(203 days)
The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.
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.
The provided 510(k) summary describes a new medical device, Lagis Endoscopic Instruments, and its substantial equivalence to predicate devices. However, it does not contain the level of detail regarding acceptance criteria and study particulars that is typically found in a clinical study for AI/software-based medical devices.
The document describes a physical medical instrument (electrosurgical instruments), not an AI or software-based device. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, and training set details) are not applicable or not provided in the context of this device.
Here's an attempt to answer the questions based on the provided text, while acknowledging the inherent differences for a hardware device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it states that "Test results demonstrated acceptable results with respect to predicate devices." The performance evaluation focused on mechanical and electrical characteristics.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Unit Packaging Integrity | Acceptable results |
| Functional Characteristics | Acceptable results (e.g., jaw/scissor movement) |
| Performance Characteristics | Acceptable results (e.g., tip rotation, shaft sturdiness) |
| Electrical Safety | Acceptable results (e.g., shaft dielectric strength, monopolar connection capability) |
| Grasping Force | Acceptable results (in respect to predicate devices) |
| Cutting Capability | Acceptable results (in respect to predicate devices) |
| Biocompatibility | Satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and US FDA G-95 requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the bench tests. It broadly mentions "Performance bench tests were carried out." The "data provenance" in this context refers to the origin of the test results, which are from internal bench tests conducted by the manufacturer, Lagis Enterprise Co. Ltd. This is a retrospective evaluation against established engineering and safety standards, rather than prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of device and study. Bench tests for electrosurgical instruments typically involve engineering and quality control personnel following defined test protocols and specifications, not clinical experts establishing "ground truth" in the way it's done for diagnostic AI. The "ground truth" here is adherence to engineering specifications and safety standards.
4. Adjudication Method for the Test Set
This question is not applicable. The performance tests are objective measurements against specifications (e.g., torque, force, electrical resistance), not subjective assessments requiring adjudication by multiple readers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This is a hardware medical device, not an AI or software-based diagnostic or assistive system that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on engineering specifications, established safety standards (e.g., ISO 10993 for biocompatibility), and comparison to the performance characteristics of predicate devices. For example, a "grasping force" test would have an engineering specification for the minimum/maximum force the jaws should exert, which serves as the ground truth.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical device, and the concept of a "training set" is not relevant to its development or pre-market notification process.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
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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.
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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.
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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.
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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
§ 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.