The ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.

Device Description

The ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (ENDO CLIP™ III 5mm Clip Applier). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific acceptance criteria and detailed study results in the way a clinical trial for a new drug or high-risk device might.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics in a tabular format typically found in detailed performance studies. Instead, it lists a series of in-vitro and ex-vivo tests designed to demonstrate that the new device is "substantially equivalent" to the predicate device (ENDO CLIP™ III 5mm Clip Applier - K071406) and "performed as intended."

The listed tests cover aspects like:

Mechanical Performance: Insertion/Removal force, Counter Reliability, Firing Force/Clip Formation, Interlocking Break Force, Clip Formation, Perpendicular/Parallel Clip Pulls, Jaw Deflection Resistance, Jaw Twist Resistance, Clip next to clip proximity.
Physiological Performance (Ex Vivo/In Vivo): Burst Evaluation, Hemostasis Evaluation, Jaw Trauma, Blunt Dissection Evaluation, Clip Trauma.

The conclusion states: "Based on the testing data, substantial equivalence has been established." This implies that the results of all these tests met a pre-defined range of acceptable performance that was either comparable to the predicate device or within specified engineering tolerances for safe and effective use. However, the specific numerical values of these criteria and the measured performance are not detailed in this summary.

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

Sample Size: The document does not specify the sample sizes used for each of the in-vitro, ex-vivo, or in-vivo tests. It simply lists the types of tests performed.
Data Provenance: The tests are described as in-vitro (performed in a controlled environment, e.g., lab bench testing), ex-vivo (performed on excised animal tissue or organs), and in-vivo (performed on living organisms, likely animal models given the context of a 510(k) for a surgical clip applier). No information on the country of origin for the data is provided, nor is it explicitly stated whether the data is retrospective or prospective, though performance testing for a 510(k) is typically prospective for the new device.

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

This type of information (number and qualifications of experts for ground truth) is not applicable to this submission. The tests described are primarily engineering and functional performance tests for a mechanical device. They involve objective measurements (e.g., force, burst pressure, visual assessment of clip formation) rather than subjective interpretation by medical experts to establish a "ground truth" for a diagnostic outcome, for example.

4. Adjudication Method for the Test Set

Again, an adjudication method (like 2+1, 3+1) is not applicable as the tests are objective performance measurements. There is no subjective interpretation requiring consensus among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic imaging or AI systems where human readers interpret cases, often with and without AI assistance. The ENDO CLIP™ III 5mm Clip Applier is a surgical instrument, and its performance is evaluated through mechanical and physiological tests, not human interpretation of cases.

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

This question is not applicable because the device is a mechanical surgical instrument, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

For the in-vitro and ex-vivo tests, the "ground truth" is generally based on objective physical measurements (e.g., force measurements, visual inspection criteria for proper clip formation, burst pressure in vessels, hemostasis, absence of trauma). For example, a clip successfully occludes a vessel or structure, or an interlocking break force meets a specified value. These are engineering and biological endpoints, not expert consensus on a diagnostic finding or pathology.

For the in-vivo tests, the ground truth would be direct observation of physiological effects such as effective hemostasis, lack of significant trauma, and proper functioning within a living system.

8. The Sample Size for the Training Set

This question is not applicable. The ENDO CLIP™ III 5mm Clip Applier is a mechanical medical device, not a machine learning or AI algorithm that requires a "training set" of data. Its design and performance are based on engineering principles and materials science, validated through the described performance tests.

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

This question is not applicable for the same reason as point 8.

