LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

K232313 · Ethicon Endo Surgery, LLC · FZP · Aug 29, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K232313
• Device Name: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
• Applicant: Ethicon Endo Surgery, LLC
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Aug 29, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Sterile, single-patient use endoscopic instrument; delivers titanium clips to ligate tubular structures or vessels. Operated by surgeons via surgical trocars; features 360-degree shaft rotation; low-glare shaft material minimizes reflective distortion. Device includes manual trigger mechanism; internal clip counter indicator bar turns yellow when 3 or fewer clips remain; trigger squeeze force increases when empty. Provides mechanical ligation to secure vessels; benefits patient by enabling effective hemostasis or structure closure during endoscopic procedures.

Clinical Evidence

Bench testing only. Usability study conducted to evaluate Instructions for Use (IFU) with representative users, demonstrating successful performance without use errors or difficulties. Verification testing performed for the minor component design change confirmed acceptable device functionality and adherence to finished good specifications.

Technological Characteristics

Manual endoscopic clip applier; titanium clips; low-glare shaft material; 360-degree rotation; mechanical trigger-actuated; includes visual clip counter indicator. Sterile, single-patient use.

Indications for Use

Indicated for ligation of tubular structures or vessels in patients requiring surgical clip placement, provided tissue size is consistent with clip dimensions.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier (K181488)
• LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (K150840)

Submission Summary (Full Text)

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August 29, 2023

Ethicon Endo Surgery, LLC. Lakrisha Tinner Manager, Regulatory Affairs 475 Calle C Guaynabo, 00969 Puerto Rico

Re: K232313

Trade/Device Name: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: August 1, 2023 Received: August 2, 2023

Dear Lakrisha Tinner:

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. 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 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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Date: 2023.08.29 23:01:31 -04'00'

Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232313

Device Name

LIGACIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420);

LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

ndications 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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| K232313 | | 510(k) Summary | Prepared on: 2023-08-28 | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------|---------------------|--|
| Contact Details | | | | 21 CFR 807.92(a)(1) | |
| Applicant Name | Ethicon Endo Surgery, LLC. | | | | |
| Applicant Address | 475 Calle C Guaynabo 00969 Puerto Rico | | | | |
| Applicant Contact Telephone | [phone] | | | | |
| Applicant Contact | Mrs. Lakrisha Tinner | | | | |
| Applicant Contact Email | [e-mail] | | | | |
| Device Name | | | | 21 CFR 807.92(a)(2) | |
| Device Trade Name | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420);<br>LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | | | | |
| Common Name | Implantable clip | | | | |
| Classification Name | Clip, Implantable | | | | |
| Regulation Number | 878.4300 | | | | |
| Product Code | FZP | | | | |
| Legally Marketed Predicate Devices<br>21 CFR 807.92(a)(3) | | | | | |
| Predicate # | | Predicate Trade Name (Primary Predicate is listed first) | | Product Code | |
| K181488 | | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | | FZP | |
| K150840 | | LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier | | FZP | |
| Device Description Summary<br>21 CFR 807.92(a)(4) | | | | | |
| The LIGACLIP 12mm L and 10mm M/L Endoscopic Rotating Clip Appliers are sterile, single-patient use instruments designed to provide a<br>means of ligation through surgical trocars. The instruments deliver titanium clips that individually advance after each firing. The shafts of<br>these devices are made of a low glare material that minimizes reflective distortion. The are designed to rotate 360 degrees in either<br>direction. | | | | | |
| Intended Use/Indications for Use | | | | 21 CFR 807.92(a)(5) | |
| The LIGACLIP Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip<br>is indicated. The tissue being ligated should be consistent with the size of the clip. | | | | | |
| Indications for Use Comparison | | | | 21 CFR 807.92(a)(5) | |
| The indications for use are identical to the predicate devices. | | | | | |
| Technological Comparison | | | | 21 CFR 807.92(a)(6) | |
| The Subject devices, LIGACLIP 12mm L and 10mm M/L Endoscopic Rotating Multiple Clip Applier instruments, are substantially<br>equivalent to the predicate Ligaclip® 12mm L and 10mm M/L Rotating Multiple Clip Applier instruments. The only technological | | | | | |

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difference between the Subject and Predicate device is a minor dimensional change to an internal component of the device. The changes described in this submission do not affect the intended use of the alter the fundamental scientific technology of the device. The subject devices share technological characteristics with respect to materials, design, energy source, and principles of operation as the predicate devices have similar dimensional characteristics compared to the Predicate. The clip continues to ligate tubular structures and the clip formation is unchanged. The configuration of the Subject devices, Ligaclip® 12mm Land 10mm M/L Endoscopic Rotating Multiple Clip Appliers consist of a pistion knob, and a shaft. The shaft is made of a low glare material that mininizes reflective distal end of the shaft are the jaws, which form ligating dips. 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.

## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

A usability study was conducted to evaluate the ease-of-use of the Instructions for Use. The usability testing conducted to evaluate the usability and acceptance of the IFU met the success criteria. The usability study demonstrated that the evaluated IFU steps can be performed as intended by representative users without a pattern of use error, close calls or use difficulty.

Verification testing for the minor component design change was conducted to demonstrate acceptable device functionality performance of the subject device and to ensure to meet the existing finished good specification of the predicate device. The verification testing conducted to evaluate the change to the device component met the success criteria.

The conclusions drawn from the non-clinical tests demonstrate that the subject device, LIGACLIP Endoscopic Rotating Multiple Clip Applier 1 2mm L (ER20); IGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) (K232313), is as saffective, and performs as well as the legally marketed predicate devices, K181488 and K150840.