(84 days)
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.
| Acceptance Criteria Category | Reported Device Performance (XSTAT 30 vs. XSTAT predicate) |
|---|---|
| Intended Use | Same |
| Technological Characteristics | Identical (Mini-sponges, Applicator, Casualty Card, Packaging) |
| Dimensions | Identical |
| Weight | Identical |
| Safety Features | Identical (Radiopaque marker) |
| Biocompatibility | Identical testing performed and passed (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Hemocompatibility per ISO 10993 standards) |
| Sterilization | Identical (Gamma radiation sterilization) |
| Indications for Use (Key difference) | XSTAT 30 expands to include "patients at high risk for immediate life-threatening, 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." (Predicate was more restricted to battlefield only for user population). |
| User Population (Key difference) | Civilian and battlefield patients (Predicate was battlefield patients only) |
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.
§ 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.