(77 days)
The LARIAT Loop Applicator 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 LARIAT Loop Applicator is a one piece, single-use suture delivery and deployment device with a pre-tied polyester suture loop that is pre-loaded on the device. A central lumen within the LARIAT Loop Applicator is designed for aspiration and stabilization of tissue during the delivery of the LARIAT Suture Loop.
The provided 510(k) notification describes a medical device, the LARIAT Loop Applicator, and its intended use. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets particular acceptance criteria in the manner typically associated with studies for AI/ML devices or diagnostic tools.
Instead, this 510(k) focuses on demonstrating substantial equivalence to predicate devices, primarily through in-vitro testing and assessment of biocompatibility. The information provided is characteristic of a medical device submission that relies on established safety and effectiveness profiles of already cleared devices and materials.
Given this, I cannot fully complete all sections of your request as they are not explicitly addressed in the provided text. I will fill in what is available and indicate where information is missing.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective for Intended Use | "Results of in-vitro testing demonstrate that the LARIAT Loop Applicator is safe and effective for its intended use." (Based on comparison to predicate devices and material biocompatibility.) |
| Biocompatible | "Biocompatibility testing determined the LARIAT Loop Applicator components and materials to be biocompatible. The materials are used in the identified predicates and are also commonly used in other medical devices." |
| Substantial Equivalence to Predicate Devices (Ethicon Endosuture System K963329, Genzyme Saph-Loop Ligating Lopic K022410, HysteRx Liga-Loop Suture Applicator K993695) | "Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for in-vitro testing.
- Data Provenance: Not specified, but generally, in-vitro testing for 510(k) submissions would be conducted in a controlled lab setting, likely within the US where the applicant is located.
- Retrospective/Prospective: Neither. The testing mentioned is in-vitro performance and biocompatibility testing, not clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a surgical applicator, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for its performance would be its mechanical functionality (e.g., suture delivery, knot tying) and material safety, evaluated through engineering and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is relevant for studies involving human interpretation or clinical endpoints, not for the in-vitro performance and biocompatibility testing described.
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-assisted diagnostic or interpretive system. Therefore, MRMC studies and AI improvement effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical surgical applicator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this device involves:
- Engineering specifications and functional requirements for safe suture delivery and deployment.
- Biocompatibility standards and established safety profiles for the materials used and similar predicate devices.
- The effectiveness of the predicate devices in their intended uses.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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Ko6072/
510(k) Notification
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510(k) Summary
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. Date Prepared: March 10, 2006
510(k) number:
Applicant Information:
SentreHeart 2468 Embarcadero Way Palo Alto, CA 94303
Contact Person
| Russell Seiber | |
|---|---|
| Phone Number: | (650) 354-1200 |
| Fax Number: | (650) 354-1204 |
Device Information:
| Trade Name: | LARIAT Loop Applicator |
|---|---|
| Classification: | Class II |
| Classification Name: | Suture, Non-absorbable, Synthetic |
Physical Description:
The LARIAT Loop Applicator is a one piece, single-use suture delivery and deployment device with a pre-tied polyester suture loop that is pre-loaded on the device. A central lumen within the LARIAT Loop Applicator is designed for aspiration and stabilization of tissue during the delivery of the LARIAT Suture Loop.
The suture is itself a cleared medical device as a part of Pre-Market Notification K021019.
Intended Use:
The LARIAT Loop Applicator 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.
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the Ethicon Endosuture System (K963329), the Genzyme Saph-Loop Ligating Lopic (K022410), and the HysteRx Liga-Loop Suture Applicator (K993695),
Test Results:
Performance
Results of in-vitro testing demonstrate that the LARIAT Loop Applicator is safe and effective for its intended use.
SentreHeart
JUN - 2 2006
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Biocompatibility
Bloompatibling biocompatible. The materials are used in the identified predicates and are also commonly used in other medical devices.
Summary:
Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
SentreHeart
CONFIDENTIAL
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized lines representing the wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the emblem. The emblem is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
SentreHeart™ % Mr. Robert Chin Regulatory Consultant 2468 Embarcadero Way Palo Alto, California 94303
Re: K060721
Trade/Device Name: LARIAT Loop Applicator Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulation Class: II Product Code: GAT Dated: May 24, 2006 Received: May 25, 2006
Dear Mr. Chin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Mr. Robert Chin
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address .http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hubert Lenoir us
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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LARIAT Loop Applicator
| 510(k) Number (if known): | K060721 |
|---|---|
| Indications for Use |
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The LARIAT Loop Applicator 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 V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K060721 |
|---|---|
| --------------- | --------- |
SentreHeart
CONFIDENTIAL
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Page 9
§ 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.