LARIAT II SUTURE DELIVERY DEVICE

K090385 · Sentreheart, Inc. · GAT · May 6, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090385
• Device Name: LARIAT II SUTURE DELIVERY DEVICE
• Applicant: Sentreheart, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: May 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LARIAT II 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 II is a single-use, one-piece suture delivery and deployment device. It features a pre-tied size 0 polyester suture loop. The device includes a lumen for aspiration and flushing during delivery, capture, or release of the suture. It is packaged with a guide cannula, dilator for placement, and a surgical blade for cutting excess suture. Used by surgeons in clinical settings to approximate or ligate soft tissue. The device simplifies the mechanical process of suture placement and knot tying, facilitating surgical closure or ligation procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Functional testing and biocompatibility testing were conducted to demonstrate safety and performance equivalence to predicate devices.

Technological Characteristics

Single-use, one-piece delivery system. Materials are biocompatible and commonly used in medical devices. Includes pre-tied size 0 polyester suture loop. Features a lumen for aspiration/flushing, guide cannula, dilator, and surgical blade. Mechanical operation; no energy source or software.

Indications for Use

Indicated for surgical applications requiring soft tissue approximation 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 Loop Applicator, SentreHEART (K060721)
• Endosuture System, Ethicon Endo-Surgery (K963329)
• Saph-Loop Ligating Loop, Genzyme (K022410)
• Surgietie Ligating Loop US Surgical (K905379)

Submission Summary (Full Text)

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K090385

### SECTION 4 - 510(K) SUMMARY

MAY - 6 2009

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) number:

Date Prepared: February 2009

Applicant Information: SentreHEART 2468 Embarcadero Way Palo Alto, CA 94303

#### Contact Person:

Linda Guthrie, Manager Regulatory Affairs Phone Number: [phone] x105 Fax Number: [phone]

Device Information:

| Trade Name: | LARIAT II Suture Delivery Device |
|------------------|----------------------------------|
| Classification: | Class II per 21CFR 878.5000 |
| Regulation Name: | Suture, Nonabsorbable, Synthetic |
| Product Code: | GAT |

#### Physical Description:

The LARIAT II 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 the device. A lumen within the LARIAT II is designed for aspiration, flushing during the delivery, capture or release of the LARIAT II Suture.

The LARIAT II is packaged with a guide cannula and a dilator which may be used for guidance and placement of the LARIAT II, and a surgical blade which is used for cutting excess suture.

The suture is itself a cleared medical device as a part of Pre-Market Notification K021019.

#### Intended Use:

The LARIAT II 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.

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## SECTION 4 - 510(k) SUMMARY

#### Predicate Devices:

Lariat Loop Applicator, SentreHEART (K060721) Endosuture System, Ethicon Endo-Surgery (K963329) Saph-Loop Ligating Loop, Genzyme (K022410) Surgietie Ligating Loop US Surgical (K905379)

#### Safety and Performance:

#### Performance

Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the LARIAT II is safe and effective for its intended use.

#### Biocompatibility

The materials used in the LARIAT II are commonly used materials in other medical devices. Results of testing demonstrate the LARIAT II is biocompatible.

#### Summary:

Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to be safe and effective for its intended use and substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of several curved lines.

Public Health Service

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SentreHeart, Inc. % Ms. Linda Guthrie Manager, Regulatory Affairs 2468 Embarcadero Way Palo Alto, California 94303

Re: K090385

Trade/Device Name: LARIAT II Suture Deliver Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, HCF Dated: February 12, 2009 Received: February 17, 2009

Dear Ms. Guthrie:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at

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Page 2 - Ms. Linda Guthrie

[phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R. Oyler

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): KO 90385

Device Name: LARIAT II Suture Delivery Device

Indications for Use:

The LARIAT II 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.

Prescription Use (Part 21 CFR 801 Subpart D)

- -

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

> Concurrence of CDRH, C ffice of Device Evaluation (ODE)

Daniel Kane for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090365