(53 days)
No
The description focuses on the electrosurgical, suction, and irrigation functions of the device, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is an electrosurgical accessory used for cutting, coagulation, suction, and irrigation during surgical procedures, not for therapeutic treatment itself.
No
The device is an electrosurgical accessory used for cutting, coagulation, suction, and irrigation during surgical procedures, which are therapeutic functions, not diagnostic ones.
No
The device description clearly indicates it is a physical electrosurgical accessory with components like electrodes, handles, and connectors, designed to conduct electrosurgical current and provide suction/irrigation. It is not solely software.
Based on the provided information, the LAP-iX device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description reinforces this by detailing its use in "laparoscopic and endoscopic procedures" to "ablate, remove, resect, and coagulate soft tissue." It also mentions delivering fluids to and evacuating fluids from the surgical site.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a person's health. The LAP-iX does not perform any such analysis of specimens.
The LAP-iX is a surgical accessory used in vivo (within the living body) during surgical procedures.
N/A
Intended Use / Indications for Use
LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
Product codes
GEI
Device Description
The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures.
It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required.
Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. PISTOL Type has pistol grip handle design. TRUMPET Type has Trumpet grip handle design. Each type also offer both Unlock Type and Lock Type. There are 8 models in total. Unlock type model does not have S lock key and it has a stopper. The stopper has no specific function; it is just to show that the model is the Unlock Type. The Unlock type works only when S / I key is pressed. When the button is not pressed, the device stop working. The Lock Type keeps suction function when S key is pressed once. Pressing the S lock key turns off the suction function.
The electrode offers two types: L-HOOK and SPOON Type. The both electrode types are compatible with the PISTOL Type and the TRUMPET Type. The L-Hook electrode tip has a sharp contact surface that facilitates cutting especially for thin and long tissue. The SPOON electrode tip is mainly used for large area tissue and also for hemostasis procedure as well.
The voltage should not exceed 175Vrms (3002 standard), and set to minimum power (100W, 3002 standard). The connector (banana jack) of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode). All equipment conforming to this specs can be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
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
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Sterilization Validation Test in accordance with ISO11737-1
- Shelf Life Validation Test
- Biocompatibility Tests in accordance with ISO 10993
- Cytotoxicity ISO 10993-5
- Ethylene Oxide Sterilization Residuals ISO 10993-7
- Skin Sensitization ISO 10993-10
- Irritation ISO 10993-10
- Performance Tests: Surface (visual inspection), Nominal size, Leakage, Continuity, Dielectric Strength Test of Electrode cable, HF Leakage current Test of Electrode cable, and Tensile Strength Test of Electrode cable
The length of the electrode of the subject device is slightly longer than the predicate device, however, 2cm difference does not raise a questions in safety and effectiveness based on the performance test results including the tensile strength test.
Key Metrics
Not Found
Predicate Device(s)
CONMED UNIVERSAL PLUS (K934828)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2017
Sejong Medical Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620
Re: K173112
Trade/Device Name: LAP-iX Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 27, 2017 Received: September 29, 2017
Dear Priscilla Chung:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173112
Device Name
LAP-iX
Indications for Use (Describe)
LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ¡× Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary (K173112)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
1. Submitter/Applicant
Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, Gyeonggi-do Republic of Korea 10880
Tel: +82-31-945-8191 Fax: +82-31-945-8190
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: LAP-iX
- Common Name: Electrosurgical Cutting and coagulation device and accessories ●
- Classification: Class II ●
- Classification regulation: 21 CFR 878.4400 ●
- Product Code: GEI
4. Predicate Devices:
CONMED UNIVERSAL PLUS (K934828) by CONMED CORP
5. Description:
The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures.
It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids
4
from the surgical site to aid visualization. They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required.
Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. PISTOL Type has pistol grip handle design. TRUMPET Type has Trumpet grip handle design. Each type also offer both Unlock Type and Lock Type. There are 8 models in total. Unlock type model does not have S lock key and it has a stopper. The stopper has no specific function; it is just to show that the model is the Unlock Type. The Unlock type works only when S / I key is pressed. When the button is not pressed, the device stop working. The Lock Type keeps suction function when S key is pressed once. Pressing the S lock key turns off the suction function.
The electrode offers two types: L-HOOK and SPOON Type. The both electrode types are compatible with the PISTOL Type and the TRUMPET Type. The L-Hook electrode tip has a sharp contact surface that facilitates cutting especially for thin and long tissue. The SPOON electrode tip is mainly used for large area tissue and also for hemostasis procedure as well.
The voltage should not exceed 175Vrms (3002 standard), and set to minimum power (100W, 3002 standard). The connector (banana jack) of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode). All equipment conforming to this specs can be used. The following devices are the examples of the compatible devices.
| Device Name | ForceTriad™ Electrosurgical
Generator | MEGA Power |
|----------------|------------------------------------------|------------|
| Applicant Name | Covidien | MEGADYNE |
| 510(K) Number | K102913 | K050579 |
Electrosurgical Unit
Suction/Irrigation Pump
| Device Name | Aqua-Purator |
|---|---|
| Applicant Name | WISAP |
| 510(K) Number | K982518 |
Indication for use: 6.
LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
7. Performance Data
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
5
- · Sterilization Validation Test in accordance with ISO11737-1
- · Shelf Life Validation Test
- · Biocompatibility Tests in accordance with ISO 10993
| Cytotoxicity | ISO 10993-5 |
|---|---|
| Ethylene Oxide Sterilization | |
| Residuals | ISO 10993-7 |
| Skin Sensitization | ISO 10993-10 |
| Irritation | ISO 10993-10 |
- · Performance Tests: Surface (visual inspection), Nominal size, Leakage, Continuity, Dielectric Strength Test of Electrode cable, HF Leakage current Test of Electrode cable, and Tensile Strength Test of Electrode cable
Basis for Substantial Equivalence 8.
The subject device device, LAP-iX, is substantially equivalent to the predicate device, CONMED UNIVERSAL PLUS (K934828). Both the device has the exactly the same Indications for Use statement. The both devices provide suction and irrigation functions, and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures. They offer both straight and pistol handle types. The raw material for the electrode is the same between the devices which is stainless steel.
The length of the electrode of the subject device is slightly longer than the predicate device, however, 2cm difference does not raise a questions in safety and effectiveness based on the performance test results including the tensile strength test. Based on this, we determined that the subject device is substantially equivalent to the predicate device.
9. Conclusion
Upon reviewing the information including testing data provided in this submission and comparing intended use, principle of operation and overall technological characteristics, we conclude that the LAP-iX is substantially equivalent to the predicate device.