(146 days)
No
The device description and performance studies focus on mechanical aspects and material properties, with no mention of AI or ML.
No.
The device's intended use is to deliver clips for ligating tubular structures or vessels, which is a surgical tool function, not a direct therapeutic treatment of disease or condition.
No
The device is described as a clip applier intended for ligating tubular structures or vessels, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, sterile, single-patient use device with mechanical components (shaft, rotating knob, clip delivery mechanism). The performance studies focus on bench testing of physical properties and mechanical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply metal ligating clips to tubular structures or vessels during surgery. This is a surgical procedure performed in vivo (within the living body), not a test performed in vitro (outside the living body) on biological samples to diagnose a condition.
- Device Description: The description details a surgical instrument for applying clips, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic results.
- Performance Studies: The performance studies focus on the mechanical function and safety of the clip applier itself (clip retention, strength, torque, etc.), not on the accuracy or reliability of a diagnostic test.
Therefore, the Ligaclip® Endoscopic Rotating Multiple Clip Applier is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FZP
Device Description
The Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier is a sterile, single-patient use device designed to provide a means of ligation through Endopath surgical trocars. The device delivers 20 large titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique.
The Subject Device, Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier's configuration consists of a pistol handle, a rotation knob, and a shaft with an outer diameter of approximately 11.84 mm and length of 34.1 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tubular structures or vessels
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)
Ex-vivo tests were performed to verify that the performance of the Subject Device, Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier, meets the definition of substantial equivalence to the Primary Predicate Device, Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier. Device performance was assessed against the Subject Device's design requirement and comparative testing against the Primary and Secondary Predicate Devices. 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. Product Stability and Biocompatibility data from the Primary Predicate Device was leveraged in this submission as the Subject and Primary Predicate Device materials remain unchanged. Data from Pre-Clinical studies, specifically rabbit pyrogenicity and limulus amoebocyte lysate (LAL) testing, was included in the submission. This submission does not contain data from Clinical studies.
The conclusions of the testing criteria demonstrate that the Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier device is substantially equivalent to the legally marketed Primary Predicate Device, K150840, and Secondary Predicate Device, K864102.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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October 30, 2018
Ethicon Endo-Surgery, LLC % Ms. Melissa Iwu Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc 4545 Creek Rd Cincinnati, Ohio 45245
Re: K181488
Trade/Device Name: LIGACLIP 12mm 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 30, 2018 Received: August 31, 2018
Dear Melissa Iwu:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows the name "Joseph Nielsen -S" in a large, bold font. To the right of the name is a digital signature from Joseph Nielsen -S. The signature includes the date 2018.10.30 08:03:39-04'00' and other information such as DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Joseph Nielsen -S, 0.9.2342.19200300.100.1.1=2000367505.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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)
K181488
Device Name
LIGACLIP 12mm 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
Melissa Iwu, Senior Specialist, Regulatory Affairs Ethicon Endo-Surgery, Inc. Telephone: 513.337.7623 Email: miwu2@its.jnj.com
| Date Prepared: | October 19, 2018 |
|---|---|
| Trade Name: | Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier |
| Common Name: | Clip Applier |
| Classification Name: | Implantable Clip |
| Device Class: | Class II |
| Classification Regulation: | 878.4300 |
| Panel: | 79, General and Plastic Surgery |
| Classification Code: | FZP |
| Primary Predicate Device: | Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier, K150840 |
| Secondary 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® 12mm L Endoscopic Rotating Multiple Clip Applier is a sterile, single-patient use device designed to provide a means of ligation through Endopath surgical trocars. The device delivers 20 large titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located 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.
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PART OF THE Johnson Johnson FAMILY OF COMPANIES
Technological Characteristics
The Subject Device, Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier's configuration consists of a pistol handle, a rotation knob, and a shaft with an outer diameter of approximately 11.84 mm and length of 34.1 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.
The Subject Device is comprised of the same technological characteristics as the Primary Predicate Device with respect to materials, design, energy source, and other features. The key differences between the two devices are the working shaft length (28.9 cm for Primary Predicate, and 34.1 cm for Subject), trocar sizes (10/11 mm for Primary Predicate and 12 mm for Subject), and closed clip length (8.8 mm for Primary Predicate and 11.0 mm for Subject). The clip continues to ligate tubular structures and vessels and the clip formation remains unchanged.
Performance Data
Ex-vivo tests were performed to verify that the performance of the Subject Device, Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier, meets the definition of substantial equivalence to the Primary Predicate Device, Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier. Device performance was assessed against the Subject Device's design requirement and comparative testing against the Primary and Secondary Predicate Devices. 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. Product Stability and Biocompatibility data from the Primary Predicate Device was leveraged in this submission as the Subject and Primary Predicate Device materials remain unchanged. Data from Pre-Clinical studies, specifically rabbit pyrogenicity and limulus amoebocyte lysate (LAL) testing, was included in the submission. This submission does not contain data from Clinical studies.
The conclusions of the testing criteria demonstrate that the Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier device is substantially equivalent to the legally marketed Primary Predicate Device, K150840, and Secondary Predicate Device, K864102.