(311 days)
No
The summary describes a standard electrosurgical instrument for coagulation, dissection, and grasping. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities. The performance studies focus on standard device safety and functionality tests.
No.
The device is described as an invasive instrument used for electrosurgical cutting and grasping of tissue during surgery, rather than for treating a disease or condition. It is a component of an electrosurgical device.
No
This device is an invasive surgical instrument used for electrosurgical coagulation, dissection, and grasping of tissue during surgical procedures. It is a tool for performing surgical actions, not for diagnosing conditions.
No
The device description explicitly states it is a sterile, single-use, invasive instrument used in laparoscopic surgery, indicating it is a physical 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 for "electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures." This describes a surgical instrument used directly on tissue within the body.
- Device Description: The description confirms it's a "sterile, single-use, invasive instrument that used in laparoscopic surgery." This further reinforces its role as a surgical tool.
- 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 physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to aid in diagnosis or monitoring. This device is a surgical tool used for manipulating and treating tissue during a procedure.
N/A
Intended Use / Indications for Use
Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
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
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)
Performance data included:
7.1 Biocompatibility: Evaluated according to ISO 10993-1, assessing cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity.
7.2 Electrical Safety: Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. The test setup included active accessory insulation, active accessory hf leakage, active accessory hf dielectric strength, active accessory mains frequency dielectric strength, and feedthrough test. All performed tests were passed.
7.3 Sterilization: Provided sterile and intended for single-use, sterilized by EO-Sterilization in accordance with ISO-11135.
7.4 Shelf life: Proposed expiration date is 2 years from manufacturing date, with real-time testing performed to confirm shelf-life for 3 years.
7.5 Performance test: Evaluated appearance (no defects), dimension (within ± 5% of indicated value), operational test (smooth opening/closing, bending ±80° or more, 360° rotation), tensile strength (no damage from 20 N pull), and feedthrough test (electrical conduction between electrode tip and connector, resistance less than 1Ω). All performed tests were passed.
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.
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.
February 13, 2020
Livsmed Inc. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, Korea 06210
Re: K190909
Trade/Device Name: ArtiSential Bipolar Fenestrated Forceps (Model ABF01-L, ABF01-F) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 21, 2020 Received: January 22, 2020
Dear Do Hyun Kim:
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.
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
1
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 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190909
Device Name
ArtiSential Bipolar Fenestrated Forceps (Model name: ABF01-L, ABF01-F)
Indications for Use (Describe)
Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
6. 510(k) Summary
1. General Information
| Applicant/Submitter: | Livsmed Inc. |
|---|---|
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516 |
| Seongnam-si, Gyeonggi-do, Republic of Korea | |
| Tel) +82-70-4282-7652 | |
| Fax) +82-31-706-3211 | |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86-gil 5, Gangnam-gu, 06210 |
| Seoul, Republic of Korea | |
| Tel) +82-2-538-9140 | |
| Fax) +82-2-539-9140 | |
| Email) smanager@btsolutions.co.kr | |
| Preparation Date: | 01-02-2020 |
2. Device Name and Code
| Device Trade Name: | ArtiSential Bipolar Fenestrated Forceps
(Model name: ABF01-L, ABF01-F) |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical, cutting & coagulation & accessories |
| Product Code: | GEI |
| Regulation Number: | 21 CFR 878.4400 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3. Predicate Devices
ArtiSential Bipolar Fenestrated Forceps is substantially equivalent to the following devices
| Table 3.1 Predicate device | ||
|---|---|---|
| Applicant | Device Name | 510(k) Number |
4
ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
| Gyrus Medical, Inc. | Everest Bipolar MACRO, | K031078 |
|---|---|---|
| MICRO&MOLLY Forceps Gyrus | ||
| Bipolar MACRO, MICRO&MOLLY | ||
| Forceps |
Table 3.2 Reference Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Ethicon Endo-Surgery, LLC | ENSEAL® G2 Articulating Tissue | |
| Sealers | K122797 | |
| Intuitive Surgical, Inc. | Intuitive Surgical Da Vinci Surgical | K050369 |
| Intuitive Surgical, Inc. | da Vinci® SpTM Surgical System, | |
| Model SP999, EndoWrist® SpTM | ||
| Instruments, and Accessories | K131962* |
- This reference device is referred, of which articulating parts are the same to those of the ArtiSential Bipolar Fenestrated Forceps. This device is used in robotic surgery, but articulating function is very similar.
4. Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
5. Indications / Intended Use
5.1 Intended use
The ArtiSential Bipolar Fenestrated Forceps are invasive instruments which is used with electrosurgical generator. They are intended to be used during laparoscopic surgical procedures for incision/coagulation (to electrocauterize, grasp and dissect tissue) during surgery.
