(90 days)
The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
The LAGIS Suction Irrigation System consists of flexible tubing attached to a plastic housing/handle with a spring activated valve/stopper. Attached distally is a stainless steel probe and proximally is a plastic housing cap. When properly connected and operated, the device irrigates and evacuates fluids during laparoscopic procedures. The LAGIS Suction Irrigation System has multiple models, which can be categorized into two types based on the handle design, including direct type (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the different handle designs, all models provide the same function.
The provided document is a 510(k) summary for the LAGIS Suction Irrigation System, which is a medical device, not an AI/ML algorithm. Therefore, the information requested regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device is not applicable to this document.
This document details:
- Device Name: LAGIS Suction Irrigation System
- Intended Use: To provide suction and irrigation functions in laparoscopic procedures to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
- Regulatory Class: Class II (Product Code GCJ - Laparoscope, General & Plastic Surgery)
- Predicate Device: Taiwan Surgical Disposable Suction Irrigation (K150253)
- Performance Tests: The summary lists performance bench tests conducted to verify design characteristics and ensure the device can be used as intended. These include:
- Biocompatibility testing (following ISO 10993-1)
- Sterilization validation (according to ISO 11135)
- Functional and performance characteristics (airtightness, kinking resistance, flattening resistance, bending resistance, and pressing force performances).
- Conclusion: The tests met the predefined acceptance criteria, and no new questions of safety and effectiveness were identified. The device was deemed substantially equivalent to the predicate device.
Since the device is a physical medical instrument (suction irrigation system) and not a software/AI product, the detailed questions about AI model training, test sets, expert ground truth, adjudication methods, and MRMC studies are irrelevant to this submission.
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March 17, 2025
Lagis Enterprise Co., Ltd. Lynn Chen Regulation Affairs No. 29, Gong 1st Rd., Dajia Dist. Taichung City, 43762 Taiwan
Re: K243867
Trade/Device Name: LAGIS Suction Irrigation System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 29, 2024 Received: December 17, 2024
Dear Lynn Chen:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
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assistance/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,
James H.
Jang -S
Digitally signed by
James H. Jang -S
Date: 2025.03.17
16:26:26 -04'00'
For 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
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Indications for Use
Submission Number (if known)
Device Name
LAGIS Suction Irrigation System
Indications for Use (Describe)
The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
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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510(k) Summary_K243867
Lagis Enterprise Co., Ltd.
=
No.29,Gong 1* Rd.,Dajia Dist, Taichung City 43762 Taiwan l Tel:+886-4-26820767 | Fax:+886-4-26820766 | www.Lagis.com.tw
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Image /page/5/Picture/0 description: The image shows the word "LAGIS" in red font. To the left of the word is a red abstract image of a person. To the right of the word is a circled R symbol.
510(k) Summary
| Submitted By: | Lagis Enterprise Co., Ltd.No. 29, Gong 1st Rd., Dajia, Taichung 437, Taiwan |
|---|---|
| Contact Person: | Lynn ChenTEL: +886-4-26820767 #4191FAX: +886-4-26820766 |
| Date Prepared: | March 11, 2025 |
| Device Name: | Suction Irrigation System |
| Trade Name: | LAGIS Suction Irrigation System(Proprietary Name) |
| Common Name ofthe Device: | Suction Irrigation |
| Model: | SA-360C, SA-450C, SA-520C, SA-360C-B, SA-360E, SA-110H, SA-250P,SA-300P, SA-320CT, SA-360CT, SA-450CT, SA-520CT, SA-360CT-B, SA-320ET, SA-T110 |
| ClassificationName: | Laparoscope, General & Plastic Surgery(21 CFR 876.1500, Product Code GCJ) |
| Regulatory Class: | Class II |
| Predicate Device: | 510(k) Number - K150253Product Code – GCJSubmitter - TAIWAN SURGICAL CORPORATIONTrade Name - Taiwan Surgical Disposable Suction Irrigation |
| Description: | The LAGIS Suction Irrigation System consists of flexible tubing attached toa plastic housing/handle with a spring activated valve/stopper. Attacheddistally is a stainless steel probe and proximally is a plastic housing cap. Whenproperly connected and operated, the device irrigates and evacuates fluidsduring laparoscopic procedures.The LAGIS Suction Irrigation System has multiple models, which can becategorized into two types based on the handle design, including direct type |
| (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the differenthandle designs, all models provide the same function. | |
| Indications ForUse: | The LAGIS Suction Irrigation System has applications in laparoscopicprocedures to provide suction and irrigation functions to help flush blood andtissue debris from the operative site during laparoscopy to aid visualization. |
| TechnologicalCharacteristics: | The subject device, LAGIS Suction Irrigation System, is substantiallyequivalent to the predicate device. Both devices are intended for suction andirrigation in laparoscopic procedures, aiding in the removal of blood and tissuedebris to enhance visualization. While the predicate device is indicated for bothlaparoscopic and general surgeries, the subject device is specifically intendedfor laparoscopic use. This difference does not affect the device's corefunctionality, safety and effectiveness. Minor differences in working lengthPVC soft tube length, and button pressure do not affect substantial equivalenceto the predicate device. The materials are comparable to the predicate deviceand meet the requirements of ISO 10993 and 21 CFR Part 58. |
| Performance TestSummary: | Performance bench tests were carried out to verify design characteristics andto ensure that the device can be used as intended. The studies includedbiocompatibility, sterilization validation, material characteristics, functionaland performance characteristics of the devices.• Biocompatibility testing was conducted following ISO 10993-1 and FDA'sguidance document, Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process".• Sterilization validation was performed according to ISO 11135.• Functional and performance characteristics were assessed throughtesting, including airtightness, kinking resistance, flattening resistance,bending resistance, and pressing force performances. |
Lagis Enterprise Co., Ltd.
=
No.29,Gong 181Rd.,Dajia Dist, Taichung City 43762 Taiwan l Tel:+886-4-26820767 | Fax:+886-4-26820766 | www.Lagis.com.tw
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All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness.
Conclusions: The LAGIS Suction Irrigation System has the same intended use and design, specifications and properties, principles of operations, and similar range of sizes as the predicate devices, the Taiwan Surgical Disposable
Lagis Enterprise Co., Ltd.
No.29,Gong 18 Rd.,Dajia Dist, Taichung City 43762 Taiwan l Tel:+886-4-26820767 I Fax:+886-4-26820766 I www.Lagis.com.tw
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Image /page/7/Picture/1 description: The image shows the logo for LAGIS. The logo is red and consists of a stylized figure on the left and the word "LAGIS" in capital letters on the right. There is a registered trademark symbol in the upper right corner of the logo.
Suction Irrigation. The LAGIS Suction Irrigation System has similarities in technological characteristics to its predicate device. The technological similarities are all supported by performance activities, which demonstrate that the device functions as intended. These differences in technological characteristics do not raise different questions of safety and effectiveness. After analyzing all testing data and comparing it with the predicated device, it can be concluded that the LAGIS Suction Irrigation System is substantially equivalent to the predicate device.
Lagis Enterprise Co., Ltd.
No.29,Gong 1st Rd.,Dajia Dist, Taichung City 43762 Taiwan l Tel:+886-4-26820767 | Fax:+886-4-26820766 | www.Lagis.com.tw
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.