(88 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
(a)
Identification. A nonabsorbable expandable hemostatic sponge for temporary internal use is a prescription device intended to be placed temporarily into junctional, non-compressible wounds, which are not amenable to tourniquet use, to control bleeding until surgical care is acquired. The sponges expand upon contact with blood to fill the wound cavity and provide a physical barrier and pressure that facilitates formation of a clot. The device consists of sterile, nonabsorbable radiopaque compressed sponges and may include an applicator to facilitate delivery into a wound.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate the biocompatibility of patient-contacting components.
(2) Performance data must demonstrate the sterility of patient-contacting components including endotoxin and pyrogenicity assessments.
(3) Performance data must support device stability by demonstrating continued sterility of the patient-contacting components of the device, package integrity, and device functionality over the requested shelf life.
(4) Assessment of material characteristics must be sufficient to support safety under anticipated conditions of use. Assessments must include the following:
(i) Material specifications.
(ii) Immunogenicity.
(iii) Viral inactivation for animal-derived materials.
(5) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Absorption capacity.
(ii) Extent of swelling.
(iii) Mechanical properties.
(iv) Expansion force/pressure.
(v) Radiopacity.
(vi) Deployment/applicator functionality.
(6) In vivo performance data must demonstrate safe and effective use by verifying that the device performs as intended under anticipated conditions of use. Appropriate analysis/testing must demonstrate that the product: Controls bleeding, does not promote adverse local or systemic effects, and can be completely removed from the wound. The following performance characteristics must be tested:
(i) Deployment.
(ii) Control of bleeding.
(iii) Radiopacity.
(iv) Retrieval.
(v) Assessment of local and systemic effects.
(7) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by emergency responders deploying the device as well as surgeons retrieving the device from wounds.
(8) Labeling must include:
(i) Specific instructions for deployment by emergency responders and retrieval by surgeons.
(ii) Warnings, cautions, and limitations needed for safe use of the device.
(iii) Information on how the device operates and the typical course of treatment.
(iv) A detailed summary of the in vivo and human factors testing pertinent to use of the device.
(v) Appropriate imaging information to ensure complete retrieval of device.
(vi) An expiration date/shelf life.