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XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from, immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in the thorax, the pleural cavity, the mediastinum, the abdomen, the retroperitoneal space, the sacral space, tissues above the inguinal ligament; or tissues above the clavicle.

XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 12 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament, or tissues above the clavicle.

The XSTAT 30 device consists of an applicator that facilitates delivery of minisponges to external bleeding wounds. The applicator with a telescoping handle is filled with ~ 92 minisponges and packaged in a vacuum-sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°. The XSTAT 30 3-pack consists of three (3) applicators in an individually sealed foil pouch and terminally sterilized by gamma radiation. The Instructions for Use ("FU") are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging. The XSTAT 30 1-pack consists of one (1) applicator in an individually sealed foil pouch and terminally sterilized by gamma irradiation. The Instructions for Use (IFU) are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging.

The XSTAT 12 device consists of an applicator and plunger that facilitate delivery of minisponges to external bleeding wounds. Individual applicators are filled with minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, and terminally sterilized by gamma radiation to a sterility assurance level of 10 °. The XSTAT 12 device consists of vacuum-sealed, gamma radiated, inner pouches which are packaged inside a larger outer pouch as a three (3) pack or one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch.

The XSTAT devices comprise standard, regenerated cellulose medical sponge that is compressed and formed into minisponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The minisponges absorb blood upon contact, and within approximately 20 seconds expand to their pre-compressed height of 40-50 mm. Each minisponge contains a radiopaque marker for easy detection via X-ray.

This document is a 510(k) summary for medical devices (XSTAT 30 and XSTAT 12), primarily focusing on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria for an AI/ML algorithm. Therefore, many of the requested details about acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not present in this document.

However, I can extract the information relevant to the device's performance and the studies conducted to support its safety and effectiveness, interpreting them in the context of device approval rather than AI/ML model validation.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance metrics for the XSTAT devices in the way one would for an AI/ML algorithm. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices. This means the new devices (XSTAT 30 and XSTAT 12) must be shown to be as safe and effective as previously cleared devices.

The reported "performance" is qualitative, asserting that based on the conducted studies, the devices meet the bar for substantial equivalence.

Qualitative Performance Claims based on Studies:

• Hemostatic Efficacy: Demonstrated effectiveness in controlling severe, life-threatening bleeding.
• Radiopacity: Minisponges contain a radiopaque marker for easy detection via X-ray (a critical safety feature).
• Expansion Properties: Minisponges absorb blood and expand rapidly (within ~20 seconds) to fill the wound.
• Sterility: Terminally sterilized by gamma radiation to a sterility assurance level of 10⁻⁶.
• Biocompatibility: Demonstrated per ISO 10993.
• Mechanical Integrity (Applicator): Shown to be identical to predicate devices and thus assumed to perform similarly.
• Safety/Effectiveness: Overall claim that the devices are "as safe and effective" as predicate devices.

Summary of Studies and Data Provenance:

The document describes the following types of studies:

1. Bench Testing:

   • Applicator: Mechanical testing was not repeated because the applicators are identical to the predicate devices (K152624 for XSTAT 30, K161020 for XSTAT 12).
   • Minisponges: Performed to verify properties like:
     • Radiopacity and Radiopaque Marker Durability
     • Immunogenicity
     • Absorption Capacity
     • Extent of Swelling
     • Expansion Force/Pressure
   • Data Provenance: Not explicitly stated, but typically these are internal lab tests conducted by the manufacturer.

2. Biocompatibility Testing:

   • Conducted: Per ISO 10993 for the minisponges. Applicator biocompatibility was also demonstrated via predicate device clearance.
   • Data Provenance: Not explicitly stated, but likely conducted by the manufacturer or a contract research organization.

