(78 days)
NOT APPLICABLE
No
The device description and intended use focus on mechanical suture delivery and knot tying, with no mention of AI/ML capabilities or related performance metrics.
No
The device is described as a suture delivery and deployment device for soft tissue approximation and ligation, which is a surgical tool rather than a therapeutic device designed to treat a medical condition.
No
The device is a suture delivery and deployment device, used for approximating and/or ligating soft tissue with a pre-tied suture during surgical applications. It does not gather information about the patient's health or condition, which is the primary function of a diagnostic device.
No
The device description clearly outlines physical components like a suture delivery device, suture loop, guide cannula, dilator, and surgical blade, indicating it is a hardware-based medical device.
Based on the provided information, the LARIAT II Suture Delivery Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "facilitat[ing] suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated". This describes a surgical tool used directly on a patient's tissue during a procedure.
- Device Description: The description details a device for delivering and deploying a suture, along with accessories for guidance and cutting. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health, diagnosis, or condition. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
- Anatomical Site: The anatomical site is "soft tissue," which is where the surgical procedure is performed, not a sample being analyzed.
- Intended User/Care Setting: The intended user is in "surgical applications," further reinforcing its use in a surgical setting on a patient.
In summary, the LARIAT II is a surgical device used for performing a procedure on a patient's tissue, not for analyzing samples to provide diagnostic information.
N/A
Intended Use / 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.
Product codes
GAT, HCF
Device 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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060721, K963329, K022410, K905379
Reference Device(s)
Not Found
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
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: (650) 354-1200 x105 Fax Number: (650) 354-1204
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.
1
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.
2
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
3
Page 2 - Ms. Linda Guthrie
(240) 276-0115. 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 (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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