(59 days)
Not Found
No
The summary describes a mechanical and electrical surgical instrument with no mention of AI or ML capabilities. The performance studies focus on biocompatibility, electrical safety, sterilization, and mechanical performance.
No.
The device is described as an instrument used for cutting and coagulation in surgical procedures, not for treating a disease or condition.
No
The device is described as an instrument for cutting and coagulation in surgical procedures, not for diagnosis.
No
The device description explicitly states it is a sterile, single-use, invasive instrument used in laparoscopic surgery, which are physical hardware components.
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 for "cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures." This describes a surgical instrument used on the patient's body during a procedure.
- Device Description: The description further clarifies it's a "sterile, single-use, invasive instrument that used in laparoscopic surgery." This reinforces its role as a surgical tool.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The description and intended use of this device do not involve the analysis of biological specimens.
Therefore, the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic 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 Version, one for Dissector and Scissors. The two models are same except for jaw. 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)
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, Intracutaneous reactivity, Skin Sensitization, Acute systemic toxicity, and Pyrogenicity.
Electrical safety tests were performed according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. The device passed all performed tests.
Sterilization was performed using EO-Sterilization in accordance with ISO-11135.
The proposed expiration date is 3 years from the manufacturing date, with real-time testing to confirm.
Performance tests conducted include:
- Appearance: No crack, stain or no substances on the surface of the product.
- Dimension: Pass. Measurements within ± 5% of the indicated value.
- Operational test: The end-tip and hub can be bent up, down, left and right within above 80° and can rotate 360°.
- Tensile strength: No damage to the connection when applying a force of 20N.
- Feedthrough test: The resistance value between the electrode tip and the connector is less than 1Ω.
Thermal effects on tissue were tested, involving a histological analysis on porcine tissues (liver, kidney and abdominal muscle) through an electrosurgical device.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 27, 2023
LivsMed Inc. Dong Wook Lee OMR (Ouality Management Representative) #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13516 Korea. South
Re: K230539
Trade/Device Name: ArtiSential Laparoscopic Instruments-Electrodes Monopolar Series (two versions, one for Dissector and the other for Scissors)
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 24, 2023 Received: February 27, 2023
Dear Dong Lee:
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 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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2013.04.27
08:43:53-04'00'
Mark Trumbore, 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
Image /page/2/Picture/0 description: The image shows the logo for LIV'SMED. The logo is in a dark blue color. The apostrophe in LIV'SMED is a lighter blue color.
3. Indications for Use Statement
A FDA Form 3881 is provided on the following pages.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230539
Device Name
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors)
Indications for Use (Describe)
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
| 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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4
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors)
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: | Dong Wook Lee / QMR |
| (Quality Management Representative) | |
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516 |
| Seongnam-si, Gyeonggi-do, Republic of Korea | |
| Tel) +82-70-7709-4993 | |
| Fax) +82-31-706-3211 | |
| Email) dongwook.livsmed@gmail.com | |
| Preparation Date: | 02-24-2023 |
2. Device Name and Code
| Device Trade Name | ArtiSential Laparoscopic Instruments-Electrodes,
Monopolar Series(two versions, one for Dissector and |
|---------------------|----------------------------------------------------------------------------------------------------------|
| | the other for Scissors) |
| 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 Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors) are substantially equivalent to the following devices.
Table 3.1 Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| LivsMed Inc. | ArtiSential Laparoscopic | |
| Instruments-Electrodes | K203580 |
5
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors)
4. Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. 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 for Use
- 5.1 Indications for use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
6. Technical Characteristics in Comparison to Predicate Devices
Table 6.1 Predicate Device
| | Proposed
device | Predicate Device |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | K230539 | K203580 |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. |
| Device Name | ArtiSential Laparoscopic Instruments-
Electrodes, Monopolar Series(two
versions, one for Dissector and the
other for Scissors) | ArtiSential Laparoscopic Instruments-
Electrodes |
| Clearance Date | N/A | 04-30-2021 |
| Classification /
Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 |
| Product Code | GEI | GEI |
| Intended for | Prescription Use | Prescription Use |
| Indications for
Use | ArtiSential Laparoscopic Instruments-
Electrodes, Monopolar Series
(Dissector) are single use articulating
dissector with monopolar cautery has
application in a variety of endoscopic,
gynecological, laparoscopic and
general surgical procedures to
temporarily grasp or clamp tissues and
small vessels or body structures, and
for use in blunt dissection.
