The Implantable Clip is a sterile single use device indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The clip is manufactured from implant grade titanium. The clips are supplied pre-packaged in a preassembled cartridge loaded with 14 functional clips. The clip applier system used to deliver the clips consists of the disposable clip cartridge and a reusable handle which provide the mechanical mechanism for storing, advancing and delivering the implantable clips. The system is designed for use with an 11mm diameter or larger trocar cannula.

AI/ML Overview

The provided text is a 510(k) summary for an Implantable Clip and does not contain detailed information about acceptance criteria and a study that definitively proves the device meets those criteria in the way a diagnostic AI device disclosure would.

The document states:
"PERFORMANCE DATA SUMMARY: The performance and functional testing of the Implantable Clip included tests to analyze the jaw occlusion force of the clip appliers used with the clips discussed in this submission, leak pressure tests on vessels ligated by the clips and clip retention force of the clips. The performance and functional testing demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed."

This is typical for a medical device 510(k) submission where "substantial equivalence" to a predicate device is the primary pathway for clearance, rather than a performance study demonstrating meeting specific quantitative acceptance criteria for a novel diagnostic algorithm.

Therefore, many of the requested details about acceptance criteria, study design involving test sets, experts, ground truth, and AI-specific metrics (MRMC, standalone performance, training sets) are not applicable or provided in this type of submission.

However, I can extract the implied acceptance criteria based on the testing performed and articulate what would be expected if this were a typical AI/diagnostic device submission.

Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from testing)	Reported Device Performance
Jaw Occlusion Force: Acceptable force to ensure proper closure and secure ligation.	Performance and functional testing demonstrated substantial equivalence to predicate devices, indicating acceptable jaw occlusion force.
Leak Pressure: Ability to withstand specified pressure without leakage in ligated vessels.	Performance and functional testing demonstrated substantial equivalence to predicate devices, indicating acceptable leak pressure.
Clip Retention Force: Acceptable force to retain the clip on the vessel/structure post-ligation.	Performance and functional testing demonstrated substantial equivalence to predicate devices, indicating acceptable clip retention force.
Safety and Effectiveness: No new safety and effectiveness issues compared to predicate devices.	The device "introduces no new safety and effectiveness issues when used as instructed," suggesting established safety and effectiveness through substantial equivalence.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not specified. The document refers to "performance and functional testing" which would involve a sample size but the specific number of clips, appliers, or vessels tested is not provided.
Data Provenance: Not specified. Given the nature of a 510(k) for a physical implantable device, this would typically involve in-house laboratory testing or animal studies, rather than a clinical dataset from a specific country. It is almost certainly prospective testing performed for the submission.

3. Number of Experts and Qualifications

Number of Experts: Not applicable/not specified. The testing described (jaw occlusion, leak pressure, retention force) would typically be performed by engineers or technicians in a laboratory setting, not by clinical "experts" establishing ground truth in the way a diagnostic study would.
Qualifications: Not applicable/not specified.

4. Adjudication Method

Adjudication Method: Not applicable. This type of testing does not involve subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is a physical implantable device, not a diagnostic algorithm, so an MRMC study is not relevant or performed.

6. Standalone Performance (Algorithm Only)

Standalone Performance: Not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

Ground Truth: For the "Performance and Functional Testing," the ground truth would be based on physical measurements and objective criteria established through engineering specifications and industry standards for surgical clips, often benchmarked against predicate devices. For example:
- Jaw Occlusion Force: Measured in units of force (e.g., Newtons) against a predefined threshold.
- Leak Pressure: Measured in units of pressure (e.g., mmHg) at which a leakage occurs, verified against predicate device performance or clinical requirements.
- Clip Retention Force: Measured in units of force required to dislodge the clip, against predefined thresholds.

8. Sample Size for Training Set

Sample Size: Not applicable. This is a physical device, not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Ground Truth Establishment: Not applicable.

Summary of what the document does tell us about meeting acceptance criteria:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing predicate devices (Applied Medical Clip Applier and LIGACLIP™ ERCA). The study, referred to as "performance and functional testing," aimed to demonstrate this substantial equivalence in terms of:

Jaw occlusion force of the clip appliers.
Leak pressure of vessels ligated by the clips.
Clip retention force of the clips.

The document states that this testing "demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This statement serves as the proof that the device meets the implied acceptance criteria for a 510(k) clearance.

Summary

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510(k) SUMMAR Y

510(k) NUMBER:	PENDING
SUBMITTED BY:	Applied Medical Resources Corporation26051 Merit Circle, Unit # 104Laguna Hills, California 92653(949) 582-6120
CONTACT PERSON:	Anil BhalaniDirector of Regulatory Affairs and Clinical Programs
DATE OF PREPARATION:	September 15, 1999
NAME OF DEVICE:	Implantable Clip
CLASSIFICATION NAME:	Implantable Clip (21 CFR 878.4300)
TRADE NAME:	Not Determined
PREDICATE DEVICES:	1. APPLIED MEDICAL CLIP APPLIER2. LIGACLIP™ ERCA, Ethicon, Inc.

INTENDED USE: The Applied Medical Implantable Clip is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

DEVICE DESCRIPTION: The Implantable Clip is a sterile single use device indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The clip is manufactured from implant grade titanium. The clips are supplied pre-packaged in a preassembled cartridge loaded with 14 functional clips. The clip applier system used to deliver the clips consists of the disposable clip cartridge and a reusable handle which provide the mechanical mechanism for storing, advancing and delivering the implantable clips. The system is designed for use with an 11mm diameter or larger trocar cannula.

PERFORMANCE DATA SUMMARY: The performance and functional testing of the Implantable Clip included tests to analyze the jaw occlusion force of the clip appliers used with the clips discussed in this submission, leak pressure tests on vessels ligated by the clips and clip retention force of the clips. The performance and functional testing demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed.

LIGACLIP™ is a trademark of Ethicon, Inc.

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anil Bhalani Director of Regulatory Affairs and Clinical Programs Applied Medical Resources 26051 Merit Circle, #104 Laguna Hills. California 92653

DEC - 1 1999

Re: K993135 Trade Name: Implantable Clip Regulatory Class: II Product Code: FZP Dated: September 15, 1999 Received: September 20, 1999

Dear Mr. Bhalani:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Anil Bhalani

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Nail R.P. Ogden

James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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993135

INDICATIONS FOR USE

Applied Medical Resources is providing this separate cover page for the Implantable Clip "Indications for Use" as required.

Not assigned 510(k) Number:

Implantable Clip Device Name:

Indications for Use: The Applied Medical Implantable Clip is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Signature: A.S. Bhal Title: Director RA/Clinical Programs Date: 9-15-99

NRO for

(Division Sign-Off) Division of General Restorative Devices
510(k) Number	K993135

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The -Counter Use

(Optional Format 1-2-96)

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.