(146 days)
Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.
The Hepatostat Set® is an absorbable compression device which allows to perform any type of hepatic resection, large or small, without any significant bleeding. It is made of four pre-perforated absorbable strips. These strips are connected together by twenty Safil® polyfilament ligatures introduced through the liver by a special tubular needle holder. Each suture is terminated by a stainless steel dart and already inserted into a stainless steel tubular needle holder, fitted to the liver thickness. Two clamps enable to bring together two strips.
The provided text describes a 510(k) premarket notification for the "Hepatostat" device, which is an absorbable compression system. The submission expands the intended use of a previously cleared device (K061796).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide specific quantitative acceptance criteria (e.g., success rates, hemostasis time limits) or detailed reported device performance metrics from a clinical study in a table format.
The closest statement to device performance is:
- "Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use."
This is a general statement of equivalence and safety/efficacy rather than specific metrics against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only mentions "Animal testing has been conducted to demonstrate the safety and efficacy for use in splenic and nephric resection." It does not provide the number of animals or specific cases.
- Data Provenance: Animal testing. The country of origin is not specified, but the applicant is Vygon Corporation in the USA. The testing would be considered prospective as it was conducted to support the expanded indication.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The ground truth was established through animal testing, which would involve direct observation of hemostasis and tissue response, likely by veterinary surgeons or animal researchers, rather than human expert interpretation of images or clinical outcomes in humans.
4. Adjudication Method for the Test Set:
- Not applicable. As the ground truth was established through direct observation in animal studies, an adjudication method for human expert review is not relevant.
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:
- No, an MRMC comparative effectiveness study was not done. The device described is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, questions regarding human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was not done. As stated above, this is a physical surgical device, not an algorithm.
7. The Type of Ground Truth Used:
- The ground truth used was direct observation of hemostasis and tissue response in animal studies. This is a form of outcomes data in an animal model.
8. The Sample Size for the Training Set:
- Not applicable. The document describes animal testing done for performance demonstration to support regulatory submission, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no machine learning model training is described.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria, as described in the document, is animal testing.
- Purpose: To demonstrate the safety and efficacy of the Hepatostat for use in splenic and nephric resection.
- Methodology (implied): Direct surgical application of the Hepatostat device in animals undergoing splenic and nephric resections. Observation of hemostasis achievement and potentially post-operative recovery and tissue resorption.
- Results (stated generally): "Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use..."
The document suggests that the acceptance criterion for this animal testing was simply to demonstrate safety and efficacy and substantial equivalence to the previously cleared Hepatostat (K061796) for the expanded indications. Specific quantitative acceptance criteria or detailed results of the animal study are not provided in this 510(k) summary.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.