5.2 Indications for use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
6. Technical Characteristics in Comparison to Predicate and Reference Devices
ArtiSential Bipolar Fenestrated Forceps is substantially equivalent to the following legally marketed predicate device.
Table 6.1 Predicate Device
5
ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(K) Number | Not Available | K031078 |
| Manufacturer | LivsMed, Inc. | Gyrus Medical, Inc. |
| Device Name | ArtiSential Bipolar Fenestrated Forceps | Everest Bipolar MACRO, |
| MICRO&MOLLY Forceps Gyrus Bipolar | ||
| MACRO, MICRO&MOLLY Forceps | ||
| Clearance Date: | N/A | 05/16/2003 |
| Classification / | ||
| Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 |
| Product Code | GEI | GEI |
| Intended for | Prescription Use | Prescription Use |
| Indications for | ||
| Use | Electrosurgical coagulation, dissection, and | |
| grasping of tissue during the performance of | ||
| laparoscopic and general surgical | ||
| procedures. | Electrosurgical coagulation, dissection, and | |
| grasping of tissue during the performance of | ||
| laparoscopic and general surgical | ||
| procedures. | ||
| Principles of | ||
| operation | This product is a single-use instrument used | |
| in electrosurgical units to hold soft tissues or | ||
| coagulate and make an incision (tissue | ||
| dissection) during general laparoscopic | ||
| surgery, which uses the principle of | ||
| applying high-frequency currents from the | ||
| electrode to the human body to generate | ||
| heat by bioimpedance when radio frequency | ||
| (RF) energy from the electrosurgical unit | ||
| applies an electric current to the electrode | ||
| part, and using the generated heat to incise | ||
| cellular tissues and cause coagulation. | ||
| It is composed of a jaw, Φ8 diameter shaft, | ||
| grip (including a control ring), and | ||
| electrosurgical unit connection electrode | ||
| connector. | ||
| During a procedure with this product, the | ||
| jaw opens if the control ring opens, and jaw | ||
| closes if the control ring closes. In addition, | ||
| the jaw is also bent up, down, left and right | ||
| within a range of ±80° or more by moving | ||
| the grip up, down, left and right, and the jaw | ||
| can also turn 360° when rotating the grip. | Unknown | |
| Energy Type | Radiofrequency | Radiofrequency |
| Electrode type | ||
| (monopolar or | ||
| bipolar) | Bipolar | Bipolar |
| Physical | ||
| dimensions and | ||
| design (size, | ||
| length, | ||
| connector type) | Shaft diameter: 8mm | |
| Length: 411.4mm | ||
| Connector type: Dual-pin connector type | Shaft diameter: 5mm | |
| Length: 450mm | ||
| Connector type: Dual-pin connector type | ||
| Rated voltage | 200 Vp | Unknown |
| Materials | ||
| (electrode) | Stainless steel | Unknown |
| Materials | ||
| (insulation) | Polyetherimide | Unknown |
| Materials | ||
| (Shaft) | Glass fiber | Unknown |
| Rotation | Pitch:±80° or more, Yaw:±80° or more | |
| and Open-Close | Unknown | |
| Sterilization | EO | EO |
6
ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
Table 6.2 Reference Predicate Device
| | Proposed Device | Reference Predicate
Device 1 | Reference Predicate Device
2 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | Not Available | K122797 | K050369 |
| Manufacturer | LivsMed, Inc. | Ethicon Endo-Surgery, LLC | Intuitive Surgical, Inc. |
| Device Name | ArtiSential Bipolar
Fenestrated Forceps | ENSEAL® G2 Articulating
Tissue Sealers | Intuitive Surgical Da Vinci
Surgical System, Model
IS2000 |
| Clearance
Date: | N/A | 01/25/2013 | 04/29/2005 |
| Classification /
Regulation | Class 2 / 878.4400 | Class 2 / 878.4400
Class 2/ 884.4120 | Class 2/ 876.1500 |
| Product Code | GEI | GEI, HGI | NAY |
| Intended for
Indications for
Use | Prescription Use
Electrosurgical coagulation,
dissection, and grasping of
tissue during the
performance of laparoscopic
and general surgical
procedures. | Prescription Use
The ENSEAL® G2
Articulating Tissue Sealers
are indicated for bipolar
coagulation and mechanical
transection of tissue during
laparoscopic and open
procedures. The devices are
bipolar electrosurgical
instruments for use with the
Generator GEN11
(GEN11). They are intended
for use during open or
laparoscopic, general and
gynecological surgery to cut
and seal
vessels, and to cut, grasp
and dissect
tissue during surgery.
