(203 days)
Not Found
No
The description focuses on mechanical and electrical functions of a surgical instrument, with no mention of AI/ML terms or capabilities.
No
The device is described as an endoscopic instrument for grasping, dissecting, and transecting tissues during surgical procedures, and for electrosurgical applications. These are surgical tools, not devices designed for therapy.
No
The device is described as an endoscopic instrument used for surgical procedures such as grasping, dissecting, and transecting tissues, and it can be connected to a generator for electrosurgical applications. Its function is to facilitate surgical intervention, not to diagnose conditions.
No
The device description clearly outlines physical components like a shaft, handles, and an electrical connector, indicating it is a hardware device, not software-only.
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 "use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues." This describes a surgical instrument used on the body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description details a surgical instrument with a shaft, handles, and a tip for grasping or cutting. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Lagis Endoscopic Instruments are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.
Product codes
GEI
Device Description
The Lagis Endoscopic Instruments is a sterile, single use device having an insulated shaft with a diameter of 4.5-5.0 mm for use in 6mm and larger size trocar. The shaft can be rotated through the actions of a roller knob. A pair of plastic handles manipulates closing or opening of the tip scissors or graspers. An electrical connector allows for connection of the instrument to a generator for electrosurgical applications.
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 bench tests were carried out to verify design characteristics and to ensure that the device can be used as intended. The studies included testing of unit packaging integrity, functional and performance characteristics, as well as electrical safety of the devices. Test results demonstrated acceptable results with respect to predicate devices in tip rotation, shaft sturdiness, shaft dielectric strength, grasping force, and cutting capability of the instrument, etc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) SUMMARY
Pre-market Notification for Lagis Endoscopic instruments
1. Submitter's Name
LAGIS ENTERPRISE CO. LTD. No. 33, Lane 908, Sect. I, Jhongshan Road Dajia, Taichung TAIWAN Zip Code; 437 Joanne Chen, Manager, R&D Contact Person:
2. Name of Device
| Common/Usual Name: | Electrosurgical instruments |
|---|---|
| Proprietary Name: | Lagis Endoscopic Instruments |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number: | CFR 878.4400 |
| Product Code: | GEI |
3. Predicate Device
| Device Name | 510(k) Number | Clearance Date |
|---|---|---|
| Auto Suture ENDO Clinch II | K951589 | 05/03/1995 |
| ConMed Graspers & Scissors | K924469 | 04/07/1993 |
4. Device Description
The Lagis Endoscopic Instruments is a sterile, single use device having an insulated shaft with a diameter of 4.5-5.0 mm for use in 6mm and larger size trocar. The shaft can be rotated through the actions of a roller knob. A pair of plastic handles manipulates closing or opening of the tip scissors or graspers. An electrical connector allows for connection of the instrument to a generator for electrosurgical applications.
5. Indication for Use
The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.
1
Technological Characteristics 6.
Same as predicate devices, when the handles of the Lagis Endoscopic Instruments are compressed or released, the instrument jaws or scissor blades close or open accordingly. The rotating knob located on the handle can be turned for rotating the shaft 360 degrees in either direction. A monopolar electrical connector extending from the handle allows for connection with a standard cable to a proper HF generator. Due to different functional requirements, the tip can be of various designs such as straight scissors, curved scissors, and graspers, etc. The materials of construction are similar to the predicate devices and are satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and US FDA G-95 requirements
7. Performance Summary
Performance bench tests were carried out to verify design characteristics and to ensure that the device can be used as intended. The studies included testing of unit packaging integrity, functional and performance characteristics, as well as electrical safety of the devices. Test results demonstrated acceptable results with respect to predicate devices in tip rotation, shaft sturdiness, shaft dielectric strength, grasping force, and cutting capability of the instrument, etc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Lagis Enterprises Co., Ltd. % Innomedtech LLC Joseph J. Chang, Ph.D. Consultant 7128 Staffordshire Street Houston, Texas 77030
AUG 2 8 2009
Re: K090309
Trade Name: Lagis Endoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 20, 2009 Received: July 22, 2009
Dear Dr. Chang:
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, labeling, and prohibitions against misbranding and adulteration.
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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Joseph J. Chang, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default}htm.
Sincerely yours,
for
Mark N. Melkerson
Director
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K090309
Device Name: Lagis Endoscopic Instruments
Indication for Use:
The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Lawrence P. Payne
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K090309