Summary

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K12494
page 1/a

Covidien 510(k) Premarket Notification

510(k) Summary of Safety and Effectiveness

MAY - 3 2012

SUBMITTER:	Covidien60 Middletown AvenueNorth Haven, CT 06473Tel. No.: (203) 492-5496Fax No.: (203) 492-5029
CONTACT PERSON:	Angela Van ArsdaleRegulatory Affairs Product Specialist
DATE PREPARED:	April 02, 2012
TRADE/PROPRIETARY NAME:	ENDO CLIP™ III 5mm Clip Applier
COMMON/USUAL NAME:	Implantable Clip
CLASSIFICATION NAME:	Implantable Clip
PREDICATE DEVICE(S):	ENDO CLIP™ III 5mm Clip Applier (K071406)
DEVICE DESCRIPTION:	The ENDO CLIP™ III 5mm Clip Applier contains 16 titaniumclips. The applier is designed for introduction and use throughan appropriately sized trocar sleeve, or larger with the use of aconverter. The ENDO CLIP™ III 5mm Clip Applier consists ofa trigger handle, shaft rotation knob, clip counter window and a33 cm shaft with jaws at its distal end. Squeezing the handleplaces a titanium clip in the jaws and closes the jaws to closethe clip on the vessel or structure.
INTENDED USE:	The ENDO CLIP™ III 5mm Clip Applier is primarily indicatedfor patients undergoing laparoscopic surgical proceduresinvolving dissection and occlusion of blood vessels, ducts andother tubular structures, and for radiographic marking.
TECHNOLOGICALCHARACTERISTICS:	The ENDO CLIP™ III 5mm Clip Applier isidentical to the predicate device in terms of intended use and itoperates in a similar manner as the predicate device.
MATERIALS:	All patient contact components of the ENDO CLIP™ III 5mmClip Applier are comprised of materials which are inaccordance with ISO Standard 10993-1.

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K121194

Covidien 510(k) Premarket Notification

PERFORMANCE DATA:

In-vitro and in-vivo tests were performed to verify that the ENDO CLIP™ III 5mm Clip Applier was substantially equivalent to the predicate device (K071406) in occluding vessels and other tubular structures and to validate that the ENDO CLIP™ III 5mm Clip Applier performed as intended.

The following describes the testing performed:

· In Vitro Insertion / Removal force
· In Vitro Counter Reliability Test
· In Vitro Firing Force / Clip Formation
· In Vitro Interlocking Break Force
· In Vitro Clip Formation Test
· In Vitro Perpendicular Clip Pulls
· In Vitro Paralle! (Axial) Clip Pulls
· In Vitro Jaw Deflection Resistance
- In Vitro Top Load on Jaw .
- In Vitro Bottom Load on Jaw with wedge plate . engaged prior to clip leading
- In Vitro Bottom Load on Jaw with wedge plate � disengaged prior to clip loading
- In Vitro Side Load on Jaw (Vessel approximated . first prior to trigger squeeze)
- . In Vitro Side Load on Jaw (Vessel approximated after wedge plate feed)
- In Vitro Media! Load on Jaw .
· In Vitro Jaw Twist Resistance
· In Vitro Clip next to clip proximity test
· Ex Vivo Burst Evaluation
· Ex Vivo Perpendicular Clip Pull
· Ex Vivo Parailel Clip Pull
· Ex Vivo Clip Twist Normal Firing (jaw tips vertical to vessel and no underlying tissue)
· Ex Vivo Clip Twist with Shaft Rotation Normal firing with shaft rotation (jaw tips twisted 90 to vessel and no underlying tissue)
· Ex Vivo Clip Twist Firing embedded tissue (jaw tips vertical to vessel with underlying tissue)
· In Vivo Hemostasis Evaluation
· In Vivo Jaw Trauma
· In Vivo Blunt Dissection Evaluation
· In Vivo Clip Trauma
· In Vivo Jaw Deflection (Twist) Resistance

Based on the testing data, substantial equivalence has been established.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.

Public Health Service

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

Covidien % Ms. Angela Van Arsdale Regulatory Affairs Product Specialist 60 Middletown Avenue North Haven, Connecticut 06473

MAY - 3 2012

Re: K121194

Trade/Device Name: ENDO CLIP™ III 5mm Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP, GDO Dated: April 17, 2012 Received: April 19, 2012

Dear Ms. Arsdale:

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 corply with all the Act's requirements, including, but not limited to: registration and listing (21

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. Page 2 - Ms. Angela Van Arsdale

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yo

Oth. Der Lurr
Dr.

Mark N. Melkerson . Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ENDO CLIP™ III 5mm Clip Applier

Indications For Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K121194
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Page 1 of ____

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.