The ThruPort Knotting Instrument is used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot and is indicated for use in the approximation of soft tissue and prosthetic materials.

Device Description

Edwards Lifesciences' ThruPort OptiClip Knotting System is a sterile, nonpyrogenic, single-use surgical instrument made of metal and polymeric materials. lt consists of the ThruPort OptiClip Knotting Instrument and the ThruPort OptiClip Knot Loader.

AI/ML Overview

This document describes the regulatory approval for the Edwards ThruPort OptiClip Knotting System. It is a not a clinical study report and therefore does not contain information about acceptance criteria or device performance as would be expected for a clinical study.

However, it does describe the functional and safety testing performed, and that all results met acceptance criteria. It also details the MR safety information testing.

Here's an analysis of the provided text based on your request, highlighting what is available and what is not:

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

This information is not provided in a table format, nor are specific quantitative acceptance criteria or reported performance values given. The document states: "The functional data indicate that the device performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were completed and all results met acceptance criteria." This implies that acceptance criteria were defined and met, but the specific details are not disclosed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document describes "Functional bench testing (design verification)" and "Non-clinical testing" for MR Conditional assessment. It does not mention a "test set" in the context of human subjects or clinical data. All testing appears to be laboratory-based verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The testing performed is functional and safety testing, not diagnostic performance evaluation requiring expert ground truth.

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

This information is not applicable/provided. Adjudication methods are typically associated with clinical studies involving human observers or image interpretation, which is not the nature of the testing described.

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/provided. This device is a surgical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

This information is not applicable/provided. This device is a medical instrument and does not involve an algorithm or AI.

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

For the functional and safety testing, the "ground truth" would be the engineering specifications, established medical device standards (e.g., ISO 10993-1:2009 for biocompatibility), and internal design requirements. For MR safety, the ground truth is based on established physics principles and testing methodologies for MR compatibility. There is no biological or diagnostic "ground truth" in the clinical sense mentioned in the document.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/provided for the same reason as point 8.

Summary of available information related to acceptance criteria and study (non-clinical):

The document describes several non-clinical tests (functional bench testing, MR evaluation testing, biocompatibility, sterility, shelf life, packaging, design validation) performed to demonstrate that the device is substantially equivalent to a predicate device and meets safety and effectiveness requirements.

Acceptance Criteria Overview: The document broadly states that "all results met acceptance criteria" for the functional tests. For MR safety, specific conditions for MR Conditional use are provided (static magnetic field, spatial gradient, SAR, temperature rise, and image artifact size), which serve as the acceptance criteria for claiming MR Conditional status.
Study Type: Non-clinical (laboratory/bench) testing for design verification and validation.
MR Evaluation Testing:
- Acceptance Criteria (as stated in the document):
  - Static magnetic field must be 1.5 Tesla and 3.0 Tesla only.
  - Maximum spatial gradient magnetic field of 3,000 Gauss/cm (30 T/m) or less.
  - Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode).
  - Maximum temperature rise of less than 1.5 ℃ after 15 minutes of continuous scanning.
  - Image artifact caused by the nitinol knot extends approximately 1 mm from the knot with a spin echo pulse sequence in a 3.0 T MRI system, and 5 mm with a gradient echo pulse sequence in a 3.0 T MRI system.
- Reported Device Performance (as stated in the document): The device (specifically the nitinol knot) meets these conditions and is therefore classified as "MR Conditional." The image artifact characteristics are also reported.
- Sample Size for Test Set: Not explicitly stated, but typical for non-clinical MR testing, it would involve a specific number of device samples.
- Data Provenance: Non-clinical (laboratory testing).
- Ground Truth: Engineering specifications and established MR safety testing standards.

In conclusion, this document primarily serves as a regulatory clearance letter and a 510(k) summary, detailing the types of tests performed to achieve substantial equivalence. It does not provide the granular details of acceptance criteria and performance data typically found in a clinical study report for diagnostic devices.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

January 16, 2015

Edwards Lifesciences LLC Ms. Nina Brooke Regulatory Affairs Associate III One Edwards Way Irvine, California 92614

Re: K141206

Trade/Device Name: ThruPort Knotting Instrument Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW, HCF Dated: January 12, 2015 Received: January 14, 2015

Dear Ms. Brooke:

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

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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

510(k) Number (if known)

K141206

Device Name ThruPort Knotting Instrument

Indications for Use (Describe)

The knotting instrument used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot is indicated for use in the approximation of soft tissue and prosthetic materials.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary
Submitter:	Edwards Lifesciences LLC
Contact Person:	Nina Brooke, Regulatory Affairs Associate IIIOne Edwards WayIrvine, CA 92614Phone: (949) 244-6444Fax: (949)756-4573
Date Prepared:	January 15, 2015
Trade Name:	Edwards ThruPort OptiClip Knotting System
Classification Name:	Suture, Nonabsorbable, Synthetic, Polypropylene (21 CFR§878.5010, Product Code GAW, Class II)Instrument Ligature Passing and Knot Tying, General &Plastic Surgery Panel (21 CFR §878.4800, Product CodeHCF, Class I)
Predicate Device:	K100593, Suture Placement Devices and Accessories, LSISolutions, Inc.

