LARIAT sulture Delivery Device

K142241 · Sentreheart, Inc. · GAT · Sep 12, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142241
• Device Name: LARIAT sulture Delivery Device
• Applicant: Sentreheart, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Sep 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

LARIAT® III is a single-use, one-piece suture delivery device; features pre-tied size 0 polyester suture loop pre-loaded on retractable distal Delivery Snare. Device allows multiple opening/closing of suture loop without release; tightening releases suture. Includes accessory lumen for aspiration/flushing; compatible with access sites ≥4.3mm. Operated by surgeons in clinical settings. Device facilitates soft tissue approximation/ligation; provides mechanical delivery of suture to target site. Benefits include controlled, repeatable suture placement and knot tying for surgical procedures.

Clinical Evidence

Bench testing only. Testing included visual/dimensional verification, snare loop actuation/force, perfusion/aspiration capability, suture preparation/deployment, snare loop lock, suture recoil, suture tensile strength, snare wire joint strength, shaft-to-handle joint strength, catheter tip-to-shaft joint strength, snare anchor joint strength, hypotube-to-shaft joint strength, suture knot strength, and suture/suture fob joint strength.

Technological Characteristics

Single-use, one-piece delivery device. Materials include braided stainless steel wire in catheter shaft. Features 4-lumen catheter, 45mm snare, and radiopaque marker. Suture is pre-tied size 0 polyester. Mechanical actuation via thumb slide. No software or energy source.

Indications for Use

Indicated for surgical applications requiring soft tissue approximation and/or ligation using a pre-tied polyester suture.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LARIAT II Suture Delivery Device (K090385)

Reference Devices

• Suture (K021019)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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: [phone] Fax: [phone]

## Contact Person:

Kit Cariquitan Vice President, Clinical and Regulatory Affairs SentreHEART, Inc. 300 Saginaw Drive Redwood City, CA U.S.A. Phone: [phone] Fax: [phone] Email: [e-mail]

## 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:

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.

# Product 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.

# 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