | Disposable and
reusable | Equivalent | Evidence: IFU |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence:
Material
Technical Data
Sheet |
| Size (distal
tips) | 0.1-1.2mm | 0.5-1.5mm | Not Equivalent | Tip Size doesn't
increase any risk
for the product.
Evidence:
955MVPE1N-211
1122R. |
| Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| Electrical
Safety
Testing | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence:
DSS GZES2008
02563702-IEC
60601-2-2 |
| Energy delivery | Monopolar
electrosurgical
Forceps which
delivers
electrosurgical
current to target
tissue. | Monopolar or
bipolar
electrosurgical
Forceps which
delivers
electrosurgical
current to target
tissue. | Equivalent | Evidence: test
report number
954MVPE2N-201
2196R |
| Rated Accessory
Voltage | 2.0kVp | The bipolar
forceps are
intended for use
with a maximum
voltage of 500
volts while the
monopolar
forceps have a
maximum voltage
of 2000 volts. | Equivalent | Evidence:
Accelerated
aging test report |
| Biocompatibility | Non irritant, non
sensitive to skin,
non toxic to cells | Non irritant, non
sensitive to skin,
non toxic to cells | Equivalent | Evidence:
Biocompatibility
test report |
| Shelf life | 3 years | 3 years | Equivalent | Evidence:
Labeling |
| Target population | All patients, no
specific
restriction | All patients, no
specific
restriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Equivalent | Evidence: IFU |
16
We conclude that proposal devices are substantial equivalence to predicate devices.
9. Performance Testing Data
Validation and Verification testing was performed on device sterility in accordance with
ISO11135:2014/AMD 1:2018 Sterilization of health-care products - Ethylene oxide - Requirement s for the development, validation and routine control of a sterilization process for medical devices
Performance Testing included comparative device use on porcine tissue: kidney, liver and 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.
10. Safety and Biocompatibility testing data
Electrical Safety complies with
IEC 60601-1:2005+AMD1:2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential perfor mance
IEC 60601-1-2:2014
Medical electrical equipment - Part 1 -2: General requirements for basic safety and essential perf ormance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2:2017
Medical electrical equipment - Part 2- 2: Particular requirements for the basic safety and essentia I performance of high frequency surgical equipment and high frequency surgical accessories
The proposed devices are an external device that contacts tissue/bone/dentin for limited contact duration (less than 24 hours). No biologically significant effect was observed in tests conducted in accordance with following ISO 10993 standards for Cytotoxicity, Sensitization, Intracutaneous reactivity, Material-mediated pyrogenicity and Acutesystemic toxicity.
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
17
ISO 10993-11:2017
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
11. Conclusion
The proposed Modern Medical Monopolar and Bipolar Forceps is similar in design as its predicates. The Modern Medical Forceps are sterilized using equivalent material and processes as its predicates. The subject devices also have same intended use and performance characteristics as their predicates. No new technological characteristics were introduced and as such, the proposed forceps do not raise new types of safety and effectiveness issues as compared to the predicates.