(164 days)
No
The summary describes a mechanical clip applier and does not mention any AI/ML components or functions.
No
This device is an endoscopic clip applier used for ligation during surgical procedures; it does not directly treat or prevent a disease or condition.
No
This device is an endoscopic clip applier used for ligation, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly indicates it is a physical, sterile, single-patient use device containing titanium clips and a rotating shaft, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ligating tubular structures or vessels within the body during surgical procedures. This is an in vivo application.
- Device Description: The device is an endoscopic clip applier, designed to be used through a trocar to apply clips internally.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body for a surgical procedure.
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® 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.
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 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.
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.
This submission does not include data from Clinical Studies.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
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
1
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.