(107 days)
Intended Use:
The XSTAT-12 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-12 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-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 for immediate life-threatening 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-12 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inquinal ligament; or tissues above the clavicle.
The XSTAT-12 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 38 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. The minisponges expand only in length, not radially. Each minisponge absorbs approximately 3 mL of blood. Each minisponge contains a radiopaque marker for easy detection via X-ray. The XSTAT-12 dressing includes an applicator and plunger that facilitate delivery of the minisponges to external bleeding wounds. Individual applicators are filled with the STAT-12 minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, terminally sterilized by gamma radiation to a sterility assurance level of 10°. The inner pouches are then packaged inside a larger outer pouch, along with one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch.
For the treatment of severe. life-threatening bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT-12 sponges are applied to the applicator. Once applied to the wound, the XSTAT-12 sponges absorb blood and expand, thereby packing the wound. All minisponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the minisponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every minisponge has been removed.
The acceptance criteria and study proving the device meets them are summarized below.
1. Table of Acceptance Criteria & Reported Device Performance:
| Category | Acceptance Criteria (from predicate K152624 & DEN130016/K130218, 21 CFR 878.4452) | XSTAT-12 Reported Performance (via reference to predicate) |
|---|---|---|
| Mechanical Testing | Specific mechanical criteria for deployment force, plunger axial force, tip tensile strength, fluid immersion, and wound volume for the applicator (not explicitly detailed in provided text, but implied as standards met by predicate). | Applicator: Demonstrated safety and efficacy through Deployment Force Testing, Plunger Axial Force Testing, Tip Tensile Strength Testing, Fluid Immersion Testing, and Wound Volume Testing. |
| Minisponges: Demonstrated through predicate (K152624) for radiopacity, immunogenicity, absorption capacity, extent of swelling, expansion force/pressure, and viral inactivation. | ||
| Biocompatibility | Biocompatibility in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1 for external communicating, limited duration (≤ 24 hour) devices with potential for tissue/bone contact and indirect blood contact (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility). | Applicator: Demonstrated biocompatibility per ISO 10993 for external communicating, limited duration (≤ 24 hour), blood-contacting devices through Cytotoxicity, Sensitization, Irritation, System Toxicity, and Hemocompatibility tests. |
| Minisponges: Demonstrated through predicate (K152624) via ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Hemocompatibility). | ||
| Animal Study | Performance in animal studies for hemostatic efficacy (exact criteria not detailed, but demonstrated by predicate). | Demonstrated through predicate (K152624) for hemostatic efficacy. |
| Sterilization | Gamma radiation to a sterility assurance level of 10⁻⁶. | Gamma radiation to a sterility assurance level of 10⁻⁶. |
| Safety Features | Radiopaque marker for easy detection via X-ray. | Each minisponge contains a radiopaque marker for easy detection via X-ray. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the "test set" for the XSTAT-12 device. Instead, it relies heavily on equivalence to a previously cleared predicate device (XSTAT 30, K152624, and reference device DEN130016/K130218).
- Mechanical Testing: Performed on the XSTAT-12 applicator in expected use scenarios and extreme temperature conditions. No specific sample counts for each test are provided.
- Biocompatibility Testing: The battery of tests for the XSTAT-12 applicator included Cytotoxicity, Sensitization, Irritation, System Toxicity, and Hemocompatibility. Specific sample sizes for these tests are not provided.
- Minisponges & Animal Study: The XSTAT-12 minisponges are stated to be identical to the predicate device. Therefore, the testing and data provenance for these aspects are implicitly derived from the predicate's clearance. The original provenance for the predicate data is not detailed in this document.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The studies mentioned (mechanical, biocompatibility) appear to be conducted specifically for this device and its predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not provided in the document. The studies primarily involve mechanical and biological testing, rather than human expert interpretation of medical images or conditions for establishing ground truth.
4. Adjudication Method:
This information is not provided. As the studies are primarily about device performance in mechanical and biological contexts, an adjudication method for human interpretation is not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through engineering, mechanical, and biological performance data. There is no mention of human readers, AI assistance, or comparative effectiveness with or without AI.
6. Standalone (Algorithm Only) Performance:
Not applicable. The XSTAT-12 is a physical medical device (hemostatic sponges and applicator), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance is established through:
- Mechanical performance standards: Demonstrating the applicator functions as intended under various conditions.
- Biocompatibility standards: Proving the materials are safe for biological contact.
- Material properties: Verifying the minisponges (identical to predicate) meet specifications for radiopacity, absorption, expansion, etc.
- Animal study results: (from predicate) demonstrating hemostatic efficacy.
This is primarily empirical evidence against pre-defined physical and biological criteria, rather than expert consensus, pathology, or outcomes data in the typical sense of AI/imaging studies.
8. Sample Size for the Training Set:
Not applicable. This device is hardware (sponges and applicator), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As the device is not an AI algorithm, there is no training set or ground truth in that context.
§ 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.