ArtiSential Laparoscopic Instruments-
Electrodes, Monopolar Series
(Scissors) are single use articulating
shears with monopolar cautery has
application in a variety of endoscopic,
gynecological, laparoscopic and
general surgical procedures for
transection and cutting of tissues. | ArtiSential Laparoscopic Instruments-
Electrodes, Monopolar Series
(Dissector) are single use articulating
dissector with monopolar cautery has
application in a variety of endoscopic,
gynecological, laparoscopic and
general surgical procedures to
temporarily grasp or clamp tissues and
small vessels or body structures, and
for use in blunt dissection.
ArtiSential Laparoscopic Instruments-
Electrodes, Monopolar Series
(Scissors) are single use articulating
shears with monopolar cautery has
application in a variety of endoscopic,
gynecological, laparoscopic and
general surgical procedures for
transection and cutting of tissues. |
| | | |
| Principles of
operation | It 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 (dissector or
Scissors type), 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. | It 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 (dissector or
Scissors type), 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. |
| Energy Type | Radiofrequency | Radiofrequency |
| Electrode type
(monopolar or
bipolar) | Monopolar | Monopolar |
| Jaw type | Dissector, Scissors | Dissector, Scissors |
| Physical
dimensions
and design
(size, length) | - Shaft diameter: 8mm
-
Shaft Length: 250mm, 380mm, 450mm | - Shaft diameter: 8mm
-
Shaft Length: 250mm, 380mm, 450mm |
| Rated voltage | 3,933Vp | 3,933Vp |
| Materials
(electrode) | Stainless steel | Stainless steel |
| Materials
(insulation) | Teflon, Silicone | Zirconia |
| Materials
(Shaft) | Glass fiber | Glass fiber |
| Articulating
feature | Pitch:±80° or more,
Yaw:±80° or more and Open-Close | Pitch:±80° or more,
Yaw:±80° or more and Open-Close |
| Tip rotation | 360° | 360° |
6
Monopolar Series(two versions, one for Dissector and the other for Scissors)
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:
7
Monopolar Series(two versions, one for Dissector and the other for Scissors)
K230539
- Cytotoxicity -
- -Intracutaneous reactivity
- -Skin Sensitization
- Acute systemic toxicity -
- Pyrogenicity -
7.2 Electrical Safety
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors) have 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 device had passed all performed tests.
7.3 Sterilization
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors) are 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 3 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years
7.5 Performance test
The device had passed all performed tests.
| 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 shall be within $\pm$ 5% of the | ||
| indicated value of the dimensional | ||
| term. | Measure by Vernier | |
| calipers and dial gauge | ||
| etc. | Pass | |
| Refer to [Test result] on | ||
| 6-26 page at attachment | ||
| 13 | ||
| 3. Operational test | ||
| The end-tip and hub can be bent | ||
| up, down, left, and right a range of | ||
| above $\pm$ 80° and are capable of | ||
| 360° rotation. | Adjusting the end-tip by | |
| manipulating the grip | ||
| and control ring and | ||
| measure the angle at | ||
| bending and turning. | The end-tip and hub are | |
| bent up, down, left and | ||
| right within above 80° | ||
| and can rotate 360°. | ||
| 4. Tensile strength | Hold the end-tip and | No damage to the |
8
Monopolar Series(two versions, one for Dissector and the other for Scissors)
[K230539](https://510k.innolitics.com/search/K230539)
| The end-tip and shaft connections
shall not be damaged from pulling
of 20 N. | shaft connections
respectively and apply a
force of 20 N using Push
pull gauge. | 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 |
7.6 Thermal effect
Thermal effects on tissue were also tested. A histological analysis was performed on thermal effect to porcine tissues(liver, kidney and abdominal muscle) through an electrosurgical device.
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 devices.
8. Substantial Equivalence
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors) indication for use is as same as the predicate device (K203580). 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 Monopolar Series 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, models, sizes, and the entire intended purpose of the device under evaluation. The subject device which is the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series(two versions, one for Dissector and the other for Scissors) are considerably as same as the predicate and the reference device 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 the reference device. 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.