Indications for use include
open and laparoscopic,
general and gynecological
surgical procedures
(including urologic,
thoracic, plastic and
reconstructive, bowel
resections, hysterectomies,
cholecystectomies, gall
bladder procedures, Nissen | Prescription Use
The Intuitive Surgical' da
Vinci Surgical System is
intended to assist in the
accurate control of Intuitive
Surgical Endoscopic
Instruments including rigid
endoscopes, blunt and sharp
endoscopic dissectors,
scissors, scalpels, ultrasonic
shears, forceps/pick-ups,
needle holders, endoscopic
retractors, stabilizers,
electrocautery and
accessories for endoscopic
manipulation of tissue,
including grasping, cutting,
blunt and sharp dissection,
approximation, ligation,
electrocautery, suturing, and
delivery and placement of
microwave ablation probes
and accessories during
urologic surgical procedures,
general laparoscopic surgical
procedures, gynecologic
laparoscopic surgical
procedures, general non-
cardiovascular thoracoscopic |
| | | fundoplication, adhesiolysis,
oophorectomies, etc.), or
any procedure where vessel
ligation (cutting and
sealing), tissue grasping,
and dissection is performed.
The devices can be used on
vessels up to (and including)
7mm and tissue and/or
vascular bundles as large as
will fit in the jaws of the
instruments. | surgical procedures, and
thoracoscopically assisted
cardiotomy procedures. The
system can also be
employed, with adjunctive
mediastinotomy to perform
coronary anastomosis during
cardiac revascularization. It
is intended for use by trained
physicians in an operating
room environment in
accordance with the
representative specific
procedures set forth in the
Professional Instructions for
Use. |
| Principles of
operation | This product is a single-use
instrument used in
electrosurgical units to hold
soft tissues or coagulate and
make an incision (tissue
dissection) during general
laparoscopic surgery, which
uses the principle of
applying high-frequency
currents from the electrode
to the human body to
generate heat by
bioimpedance when radio
frequency (RF) energy from
the electrosurgical unit
applies an electric current to
the electrode part, and using
the generated heat to incise
cellular tissues and cause
coagulation.
It is composed of a jaw, Φ8
diameter shaft, grip
(including a control ring),
and electrosurgical unit
connection electrode
connector.
During a procedure with
this product, the jaw opens
if the control ring opens,
and jaw closes if the control
ring closes. In addition, the
jaw is also bent up, down,
left and right within a range
of ±80° or more by moving
the grip up, down, left and
right, and the jaw can also | The ENSEAL G2
Articulating Tissue
Sealers have a 5 mm
diameter shaft
and are available in two
shafts
lengths: 35 and 45cm; and
two jaw types: 3mm curved
jaw and 5mm straight jaw.
The jaws are normally in the
opened position and can be
partially or fully closed by
squeezing
the closing handle. The jaws
have atraumnatic teeth for
grasping and holding
targeted tissue when
clamped. The handles of the
Subject ENSEAL G2
Articulating Tissue Sealers
have an ergonomic interface
for the user. Like the
Predicate, the Subject
devices include an
integrated energy activation
button. The devices use a
combination of the
application of bipolar
electrosurgical energy in
conjunction with the I-
BLADE knife, to compress,
coagulate, and transect
tissue. | This product is a reusable
foot control electro-surgical
electrode equipped with a
product mounted on a
cleared product like da Vinci
S Surgical system or da
Vinci Si Surgical System and
used by connecting it to an
electrosurgical machine with
a cable. It consists of a
housing, which is attached to
the robotic arm of the da
vinci system, and shaft
which the bipolar energy is
transferred and an electrode
(tip) that coagulates,
removes, dissects, or
destroys tissues using the
energy. The principles
applied to the development
of this product are as
follows.
