The Ligaclip® Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
The Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier is a sterile, single-patient use device, designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The device contains 20 medium-large titanium clips that individually advance after each firing. The device shaft rotates 360° in either direction. The rotating knob is located on the handle to allow for a one-handed technique.
The provided FDA 510(k) summary for the LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier details performance testing. Here's a breakdown based on your request, keeping in mind that this document focuses on demonstrating substantial equivalence rather than a clinical effectiveness study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Trocar Compatibility | Verified to meet design requirements. |
| Retention Strength of Unformed Clip in Jaws | Verified to meet design requirements. |
| Ratchet Mechanism Strength | Verified to meet design requirements. |
| Ergonomic Torque to Fire Device | Verified to meet design requirements. |
| Tactile Indication Torque for "No-Clip Lockout" Function | Verified to meet design requirements. |
| Low Clip Indicator Bar Performance | Verified to meet design requirements. |
| Clip Occlusion of the Formed Clip | Verified to meet design requirements. |
| Clip Security of the Formed Clip | Verified to meet design requirements. |
| Clip Leak Resistance | Demonstrated in hydrodynamic testing on excised porcine vessels. |
| Biocompatibility | Met compliance with ISO 10993-1 and FDA Blue Book Memorandum #G95-1. Pyrogenicity testing conducted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices, number of clips, number of tests) for each individual ex-vivo test. It broadly states "Ex-vivo tests were performed."
- Data Provenance: The tests are described as "Ex-vivo tests" and "hydrodynamic testing on excised porcine vessels." This indicates the data is from laboratory bench testing using non-human biological material (porcine vessels) and the device itself.
- The document explicitly states: "This submission does not include data from Clinical Studies." This confirms the data is retrospective in the sense that it's laboratory-generated and not from human clinical trials. The country of origin of this lab data is not specified, but given the manufacturer is Ethicon Endo-Surgery, LLC (with an address in Puerto Rico, USA), it's highly likely to be U.S.-based or internally generated by the company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document.
- For ex-vivo bench testing of this nature, "ground truth" is typically established by engineering specifications, validated test methods, and potentially comparison to predicate device performance, rather than expert clinical consensus as might be the case for image interpretation.
4. Adjudication Method for the Test Set
- This information is not provided as it's not relevant for this type of ex-vivo mechanical and biological performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done.
- The document states: "This submission does not include data from Clinical Studies." An MRMC study would be a type of clinical study.
- Therefore, no effect size for human readers improving with or without AI (as the device is a mechanical clip applier, not an AI diagnostic tool) can be reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a mechanical clip applier, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the performance tests: Engineering design requirements and specifications serve as the ground truth/acceptance criteria for mechanical and functional aspects.
- For the hydrodynamic testing: The successful demonstration of clip leak resistance in excised porcine vessels serves as the "ground truth" for that functional aspect.
- For biocompatibility: Compliance with specified international standards (ISO 10993-1) and FDA guidance serves as the ground truth.
8. The Sample Size for the Training Set
- This question is not applicable because the device is a mechanical clip applier and does not involve AI or algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Ethicon Endo-Surgery, LLC % Ms. Emily Kruetzkamp Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati. Ohio 45245
Re: K150840
Trade/Device Name: LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: August 7, 2015 Received: August 11, 2015
Dear Ms. Kruetzkamp:
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. 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 of medical device-related
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150840
Device Name
LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier
Indications for Use (Describe)
The Ligaclip® Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
| 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
Company
Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact
Emily Kruetzkamp, Manger, Regulatory Affairs Ethicon Endo-Surgery, Inc. Telephone: 513.337.1546 Email: ekruetzk@its.jnj.com
| Date Prepared: | March 26, 2015 |
|---|---|
| Trade Name: | Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier |
| Common Name: | Clip Applier |
| Classification Name: | Clip, Implantable |
| Device Class: | Class II |
| Classification Regulation: | 878.4300 |
| Panel: | 79, General and Plastic Surgery |
| Classification Code: | FZP |
| Predicate Device | Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier submitted as Ligaclip® 20/20 Multiple Clip Applier, K864102 |
| Reference Device | Ligamax™ 5, K110699 |
Device Description
The Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier is a sterile, single-patient use device, designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The device contains 20 medium-large titanium clips that individually advance after each firing. The device shaft rotates 360° in either direction. The rotating knob is located on the handle to allow for a one-handed technique.
Indications for Use
The Ligaclip Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
Technological Characteristics
The instrument configuration consists of a pistol handle, a rotation knob, and a shaft with an outer diameter of approximately 10 mm and length of 28.9 cm. The shaft is made of a low glare material that minimizes reflective distortion. At the distal end of the shaft are the jaws, which form ligating clips. The force to squeeze the trigger increases when no clips remain in the device. The shaft contains a yellow clip counter indicator bar, which appears yellow when only 3 clips or fewer remain in the device.
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Performance Data
Ex-vivo tests were performed to verify that the performance of the Subject Device, Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier instrument, meets the definition of substantial equivalence to the Predicate Device, Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier submitted as Ligaclip® 20/20 Multiple Clip Applier instrument. Device performance was assessed against design requirements. Bench testing includes trocar compatibility, retention strength of unformed clip in jaws, ratchet mechanism strength, ergonomic torque to fire device, tactile indication torque for "no-clip lockout" function, low clip indicator bar performance, clip occlusion of the formed clip, and clip security of the formed clip. Hydrodynamic testing on excised porcine vessels was included to demonstrate clip leak resistance.
Biocompatibility Testing
The biocompatibility evaluation for the Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier device was conducted in accordance with the FDA Blue Book Memorandum #G95- 1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Pyrogen Testing was conducted.
The conclusions of the testing criteria demonstrate that the Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier device is substantially equivalent to the legally marketed Predicate Device, K864102.
This submission does not include data from Clinical Studies.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.