The Weck Auto Endo5® Hem-o-lok® ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok® ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.

Hem-o-lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.

Device Description

The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok® medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49cm long with a working length of 35cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.

AI/ML Overview

This document describes the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML), a device intended for delivering Hem-o-lok ML non-absorbable polymer ligating clips during laparoscopic procedures. The provided information is from an FDA 510(k) summary (K230480) and does not contain details about a study evaluating AI performance. Therefore, I cannot address aspects related to AI/human reader studies, ground truth establishment, or specific acceptance criteria for an AI device.

However, I can extract information related to the performance data and acceptance criteria for the medical device itself, as described in the 510(k) summary.

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with explicit acceptance criteria and corresponding performance metrics in a quantitative format as might be seen for an AI device. Instead, it states that:

Acceptance Criterion (Implied)	Reported Device Performance
Performance after sterilization, environmental conditioning, and simulated distribution	Non-clinical performance testing was conducted following these conditions. The purpose was to "support device modifications and ensure the device performed equivalently to the predicate." (Implies successful performance upholding equivalence).
Usability and design validation in a simulated use environment	"Usability and design validation... was conducted to document that the user was able to operate the system as intended, and the product conformed to user needs." (Implies successful demonstration of intended operation and user satisfaction).
Substantial Equivalence to Predicate	The conclusion states: "Based upon the performance and comparative test results, the proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K152081." (Implies all necessary performance aspects were met to establish substantial equivalence). The modifications "do not introduce any new issues of safety and effectiveness."

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

The document does not specify a "test set" sample size in the context of clinical data for human or AI performance. The performance testing mentioned ("Non-clinical performance testing") likely refers to mechanical, functional, and usability evaluations of the device itself. No explicit sample sizes for these tests are provided, nor is the provenance of any data specified (e.g., country of origin, retrospective/prospective).

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

This information is not applicable as the document describes a medical device, not an AI system that requires expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document does not describe a study involving expert adjudication for a test set.

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

This information is not applicable. The document describes a medical device (surgical clip applier), not an AI system, and therefore no MRMC study or AI assistance evaluation was conducted or is relevant.

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

This information is not applicable as the device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to AI performance evaluation is not relevant here. The device's performance is assessed against engineering specifications, functional requirements, and equivalence to a predicate device. This would involve objective measurements, material analysis, mechanical testing, and usability assessments, rather than an expert-determined "ground truth."

8. The sample size for the training set

This information is not applicable as the device is not an AI system.

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

This information is not applicable as the device is not an AI system.

Summary

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April 28, 2023

Teleflex Medical Hope West Senior Regulatory Affairs Specialist 3015 Carrington Mill Blyd Morrisville, North Carolina 27560

Re: K230480

Trade/Device Name: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP, GDO Dated: February 21, 2023 Received: February 22, 2023

Dear Hope West:

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Tajanay R. Ki -S

Digitally signed by Taianav R. Ki -S Date: 2023.04.28 17:06:11 -04'00'

for Deborah Fellhauer RN. BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230480

Device Name Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)

Indications for Use (Describe)

The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.

Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

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 - K230480 - 28April2023

Weck® Auto Endo5® 5mm Automatic Endoscopic 35cm Applier

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-544-8000 919-433-4996 Fax:

B. Contact Person

Hope West, RAC-Devices, Sr. Regulatory Affairs Specialist

C. Date Prepared

February 21, 2023

D. Device Name

Trade Name:	Weck Auto Endo5® 5mm Automatic Endoscopic 35cm Applier
Common Name:	Implantable Clip
Classification Name:	Applier, Surgical, ClipClip, Implantable
Product Code:	GDO,FZP

E. Predicate Device

The proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is substantially equivalent to the predicate device:

Predicate Device	Manufacturer	510(k) No.	Product Code	DateCleared
Weck Auto Endo5®Hem-o-lok® Ligating ClipApplier	Teleflex Medical	K152081	FZP	08/26/2015

F. Comparison To Predicate Devices

The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier is substantially equivalent to the predicate device with respect to technology, intended use, indications, and functional characteristics. The modifications proposed within this submission are minor changes that align to the original device design intent and do not introduce any new issues of safety and effectiveness.

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G. Device Description

H. Indications for Use

. Contraindications

Hem-o-lok Ligating Clips are not intended for use as a fallopian contraceptive tubal occlusion device.

Hem-o-lok Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.

J. Environmental Conditions

Hem-o-lok Ligating Clips are "MR Safe" and pose no known hazards in MR environments, as cleared under K133202, December 2013.

K. Materials

All patient contacting materials are equivalent to the predicate, including those with indirect patient contact, and are in compliance with ISO 10993-1 according to their nature and duration of contact.

L. Technological Characteristics

A comparison of the technological characteristics of the proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier and the predicate has been performed. The results of this comparison demonstrate that the Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is equivalent to the marketed predicate device.

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M. Performance Data

Non-clinical performance testing has been conducted following product sterilization, environmental conditioning, and simulated distribution in order to support device modifications and ensure the device performed equivalently to the predicate.

Usability and design validation of the Auto Endo5® 5mm Automatic Endoscopic 35cm Applier in a simulated use environment was conducted to document that the user was able to operate the system as intended, and the product conformed to user needs.

N. Conclusion

Based upon the performance and comparative test results, the proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K152081. The modifications made to the Auto Endo5® 5mm Automatic Endoscopic 35cm Applier do not introduce any new issues of safety and effectiveness.

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.