When high-frequency energy
from an electrosurgical
machine is energized on the
electrodes through cables,
housings, and shafts, high-
frequency currents from
electrodes are applied to the
human body to generate heat
due to bio-resistance, and the
heat generated is used to
generate incision and
coagulation of tissue. This
product is a medical device
that can be reused by |
7
ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
8
| ArtiSential Bipolar Fenestrated Forceps |
|---|
| 510(k) Summary |
| turn 360° when rotating the grip. | cleaning and sterilizing after use. | ||
|---|---|---|---|
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency |
| Electrode type | |||
| (monopolar or | |||
| bipolar) | Bipolar | Bipolar | Bipolar |
| Physical | |||
| dimensions and | |||
| design (size, | |||
| length, | |||
| connector type) | Shaft diameter: 8mm | ||
| Length: 411.4mm | |||
| Connector type: Dual-pin | |||
| connector type | Shaft diameter: 5mm | ||
| Length: 350mm, 450mm | |||
| Connector type: Unknown | Shaft diameter: 8mm | ||
| Total length: 511mm | |||
| Connector type: Dual-pin | |||
| connector type | |||
| Rated voltage | 200 Vp | Unknown | 384 Vp |
| Materials | |||
| (electrode) | Stainless steel | Stainless steel | Stainless steel |
| Materials | |||
| (insulation) | Polyetherimide | Unknown | Polyetherimide / ETFE |
| (Ethylenetetrafluoroethylene) | |||
| Materials | |||
| (Shaft) | Glass fiber | Unknown | Glass fiber |
| Rotation | Pitch:±80° or more, | ||
| Yaw:±80° or more and | |||
| Open-Close | Articulates approximately | ||
| 50~65° to | |||
| the left and the right of | |||
| center and | |||
| Open-Close | Pitch: ±70° | ||
| Yaw: ±90° | |||
| Sterilization | EO | EO | Moist Heat or Steam |
| Sterilization |
7. Performance Data
7.1 Biocompatibility
The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:
- Cytotoxicity
- . Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
7.2 Electrical Safety
The ArtiSential Bipolar Fenestrated Forceps has been tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. The test setup included:
- Active accessory insulation
- Active accessory hf leakage ●
- Active accessory hf dielectric strength ●
- Active accessory mains frequency dielectric strength ●
- Feedthrough test ●
9
The device had passed all performed tests. 7.3 Sterilization
ArtiSential Bipolar Fenestrated Forceps is provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.
7.4 Shelf life
The proposed expiration date is 2 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years.
7.5 Performance test
| Test clause and Test requirement | Test specification | Results- Remarks |
|---|---|---|
| 1. Appearance | ||
| There should be no defects in the | ||
| appearance of the product and there | ||
| should be no problem in use. | Visual observation | No crack, stain or |
| no substances on | ||
| the surface of the | ||
| product | ||
| 2. Dimension | ||
| It should be within ± 5% of the indicated | ||
| value of the dimensional term. | Measure by Vernier calipers | |
| and dial gauge etc. | Pass | |
| Refer to | ||
| [Measurement | ||
| data] on 65 page | ||
| at attachment #3 | ||
| 3. Operational test | ||
| The jaw must be smoothly opened and | ||
| closed and free from jamming, the jaw | ||
| and hub can be bent up, down, left, and | ||
| right a range of above ±80° and are | ||
| capable of 360° rotation. | Adjusting open and close the | |
| jaw by manipulating the grip | ||
| and control ring, and measure | ||
| the angle at bending and | ||
| turning. | The jaw and hub | |
| are bent up, down, | ||
| left and right | ||
| within above 80°, | ||
| and can rotate | ||
| 360°. | ||
| 4. Tensile strength | ||
| The jaw and shaft connections shall not | ||
| be damaged from pulling of 20 N. | Hold the jaw and shaft | |
| connections respectively and | ||
| apply a force of 20 N using | ||
| Push pull gauge. | No damage to the | |
| connection when | ||
| applying a force of | ||
| 20N | ||
| 5. Feedthrough test | ||
| Electricity should be transmitted | ||
| between the electrode tip and the | ||
| connector. | Electrical conduction between | |
| the electrode tip and the | ||
| connector is tested using a DMM | ||
| (digital multi meter). | The | |
| resistance | ||
| value between the | ||
| electrode tip and | ||
| the connector is | ||
| less than 1Ω |
The device had passed all performed tests.
10
Based on these performance characteristics, the results demonstrate that the performance requirements were met, the device performs as intended and that the subject device has substantially equivalent performance characteristics to the predicate and reference predicate devices.
8. Substantial Equivalence
The ArtiSential Bipolar Fenestrated Forceps indication for use is similar to the predicate device (K031078). The energy type, electrode type, sterilization as well as similar physical characteristics are the same. Although there are some minor differences with each product, these differences between the ArtiSential Bipolar Fenestrated Forceps and the predicate device do not raise new or different questions of safety and efficacy. There is no new technology and no difference that would raise new or different questions of safety or efficacy.
9. Conclusions
In conclusion, the comparison carried out covers all products, sizes, and the entire intended purpose of the device under evaluation. The subject device which is the Disposable Laparoscopic Instruments - ArtiSential Bipolar Fenestrated Forceps - is considerably similar to the predicate and reference devices in principles of operation, technological characteristics, as well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison to the predicate and reference devices. Results of validation and verification activities in design control that include testing/certification to designated standards and performance testing of the devices has demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.