The LARIAT® III Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

Device Description

The LARIAT® III Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size "0" polyester suture loop that is pre-loaded on a retractable Delivery Snare on the distal end of the device. The pre-tied suture loop is held onto the Delivery Snare and allows for multiple opening and closings of the suture loop without release. Upon tightening of the suture loop, the suture is released from the Delivery Snare. An accessory lumen within the LARIAT III device is designed for aspiration and flushing. The LARIAT III device is compatible with access site diameters of 4.3mm and larger. The suture is itself a cleared medical device as a part of K021019.

AI/ML Overview

The provided document is a 510(k) premarket notification for the LARIAT® III Suture Delivery Device. It details the device's characteristics, intended use, and claims of substantial equivalence to a predicate device (LARIAT II Suture Delivery Device). This type of submission relies on comparisons to already-cleared devices and bench testing rather than clinical study data for device performance metrics related to diagnostic accuracy or clinical outcomes often seen with AI/ML devices. Therefore, a direct application of typical "acceptance criteria" for AI/ML performance metrics and detailed clinical study information is not present in this document.

However, I can extract the information that is available regarding the device's performance through bench testing in support of its substantial equivalence claims.

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

The document does not explicitly state numerical "acceptance criteria" with thresholds for each test, but rather lists the types of bench tests performed to confirm the device performs "according to the stated intended use." The reported device performance is broadly stated as successful completion of these tests.

Acceptance Criterion (Test Name)	Reported Device Performance
Visual and Dimensional Verification	Performed according to stated intended use (implied success)
Snare Loop Actuation and Force Testing	Performed according to stated intended use (implied success)
Ability to Perfuse and Aspirate Testing	Performed according to stated intended use (implied success)
Suture Preparation and Deployment Testing	Performed according to stated intended use (implied success)
Snare Loop Lock Testing	Performed according to stated intended use (implied success)
Suture Recoil Testing	Performed according to stated intended use (implied success)
Suture Tensile Strength Testing	Performed according to stated intended use (implied success)
Snare Wire Joint Strength Testing	Performed according to stated intended use (implied success)
Shaft to Handle Joint Strength Testing	Performed according to stated intended use (implied success)
Catheter Tip to Shaft Joint Strength	Performed according to stated intended use (implied success)
Snare Anchor Joint Strength Testing	Performed according to stated intended use (implied success)
Hypotube to Shaft Joint Strength Testing	Performed according to stated intended use (implied success)
Suture Knot Strength Testing	Performed according to stated intended use (implied success)
Suture/Suture Fob Joint Strength Testing	Performed according to stated intended use (implied success)

2. Sample size used for the test set and the data provenance

The document specifies "bench testing" was conducted. This typically refers to laboratory-based tests on physical devices or components, not clinical data. Therefore, details like "country of origin of the data" or "retrospective or prospective" do not apply. The sample size for each specific bench test is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Bench testing of a mechanical device does not typically involve human experts establishing ground truth in the way it would for an AI diagnostic device. The "ground truth" for these tests would be derived from engineering specifications and widely accepted physical/material science principles.

4. Adjudication method for the test set

Not applicable, as this refers to a method used to resolve discrepancies among human experts during ground truth establishment for clinical/diagnostic performance, which is not relevant for this type of bench testing.

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

Not applicable. This device is a surgical tool, not an AI/ML diagnostic or assistive device that would involve human "readers" or AI assistance.

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

Not applicable. This device is a mechanical surgical tool, not an algorithm.

7. The type of ground truth used

For bench testing, the "ground truth" is typically defined by accepted engineering specifications, material properties, and functionality requirements rather than expert consensus, pathology, or outcomes data. For example, a "suture tensile strength test" would have a specified minimum tensile strength (ground truth) that the suture must meet.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set.

Summary

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

September 12, 2014

SentreHEART Incorporated Ms. Kit Cariquitan Vice President, Clinical and Regulatory Affairs 300 Saginaw Drive Redwood City, California 94063

Re: K142241

Trade/Device Name: LARIAT® III Suture Delivery Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, HCF Dated: August 11, 2014 Received: August 13, 2014

Dear Ms. Cariquitan:

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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Indications for Use

510(k) Number (if known) K142241

Device Name LARIAT® III Suture Delivery Device

Indications for Use (Describe)

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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SECTION 6 510(k) SUMMARY

510(k) Notification K142241

GENERAL INFORMATION

Applicant:

SentreHEART, Inc. 300 Saginaw Drive Redwood City, CA U.S.A. Phone: 650-241-6038 Fax: 650-241-5985

Contact Person:

Kit Cariquitan Vice President, Clinical and Regulatory Affairs SentreHEART, Inc. 300 Saginaw Drive Redwood City, CA U.S.A. Phone: 650-241-6038 Fax: 650-241-5985 Email: kcariquitan@sentreheart.com

Date Prepared: August 11, 2014

Classification:

Class II, 21 CFR§87: .5000

Product Code:

GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) HCF (Instrument, Ligature Passing And Knot Tying)

Trade Name:

LARIAT® III Suture Delivery Device

Generic/Common Name:

Nonabsorbable (ethylene terephthalate) surgical suture Instrument, Ligature Passing And Knot Tying

Predicate Device:

LARIAT II Suture Delivery Device, SentreHEART (K090385)

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SECTION 6 510(k) SUMMARY (CONT.)

Intended Use:

Product Description:

Substantial Equivalence:

This Special 510(k) premarket notification is for the LARIAT III device, which is a modified version of the cleared and commercially available LARIAT II device (K090385). The LARIAT III device's handle was updated to lengthen the thumb slide slot and the suture fob that is on the end of the handle is now molded and is 1 piece. The LARIAT III device's catheter shaft is braided with stainless steel wire and has 4 lumens. Lastly, the LARIAT III device's distal tip has been updated to include a larger snare size of 45mm and a radiopaque marker. The minor design modifications outlined in this Special 510(k) premarket notification do not (1) affect the intended use or (2) alter the fundamental scientific technology of the device. The LARIAT III device shares the same intended use, similar technological characteristics and the same principles of operation as the predicate device. Any differences between the devices do not raise any new issues of safety or effectiveness. Thus, the LARIAT III device is substantially equivalent to the predicate device.

Testing in Support of Substantial Equivalence Determination:

All necessary bench testing was conducted on the LARIAT III device to support a determination of substantial equivalence to the predicate device.

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SENTREHEART, INC.

SECTION 6 510(k) SUMMARY (CONT.)

The bench testing included the following:

•	Visual and Dimensional Verification	•	Snare Wire Joint Strength Testing
•	Snare Loop Actuation and Force Testing	•	Shaft to Handle Joint Strength Testing
•	Ability to Perfuse and Aspirate Testing	•	Catheter Tip to Shaft Joint Strength
•	Suture Preparation and Deployment Testing	•	Snare Anchor Joint Strength Testing
•	Snare Loop Lock Testing	•	Hypotube to Shaft Joint Strength Testing
•	Suture Recoil Testing	•	Suture Knot Strength Testing
•	Suture Tensile Strength Testing	•	Suture/Suture Fob Joint Strength Testing

The above testing confirmed that the LARIAT III device performs according the stated intended use.

Summary:

The LARIAT III device is substantially equivalent to the predicate device

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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.