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, nonabsorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used by a surgeon or physician's assistant 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 49.37cm long with a working length of 35.2cm. 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

Here's an analysis of the provided text regarding the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier, specifically addressing the requested information about acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria in the same way one might for an AI/ML algorithm. Therefore, many of the requested points, especially those related to AI/ML study design (sample size for test/training sets, expert ground truth, MRMC studies, standalone performance), are not directly applicable or present in this context. The answers below will reflect the information that is available.

Acceptance Criteria and Device Performance Study

The Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier is a ligation clip applier, a mechanical surgical device, not an AI/ML diagnostic system. Therefore, the "acceptance criteria" and "device performance" are typically related to its mechanical function, safety, and effectiveness in performing its intended task, usually compared against a similar legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device and document, explicit, quantitatively defined acceptance criteria (e.g., "sensitivity > X%, specificity > Y%") are not presented in a traditional table format. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device and successful performance in non-clinical and usability testing.

Acceptance Criterion (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device: The device should perform its intended function similarly to the predicate.	"The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier has the same technology and functional characteristics as the predicate device." "The results of this comparison demonstrate that the Auto Endo5 5mm Automatic Endoscopic 35cm Applier is equivalent to the marketed predicate device." "The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K142777."
Safety and Effectiveness (Post-Modification): Modifications should not introduce new safety or effectiveness issues.	"The modifications made to the Auto Endo5 5mm Automatic Endoscopic 35cm Applier do not introduce any new issues of safety and effectiveness." (This is a conclusion reached based on the non-clinical performance testing and usability study).
Mechanical Integrity/Performance (after sterilization, conditioning, distribution): The device should maintain its intended function and integrity under various conditions.	"Non-clinical performance testing has been conducted following product sterilization, environmental conditioning, and simulated distribution in order to support a change to the device's working length and ratcheting mechanism." (No specific quantitative results are presented in this summary, but the conclusion is that it was successful in demonstrating equivalence and safety.)
Usability/User Needs: The device should be operable by the user as intended and meet user needs.	"Usability and design validation of the Auto Endo5 5mm Automatic Endoscopic 35cm Applier in a porcine model was conducted to document that the clip applier performed to its intended use in vivo, the user was able to operate the system as intended, and the product conformed to user needs." (Again, no quantitative metrics are given in this summary, but the study conclusion supports satisfactory performance against this criterion.)
Biocompatibility: Patient-contacting materials must be safe.	"All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1." (This is a compliance statement, not a performance metric from a study, but an underlying safety requirement.)
MR Safety: (Relevant for the associated clips, reaffirmed).	"Hem-o-lok Ligating Clips are 'MR Safe' and pose no known hazards in MR environments. This claim was cleared under K133202, December 30, 2013." (This is a historical clearance, not directly tested in this submission's study, but relevant for the overall product system.)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in the summary for the non-clinical and usability testing. These studies typically use a pre-determined number of devices or animal models to generate sufficient data for statistical confidence or to demonstrate functionality.
Data Provenance: The usability and design validation study was conducted "in a porcine model." This indicates prospective animal model data. The non-clinical performance testing would have been conducted in a laboratory setting. There is no mention of human subject data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable to this type of device and study. The "ground truth" for a mechanical device like a clip applier is its physical function (e.g., does it successfully deploy a clip? does the clip close correctly? does it damage tissue unnecessarily?). The "experts" in this context would be the engineers performing the tests and potentially the surgeons/physicians conducting the usability study, but they are evaluating mechanical performance against design specifications and intended use, not establishing a "ground truth" in the diagnostic sense. The summary refers to the device being used "by a surgeon or physician's assistant."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in diagnostic studies to resolve disagreements among multiple expert readers in establishing ground truth for images or clinical cases. This is not relevant for a mechanical device undergoing performance and usability testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. MRMC studies are specific to diagnostic performance, often for AI/ML systems or new imaging modalities, where multiple human readers assess multiple cases. This is not relevant for a surgical clip applier.

6. If a Standalone Study Was Done

Yes, in a sense. The non-clinical performance testing and usability/design validation in a porcine model were "standalone" in that they evaluated the device itself (with its associated clips) in a controlled environment or animal model to confirm its function and safety. This is not "standalone algorithm performance" as you'd ask for an AI/ML product, but standalone device performance.

7. The Type of Ground Truth Used

For the usability/design validation study in the porcine model, the "ground truth" was the successful and intended application of the Hem-o-lok clips by the applier in vivo, confirming that "the clip applier performed to its intended use in vivo, the user was able to operate the system as intended, and the product conformed to user needs." For non-clinical testing, it would be adherence to engineering specifications and performance criteria. This is based on observational performance and functional assessment rather than, for example, pathology reports or long-term outcomes data, which are typically used for diagnostic or treatment efficacy studies.

8. The Sample Size for the Training Set

Not applicable. The device is a mechanical surgical tool, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 26, 2015

Teleflex Medical Incorporated Ms. Ashlea Ricci Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K152081

Trade/Device Name: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: July 24, 2015 Received: July 27, 2015

Dear Ms. Ricci:

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 (reporting of medical

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device-related 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152081

Device Name

Weck Auto Endo5, 5mm Automatic Endoscopic 35cm Applier

Indications for Use (Describe)

Indications for Use (Describe)
Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as devices for West Auto Lludo I reali-e-lok mo actions 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 stractives services as normals Hem-of-on mgainly crips are miculed for use in proceanse or tissue structure to be ligated so 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the sepplate I he durden instructions, search existing data sources, gather and maintain the data needed and complete time to review instruction. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, fo:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

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: 919-361-4071 Fax: 919-433-4996

B. Contact Person

Ashlea Ricci, MSRS, RAC Senior Regulatory Affairs Specialist

C. Date Prepared

August 5, 2015

D. Device Name

Trade Name:	Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier
Common Name:	Implantable Clip
Classification Name:	Clip, Implantable
Product Class:	Class 2
Product Code:	FZP
Regulation Number:	878.4300

E. Device Description

F. Indications for Use

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G. Contraindications

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

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

H. Environmental Conditions

Hem-o-lok Ligating Clips are "MR Safe" and pose no known hazards in MR environments. This claim was cleared under K133202, December 30, 2013.

-Substantial Equivalence

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

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Weck Auto Endo5 Hem-o-lokLigating Clip Applier	Teleflex Medical	K142777	12/19/2014

J. Comparison To Predicate Devices

The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier has the same technology and functional characteristics as the predicate device. The modifications proposed within this submission include extending the device's working length by 5.5cm, a minor modification to the ratcheting mechanism to improve audible cues during use and a change in the color of the trigger from green to white.

K. Materials

All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1.

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 a change to the device's working length and ratcheting mechanism.

Usability and design validation of the Auto Endo5 5mm Automatic Endoscopic 35cm Applier in a porcine model was conducted to document that the clip applier performed to its intended use in vivo, 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) K142777. 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.