(268 days)
The LAGIS Endoscopic Instruments-Grasper has applications in a variety of minimally invasive procedures to facilitate grasping and mobilization of tissue.
The LAGIS Endoscopic Instruments - Grasper is a single use device sterilized by ethylene oxide. It is composed of an insulating shaft, a rotation knob, grasping forceps, and a ratchet handle. The 5 mm diameter insulating shaft is designed for use through appropriate size trocars. The rotation knob located on the handle rotates the insulating shaft 360 degrees in either direction for better maneuverability. With the ratchet handle, the grasping forceps are allowed to be locked in place. The grasping forceps are activated by compression and release of the ring of the handle.
The provided text is a 510(k) Summary for the LAGIS Endoscopic Instruments - Grasper. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study that would involve assessing diagnostic or treatment effectiveness.
Therefore, the information typically requested in your prompt (such as acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications, and ground truth establishment) is not applicable to this document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device based on design characteristics, material similarities, and bench testing of functional performance.
Here's an breakdown of the relevant information provided in the document based on your prompt, with an explanation of why certain criteria are not met by the available text:
1. A table of acceptance criteria and the reported device performance
There isn't a table of specific acceptance criteria in the sense of diagnostic performance or clinical outcomes. Instead, the "performance" section describes the types of bench tests conducted to ensure the device functions as intended and is comparable to the predicate device. The general acceptance criterion is that the device "performed acceptably compared to the predicate device."
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Biocompatibility standards per ISO 10993 and 21 CFR Part 58 | Materials used were tested for cytotoxicity, sensitization, irritation, and systemic toxicity, demonstrating compliance. |
| Sterilization validation | Sterilization by ethylene oxide was validated. |
| Material characteristics match predicate or perform acceptably | Materials are "similar to those in the predicate device." Tested for various characteristics. |
| Functional performance (e.g., grasping force, tip hardness, corrosion resistance, bending performance, mobilization) | "Test results showed that the device performed acceptably compared to the predicate device in terms of grasping force, tip hardness, corrosion resistance, mobilization, and bending performance, among other parameters." |
| Mechanical integrity and functionality (e.g., rotation, locking) | The device's design features (rotation knob, ratchet handle) imply these functions were tested and validated to perform as intended. "These studies included assessments of (...) functional performance, along with bending and ex vivo tissue testing." |
| No new safety or effectiveness concerns compared to predicate | Minor differences (additional tip types, wider tip opening, longer shaft, greater grip force) are stated not to "raise any safety or performance issues" or "introduce new questions regarding safety or effectiveness," as confirmed by performance testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. Bench testing typically involves a set number of devices to demonstrate consistency and compliance, but specific numbers are not mentioned here.
- Data Provenance: The tests are "Performance bench tests" conducted by Lagis Enterprise Co., Ltd. The document does not specify a country of origin for data in the sense of patient data, as this is a device for grasping tissue and not a diagnostic or AI-driven tool. The data is from laboratory testing. It is a pre-market submission, not a post-market study or clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an endoscopic instrument for grasping tissue, not a diagnostic tool that requires human expert interpretation for ground truth establishment. The "ground truth" for this device's performance would be engineering specifications and validated test methods.
4. Adjudication method for the test set
Not applicable for the reasons mentioned above.
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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical surgical instrument.
7. The type of ground truth used
The "ground truth" for this device would be established engineering specifications, material standards, and functional performance benchmarks (e.g., a certain force must be achieved, a certain bending radius must be tolerated). The document states that "performance bench tests were conducted to verify the design characteristics and confirm that the device functions as intended." This implies adherence to pre-defined engineering and safety standards rather than a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
{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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 30, 2024
Lagis Enterprise Co., Ltd. Lynn Chen Regulation Affairs No. 29, Gong 1st Rd., Dajia Dist. Taichung City, 43762 Taiwan
Re: K240334
Trade/Device Name: LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 4, 2024 Received: October 4, 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/ofdocs/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}------------------------------------------------
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 (OS) 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.
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 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-regulatory
{2}------------------------------------------------
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,
Digitally signed by Long H. Chen
Long H. Chen -S -s
Date: 2024.10.30 14:35:14 -04'00'
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
{3}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
Indications for Use (Describe)
The LAGIS Endoscopic Instruments-Grasper has applications in a variety of minimally invasive procedures to facilitate grasping and mobilization of tissue.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours be response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for LAGIS. The logo consists of a stylized figure in a square shape on the left, followed by the word "LAGIS" in capital letters. A circled "R" symbol is located to the upper right of the word "LAGIS", indicating that it is a registered trademark.
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: | February 1st, 2024 |
| Device Name: | Endoscopic Instruments - Grasper |
| Trade Name:(Proprietary Name) | LAGIS Endoscopic Instruments - Grasper |
| Common Name ofthe Device: | Endoscopic Instrument |
| ClassificationName: | Laparoscope, General & Plastic Surgery(21 CFR 876.1500, Product Code GCJ) |
| Predicate Device: | 510(k) Number - K012625Product Code -GEISubmitter - ALLIANCE MEDICAL CORP.Trade Name - Reprocessed Unipolar Laparoscopic/Endoscopic Instruments |
| Description: | The LAGIS Endoscopic Instruments - Grasper is a single use devicesterilized by ethylene oxide. It is composed of an insulating shaft, a rotatiorknob, grasping forceps, and a ratchet handle. The 5 mm diameter insulatingshaft is designed for use through appropriate size trocars. The rotation knoblocated on the handle rotates the insulating shaft 360 degrees in either directionfor better maneuverability. With the ratchet handle, the grasping forceps areallowed to be locked in place. The grasping forceps are activated bycompression and release of the ring of the handle. |
| Indications ForUse: | The LAGIS Endoscopic Instruments - Grasper has applications in a varietyof minimally invasive procedures to facilitate grasping and mobilization oftissue. |
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
{5}------------------------------------------------
Technological The subject device, LAGIS Endoscopic Instruments - Grasper, is Characteristics substantially equivalent to the predicate device. Both devices have the same intended use, which is to facilitate tissue grasping and mobilization during minimally invasive surgical procedures. The subject device includes additional grasping forceps tip types and a wider tip opening distance. However, these differences do not raise any safety or performance issues, as the device maintains the same functionality. The subject device also has a longer shaft length and generates greater grip force. These differences are minor and do not introduce new questions regarding safety or effectiveness, as confirmed by performance testing, including bending and ex vivo tissue testing. The materials used in the subject device are similar to those in the predicate device and have been tested for cytotoxicity, sensitization, irritation, and systemic toxicity per ISO 10993 and 21 CFR Part 58 requirements. Performance Performance bench tests were conducted to verify the design characteristics Summary: and confirm that the device functions as intended. These studies included assessments of biocompatibility, sterilization validation, material characteristics, and functional performance, along with bending and ex vivo tissue testing. The test results showed that the device performed acceptably compared to the predicate device in terms of grasping force, tip hardness, corrosion resistance, mobilization, and bending performance, among other parameters. The LAGIS Endoscopic Instruments - Grasper has the same intended use Conclusions: and design, specifications and properties, principles of operations, and similar range of sizes as the predicate devices, the Reprocessed Unipolar Laparoscopic/Endoscopic Instruments. The LAGIS Endoscopic Instruments - Grasper has similarities in technological characteristics to its predicate device. The technological similarities are all supported by performance activities and 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 Endoscopic Instruments - Grasper 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 I Fax:+886-4-26820766 I 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.