3. Animal Study:

   • Type of Study: GLP (Good Laboratory Practice) animal studies.
   • Purpose: To demonstrate safety and effectiveness, specifically for the hemostatic function.
   • Applicability: The animal testing of the minisponges using the XSTAT 30 applicator was considered "fully applicable" to the XSTAT 12 device because they use the same minisponges.
   • Data Provenance: Not explicitly stated, but usually conducted in a controlled laboratory setting (e.g., animal research facility).

This document is a regulatory submission for a medical device (hemostatic sponges), not an AI/ML algorithm. Therefore, the following sections are not applicable to the provided text.

2. Sample Size used for the test set and the data provenance: Not applicable. The studies are described in terms of "bench tests," "biocompatibility testing," and an "animal study," not AI/ML test sets. There are no explicit sample sizes provided for these tests, other than the general statement that they were conducted. Data provenance is implied to be from the manufacturer's internal testing or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of human experts establishing ground truth for a test set, as this is not an AI/ML study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is mentioned, as this is not an AI/ML study.

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 is not an AI/ML device; therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through direct physical and biological testing:

   • Bench Testing: Engineering specifications, material science properties, physical measurements (e.g., expansion time, absorption).
   • Biocompatibility Testing: ISO standards for biological safety.
   • Animal Study: Direct observation of hemostatic efficacy in a live animal model (a form of "outcomes data" in a pre-clinical setting).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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Intended Use:

The XSTAT 30 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

Indications for Use:

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.

XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non- compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.

The XSTAT 30 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 92 mini-sponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The compressed regenerated cellulose sponge is coated with chitosan. Upon contact with blood, the mini-sponges absorb blood and, if unencumbered, are capable of expanding to a pre-compressed height of 40-50 mm within approximately 20 seconds. A radiopaque marker is embedded into a circular surface of the mini-sponges to render each sponge detectable via X-ray. The XSTAT 30 dressing includes an applicator that facilitates delivery of the mini-sponges to external bleeding wounds. Three applicators filled with the XSTAT 30 dressing (i.e., mini-sponges) are packaged in a sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°.

For the treatment of severe bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT 30 sponges are applied to the wound using the applicator. Once applied to the wound, the XSTAT 30 sponges absorb blood and expand, thereby packing the wound. All mini-sponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the mini-sponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every mini-sponge has been removed.

The provided document is a 510(k) summary for the XSTAT 30 device and does not contain detailed information about a study with acceptance criteria and reported device performance in the way typically found for AI/ML device evaluations. This document declares substantial equivalence to a predicate device (XSTAT, K130218) primarily based on identical technological characteristics and similar intended use, with a change to indications for use to include the civilian population.

Therefore, many of the requested points, particularly those related to a direct study proving device performance against acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies, are not present in this regulatory submission.

However, I can extract the relevant information regarding performance data and substantial equivalence as described in the document.

1. A table of acceptance criteria and the reported device performance

The document states: "The technological characteristics for XSTAT 30 are identical to the predicate device. Thus, the performance testing of the XSTAT 30 has been demonstrated by the clearance of the XSTAT predicate device. The testing provided in the cleared XSTAT notification (K130218) is incorporated herein by reference."

This means that the device (XSTAT 30) is considered to meet acceptance criteria by demonstrating substantial equivalence to its predicate device (XSTAT). The performance criteria mentioned relate to the inherent properties and safety of the device rather than a measurable diagnostic accuracy outcome.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it references performance testing from the predicate device (K130218) and does not detail a new clinical study. The performance testing mentioned refers to bench and biocompatibility tests.

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)

This information is not applicable/provided. The performance evaluation is based on device characteristics and biocompatibility, not expert-adjudicated diagnostic results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided.

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

This information is not applicable/provided. The device is a hemostatic sponge, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the biocompatibility and material properties, the "ground truth" would be established by the results of standardized tests (e.g., ISO 10993 series) showing lack of toxicity, irritation, etc. For the expansion capabilities, the ground truth would be direct measurement of expansion time and volume. This is not "ground truth" in the diagnostic sense.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device's evaluation.

9. How the ground truth for the training set was established

This information is not applicable/provided.

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