LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) by Ethicon Endo Surgery, LLC.

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 Description

The LIGACLIP 12mm L and 10mm M/L Endoscopic Rotating Clip Appliers are sterile, single-patient use instruments designed to provide a means of ligation through surgical trocars. The instruments deliver titanium clips that individually advance after each firing. The shafts of these devices are made of a low glare material that minimizes reflective distortion. The are designed to rotate 360 degrees in either direction. 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the U.S. FDA for the LIGACLIP Endoscopic Rotating Multiple Clip Applier. It aims to demonstrate substantial equivalence to previously marketed predicate devices.

The document does not describe a study involving artificial intelligence or human readers for diagnostic purposes. Instead, it refers to a medical device that physically applies clips during surgery. Therefore, many of the requested items related to AI device performance, such as MRMC studies, ground truth establishment for AI models, and training/test set sample sizes for AI, are not applicable to this submission.

However, I can extract information related to the acceptance criteria and the study performed for this specific device, to the extent that it is described.

Acceptance Criteria and Study for LIGACLIP Endoscopic Rotating Multiple Clip Applier

The device under review is an endoscopic clip applier, not an AI-powered diagnostic tool. The "performance" in this context refers to the device's mechanical functionality and usability, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Success Criteria)	Reported Device Performance
Usability of Instructions for Use (IFU)	The usability testing conducted to evaluate the usability and acceptance of the IFU met the success criteria. The 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.
Device Functionality (Minor Component Design Change)	The verification testing conducted to evaluate the change to the device component met the success criteria. This testing demonstrated acceptable device functionality performance of the subject device and ensured it meets existing finished good specifications of the predicate device.

2. Sample size used for the test set and the data provenance:

Usability Study: The document mentions "representative users" but does not specify the exact sample size for the usability study.
Verification Testing: No specific sample size is mentioned for the verification testing.
Data Provenance: Not specified, but generally, such studies are conducted by the manufacturer. The submission is from Ethicon Endo Surgery, LLC in Guaynabo, Puerto Rico. The studies are non-clinical (usability and verification of a mechanical device). These would be prospective tests conducted for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Usability Study: The "ground truth" for the usability study is whether "representative users" can perform the IFU steps as intended without errors. This isn't about expert medical diagnosis. The number and qualifications of these "representative users" are not specified.
Verification Testing: The "ground truth" for verification testing is meeting existing finished good specifications. This involves engineering and quality control, not medical experts.

4. Adjudication method for the test set:

Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretations, which is not relevant here.

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:

No. An MRMC study is not applicable as this device is a surgical instrument and not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a mechanical surgical device, not an algorithm.

7. The type of ground truth used:

Usability Study: The ground truth was the ability of representative users to successfully follow the Instructions for Use without significant errors or difficulties.
Verification Testing: The ground truth was the ability of the device to meet existing finished good specifications, based on a minor design change to an internal component. This would involve objective measurements against predefined engineering specifications.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of machine learning or AI models. It's a physical medical device.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI model, there is no ground truth establishment in that sense. The device's design and functionality are based on engineering principles and prior predicate devices.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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.

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K232313		510(k) Summary
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	(517) 337-7475
Applicant Contact	Mrs. Lakrisha Tinner
Applicant Contact Email	LTinner1@its.jnj.com
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420);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 Devices21 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 Summary21 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 ameans of ligation through surgical trocars. The instruments deliver titanium clips that individually advance after each firing. The shafts ofthese devices are made of a low glare material that minimizes reflective distortion. The are designed to rotate 360 degrees in eitherdirection.
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 clipis 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 substantiallyequivalent 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.

Regulation Number and Section

§ 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.