Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on a mechanical clip applier and do not mention any AI or ML components or functionalities.

Therapeutic

No
This device is used for surgical procedures to occlude blood vessels and other structures, rather than for treating or curing a disease or condition. It is a surgical tool, not a therapeutic device.

Diagnostic

No
The device is described as a surgical tool used for occluding vessels and other tubular structures during laparoscopic procedures, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, mechanical device (clip applier with titanium clips, trigger handle, shaft, jaws) used in surgical procedures, not a software-only application.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Description and Intended Use: The ENDO CLIP™ III 5mm Clip Applier is a surgical instrument used during a laparoscopic procedure to physically occlude blood vessels, ducts, and other structures within the patient's body. It is a surgical tool, not a diagnostic test performed on a sample.

The description clearly indicates a device used for surgical intervention, not for analyzing biological samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FZP, GDO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

ENDO CLIP™ III 5mm Clip Applier (K071406)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K12494
page 1/a

Covidien 510(k) Premarket Notification

510(k) Summary of Safety and Effectiveness

MAY - 3 2012

| SUBMITTER: | Covidien
60 Middletown Avenue
North Haven, CT 06473
Tel. No.: (203) 492-5496
Fax No.: (203) 492-5029 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Angela Van Arsdale
Regulatory 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 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. |
| INTENDED USE: | 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. |
| TECHNOLOGICAL
CHARACTERISTICS: | The ENDO CLIP™ III 5mm Clip Applier is
identical to the predicate device in terms of intended use and it
operates in a similar manner as the predicate device. |
| MATERIALS: | All patient contact components of the ENDO CLIP™ III 5mm
Clip Applier are comprised of materials which are in
accordance with ISO Standard 10993-1. |

·

1

K121194

Covidien 510(k) Premarket Notification

P

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.

2

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

3

. 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

4

Indications for Use

510(k) Number (if known):

Device Name: ENDO CLIP™ III 5mm Clip Applier

Indications For Use:

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.

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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