Device Description:

Intended Use:

Intended for use in the approximation of soft tissue and prosthetic materials.

Indications for Use:

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Comparative Analysis:

The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. It has been demonstrated that the subject device is comparable to the predicate device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations.

Functional and Safety Testing:

The functional data indicate that the device performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were completed and all results met acceptance criteria:

. Functional bench testing (design verification)
- Knot Loader Suture Snare Tensile Strength: Demonstrate that the Knot . Loader suture snare can withstand forces encountered during suture loading within the Knotting Instrument.
- Knotting System Suture Loading Force: To establish the forces . encountered during suture loading within the Knotting Instrument
- Knotting Instrument Shaft Stiffness: Demonstrate that the shaft of the Knotting Instrument has adequate stiffness to perform effectively within the intended use.
- . Knotting Instrument Weight: Demonstrate that the weight of the assembled Knotting System allows for adequate tactile feedback.
- Dimensional Interference: Demonstrate that the components of the Knotting ● System (including the un-deployed nitinol knot) do not exhibit dimensional interference relative to the suture prior to deployment.
- . Pinch Point Area: Demonstrate that the area of the exposed Knotting System pinch point is less than that of the predicate device.
- . Knotting Instrument Effective Length: Demonstrate that the effective length of the 15cm, 22cm, and 30cm Knotting Instrument are as labeled
- . Shaft Outer Diameter: Demonstrate that the outer diameter of the Knotting Instrument is less than or equal to the predicate device.
- . Overall Nitinol Knot Height: Demonstrate that the deployed nitinol knot height is less than or equal to the predicate device
- Knot Loader Outer Diameter: Demonstrate that the outer diameter of the . Knot Loader is less than or equal to the predicate device outer diameter.

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Knotting System Deployment Force: Demonstrate that the force required ● to fully depress the trigger and deploy a nitinol knot exceeds the weight of the Knotting System and is low enough to ensure ease of use
. Suture Tension: Demonstrate that the tension required to cut suture is less than or equal to the predicate device.
Knot Loader Disposable Tip Push Off Force: Demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
. Nitinol Knot Push Off Force: Demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
Nitinol Knot Suture Retention Strength: Demonstrate that the nitinol knot . can effectively secure the suture upon deployment when used for the intended use.
Knotting Instrument Handle Strength: Demonstrate that the handle of the . Knotting Instrument can withstand the force of applying suture tension and pressure onto tissue or prosthetic material.
Knotting Instrument Corrosion: Demonstrate that the Knotting Instrument . can function after exposure to a simulated use environment.
Nitinol Knot Corrosion: Demonstrate that the nitinol knot does not corrode. ●
Knotting Instrument Durability: Demonstrate that the Knotting Instrument . can function for a maximum of 25 deployment cycles.
. Knotting System Packaging Integrity: Demonstrate that the packaging configuration of the Knotting System is able to maintain a sterile barrier after worst case conditioning.
Nitinol Knot Magnetic Resonance Conditional Testing: To substantiate . the claim of magnetic resonance (MR) conditional.
· Biocompatibility testing was performed per ISO 10993-1:2009
· Sterility and sterile barrier testing
· Shelf life testing
· Packaging testing
· Design validation

MR evaluation testing:

Per testing conducted the following MR safety statement will be added to our labeling

MRI SAFETY INFORMATION

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Image /page/6/Picture/2 description: The image shows a black triangle with the letters "MR" in bold black font in the center. The triangle is equilateral, and the letters are horizontally centered within it. The background is plain white.

Non-clinical testing has demonstrated that the nitinol knot is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

Static magnetic field of 1.5 Tesla and 3.0 Tesla only .
Maximum spatial gradient magnetic field of 3,000 Gauss/cm (30 T/m) or less .
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the nitinol knot is expected to produce a maximum temperature rise of less than 1.5 ℃ after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the nitinol knot extends approximately 1 mm from the nitinol knot when imaged with a spin echo pulse sequence in a 3.0 T MRI system and 5 mm from the nitinol knot when imaged with a gradient echo pulse sequence in a 3.0 T MRI system.

The knotting instrument and knot loader are MR Unsafe.

A patient identification card is included with the knot loader, which contains the MRI safety information for the nitinol knot. Fill out the patient specific information including patient name, date of implant, doctor name, and doctor phone number and then distribute to the patient at discharge.

Conclusion:

The Edwards Thruport OptiClip Knotting System is substantially equivalent to the cited predicate device. Additionally, the device testing confirms the safety and effectiveness of the device when compared to the predicate device.

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.