(30 days)
None
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device facilitates suture placement and knot tying for approximating and ligating soft tissue with a pre-tied polyester suture, which is a surgical tool rather than a therapeutic treatment in itself.
No
The device is described as a "suture delivery and deployment device" used for "suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated." It facilitates a surgical procedure rather than diagnosing a condition.
No
The device description clearly outlines a physical, single-use suture delivery and deployment device with a pre-tied suture loop, snare, and accessory lumen, indicating it is a hardware device.
Based on the provided information, the LARIAT® RS Suture Delivery Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture." This describes a surgical procedure performed on the body, not a test performed outside the body on biological samples.
- Device Description: The description details a device for delivering and tying sutures within the body. It mentions features like a snare, suture loop, accessory lumen for aspiration/flushing/guide wire, and compatibility with access sites. These are all characteristics of a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
In summary, the LARIAT® RS Suture Delivery Device is a surgical tool used for soft tissue approximation and ligation, which falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LARIAT® RS 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 codes
GAT, HCF
Device Description
The LARIAT® RS 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 RS device is designed for aspiration. flushing or to accommodate a guide wire of up to 0.035" diameter. The LARIAT RS device offers the additional feature of allowing the user to release the Delivery Snare from the tissue during device removal from the target location following suture deployment. The LARIAT RS 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary bench testing was conducted on the LARIAT RS device to support a determination of substantial equivalence to the predicate device.
The bench testing included the following:
- Visual and Dimensional Verification
- Snare Loop Actuation and Force Testing
- Ability to Perfuse and Aspirate Testing
- Suture Preparation and Deployment Testing
- Snare Loop Lock Testing
- Suture Recoil Testing
- Suture Tensile Strength Testing
- Snare Wire Joint Strength Testing
- Shaft to Handle Joint Strength Testing
- Catheter Tip to Shaft Joint Strength Testing
- Snare Anchor Joint Strength Testing
- Hypotube to Shaft Joint Strength Testing
- Suture Knot Strength Testing
- Suture/Suture Fob Joint Strength Testing
The above testing confirms that the LARIAT RS device performs according to the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
SentreHEART, Inc. Kit Cariquitan V.P. of Clinical and Regulatory Affairs 300 Saginaw Drive Redwood City, California 94063
Re: K153096
Trade/Device Name: LARIAT RS 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: October 16, 2015 Received: October 26, 2015
Dear Kit 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
1
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
2
Indications for Use
510(k) Number (if known) K153096
Device Name
LARIAT® RS Suture Delivery Device
Indications for Use (Describe)
The LARIAT® RS 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) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
GENERAL INFORMATION
Submitter:
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: October 16, 2015
Classification:
Class II, 21 CFR§870.5000
Product Code:
GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) HCF (Instrument, Ligature Passing And Knot Tying)
Trade Name:
LARIAT® RS Suture Delivery Device
Generic/Common Name:
Nonabsorbable (ethylene terephthalate) surgical suture Instrument, Ligature Passing And Knot Tying
Predicate Device:
LARIAT III Suture Delivery Device, SentreHEART (K142241)
This predicate has not been subject to a design-related recall.
4
510(k) SUMMARY (CONT.)
No reference devices were used in this submission.
Indications for Use:
The LARIAT® RS 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.
The Indications for Use statement for the LARIAT RS Suture Delivery Device is identical to the predicate device.
Product Description:
The LARIAT® RS 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 RS device is designed for aspiration. flushing or to accommodate a guide wire of up to 0.035" diameter. The LARIAT RS device offers the additional feature of allowing the user to release the Delivery Snare from the tissue during device removal from the target location following suture deployment. The LARIAT RS 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) is for the LARIAT RS device, which is a modified version of the cleared LARIAT III device (K142241), which is currently marketed as the LARIAT+ device. The LARIAT III device's catheter handle has been modified to allow the user to release the Delivery Snare following suture deployment. In order to release the Delivery Snare, the catheter handle now has a Snare Release Actuator, which allows the fixed end of the Delivery Snare to be released from the tip. The Delivery Snare size remains unchanged from the predicate device at 45mm. The LARIAT RS device and the cleared and commercially available LARIAT III device are both single-use suture delivery and deployment devices. The minor design modifications outlined in this Special 510(k) do not (1) affect the intended use or (2) alter the fundamental scientific technology of the device. Any differences between the devices do not raise any new issues of safety or effectiveness. Thus, the LARIAT RS device is substantially equivalent to the predicate device.
Testing in Support of Substantial Equivalence Determination:
All necessary bench testing was conducted on the LARIAT RS device to support a determination of substantial equivalence to the predicate device.
5
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 Testing |
| • | 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 confirms that the LARIAT RS device performs according to the stated intended use.
Summary:
The LARIAT RS device is substantially equivalent to the predicate device.